What is Haegarda?

Haegarda is a man-made form of a protein in blood that helps control swelling in the body. People with a condition called Hereditary Angioedema (HAE) do not have enough of this protein. Hereditary Angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Haegarda is an injectable medicine used to prevent swelling and/or painful attacks in patients 6 years of age and older with Hereditary Angioedema.

Haegarda should not be used to treat an acute HAE attack. In case of an acute HAE attack, initiate individualized treatment as discussed with your health care professional.

Warnings

You should not use Haegarda if you have experienced life-threatening immediate hypersensitivity reactions (allergic reactions), including anaphylaxis, to the product.

Before taking this medicine

You should not use Haegarda if have ever had a life-threatening allergic reaction to c1 esterase inhibitor.

To make sure Haegarda is safe for you, tell your doctor if you have:

• a stroke or blood clot;
• heart problems; or
• an “in-dwelling” catheter.

Tell your doctor if you are pregnant or breast-feeding.

Haegarda is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

How should I use Haegarda?

Use Haegarda exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Haegarda is injected under the skin. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Prepare an injection only when you are ready to give it. Ask your doctor or pharmacist if you don’t understand all instructions.

Storing unopened vials: Store in a refrigerator or at cool room temperature and use until expiration date. Protect from light and do not freeze.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

After mixing Haegarda, use the injection right away or store at room temperature and use within 8 hours.

Haegarda contains no preservative. Once you have pierced the rubber top of a vial with a needle, you must use that vial right away or throw it away.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Usual Adult Dose for Hereditary Angioedema:

Haegarda is intended for self-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer the subcutaneous injection.

Use: routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks 

Usual Pediatric Dose for Hereditary Angioedema:

Haegarda is intended for self-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer the subcutaneous injection.

Use: routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Haegarda.

Keep Haegarda on hand at all times to prevent angioedema, especially while traveling.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid after using Haegarda?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Haegarda side effects

Get emergency medical help if you have signs of an allergic reaction to Haegarda: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficult breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden numbness or weakness on one side of the body;
• pain, swelling, warmth, or redness in an arm or leg;
• sudden severe headache, confusion, problems with vision, speech, or balance;
• chest pain while taking deep breaths; or
• fast heart rate.

Common Haegarda side effects may include:

• unusual or unpleasant taste in your mouth;
• headache, dizziness;
• nausea, vomiting;
• pain, bruising, itching, swelling, bleeding, warmth, or a hard lump where the medicine was injected;
• stuffy nose, sore throat;
• rash; or
• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Haegarda?

Tell your doctor about all your other medicines, especially:

• testosterone; or
• birth control pills.

What is Haldol?

Haldol is an antipsychotic medicine that is used to treat schizophrenia.

Haldol is also used to control motor and speech tics in people with Tourette’s syndrome.

Haldol may also be used for purposes not listed in this medication guide.

Haldol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of haloperidol can cause a serious movement disorder that may not be reversible. The longer you use Haldol, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Haldol may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• muscle spasms in your neck, tightness in your throat, trouble swallowing;
• rapid changes in mood or behavior;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• cough with mucus, chest pain, feeling short of breath;
• low white blood cell counts–fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of Haldol may include:

• drowsiness;
• headache;
• dizziness, spinning sensation;
• uncontrolled muscle movements;
• feeling restless or anxious;
• sleep problems (insomnia); or
• breast enlargement, irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Haldol is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

You should not use Haldol if you are allergic to it, or if you have:

• Parkinson’s disease; or
• certain conditions that affect your central nervous system (such as severe drowsiness, or slowed thinking caused by taking other medicines or drinking alcohol).

Haldol may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems, angina (chest pain);
• long QT syndrome (in you or a family member);
• low blood pressure;
• a seizure;
• a thyroid disorder;
• breast cancer; or
• an electrolyte imbalance (such as low blood levels of potassium or magnesium).

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. If you get pregnant, tell your doctor right away. Do not stop the medicine without your doctor’s advice.

Ask a doctor if it is safe to breastfeed while using Haldol.

How should I take Haldol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Taking too much Haldol can cause a serious heart rhythm disorder or sudden death. Never take more than your prescribed dose.

Measure liquid medicine with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Your symptoms may not improve for several weeks.

You may have withdrawal symptoms if you stop using Haldol suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture, heat, and light. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of Haldol can be fatal.

What should I avoid while taking haloperidol?

Drinking alcohol with Haldol can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

What other drugs will affect Haldol?

Haldol can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Haldol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• lithium;
• rifampin;
• medicine to treat Parkinson’s disease;
• seizure medicine; or
• a blood thinner–warfarin, Coumadin, Jantoven.

What is halobetasol topical?

Halobetasol topical is a super high potency, Class I corticosteroid product that is applied to the skin to reduce inflammation and itching caused by plaque psoriasis or other skin conditions that respond to corticosteroid medication.

Halobetasol topical is available as a cream, ointment, lotion, or foam:

• Halobetasol propionate 0.05% foam: Lexette foam           
• Halobetasol propionate 0.05% cream/ointment/lotion: Ultravate cream/ointment/lotion
• Halobetasol propionate 0.01% lotion: Bryhali lotion

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Halobetasol (halobetasol propionate) is a highly potent, Class I corticosteroid that can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 2 weeks and do not exceed the recommended dose. Periodic monitoring for HPA suppression may be required.

Before taking this medicine

You should not use halobetasol topical if you are allergic to it.

Halobetasol topical should not be applied to lesions that are exuding serum or to skin folds (where two areas of skin touch each other).

Tell your doctor if you have ever had:

• any type of skin infection;
• a skin reaction to any steroid medicine;
• liver disease; or
• an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children are more susceptible to systemic absorption of topical corticosteroids. Most preparations of halobetasol topical are not approved for use by anyone younger than 12 years old. Some brands or forms of this medicine are for use only in adults 18 and over.

It is not known whether halobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use halobetasol topical, use a small amount for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use halobetasol topical, use a small amount for the shortest time possible. Do not apply to the breasts.

How do I use halobetasol topical?

Use halobetasol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take it by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or sunburned, windburned, dry, or irritated skin. Rinse with water if halobetasol gets in your eyes or mouth.

Wash your hands before and after using halobetasol, unless you are using this medicine to treat the skin on your hands.

Shake the foam before each use.

• Apply a thin layer of halobetasol topical to the affected area once or twice daily as directed by your doctor. Rub in gently and completely. Do not apply this medicine over a large area of skin unless your doctor has told you to.
• Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.
• Halobetasol is for short-term use only (2 weeks, or up to 8 weeks for psoriasis). Follow your doctor’s dosing instructions very carefully. Do not use more than 50 grams per week.

Call your doctor if your symptoms do not improve after 2 weeks (8 weeks for psoriasis), or if they get worse. Stop using the product if your symptoms improve sooner.

What happens if I miss a dose?

Apply the product as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

High doses or long-term use of halobetasol topical can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using halobetasol topical?

• Avoid applying halobetasol topical to your face, scalp, underarms, or groin area.
• Do not use halobetasol topical to treat any skin condition that has not been checked by your doctor.
• Avoid using other topical steroid medications on the areas you treat with halobetasol unless your doctor tells you to.

What are the side effects of halobetasol topical?

Get emergency medical help if you have signs of an allergic reaction to halobetasol, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• possible signs of absorbing this medicine through your skin – weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Common halobetasol side effects may include:

• burning, stinging, itching, or dryness of treated skin;
• pain where the foam was applied;
• redness or crusting around your hair follicles;
• stretch marks;
• spider veins;
• headache; or
• cold symptoms such as stuffy nose, sneezing, and a sore throat.

What is haloperidol?

Haloperidol is an antipsychotic medicine that is used to treat schizophrenia.

Haloperidol is also used to control motor and speech tics in people with Tourette’s syndrome.

Haloperidol may also be used for purposes not listed in this medication guide.

Haloperidol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of haloperidol can cause a serious movement disorder that may not be reversible. The longer you use haloperidol, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Haloperidol may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• muscle spasms in your neck, tightness in your throat, trouble swallowing;
• rapid changes in mood or behavior;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• cough with mucus, chest pain, feeling short of breath;
• low white blood cell counts–fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of haloperidol may include:

• drowsiness;
• headache;
• dizziness, spinning sensation;
• uncontrolled muscle movements;
• feeling restless or anxious;
• sleep problems (insomnia); or
• breast enlargement, irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Haloperidol is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

You should not use haloperidol if you are allergic to it, or if you have:

• Parkinson’s disease; or
• certain conditions that affect your central nervous system (such as severe drowsiness, or slowed thinking caused by taking other medicines or drinking alcohol).

Haloperidol may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems, angina (chest pain);
• long QT syndrome (in you or a family member);
• low blood pressure;
• a seizure;
• a thyroid disorder;
• breast cancer; or
• an electrolyte imbalance (such as low blood levels of potassium or magnesium).

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. If you get pregnant, tell your doctor right away. Do not stop the medicine without your doctor’s advice.

Ask a doctor if it is safe to breastfeed while using haloperidol.

How should I take haloperidol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Taking too much haloperidol can cause a serious heart rhythm disorder or sudden death. Never take more than your prescribed dose.

Measure liquid medicine with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Your symptoms may not improve for several weeks.

You may have withdrawal symptoms if you stop using haloperidol suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture, heat, and light. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line. An overdose of haloperidol can be fatal.

What should I avoid while taking haloperidol?

Drinking alcohol with haloperidol can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

What other drugs will affect haloperidol?

Haloperidol can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using haloperidol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• lithium;
• rifampin;
• medicine to treat Parkinson’s disease;
• seizure medicine; or
• a blood thinner–warfarin, Coumadin, Jantoven.

What is Harvoni?

Harvoni is used to treat hepatitis C virus (HCV) infections in adults and children aged 3 years and older.

Harvoni’s mechanism of action involves preventing HCV from replicating (making copies of itself) in the body. Harvoni contains 2 antivirals, ledipasavir and sofosbuvir. Each has a different mechanism of action. Ledipasvir blocks the effects of an HCV protein required for HCV replication. Sofosbuvir is converted in the body to its active metabolite which incorporates itself into the RNA of HCV, also preventing HCV replication.  from making copies of itself.

Harvoni gained FDA approval for HCV on October 10, 2014. A Harvoni generic is available as ledipasvir 90 mg and sofosbuvir 400 mg. There is no Harvoni generic for the other strength of Harvoni (ledipasvir 45 mg sofosbuvir 200 mg) or Harvoni oral pellets.

Harvoni uses

Harvoni is used for HCV genotypes 1, 4, 5, or 6 infections without cirrhosis or with compensated cirrhosis.

Harvoni also treats HCV genotype 1 infection with advanced cirrhosis (decompensated) in combination with ribavirin and people with HCV genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis who have had a liver transplant, in combination with ribavirin.

Your doctor will perform tests to find out which hepatitis genotype you have. The treatment duration of Harvoni is usually 12 weeks.

Harvoni cost

Most insurance companies and Medicare cover the cost of Harvoni; however, you may have to meet certain criteria and you should always check with your insurance company first before you and your doctor make it your preferred treatment. There may also be a co-pay.

Harvoni side effects

The most common side effects of Harvoni include:

• tiredness
• headache
• weakness.

Serious side effects and warnings

Harvoni carries a Boxed Warning for the risk of hepatitis B (HBV) reactivation in people coinfected with HCV and HBV. 

Hepatitis B virus (HBV) reactivation. Before starting treatment with Harvoni, your healthcare provider will do blood tests to check for HBV. If you have ever had HBV, the hepatitis B virus could become active again during or after treatment of HCV with Harvoni. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking Harvoni. Call your healthcare provider right away if you develop right-sided upper abdominal pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Slow heart rate (bradycardia). Harvoni may slow your heart rate and cause other symptoms when taken alongside other heart medications such as amiodarone (Cordarone, Nexterone, Pacerone). In some cases, this has led to death or the need for a heart pacemaker. Get medical help right away if you take amiodarone with Harvoni and develop any of the following symptoms fainting or near-fainting, weakness, chest pains, dizziness or lightheadedness, extreme tiredness, confusion, not feeling well, shortness of breath, or memory problems.

Harvoni is used in combination with ribavirin in people with decompensated cirrhosis. Ribavirin can cause birth defects or death in an unborn baby. Do not use ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant. Use effective birth control to prevent pregnancy while using these medicines together and for at least 6 months after treatment ends.

It is unknown if Harvoni is safe and effective in children under 3 years of age.

These are not all the possible side effects of Harvoni. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking

Before taking Harvoni, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had a hepatitis B virus infection
• have liver problems other than hepatitis C infection
• have had a liver transplant
• have kidney problems or you are on dialysis
• have HIV infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Harvoni will harm your unborn baby. Males and females who take Harvoni in combination with ribavirin should also read the Ribavirin Medication Guide for important pregnancy, contraception, and infertility information.

Breastfeeding

It is not known if Harvoni passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Harvoni.

How do I take Harvoni?

Take Harvoni treatment exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to. Do not stop taking Harvoni without first talking with your healthcare provider.

• Take Harvoni tablets or oral pellets by mouth, with or without food.
• You must not miss or skip doses during treatment.
• Harvoni is usually given for 12 weeks.

Harvoni treatment

The usual dosage of Harvoni to treat HCV in adults is Harvoni 90 mg/400 mg, 1 tablet each day.

The usual dosage of Harvoni to treat HCV in children 3 years of age and older is based on body weight.

• Tell your healthcare provider if your child has problems with swallowing tablets.
• If your healthcare provider prescribes Harvoni oral pellets for your child, see below.

How should I give Harvoni oral pellets to my child?

See the Instructions for Use in the Harvoni Package insert for detailed information about giving or taking Harvoni oral pellets if you or your child are prescribed Harvoni treatment. Administer the pellets exactly as instructed by your healthcare provider.

• Do not open the packet until ready to use.
• Hold the Harvoni pellets packet with the cut line on top.
• Shake the pellets packet gently to settle the pellets.
• Tear or cut the packet along the cut line.
• Harvoni oral pellets can be taken with or without food.
• If your healthcare provider has prescribed more than one packet of pellets, take the next packet in the same way.

Taking Harvoni pellets with food 

If Harvoni pellets are taken with food, sprinkle the pellets on one or more spoonfuls of non-acidic soft food at or below room temperature.

• Examples of non-acidic foods include pudding, chocolate syrup, mashed potato, and ice cream.
• Take Harvoni pellets within 30 minutes of gently mixing them with food and swallow the entire contents without chewing to avoid a bitter taste.
• Do not store any leftover Harvoni mixture (oral pellets mixed with food) for use at a later time. Throw away any unused portion.

Taking Harvoni pellets without food

If Harvoni pellets are taken without food, sprinkle the entire contents of the packet directly into the mouth and swallow without chewing to avoid a bitter taste.

• Water may be taken after swallowing the pellets to avoid a bitter taste. Make sure no pellets remain in the packet.

What to avoid

Ask your doctor before using an antacid or stomach acid-reducing medicine with Harvoni. Use only the type and amount your doctor recommends.

Using Harvoni will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes if you have HCV. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drugs or medicine needles is never safe, even for a healthy person.

What happens if I miss a dose?

Do not miss a dose of Harvoni. Missing a dose lowers the amount of medicine in your blood. Refill your Harvoni prescription before you run out of medicine.

If you miss a dose of Harvoni, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

If you take too much Harvoni, call your healthcare provider, call the Poison Help line, or go to the nearest hospital emergency room right away.

What other drugs will affect Harvoni?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• Amiodarone, because coadministration may result in a seriously slow heartbeat ( bradycardia). Amiodarone should not be used with Harvoni
• P-gp inducers and/or moderate to strong CYP inducers (such as rifampin, St. John’s wort, and carbamazepine). May decrease concentrations of Harvoni. Use together is not recommended
• Omeprazole (Prilosec) or an antacid. Do not take them for at least 4 hours after you have taken your dose of Harvoni because these may affect the absorption of Harvoni.

Clearance of HCV with direct-acting antivirals may lead to changes in liver function, which may impact the safe and effective use of other medications. Frequent laboratory monitoring (INR and blood glucose) and dose adjustments may be necessary.

This is not a full list of interactions. Ask your healthcare provider or pharmacist for a list of medicines that interact with Harvoni. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Harvoni with other medicines.

Storage

Store Harvoni tablets or pellets below 86°F (30°C). Keep them in their original container. Do not use:

• Harvoni tablets if the seal over the bottle opening is broken or missing
• Harvoni pellets if the carton tamper-evident seal, or the pellets packet seal, is broken or damaged.

Keep out of the reach of children.

Harvoni ingredients

Active ingredients: ledipasvir and sofosbuvir

Inactive ingredients, Harvoni 90/400 mg: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Tablet film-coating contains FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Inactive ingredients, Harvoni 45/200 mg: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Tablet film-coat contains polyethylene glycol, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.

Inactive ingredients, Harvoni Oral Pellets: amino-methacrylate copolymer, colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Who makes Harvoni?

Gilead Sciences, Inc., makes Harvoni.

• Harvoni tablets 90 mg/ 400 mg and 45 mg/ 200 mg
• Harvoni pellets 45 mg/ 200 mg, 33.75 mg/150 mg.

Asegua Therapeutics LLC., a subsidiary of Gilead Sciences Inc., makes generic Harvoni tablets under the name ledipasvir 90 mg/ sofosbuvir 400 mg.

What is heparin injection?

Heparin is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Heparin is used to treat and prevent blood clots caused by certain medical conditions or medical procedures. It is also used before surgery to reduce the risk of blood clots.

Do not use heparin injection to flush (clean out) an intravenous (IV)  catheter. A separate product is available to use as catheter lock flush. Using the wrong type of heparin to flush a catheter can result in fatal bleeding.

Warnings

Do not use heparin injection to flush (clean out) an intravenous (IV) catheter, or fatal bleeding could result. A separate product is available to use as catheter lock flush.

You should not use heparin if you have uncontrolled bleeding or a severe lack of platelets in your blood. Do not use this medicine if you have ever been diagnosed with “heparin-induced thrombocytopenia,” or low platelets caused by heparin or pentosan polysulfate.

Heparin increases your risk of bleeding, which can be severe or life-threatening. You will need frequent tests to measure your blood-clotting time.

Call your doctor or seek emergency medical attention if you have unusual bleeding or bruising, severe stomach or back pain, unusual tiredness, a nosebleed, blood in your urine or stools, coughing up blood, or any bleeding that will not stop.

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop.

Certain medicines can increase your risk of bleeding while you are using heparin, such as aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) including ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), piroxicam (Feldene), and others. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Do not use heparin injection to flush (clean out) an intravenous (IV) catheter, or fatal bleeding could result. A separate product is available to use as catheter lock flush.

Before taking this medicine

You should not use this medicine if you are allergic to heparin or pork products, or if you have:

• a history of low platelets in your blood caused by using heparin or pentosan polysulfate;
• a severe lack of platelets in your blood; or
• uncontrolled bleeding.

You may not be able to use heparin if you are unable to receive routine blood-clotting tests at the proper intervals during treatment.

To make sure heparin is safe for you, tell your doctor if you have ever had:

• an infection of the lining of your heart (also called bacterial endocarditis);
• severe or uncontrolled high blood pressure;
• a bleeding or blood clotting disorder;
• a stomach or intestinal disorder;
• liver disease;
• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine “INR” or prothrombin time tests; or
• if you are having a menstrual period.

It is not known whether heparin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. You may need to use a form of heparin that does not contain a preservative.

You should not breastfeed while using this medicine.

How should I use heparin injection?

Heparin is injected under the skin or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use the medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not use a prefilled syringe when giving this medicine to a child. The prefilled syringe contains more than a child’s dose of heparin.

Heparin increases your risk of bleeding, which can be severe or life-threatening. You will need frequent tests to measure your blood-clotting time. The timing of these tests is very important in helping your doctor determine whether it is safe for you to continue using this medicine.

If you need surgery, dental work, or a medical procedure, tell the care provider ahead of time that you are using heparin.

Store at room temperature away from moisture and heat.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You may be switched from injectable heparin to an oral (taken by mouth) blood thinner. Do not stop using the injection until your doctor tells you to. You may need to use both the injection and the oral forms for a short time.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include easy bruising, nosebleeds, blood in your urine or stools, black or tarry stools, or any bleeding that will not stop.

What should I avoid while using heparin injection?

Avoid medication errors by using only the form and strength your doctor prescribes.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID). Using an NSAID with heparin may cause you to bruise or bleed easily.

Heparin injection side effects

Get emergency medical help if you have signs of an allergic reaction to heparin: nausea, vomiting, sweating, hives, itching, trouble breathing, swelling of your face, lips, tongue, or throat, or feeling like you might pass out.

Heparin may cause you to bleed more easily, which can be severe or life-threatening. You may also have bleeding on the inside of your body. Seek emergency medical attention if you have:

• skin warmth or discoloration;
• chest pain, irregular heartbeats;
• shortness of breath, dizziness, anxiety, sweating;
• any unusual bleeding or bruising;
• severe pain or swelling in your stomach, lower back, or groin;
• dark or blue-colored skin on your hands or feet;
• nausea, vomiting, loss of appetite;
• unusual tiredness;
• any bleeding that will not stop; or
• nosebleed, blood in your urine or stools, black or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop.

Bleeding may be more likely in older adults, especially women over 60 years of age

Stop using this medicine and call your doctor at once if you have:

• skin changes where the medicine was injected;
• fever, chills, runny nose, or watery eyes;
• easy bruising, unusual bleeding, purple or red spots under your skin; or
• signs of a blood clot – sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common heparin side effects may include:

• unusual bleeding or bruising;
• uncontrolled bleeding;
• allergic reactions; or
• abnormal liver function tests.

What is heparin injection?

Heparin is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Heparin is used to treat and prevent blood clots caused by certain medical conditions or medical procedures. It is also used before surgery to reduce the risk of blood clots.

Do not use heparin injection to flush (clean out) an intravenous (IV) catheter. A separate product is available to use as catheter lock flush. Using the wrong type of heparin to flush a catheter can result in fatal bleeding.

Warnings

Do not use heparin injection to flush (clean out) an intravenous (IV) catheter, or fatal bleeding could result. A separate product is available to use as catheter lock flush.

You should not use heparin if you have uncontrolled bleeding or a severe lack of platelets in your blood. Do not use this medicine if you have ever been diagnosed with “heparin-induced thrombocytopenia,” or low platelets caused by heparin or pentosan polysulfate.

Heparin increases your risk of bleeding, which can be severe or life-threatening. You will need frequent tests to measure your blood-clotting time.

Call your doctor or seek emergency medical attention if you have unusual bleeding or bruising, severe stomach or back pain, unusual tiredness, a nosebleed, blood in your urine or stools, coughing up blood, or any bleeding that will not stop.

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop.

Certain medicines can increase your risk of bleeding while you are using heparin, such as aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) including ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), piroxicam (Feldene), and others. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Do not use heparin injection to flush (clean out) an intravenous (IV) catheter, or fatal bleeding could result. A separate product is available to use as catheter lock flush.

Before taking this medicine

You should not use this medicine if you are allergic to heparin or pork products, or if you have:

• a history of low platelets in your blood caused by using heparin or pentosan polysulfate;
• a severe lack of platelets in your blood; or
• uncontrolled bleeding.

You may not be able to use heparin if you are unable to receive routine blood-clotting tests at the proper intervals during treatment.

To make sure heparin is safe for you, tell your doctor if you have ever had:

• an infection of the lining of your heart (also called bacterial endocarditis);
• severe or uncontrolled high blood pressure;
• a bleeding or blood clotting disorder;
• a stomach or intestinal disorder;
• liver disease;
• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine “INR” or prothrombin time tests; or
• if you are having a menstrual period.

It is not known whether heparin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. You may need to use a form of heparin that does not contain a preservative.

You should not breastfeed while using this medicine.

How should I use heparin injection?

Heparin is injected under the skin or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use the medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not use a prefilled syringe when giving this medicine to a child. The prefilled syringe contains more than a child’s dose of heparin.

Heparin increases your risk of bleeding, which can be severe or life-threatening. You will need frequent tests to measure your blood-clotting time. The timing of these tests is very important in helping your doctor determine whether it is safe for you to continue using this medicine.

If you need surgery, dental work, or a medical procedure, tell the care provider ahead of time that you are using heparin.

Store at room temperature away from moisture and heat.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You may be switched from injectable heparin to an oral (taken by mouth) blood thinner. Do not stop using the injection until your doctor tells you to. You may need to use both the injection and the oral forms for a short time.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include easy bruising, nosebleeds, blood in your urine or stools, black or tarry stools, or any bleeding that will not stop.

What should I avoid while using heparin injection?

Avoid medication errors by using only the form and strength your doctor prescribes.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID). Using an NSAID with heparin may cause you to bruise or bleed easily.

Heparin injection side effects

Get emergency medical help if you have signs of an allergic reaction to heparin: nausea, vomiting, sweating, hives, itching, trouble breathing, swelling of your face, lips, tongue, or throat, or feeling like you might pass out.

Heparin may cause you to bleed more easily, which can be severe or life-threatening. You may also have bleeding on the inside of your body. Seek emergency medical attention if you have:

• skin warmth or discoloration;
• chest pain, irregular heartbeats;
• shortness of breath, dizziness, anxiety, sweating;
• any unusual bleeding or bruising;
• severe pain or swelling in your stomach, lower back, or groin;
• dark or blue-colored skin on your hands or feet;
• nausea, vomiting, loss of appetite;
• unusual tiredness;
• any bleeding that will not stop; or
• nosebleed, blood in your urine or stools, black or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop.

Bleeding may be more likely in older adults, especially women over 60 years of age

Stop using this medicine and call your doctor at once if you have:

• skin changes where the medicine was injected;
• fever, chills, runny nose, or watery eyes;
• easy bruising, unusual bleeding, purple or red spots under your skin; or
• signs of a blood clot – sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common heparin side effects may include:

• unusual bleeding or bruising;
• uncontrolled bleeding;
• allergic reactions; or
• abnormal liver function tests.

Introduction

Anticoagulant; a heterogeneous group of anionic, sulfated glycosaminoglycans.

Unless otherwise specified in this monograph, the term “heparin” refers to “unfractionated heparin”, not low molecular weight heparin (LMWH) or both types of heparin.

Uses for Heparin Sodium

Treatment of Venous Thromboembolism

Treatment of DVT and PE.

Recommended by the American College of Chest Physicians (ACCP) as an appropriate choice of anticoagulant for initial treatment of acute proximal DVT or PE.

LMWHs or fondaparinux generally preferred over heparin for initial treatment of acute venous thromboembolism; however, heparin may be preferred in patients with renal impairment. IV heparin also may be preferred over sub-Q therapies in patients with PE in whom thrombolytic therapy is being considered or if there is concern about adequate sub-Q absorption.

After full-dose heparin therapy, warfarin or an LMWH generally is administered as follow-up anticoagulant therapy for ≥3 months in adults with venous thromboembolism.

Thromboprophylaxis in General Surgery

Prophylaxis of postoperative DVT and PE in patients undergoing general (e.g., abdominal) surgery who are at risk of thromboembolism.

ACCP recommends pharmacologic (e.g., low-dose heparin) and/or nonpharmacologic/mechanical (e.g., intermittent pneumatic compression) methods of thromboprophylaxis in patients undergoing general surgery, including abdominal, GI, gynecologic, and urologic surgery, according to the patient’s risk of thromboembolism and bleeding. In general, pharmacologic prophylaxis is recommended in patients with high (and possibly moderate) risk of venous thromboembolism who do not have a high risk of bleeding, while mechanical methods are suggested in patients who require thromboprophylaxis but have a high risk of bleeding.

If pharmacologic prophylaxis is indicated in patients undergoing general surgery, ACCP states that an LMWH or low-dose heparin is preferred.

ACCP states that the same recommendations for use of antithrombotic agents in general surgery patients can be applied to patients undergoing bariatric, vascular, and plastic/reconstructive surgery.

Thromboprophylaxis in Cardiac Surgery

Mechanical methods of prophylaxis generally recommended in patients undergoing cardiac surgery; however, ACCP states that low-dose heparin may be considered in cardiac surgery patients with a complicated postoperative course.

Thromboprophylaxis in Neurosurgery

Has been used for prevention of venous thromboembolism in patients undergoing craniotomy^{† [off-label]}; however, benefits may be outweighed by possible increased risk of intracranial hemorrhage. ACCP states that the addition of low-dose heparin to a mechanical method of prophylaxis may be considered in patients at very high risk of thromboembolism (e.g., those undergoing craniotomy for malignant disease) once adequate hemostasis established and risk of bleeding decreases.

Also may be considered as a possible addition to mechanical prophylaxis in high-risk patients undergoing spinal surgery^{† [off-label]} (e.g., those with malignancy or those undergoing surgery with a combined anterior-posterior approach) once adequate hemostasis established and risk of bleeding decreases.

Thromboprophylaxis in Thoracic Surgery

Prevention of postoperative DVT and PE in patients undergoing major thoracic surgery.

Pharmacologic thromboprophylaxis (e.g., low-dose heparin) recommended by ACCP in patients undergoing thoracic surgery who are at high risk of venous thromboembolism, provided risk of bleeding is low.

Thromboprophylaxis in Major Orthopedic Surgery

Has been used for prevention of DVT and PE in patients undergoing total hip-replacement surgery^{† [off-label]}, total knee-replacement surgery^{† [off-label]}, or hip-fracture surgery^{† [off-label]}.

ACCP recommends routine thromboprophylaxis (with a pharmacologic and/or mechanical method) in all patients undergoing major orthopedic surgery because of high risk of postoperative venous thromboembolism; continue thromboprophylaxis for at least 10–14 days, and possibly for up to 35 days after surgery.

Among several antithrombotic agents (e.g., LMWH, fondaparinux, low-dose heparin, warfarin, aspirin) recommended for pharmacologic thromboprophylaxis in patients undergoing major orthopedic surgery, ACCP states LMWHs generally preferred; may consider alternative agents when an LMWH is not available or cannot be used.

When selecting an appropriate thromboprophylaxis regimen, consider factors such as relative efficacy and safety of the drugs in addition to other logistics and compliance issues.

Thromboprophylaxis in Selected Medical Conditions

Used for prevention of DVT and PE in acutely ill hospitalized medical patients and in those with medical conditions associated with a high risk of thromboembolism (e.g., cancer).

In general, pharmacologic thromboprophylaxis recommended only in patients considered to be at high risk of venous thromboembolism.

ACCP recommends anticoagulant prophylaxis (e.g., low-dose heparin) in acutely ill, hospitalized medical patients at increased risk of thrombosis who are not actively bleeding and do not have an increased risk of bleeding. Continued thromboprophylaxis suggested for 6–21 days until full mobility is restored or hospital discharge.

Low-dose heparin also suggested by ACCP for pharmacologic thromboprophylaxis in critically ill patients (e.g., those in an intensive care unit [ICU]) who are not actively bleeding and do not have risk factors for bleeding.

Risk of venous thromboembolism is particularly high in patients with cancer. Use of low-dose heparin suggested by ACCP in cancer (solid tumors) outpatients who have additional risk factors for thromboembolism, provided risk of bleeding is low.

Thromboprophylaxis in Trauma

Low-dose heparin may be used for thromboprophylaxis in patients with major trauma^†. For major trauma patients at high risk of venous thromboembolism, including those with acute spinal cord injury, traumatic brain injury, or spinal surgery for trauma, ACCP suggests the use of both a pharmacologic and mechanical method of prophylaxis, unless contraindications exist.

Thromboembolism During Pregnancy

Has been used for prevention and treatment of venous thromboembolism during pregnancy; however, an LMWH generally is recommended by ACCP because of a more favorable safety profile.

Complications of Pregnancy

Has been used in combination with low-dose aspirin for prevention of recurrent pregnancy loss in women with antiphospholipid antibodies (APLA) syndrome^†.

Also has been used with aspirin (often combined with immune globulin) for prevention of venous thromboembolism and early pregnancy loss in women who have undergone in vitro fertilization^†.

Venous Thromboembolism in Pediatric Patients

Has been used for treatment and secondary prevention of venous thromboembolism in neonates and children^†; venous thromboembolism usually occurs secondary to an identifiable risk factor (e.g., presence of central venous access device) in such patients.

Recommendations regarding use of antithrombotic therapy in children generally based on extrapolation from adult guidelines.

In children with central venous catheters (or umbilical venous catheters) who experience venous thromboembolism, ACCP recommends removal of catheter if no longer functioning or required; at least 3–5 days of therapeutic anticoagulation suggested prior to removal. If such catheters must remain in place, ACCP suggests anticoagulant therapy until catheter is removed.

Cardioversion of Atrial Fibrillation/Flutter

Has been used to reduce the risk of stroke and systemic embolism in patients undergoing electrical or pharmacologic cardioversion^† for atrial fibrillation or atrial flutter.

Therapeutic anticoagulation with heparin may be used in patients in whom prolonged anticoagulation (e.g., with warfarin for ≥3 weeks) prior to cardioversion is not necessary or not possible; in these situations, heparin or an LMWH generally is administered at the time of transesophageal echocardiograph (TEE) or at presentation (for those with atrial fibrillation ≤48 hours) just prior to cardioversion.

In patients with hemodynamic instability who require urgent cardioversion, ACCP suggests administration of IV heparin or an LMWH prior to cardioversion, if possible; however, such anticoagulant therapy must not delay any emergency intervention.

Thromboembolism Associated with Prosthetic Heart Valves

Used during conversion to maintenance warfarin therapy to reduce the incidence of thromboembolism (e.g., stroke) in patients with prosthetic mechanical heart valves^†.

ACCP suggests bridging anticoagulation (administration of an LMWH in either prophylactic or therapeutic dosages or IV heparin in prophylactic dosages) during the early postoperative period after insertion of a mechanical heart valve until patient is stable on warfarin therapy.

Also may be used for bridging anticoagulation in patients with a mechanical heart valve in whom therapy with warfarin must be temporarily discontinued (e.g., for major surgery). ACC and AHA state that perioperative use of heparin should be considered for noncardiac surgery, invasive procedures, or dental procedures in patients with prosthetic heart valves who are at high risk for thrombosis without oral antithrombotic therapy (e.g., those with any mechanical mitral valve or a mechanical aortic valve with additional risk factors).

Used for thromboprophylaxis in pregnant women with prosthetic mechanical heart valves^†.

Renal Vein Thrombosis

Renal vein thrombosis^† is the most common cause of spontaneous venous thromboembolism in neonates. Although use of anticoagulant therapy in patients with renal vein thrombosis is controversial, heparin is suggested by ACCP as a possible treatment option in selected neonates.

Arterial Thromboembolism

Used to reduce the extent of ischemic injury in patients with acute arterial emboli or thrombosis; however, ACCP states formal studies demonstrating improved outcomes have not been conducted.

In patients with limb ischemia secondary to arterial emboli or thrombosis, immediate systemic anticoagulation with heparin to prevent thrombotic propagation is suggested by ACCP.

Prophylaxis during cardiac catheterization via an artery in neonates and children. If femoral artery thrombosis occurs following cardiac catheterization, therapeutic-dose IV heparin is recommended, followed by subsequent conversion to an LMWH or continued treatment with heparin to complete 5–7 days of therapeutic anticoagulation.

Thromboembolism Associated with Cardiac and Arterial Vascular Surgery

Prevention of activation of the coagulation mechanism during arterial and cardiac surgery.

A nonheparin anticoagulant (e.g., bivalirudin) may be used in place of heparin in patients with acute heparin-induced thrombocytopenia (HIT) or subacute HIT (platelets have recovered, but HIT antibodies still present) who require urgent cardiac surgery. Because HIT antibodies are transient, ACCP states that short-term use of heparin may be appropriate in patients with a remote (>3 months) history of HIT and no detectable antibodies who require cardiac surgery.

Disseminated Intravascular Coagulation

Treatment of acute and chronic consumptive coagulopathies, including disseminated intravascular coagulation.

Thrombosis Associated with Indwelling Venous or Arterial Devices

Maintenance of patency of indwelling peripheral or central venipuncture devices designed for intermittent injections and/or blood sampling.

ACCP suggests use of heparin flushes as an option for primary thromboprophylaxis of central venous access devices in children.

In neonates and children with peripheral arterial catheters, ACCP recommends continuous IV infusion of heparin (in low concentrations) via the catheter for prophylaxis. Also may consider use of heparin for treatment if symptomatic catheter-related thromboembolism occurs.

In neonates with umbilical arterial catheters, ACCP also suggests thromboprophylaxis with low-dose heparin via the catheter to maintain patency.

ST-Segment-Elevation MI (STEMI)

Used in combination with antiplatelet agents (e.g., aspirin) during and after successful coronary artery reperfusion (e.g., thrombolytic agents) for prevention of ischemic complications of STEMI^† (e.g., death, reinfarction, stroke).

The American College of Cardiology Foundation (ACCF) and AHA state that patients with STEMI undergoing thrombolytic therapy should receive an anticoagulant (e.g., heparin, enoxaparin, fondaparinux) for ≥48 hours, and preferably for the duration of the index hospitalization, up to 8 days or until revascularization is performed. Enoxaparin is preferred over heparin if extended anticoagulation (>48 hours) is necessary.

Acute Ischemic Complications of PCI

Used to reduce the risk of thrombotic complications in patients undergoing PCI. Used in conjunction with aspirin and other standard therapy (e.g., GP IIb/IIIa-receptor inhibitors, P2Y12 receptor antagonists).

Use of a parenteral anticoagulant is recommended in patients undergoing PCI to prevent thrombus formation during the procedure. IV heparin is recommended by AHA, the American College of Cardiology Foundation (ACCF), and the Society for Cardiovascular Angiography and Interventions (SCAI) as an appropriate choice of anticoagulant.

Non-ST-Segment-Elevation Acute Coronary Syndromes (NSTE ACS)

Reduction in the risk of acute cardiac ischemic events (death and/or MI) in patients with NSTE ACS (unstable angina or non-ST-segment-elevation MI [NSTEMI])^†.

Used concurrently with aspirin and/or other standard therapy (e.g., nitrates, β-adrenergic blocking agents [β-blockers], P2Y12 receptor antagonists).

Initial parenteral anticoagulants with established efficacy in patients with NSTE ACS include enoxaparin, heparin, bivalirudin (only in patients managed with an early invasive strategy), and fondaparinux.

In patients who will undergo CABG, if heparin is already being administered, continue during surgery. If patient is receiving other anticoagulants (enoxaparin, fondaparinux, or bivalirudin), discontinue other anticoagulant and use heparin during CABG.

In patients in whom conservative medical therapy is selected as a postangiographic management strategy, recommendations for continued antiplatelet and anticoagulant therapy generally are based on the presence of CAD.

Treatment of Cerebral Venous Sinus Thrombosis

May be used for treatment of acute cerebral venous sinus (sinovenous) thrombosis^† in adults. May convert to oral anticoagulant therapy once patient is stabilized.

Recommended by ACCP as an option for initial anticoagulation in children with cerebral venous sinus thrombosis^† without substantial intracranial hemorrhage. Also has been suggested for use in such children with substantial hemorrhage.

Acute Ischemic Stroke

Heparin anticoagulants (i.e., LMWH or heparin) have been used for thromboprophylaxis in selected patients with acute ischemic stroke^†; those with additional risk factors for venous thromboembolism are more likely to benefit.

ACCP suggests thromboprophylaxis with an LMWH (in prophylactic dosages), sub-Q heparin, or intermittent pneumatic compression in patients with acute ischemic stroke^† and restricted mobility; LMWH is preferred over heparin.

Prophylactic-dose heparin usually initiated within 48 hours of onset of stroke and continued throughout hospital stay until patient regains mobility; do not administer within the first 24 hours after thrombolytic therapy.

Also has been used for initial management of acute arterial ischemic stroke in children^† until dissection and embolic causes have been excluded.

In children with acute arterial ischemic stroke secondary to non-Moyamoya vasculopathy^†, ACCP recommends ongoing antithrombotic therapy (e.g., heparin) for 3 months.

Heparin may be considered in neonates with a first episode of arterial ischemic stroke associated with a documented cardioembolic source.

Perioperative Management of Antithrombotic Therapy

Used in the perioperative management of patients who require temporary interruption of long-term warfarin therapy for surgery or other invasive procedures.

ACCP suggests perioperative use of an LMWH or IV heparin (bridging anticoagulation) in selected patients with venous thromboembolism, atrial fibrillation, or mechanical prosthetic heart valves depending on their risk of developing thromboembolism without warfarin therapy.

In general, bridging anticoagulation is suggested in such patients who are considered to be at particularly high risk of venous thromboembolism without oral anticoagulant therapy.

Anticoagulant in Blood Transfusions, Blood Samples, and Other Procedures

Used as an in vitro anticoagulant in blood transfusions.

Used for anticoagulation during extracorporeal circulation and dialysis procedures.

Heparin Sodium Dosage and Administration

General

Laboratory Monitoring of Therapy

• Individualize dosage carefully based on clinical and laboratory findings. The generally accepted therapeutic range for the aPTT during full-dose IV or sub-Q heparin therapy is 1.5–2 times the control value in seconds. The generally accepted therapeutic range for the activated clotting time (ACT) is 2.5–3 times the control value in seconds.
• Laboratory monitoring of coagulation tests usually not performed with fixed low-dose sub-Q heparin therapy because such tests are generally unaffected or only minimally prolonged. If monitoring is required, it is best performed on samples drawn 4–6 hours after injections.
• With continuous IV infusion, perform coagulation tests prior to initiation of therapy, approximately every 4 hours during the early stages of therapy, and daily thereafter.
• With intermittent IV injection, perform coagulation tests prior to each injection during the early stages of therapy, and at appropriate intervals thereafter.
• Perform periodic platelet counts, hematocrit, and tests for occult blood in stool during the entire course of therapy.

Conversion to Oral Anticoagulation

• When warfarin is indicated for follow-up therapy after initial therapy with heparin, overlap therapy for a minimum of 5 days and until INR is at least 2 for ≥24 hours.
• When converting to oral dabigatran in patients currently receiving heparin therapy by continuous IV infusion, administer first dose of dabigatran, then immediately discontinue heparin infusion; for those currently receiving intermittently dosed IV heparin therapy, initiate dabigatran within 2 hours prior to what would have been the time of the next scheduled heparin dose.
• Some manufacturers recommend abrupt discontinuance of heparin therapy after confirmation of adequate response to warfarin. However, some clinicians recommend gradual discontinuance of heparin infusions (e.g., reducing the rate by 50% over 6 hours and then discontinuing over the next 12 hours) because of concern about possible rebound thrombosis.

Administration

Administer by IV infusion, intermittent IV injection, or deep sub-Q (intrafat) injection. Do not administer IM because of frequency of hematoma at injection site.

Do not use heparin lock flush solutions for systemic anticoagulation. Conversely, do not use heparin sodium injections as catheter lock flush products.

Use preservative-free formulations in neonates and infants, and also in pregnant and nursing women, if available. (See Pediatric Use under Cautions.)

Effective May 1, 2013, USP changed its labeling standard for Heparin Sodium Injection, USP and Heparin Lock Flush Solution, USP to require that labels of these products clearly state the strength of the entire container (amount of heparin per total volume of container), followed in close proximity by the strength per mL in parentheses. Carefully check the labels on all heparin products for correct formulation and strength prior to dispensing and administering the drug.

IV Administration

Dilution

When adding heparin to a solution for continuous IV infusion, invert the container at least 6 times to ensure adequate mixing and to prevent pooling of the drug in solution.

Standardize 4 Safety

Standardized concentrations for heparin have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. Multidisciplinary expert panels were convened to determine recommended standard concentrations. Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label. For additional information on S4S (including updates that may be available).

The S4S panel recommends trying to standardize dosing units but understands that some protocols may use “flat” dosing while others may require weight-based dosing.

Sub-Q Administration

Inject with a 25- or 26-gauge needle sub-Q deeply above the iliac crest or into the abdominal fat layer, or arm to minimize tissue trauma.

Intracatheter Instillation

Instill a quantity of heparin lock flush solution (e.g., containing 10 or 100 units/mL) sufficient to fill the indwelling venipuncture device into the lumen of the device following the initial placement of the device in the vein and after each use. Consult device manufacturer’s instructions for specific directions.

When the indwelling venipuncture device is used for repeated withdrawal of blood samples for laboratory analysis and the presence of heparin or 0.9% sodium chloride is likely to alter results of the analysis, aspirate and discard heparin lock flush solution from the device before withdrawing the blood sample. After the blood sample is drawn, may instill another dose of heparin lock flush solution into the device.

Following injection of heparin lock flush solution from a single-dose vial into an indwelling venipuncture device, discard unused portions of the solution. Multiple-dose vials are available for repeated use.

Dosage

Available as heparin sodium; dosage is expressed in terms of heparin sodium in USP units. One USP unit is equivalent to one international unit (IU).

Dosage requirements for full-dose therapy vary greatly among individuals; carefully individualize dosage based on the clinical and laboratory findings.

Pediatric Patients

Treatment of DVT and PE

IV

Because of a lack of adequate and well-controlled studies, dosage recommendations in pediatric patients are generally based on clinical experience. In children receiving full-dose (therapeutic) heparin, ACCP suggests a dosage sufficient to achieve an anti-factor Xa concentration of 0.35–0.7 units/mL or prolong the aPTT to a corresponding anti-factor Xa range or to a protamine titration range of 0.2–0.4 units/mL. Initial treatment for at least 5 days recommended. Convert to oral anticoagulation (e.g., warfarin) or an LMWH, or continue with heparin for ongoing therapy. (See Conversion to Oral Anticoagulation under Dosage and Administration.)

Initial loading dose of 75–100 units/kg (by direct IV injection over 10 minutes) has been suggested. Follow with a maintenance IV infusion of 25–30 units/kg per hour in infants or 18–20 units/kg per hour in children >1 year of age; appropriate maintenance dosage appears to be age dependent, with infants <2 months having the highest requirements (e.g., average of 28 units/kg per hour) and older children having lower requirements (e.g., average of 20 units/kg per hour in children >1 year of age). Although not preferred, a maintenance dosage of 75–100 units/kg every 4 hours by intermittent IV administration also has been used.

Individualize initial dosing strategy in children based on risk of thrombosis and risk of bleeding; in general, withhold or reduce loading doses if there are substantial bleeding risks and avoid long-term use of heparin.

Arterial Thromboembolism

IV

For neonates and children requiring cardiac catheterization via an artery^† : 100 units/kg by direct IV injection recommended by ACCP; additional doses may be required in prolonged procedures.

Neonates or children with femoral artery thrombosis associated with cardiac catheterization: Therapeutic-dose IV heparin recommended.

Disseminated Intravascular Coagulation

IV

25–50 units/kg given by IV infusion or IV injection every 4 hours. Discontinue after 4–8 hours if there is no improvement.

Thrombosis Associated with Indwelling Venous or Arterial Devices

IV

For thromboprophylaxis of central venous access devices^† in neonates, ACCP recommends 0.5 units/kg per hour as a continuous infusion.

For thromboprophylaxis of umbilical arterial catheters in neonates, ACCP suggests low-dose infusion (0.25–1 units/mL) through the catheter for a total dosage of 25–200 units/kg per day.

For thromboprophylaxis in neonates and children with peripheral arterial catheters, ACCP recommends continuous low-dose infusion (5 units/mL at 1 mL/hour).

Adults

Treatment of DVT and PE

IV, then Sub-Q

Full-dose intermittent therapy (68-kg adult): 5000 units by IV injection initially, then 10,000–20,000 units sub-Q for 1 dose, followed by 8000–10,000 units sub-Q every 8 hours or 15,000–20,000 units sub-Q every 12 hours.

IV

Full-dose continuous therapy (68-kg adult): 5000 units initial loading dose by IV injection, then 20,000–40,000 units in 1 L of compatible IV solution infused over 24 hours recommended by some manufacturers.

Full-dose intermittent therapy (68-kg adult): 10,000 units initial loading dose (either undiluted or diluted in 50 or 100 mL of 0.9% sodium chloride injection), then 5000–10,000 units every 4–6 hours recommended by some manufacturers.

ACCP suggests a weight-adjusted dosage (loading dose of 80 units/kg followed by continuous infusion of 18 units/kg per hour) or a fixed dosage (loading dose of 5000 units followed by continuous infusion of 1000 units/hour). Although the aPTT can be used to monitor either dosage regimen, ACCP states there is no evidence that monitoring improves clinical outcomes.

Sub-Q

For outpatients receiving sub-Q therapy, ACCP suggests weight-based dosing (initial dose of 333 units/kg followed by 250 units/kg twice daily) without monitoring.

General Surgery Thromboprophylaxis

Sub-Q

Usual dosage is 5000 units administered 2 hours prior to surgery and every 8–12 hours after surgery for 7 days or until patient is fully ambulatory, whichever is longer.

Thromboembolism During Pregnancy

Sub-Q

Women with APLA syndrome and a history of multiple pregnancy losses: Antepartum administration of sub-Q heparin in a prophylactic or intermediate dosage in combination with low-dose aspirin (75–100 mg daily) has been recommended.

Pregnant women with mechanical prosthetic heart valves: Initially, 17,500–20,000 units every 12 hours and adjusted to maintain the mid-interval aPTT at least twice the control value or anti-factor Xa concentration of 0.35–0.7 units/mL throughout pregnancy suggested.

Alternatively, in pregnant women with mechanical prosthetic heart valves, 17,500–20,000 units every 12 hours adjusted to maintain the mid-interval aPTT at least twice the control value or an anti-factor Xa concentration of 0.35–0.7 units/mL until week 13 of pregnancy, then switch to warfarin until close to delivery when heparin may be resumed.

Pregnant women with atrial fibrillation and additional risk factors for thromboembolism: 10,000–20,000 units every 12 hours with dosage adjusted to maintain the mid-interval aPTT (6 hours after dose) at 1.5 times the control value during the first trimester and last month of pregnancy.

IV

Pregnant women with atrial fibrillation and additional risk factors for thromboembolism: Adjusted-dose continuous therapy suggested to maintain the aPTT at 1.5–2 times control value during first trimester and last month of pregnancy.

Perioperative Management of Antithrombotic Therapy

IV

If heparin is used for bridging anticoagulation in patients who require temporary interruption of warfarin therapy (e.g., for surgery or other invasive procedure), ACCP recommends therapeutic dosages (e.g., continuous infusion adjusted to maintain an aPTT of approximately 1.5–2 times the control value); however, other dosage regimens have been used.

ACCP suggests that heparin be discontinued approximately 4–6 hours prior to surgery.

Administer postoperative anticoagulation with caution and only when hemostasis established.

Disseminated Intravascular Coagulation

IV

50–100 units/kg by IV infusion or IV injection every 4 hours. Discontinue after 4–8 hours if there is no improvement.

Thrombosis Associated with Indwelling Venipuncture Devices

Intracatheter Instillation

Inject a quantity of heparin lock flush solution (e.g., containing 10 or 100 units/mL) sufficient to fill the device after each use. (See Intracatheter Instillation under Dosage and Administration: Administration.)

STEMI

IV

Conjunctive therapy with fibrin-selective thrombolytic agents: Initially, 60 units/kg (maximum 4000 units) loading dose.

Maintenance dosage: 12 units/kg per hour (maximum 1000 units/hour), adjusted to maintain a therapeutic aPTT (1.5–2 times control value or approximately 50–70 seconds) for 48 hours or until revascularization.

IV or Sub-Q

Acute MI and concurrent atrial fibrillation: Continuous IV infusion or intermittent sub-Q injection recommended in a dosage sufficient to prolong aPTT to 1.5–2 times the control value.

Cardiac and Arterial Surgery Thromboprophylaxis

IV

Total body perfusion for open-heart surgery: Initially, ≥150 units/kg. Administer 300 units/kg for procedures estimated to last <1 hour. Administer 400 units/kg for those procedures estimated to last >1 hour.

Acute Ischemic Complications of PCI

IV

PCI without concurrent GP IIb/IIIa-receptor inhibitor: In patients who have not received prior anticoagulant therapy, a loading dose of 70–100 units/kg targeted to achieve an ACT of 250–300 seconds with the HemoTec device or 300–350 seconds with the Hemochron device suggested. If patient has received prior anticoagulant therapy, administer additional doses as needed to achieve an ACT of 250–300 seconds with the HemoTec device or 300–350 seconds with the Hemochron device.

PCI with concurrent GP IIb/IIIa-receptor inhibitors: In patients who have not received prior anticoagulant therapy, a loading dose of 50–70 units/kg targeted to an ACT of 200–250 seconds suggested. If patient has received prior anticoagulant therapy, administer additional doses (e.g., 2000–5000 units) as needed to achieve an ACT of 200–250 seconds.

Discontinue therapy after successful PCI procedures. The femoral sheath generally is removed when ACT <150–180 seconds or when aPTT <50 seconds.

NSTE ACS

IV

ACCF/AHA/ACC recommends a weight-adjusted dosing regimen (e.g., 60 units/kg [maximum 4000 units] loading dose followed by continuous infusion of 12 units/kg per hour [maximum 1000 units/hr]). Initiate therapy as soon as possible upon presentation. Optimum duration of therapy not established; in clinical trials, heparin was continued for 2–5 days.

Anticoagulant in Blood Transfusions and Blood Samples

In vitro

In blood transfusions, add 7500 units to 100 mL of 0.9% sodium chloride injection and then add 6–8 mL of this solution to each 100 mL of whole blood.

When used as an in vitro anticoagulant for blood samples, add 70–150 units to each 10–20 mL of whole blood.

Extracorporeal Dialysis

Consult equipment manufacturer’s operating instructions; if not available, dose of 25–30 units/kg, followed by infusion of 1500–2000 units/hour is suggested based on pharmacodynamic data.

Prescribing Limits

Adults

STEMI

IV

Conjunctive therapy with fibrin-selective thrombolytic agents: Maximum 4000 units loading dose.

Maintenance dosage: Maximum 1000 units/hour.

Special Populations

Geriatric Patients

Patients >60 years of age may require a lower dosage. Consider lower dosages in geriatric patients undergoing PCI, particularly when combined with GP IIb/IIIa-receptor inhibitors.

Women

Consider lower dosages in women undergoing PCI, particularly when combined with GP IIb/IIIa-receptor inhibitors.

Cautions for Heparin Sodium

Contraindications

• Uncontrollable bleeding, unless such bleeding is secondary to disseminated intravascular coagulation.
• Severe thrombocytopenia, history of HIT, or HIT with thrombosis.
• Inability to perform suitable blood coagulation tests at required intervals in patients receiving full-dose therapy. Lack of such tests generally is not a contraindication for fixed low-dose therapy, since monitoring of coagulation tests usually is not required.
• Known hypersensitivity to heparin or pork products. (See Sensitivity Reactions under Cautions.)

Warnings/Precautions

Warnings

Hematologic Effects

Hemorrhage can range from minor local ecchymoses to major hemorrhagic complications. Bleeding may occur at any site; some hemorrhagic complications may be difficult to detect.

Use with extreme caution in patients with an increased risk of hemorrhage. Such patients include those with subacute bacterial endocarditis; ulcerative GI lesions; hemorrhagic blood dyscrasias (e.g., hemophilia, some vascular purpuras, thrombocytopenia); menstruation; hepatic disease with impaired hemostasis; severe hypertension; major surgery, especially involving the eye, brain, or spinal cord; continuous tube drainage of the stomach or small intestine; and spinal tap or spinal anesthesia. Screen patients prior to treatment initiation to rule out bleeding disorders.

Monitor patients with appropriate coagulation tests just prior to surgery. Discontinue therapy immediately if hemorrhage occurs or if coagulation tests are unduly prolonged. Nosebleed, hematuria, or tarry stools may be noted as the first sign of bleeding or overdosage. Easy bruising or petechiae may precede frank bleeding. If severe hemorrhage or overdosage occurs, administer protamine sulfate immediately. Blood transfusions may also be required following massive blood loss.

If signs and symptoms of acute adrenal hemorrhage and insufficiency occur, measure plasma cortisol concentrations. Initiate vigorous therapy with IV corticosteroids after discontinuance. Do not delay initiation of corrective therapy until laboratory confirmation of the diagnosis, since any delay may be fatal.

Perform periodic hematocrit and tests for occult blood in stool during the entire course of therapy.

Obtain baseline aPTT value prior to insertion of an indwelling venipuncture device (e.g., heparin lock) since repeated injections of small doses of heparin sodium can alter aPTT results.

Risk of thrombocytopenia, including HIT (immune-mediated reaction caused by development of IgG platelet-aggregating antibodies). (See HIT under Cautions and also see Contraindications under Cautions.) Monitor thrombocytopenia of any degree closely. Mild thrombocytopenia (platelet count >100,000/mm³) may remain stable or reverse with continued therapy. If clinically important HIT occurs, discontinue the drug immediately and substitute a nonheparin anticoagulant (e.g., argatroban, bivalirudin).

Sensitivity Reactions

Hypersensitivity

Generally contraindicated in patients who are hypersensitive to the drug. Patients with documented hypersensitivity should be given the drug only in clearly life-threatening situations.

Major Toxicities

HIT

Risk of HIT; may lead to severe thromboembolic complications including DVT, cerebral vein thrombosis, limb ischemia, mesenteric thrombosis, renal artery thrombosis, skin necrosis, gangrene of the extremities (possibly requiring amputation), MI, PE, stroke, and possibly, death. Can occur even with heparin lock flush solutions. Usually evident 5–10 days after exposure to heparin, but can occur more rapidly (e.g., within 24 hours) or as late as several weeks after discontinuance of therapy.

If HIT with or without thrombosis is diagnosed or strongly suspected, discontinue all sources of heparin (including heparin flushes) and substitute a nonheparin anticoagulant (e.g., argatroban, bivalirudin). Initiate conversion to warfarin therapy only after substantial recovery from acute HIT has occurred (i.e., platelet counts ≥150,000/mm³). The manufacturer recommends against future use of heparin in patients who experience HIT, particularly within 3–6 months following the event and if HIT antibodies are still present.

Evaluate patients who develop thrombocytopenia or thrombosis after treatment discontinuance for HIT and HIT with thrombosis.

General Precautions

Heparin Resistance

Increased resistance to the antithrombotic effects of heparin reported; associated with fever, MI, thrombophlebitis, infections with thrombosing tendencies, thrombosis, antithrombin III deficiency, malignant neoplasms, and surgery (i.e., postoperatively).

Dispensing and Administration Precautions

Fatal medication errors (including in pediatric patients) have occurred as a result of confusion between different formulations of heparin, in particular with heparin sodium injection and catheter lock flush vials. Ensure accuracy of dispensing; take appropriate measures to carefully distinguish between heparin formulations when dispensing and review all labels for correct drug name, strength, and volume.

Report dispensing errors to manufacturers or directly to FDA MedWatch program by phone .

Specific Populations

Pregnancy

Category C. Manufacturers recommend use of a preservative (benzyl alcohol)-free formulation in pregnant women.

Lactation

Not likely to be distributed into milk. However, if benzyl alcohol is present in maternal serum, it is likely to distribute into milk and be absorbed by a nursing infant. Caution is advised when using heparin in nursing women; manufacturers recommend use of a preservative (benzyl alcohol)-free formulation.

ACCP recommends that heparin be continued in nursing women who are already receiving such therapy.

Pediatric Use

There are no adequate and well-controlled studies evaluating use of heparin in pediatric patients.

Some heparin sodium injections and heparin lock flush solutions contain benzyl alcohol as a preservative. Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity (e.g., “gasping syndrome”) in neonates. Manufacturers recommend use of preservative-free formulations in neonates and infants. AAP states that presence of small amounts of this preservative in a commercially available injection should not proscribe its use when indicated in neonates. If other benzyl alcohol-containing preparations are being used, consider the total daily metabolic load of benzyl alcohol from all sources.

Fatal medication dispensing errors reported in pediatric patients, including neonates. Take appropriate precautions when dispensing and administering the drug. (See Dispensing and Administration Precautions under Cautions.)

Because of the potential risk of systemic anticoagulation, avoid use of heparin lock flush solutions containing 100 units/mL in neonates and in infants <10 kg. Caution also advised when using heparin lock flush solutions containing 10 units/mL in premature infants <1 kg who are receiving frequent flushes.

Geriatric Use

Manufacturers state that risk of hemorrhage may be higher in patients >60 years of age, particularly women. (See Geriatric Patients and see Women under Dosage and Administration.)

Renal Impairment

Patients with renal failure may be at increased risk of bleeding complications.

Common Adverse Effects

Hemorrhage, thrombocytopenia, HIT or HIT with thrombosis, injection site irritation, general hypersensitivity reactions, elevated aminotransferase concentrations.

Drug Interactions

Drugs Affecting Platelet Function

Potential pharmacodynamic interaction (increased risk of bleeding complications). Use with caution.

Specific Drugs and Laboratory Tests

Heparin Sodium Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentration achieved 2–4 hours following sub-Q administration.

Onset

Immediate following direct IV injection or IV infusion of full doses.

Within 20–60 minutes following deep sub-Q injection.

Duration

Heparin lock flush solutions: Anticoagulation maintained within the device for generally up to 4 hours.

Special Populations

Plasma heparin concentrations may be increased and aPTTs more prolonged in geriatric (>60 years of age) patients compared with younger adults.

Distribution

Extent

Does not cross the placenta and is not distributed into milk.

Plasma Protein Binding

Extensively bound to LDL, globulins, and fibrinogen. May contribute to the lack of relationship between duration of anticoagulant effect and blood concentration half-life.

Elimination

Metabolism

Cleared from the circulation mainly by the reticuloendothelial system. May be partially metabolized in the liver to uroheparin, which is partially desulfated heparin.

Elimination Route

Small fraction excreted in urine as unchanged drug.

Half-life

1–2 hours in healthy adults. Half-life increases with increasing doses. Plasma half-life averages 56, 96, and 152 minutes following IV heparin sodium doses of 100, 200, or 400 units/kg, respectively. Shorter plasma half-life in patients with pulmonary embolism than in healthy individuals or patients with other thrombotic disorders.

Special Populations

Decreased plasma half-life in patients with liver impairment; half-life may be prolonged in patients with cirrhosis.

Half-life may be slightly prolonged in anephric patients or patients with severe renal impairment.

Stability

Storage

Parenteral

Solution for Injection

Heparin lock flush solutions: 20–25°C.

Heparin sodium injections: 20–25°C.

Heparin sodium injection in 5% dextrose or in 0.45 or 0.9% sodium chloride injection: 20–25°C; protect from freezing.

Actions

• Acts as a catalyst to markedly accelerate the rate at which antithrombin III (heparin cofactor) neutralizes thrombin and activated coagulation factor X (X_a). Low-dose therapy neutralizes X_a which prevents the conversion of prothrombin to thrombin. Low doses of heparin have very little effect on thrombin and exert a measurable antithrombogenic effect only if thrombin formation has not already occurred.
• Full-dose therapy neutralizes thrombin, which prevents the conversion of fibrinogen to fibrin. Also prevents the formation of a stable fibrin clot by inhibiting activation of fibrin stabilizing factor. Low-dose or full-dose therapy inhibits thrombus formation when stasis is induced. Full-dose therapy may prevent extension of existing thrombi.
• Full-dose therapy prolongs several coagulation assays including the ACT, aPTT, plasma recalcification time, PT, thrombin time, and whole blood clotting time. Clotting time is generally unaffected or only minimally prolonged by low-dose therapy.

Advice to Patients

• Importance of reporting any unexplained bleeding or bruising to clinician.
• Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary and herbal supplements, and any concomitant illnesses.
• Importance of women informing clinician if they are or plan to become pregnant or to breast-feed.
• Importance of informing patients of other important precautionary information. (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

What is hepatitis B vaccine?

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when the mother is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis B vaccine is used to help prevent this disease in adults.

This vaccine helps your body develop immunity to the disease, but will not treat an active infection you already have.

Vaccination with hepatitis B vaccine is recommended for all adults who are at risk of getting hepatitis B. Like any vaccine, the hepatitis B vaccine may not provide protection from disease in every person.

This vaccine side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

The vaccination provider may want to watch you for a short time after your shot, to make sure you don’t have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine.

You should not receive this vaccine if the first shot of this vaccine caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive this vaccine.

Not all possible side effects are known. Becoming infected with hepatitis B is much more dangerous to your health than receiving this vaccine.

Common side effects of hepatitis B adult vaccine may include:

• headache;
• tiredness; or
• redness, pain, swelling, or a lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services .

Warnings

Becoming infected with Hepatitis B is much more dangerous to your health than receiving this vaccine.

You should not receive another dose of this vaccine if you had a life threatening allergic reaction after the first shot.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

Hepatitis B vaccine will not protect against infection with hepatitis A, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis B if you are already infected with the virus, even if you do not yet show symptoms.

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis B.

Tell your doctor or vaccination provider if you have or have ever had:

• a fever;
• an allergy to yeast or latex;
• a bleeding or blood clotting disorder such as hemophilia;
• have a weak immune system caused by disease or by using certain medicine;
• have received any other hepatitis vaccine or if you are scheduled to receive a vaccine; or
• have ever fainted when or after receiving an injection; or
• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this vaccine on the baby.

How is this vaccine given?

This vaccine is given as an injection into a muscle. A healthcare provider will give you this injection.

The hepatitis B vaccine is given in a series of 2 to 3 shots usually over 6 months.

Your doctor or vaccination provider will determine if you need an additional dose based on your condition.

Your individual vaccination schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by your local health department.

Be sure to receive all recommended doses of this vaccine, or you may not be fully protected against disease.

This vaccine can affect the results of certain medical tests. Tell any doctor who treats you if you recently received the hepatitis B vaccine.

Hepatitis B adult vaccine dosing information

Usual Adult Dose for Hepatitis B Prophylaxis:

Primary Vaccination:

Engerix-B(R):
19 years and younger: Three doses (0.5 mL each) intramuscularly on a 0, 1, and 6 month schedule
20 years and older: Three doses (1 mL each) intramuscularly on a 0, 1, and 6 month schedule

Heplisav-B(R): Two doses (0.5 mL each) intramuscularly one month apart

Recombivax-HB(R):
19 years and younger: Three doses (0.5 mL each) intramuscularly on a 0, 1, and 6 month schedule (use pediatric/adolescent formulation)
20 years and older: Three doses (1 mL each) intramuscularly on a 0, 1, and 6 month schedule (use adult formulation)



Known or Presumed Hepatitis B Exposure:

Engerix-B(R) : Use recommended doses of (above) on a 0, 1, and 6 month schedule OR a 0, 1, 2, and 12 month schedule.
Recombivax-HB(R): Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP)

Comments:
-Administer hepatitis B immune globulin if appropriate.
-Start hepatitis B vaccine as soon as possible after exposure.

What happens if I miss a dose?

Contact your vaccination provider or health department if you miss a dose.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Avoid receiving other vaccines without first seeking medical advice.

What other drugs will affect hepatitis B vaccine?

Before receiving this vaccine, tell your vaccination provider about all other vaccines you have received. Other drugs may affect this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is Herceptin?

Herceptin is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Herceptin is used to treat certain types of breast cancer or stomach cancer. Other cancer medicines are sometimes used in combination with Herceptin.

Herceptin is sometimes used when the cancer has spread to other parts of the body (metastatic).

Warnings

Do not use Herceptin if you are pregnant. It could harm the unborn baby. Avoid becoming pregnant for at least 7 months after your last dose of trastuzumab. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Herceptin can cause heart failure, especially if you have heart disease or if you are also receiving certain other cancer medicines.

Some side effects may occur during the injection. Tell your caregivers if you feel dizzy, nauseated, light-headed, weak, short of breath, or if you have a headache, fever, or chills.

Before taking this medicine

You should not be treated with Herceptin if you are allergic to trastuzumab.

To make sure Herceptin is safe for you, tell your doctor if you have ever had:

• heart disease;
• congestive heart failure;
• a heart attack; or
• any allergies or breathing problems.

Trastuzumab can cause heart failure, especially if you have heart disease or if you are also receiving certain other cancer medicines (such as daunorubicin, doxorubicin, epirubicin, or idarubicin).

You may need to have a negative pregnancy test before starting this treatment.

Do not use Herceptin if you are pregnant. This medicine can cause injury or death to the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 7 months after your last dose. Tell your doctor if you become pregnant during treatment.

If you become pregnant while using this medicine or within 7 months after you stop, your name may be listed on a pregnancy registry to track the effects of trastuzumab on the baby.

It may not be safe to breastfeed while using this medicine and for up to 7 months after your last dose. Ask your doctor about any risk.

How is Herceptin given?

Herceptin is given as an infusion into a vein. A healthcare provider will give you this injection.

Herceptin is usually given once every week or every 1 to 3 weeks. Follow your doctor’s dosing instructions very carefully.

Your doctor will perform a medical test to make sure trastuzumab is the right medicine to treat your cancer.

This medicine must be given slowly, and the infusion can take up to 90 minutes to complete.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Your heart function may need to be checked before and during treatment with trastuzumab. You may also need heart function testing every 6 months for 2 years after your last dose of this medicine.

Herceptin is usually given for 52 weeks, or until your body no longer responds to the medication.

Dosing information

Usual Adult Dose of Herceptin for Breast Cancer:

For use in the treatment of metastatic breast cancer:
Administer trastuzumab, alone or in combination with paclitaxel.
Initial dose: 4 mg/kg IV infusion over 90 minutes
Subsequent therapy: 2 mg/kg IV infusion over 30 minutes once weekly until disease progression

Usual Adult Dose of Herceptin for Breast Cancer — Adjuvant:

Administer according to one of the following doses and schedules:

1) Initiate trastuzumab during and following paclitaxel, docetaxel, or docetaxel/carboplatin:
Initial dose: 4 mg/kg IV infusion over 90 minutes then 2 mg/kg IV infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
Subsequent therapy: one week after the last weekly dose of trastuzumab, give trastuzumab as 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks for a total of 52 weeks of therapy.
or
2) Initiate trastuzumab as a single agent within 3 weeks following completion of all chemotherapy.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks for a total of 17 doses (52 weeks of therapy)

Usual Adult Dose of Herceptin for Esophageal Carcinoma:

For use in the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma:
Administer trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks until disease progression

Usual Adult Dose of Herceptin for Gastric Cancer:

For use in the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma:
Administer trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks until disease progression

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your trastuzumab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Herceptin?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Herceptin side effects

Get emergency medical help if you have signs of an allergic reaction to Herceptin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection, or in the days afterward. Tell your caregiver right away if you feel dizzy, nauseated, itchy, light-headed, weak, short of breath, or if you have a headache, fever, chills, or chest pain.

Call your doctor at once if you have:

• new or worsening cough;
• a light-headed feeling, like you might pass out;
• severe headache, blurred vision, pounding in your neck or ears;
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• heart problems – pounding heartbeats, dizziness, swelling in your lower legs, rapid weight gain, feeling short of breath;
• low blood cell counts – fever, chills, tiredness, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed; or
• signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Herceptin side effects may include:

• heart problems;
• nausea, diarrhea, weight loss;
• headache;
• trouble sleeping, feeling tired;
• low blood cell counts;
• rash;
• fever, chills, cough, or other signs of infection;
• mouth sores;
• altered sense of taste; or
• cold symptoms such as stuffy nose, sinus pain, sore throat.

What is Hibiclens?

Chlorhexidine is an antiseptic that fights bacteria.

Hibiclens (for the skin) is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.

Hibiclens may also be used for purposes not listed in this medication guide.

Hibiclens side effects

Chlorhexidine can cause a rare but serious allergic reaction that may be life-threatening. Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash; wheezing, difficult breathing; cold sweats, severe dizziness; swelling of your face, lips, tongue, or throat.

Hibiclens may cause serious side effects. Stop using Hibiclens and call your doctor at once if you have:

• severe burning, itching, or redness;
• blistering or peeling;
• swelling or severe skin rash; or
• any other severe irritation of treated skin.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Chlorhexidine can cause a rare but serious allergic reaction that may be life-threatening. Get emergency medical help if you have: hives, severe skin rash; wheezing, difficult breathing; cold sweats, severe dizziness; swelling of your face, lips, tongue, or throat.

Before taking this medicine

You should not use Hibiclens if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to use Hibiclens if you have any allergies to food, dyes, animals, or medicines.

It is not known whether Hibiclens will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether chlorhexidine topical passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Be very careful when using Hibiclens on a child younger than 2 months old. This medicine may cause severe irritation or chemical burns on a very young child.

How should I use Hibiclens?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Hibiclens is for use only on the skin.

Rinse the skin before applying Hibiclens. Apply only enough medicine to cover the area you are treating. Do not apply this medicine to deep cuts, scrapes, or open skin wounds.

To use Hibiclens soap, apply only enough to cover the area you are treating. Wash the area gently, then rinse thoroughly with plain water. Avoid using over large areas of skin.

This medicine is made under sterile conditions, but its contents are not sterilized. It is possible for bacteria to get inside the product and contaminate it, which could spread infection. To avoid contaminating your medicine with bacteria:

• Use only the swab, pad, or applicator provided with your medicine.
• If no applicator is provided, use only a clean cotton ball or cotton swab to apply this medicine.
• Do not touch the tip of the medicine bottle with your fingers or touch it to your skin.
• Do not dilute the medicine with water or other liquid.
• Use the applicator (pad, swab, or other dressing) only once. Throw away after one use.

Call your doctor if your symptoms do not improve, or if they get worse while using Hibiclens.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

If this medicine is packaged in a single-use foil wrapper or other container, use it only once. Throw away after one use, even if there is still medicine left in it. Do not save for later use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of Hibiclens is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

What should I avoid while using chlorhexidine topical?

Avoid getting Hibiclens in your eyes, ears, nose, mouth, rectum, or vagina. If this does happen, rinse with water.

Avoid using other medicines on the areas you treat with Hibiclens unless your doctor tells you to.

Avoid getting this medicine on your clothing or other fabrics. Do not use bleach to wash any fabric exposed to chlorhexidine or the medicine may cause a permanent stain.

What other drugs will affect Hibiclens?

It is not likely that other drugs you take orally or inject will have an effect on topically applied chlorhexidine. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What is Hiprex?

Hiprex is an antibacterial medicine used to treat or prevent bladder infections in adults and children at least 6 years old.

Hiprex may also be used for purposes not listed in this medication guide.

Hiprex side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Hiprex may cause serious side effects. Call your doctor at once if you have:

• increased urination;
• painful urination;
• blood in your urine; or
• swelling, shortness of breath.

Common side effects of Hiprex may include:

• painful urination;
• nausea, vomiting; or
• rash, itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use Hiprex if you are allergic to it, or if you have:

• kidney disease;
• severe liver disease; or
• if you are dehydrated.

Ask a doctor or pharmacist if Hiprex is safe to use if you’ve ever had liver problems.

Ask a doctor before using this medicine if you are pregnant.

Do not breastfeed.

How should I take Hiprex?

Use exactly as directed on the label, or as prescribed by your doctor.

Hiprex works best when your urine has a low pH and is acidic. You can measure your pH levels at home using urine test strips purchased from a pharmacy. Your doctor may occasionally test your urine to make sure an infection has cleared.

Learn about the foods to eat or avoid to help keep your urine acidic. Your doctor may also prescribe other medicines. Drink plenty of liquids.

Follow your doctor’s diet and medication instructions very closely.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Hiprex will not treat a viral infection (flu or a common cold).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Hiprex.

Do not use Hiprex to treat any condition that has not been checked by your doctor.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Hiprex?

Avoid taking extra Hiprex, or you could have side effects such as bladder irritation, pain, increased urination, and blood in the urine.

What other drugs will affect Hiprex?

Other drugs may affect Hiprex, especially a sulfa drug. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

What is Hizentra?

Hizentra is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Hizentra subcutaneous infusion (for injection under the skin) is used to treat primary immunodeficiency diseases. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Hizentra infusion is also used to treat chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder in which the immune system attacks the nerves, causing muscle weakness and numbness).

Warnings

Hizentra can cause severe allergic reactions, kidney failure, liver problems, or blood clots. The risk of blood clots is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place.

Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.

This medicine can also harm your kidneys, especially if you have kidney disease or if you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.

Drink plenty of liquids while you are using Hizentra to help improve your blood flow and keep your kidneys working properly.

You should not use Hizentra if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

Before using this medicine

You should not use Hizentra if:

• you have had an allergic reaction to an immune globulin or blood product; or
• you have immune globulin A (IgA) deficiency with antibody to IgA.

You may not be able to use Hizentra if you have ever had an allergic reaction to polysorbate 80, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

This medicine can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. To make sure Hizentra injection is safe for you, tell your doctor if you have ever had:

• heart problems, blood circulation problems, or “thick blood”;
• a stroke or blood clot;
• kidney disease;
• diabetes;
• an infection called sepsis;
• if you use estrogens (birth control pills or hormone replacement therapy);
• if you have been on long-term bedrest; or
• if you have a central intravenous (IV) catheter in place.

You may need a dose adjustment if you are exposed to measles, or if you

Do not give this medicine to a child without medical advice.

Hizentra is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

How is Hizentra given?

Hizentra is injected under the skin using an infusion pump. The medicine enters the body through a catheter placed under your skin. A healthcare provider may teach you how to properly use the medication by yourself.

Hizentra is sometimes given daily, and sometimes once every 1 to 2 weeks. Use this medicine at regular intervals to keep a steady amount of the drug in your body at all times. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

Hizentra must be given slowly, and you may need to use up to 8 different catheters to infuse this medicine into different body areas at the same time. Your healthcare provider will show you where to on your body to inject Hizentra. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has is cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Do not shake the medication bottle or you may ruin the medicine.

Do not inject Hizentra into a vein.

You will need frequent blood tests. This medicine can affect the results of certain other medical tests you may need. Tell any doctor who treats you that you are using Hizentra.

Store Hizentra in the original carton at room temperature. Protect from heat and light.

You may also store this medicine in its original carton in the refrigerator. Do not freeze Hizentra, and throw the medicine away if it has frozen.

You will need to use your medicine within a certain number months. This will depend on the how you store the medicine (at room temperature, or in a refrigerator). Carefully follow the storage instructions provided with your medicine. Ask your pharmacist if you have questions.

Throw away any unused medication after the expiration date on the label has passed.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use disposable injection items (needle, catheter, tubing) only once only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Hizentra?

Vaccines may not work well for you while you are taking this medicine. Tell your doctor or healthcare professional that you are taking Hizentra before getting a vaccine.

Hizentra side effects

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction to Hizentra: hives; wheezing, chest tightness, difficult breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a blood cell disorder – pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• kidney problems – little or no urination, swelling, rapid weight gain, feeling short of breath;
• lung problems – chest pain, trouble breathing, blue colored lips, fingers, or toes;
• signs of a new infection – fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
• signs of a blood clot – shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common Hizentra side effects may include:

• wheezing, trouble breathing;
• pain, redness, bruising, itching, swelling, or a hard lump where the medicine was injected;
• fever, tiredness, dizziness;
• nausea, vomiting, diarrhea, bloating, stomach pain;
• itching, rash, or other skin problems;
• cold or flu symptoms such as stuffy nose, sneezing, sore throat, cough;
• headache, migraine; or
• pain anywhere in your body.

What is  Horizant?

Horizant is a  prescription medicine used to treat adults with restless legs syndrome and pain from damaged nerves. It affects chemicals and nerves in the body that are involved in the cause of some types of pain.

Horizant is used in adults to treat nerve pain (postherpetic neuralgia) caused by herpes virus or shingles (herpes zoster).

Horizant is also used to treat restless legs syndrome (RLS).

Use only the brand and form of gabapentin your doctor has prescribed. Check your medicine each time you get a refill to make sure you receive the correct form.

Warnings

Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using Horizant suddenly, even if you feel fine.

Before taking this medicine

You should not use Horizant if you are allergic to gabapentin.

To make sure Horizant is safe for you, tell your doctor if you have ever had:

• lung disease, such as chronic obstructive pulmonary disease (COPD);
• kidney disease (or if you are on dialysis);
• diabetes;
• depression, a mood disorder, or suicidal thoughts or actions;
• a seizure (unless you take gabapentin to treat seizures);
• liver disease;
• heart disease; or
• (for patients with RLS) if you are a day sleeper or work a night shift.

Some people have thoughts about suicide while taking this medicine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Gabapentin enacarbil can pass into breast milk, but effects on the nursing baby are not known. Ask your doctor about any risk.

How should I take Horizant?

Take Horizant exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not cut, crush, chew, or break an extended-release Horizant tablet. Swallow the tablet whole.

If your doctor changes your brand, strength, or type of gabapentin, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of gabapentin you receive at the pharmacy.

Do not stop using Horizant suddenly, even if you feel fine. Follow your doctor’s instructions about tapering your dose.

This medicine can cause unusual results with certain  medical tests. Tell any doctor who treats you that you are using gabapentin enacarbil.

Store Horizant extended-release tablets at room temperature away from light and moisture.

Dosing information

Usual Adult Dose of Horizant for Postherpetic Neuralgia:

The recommended dosage is 600 mg orally 2 times a day. Therapy should be initiated at a dose of 600 mg orally in the morning for 3 days of therapy, then increased to 600 mg 2 times a day (1200 mg/day) on day four.
Gabapentin enacarbil extended release tablets available under the trade name Horizant and gabapentin are not interchangeable.
Use: Postherpetic neuralgia

Usual Adult Dose of Horizant for Restless Legs Syndrome:

600 mg orally once daily with food at about 5 PM. A dose of 1,200 mg once daily provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions.
Use: For the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults

What happens if I miss a dose?

Take the missed dose as soon as you remember. Be sure to take the medicine with food. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid driving or hazardous activity until you know how gabapentin enacarbil will affect you. Your reactions could be impaired.

Drinking alcohol with this medicine can cause side effects.

 Horizant side effects

Get emergency medical help if you have signs of an allergic reaction to Horizant: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, upper stomach pain, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Horizant.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• weak or shallow breathing;
• blue-colored skin, lips, fingers, and toes;
• confusion, extreme drowsiness or weakness;
• problems with balance or muscle movement;
• unusual or involuntary eye movements; or
• increased seizures.

Gabapentin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.

Some side effects are more likely in children taking gabapentin. Contact your doctor if the child taking this medicine has any of the following side effects:

• changes in behavior;
• memory problems;
• trouble concentrating; or
• acting restless, hostile, or aggressive.

Common Horizant side effects may include:

• headache;
• dizziness, drowsiness, tiredness;
• problems with balance or eye movements; or
• (in children) fever, nausea, vomiting.

What is Humalog?

Humalog is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood.

Humalog is used to improve blood sugar control in adults and children with diabetes mellitus.

Humalog is used to treat type 2 diabetes in adults.

Humalog is also used to treat type 1 diabetes in adults and children who are at least 3 years old.

Warnings

Humalog is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

You should not use Humalog if you are having an episode of hypoglycemia (low blood sugar).

Humalog is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Humalog side effects

Get emergency medical help if you have signs of insulin allergy to Humalog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• weight gain, swelling in your hands or feet, feeling short of breath;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humalog side effects may include:

• low blood sugar;
• weight gain;
• swelling in your hands or feet;
• itching; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Before taking this medicine

You should not use Humalog if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humalog should not be given to a child younger than 3 years old. Humalog should not be used to treat type 2 diabetes in a child of any age.

To make sure Humalog is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• heart problems; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Humalog if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Humalog?

Use Humalog exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Humalog is injected under the skin using a syringe and needle, an injection pen, or with an infusion pump. A healthcare provider will teach you how to properly use this medicine by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors or has particles in it. Call your pharmacist for new medicine.

Humalog is to be used within 15 minutes before a meal, or right after eating.

Your healthcare provider will show you where on your body to inject insulin lispro. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not inject into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Concentrated Humalog (200 units) must not be given with an insulin pump, or mixed with other insulins. Do not transfer insulin lispro from an injection pen to a syringe or a severe overdose could occur.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin lispro:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) Humalog:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the cartridge or injection pen (without a needle attached) at room temperature and use within 28 days.

Use a needle and syringe only once and place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since Humalog is used before meals, you may not be on a timed dosing schedule. Whenever you use Humalog, be sure to eat a meal within 15 minutes. Do not use two doses at one time.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Humalog?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect Humalog?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines,  vitamins, and herbal products.

Buy vitamins and supplements

Humalog Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 3 for Humalog.Admelog (insulin lispro) – Sanofi-Aventis U.S. LLC

What is Humira?

Humira is used to treat many inflammatory conditions in adults, such as rheumatoid arthritis (RA), psoriatic arthritis (PA), ankylosing spondylitis (AS), plaque psoriasis, and a skin condition called hidradenitis suppurativa.

Humira is also used in adults and children to treat Crohn’s disease, juvenile idiopathic arthritis, ulcerative colitis, and uveitis.

Humira’s mechanism of action involves specifically targeting and blocking tumor necrosis factor (TNF)-alpha, a key inflammatory protein in the immune system. This interrupts immune system signals that cause excessive inflammation. Humira belongs to the drug class tumor necrosis factor (TNF) blockers and is also called a biologic.  

Humira gained FDA approval on December 31, 2002. There are several Humira generics (more correctly called biosimilars).

What are the Humira biosimilars?

There are 10 biosimilars of Humira. Some are fully interchangeable, others have mixed interchangeability, and others are not interchangeable.

• Abrilada is a fully interchangeable biosimilar of Humira (all strengths). An interchangeable biosimilar can automatically substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.
• For Amjevita, the following strengths are interchangeable: prefilled syringe, 20mg/0.4mL, 40mg/0.8mL, 10mg/0.2mL; autoinjector 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe 20mg/0.2mL, 40mg/0.4mL, 80mg/0.8mL; autoinjector 40mg/0.4mL, 80mg/0.8mL.
• For Cyltezo, the following strengths are interchangeable: prefilled syringe, 40mg/0.8mL, 20mg/0.4mL, 10mg/0.2mL; autoinjector 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe/autoinjector 40mg/0.4mL.
• For Hadlima, the following strengths are interchangeable: prefilled syringe/single-dose vial 40mg/0.8mL.  The following strengths are not interchangeable: prefilled syringe/autoinjector 40mg/0.4mL, autoinjector 40mg/0.8mL.
• For Hyrimoz, the following strengths are interchangeable: prefilled syringe, 40mg/0.8mL, 80mg/0.8mL, 20mg/0.4mL, 20mg/0.2mL, 10mg/0.2mL, 10mg/0.1mL. The following strengths are not interchangeable: prefilled syringe 40mg/0.4mL; autoinjector 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL. 
• For Simlandi, the following strengths are interchangeable: prefilled syringe/autoinjector, 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe 20mg/0.2mL, 80mg/0.8mL.
• Hulio, Idacio, Yuflyma, and Yusimry, are also biosimilars of Humira, but they are not interchangeable. This means they can only be dispensed in place of Humira if the healthcare provider specifically prescribes the biosimilar product by name. 

Humira uses

Humira is used to treat:

• moderate to severe RA in adults. Humira can be used alone, with methotrexate, or with certain other medicines
• moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Humira can be used alone or with methotrexate
• psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines
• ankylosing spondylitis (AS) in adults
• moderate to severe hidradenitis suppurativa (HS) in people 12 years and older
• moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older
• moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if Humira is effective in people who stopped responding to or could not tolerate TNF-blocker medicines
• moderate to severe chronic (lasting a long time) plaque psoriasis in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)
• non-infectious intermediate, posterior, and panuveitis in adults and children 2 years of age and older.

Humira side effects

The most common side effects of Humira include:

• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually go away within a few days. Call your doctor right away if you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse
• upper respiratory infections (including sinus infections)
• headaches
• rash.

Serious side effects and warnings

Humira is a medicine that affects your immune system and has a Boxed Warning for serious infections and cancer.

Serious infections. Humira can lower the ability of your immune system to fight infections. Serious infections have happened in people taking Humira. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.

• Your doctor should test you for TB before starting Humira.
• Your doctor should check you closely for signs and symptoms of TB during treatment with Humira.
• You should not start taking Humira if you have any kind of infection unless your doctor says it is okay.

After starting Humira, call your doctor right away if you have an infection or any signs of an infection. Humira can make you more likely to get infections or worsen any infection you may have.

Cancer. For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including Humira, the chances of getting cancer may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.

• People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• If you use TNF blockers including Humira your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that does not heal.
• Some people receiving TNF blockers including Humira developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6–MP).

Tuberculosis (TB). Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Humira and during treatment with Humira. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Humira. People who had a negative TB skin test before receiving Humira have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Humira:

• cough that does not go away
• low-grade fever
• weight loss
• loss of body fat and muscle (wasting).

Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Humira. Your doctor should do blood tests before you start treatment, while you are using Humira, and for several months after you stop treatment with Humira. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:

• muscle aches
• feel very tired
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting
• clay-colored bowel movements
• fever
• chills
• stomach discomfort
• skin rash.

Allergic reactions. Allergic reactions can happen in people who use Humira. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:

• hives
• trouble breathing
• swelling of your face, eyes, lips, or mouth.

Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.

Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.

New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking Humira, including:

• shortness of breath
• sudden weight gain
• swelling of your ankles or feet.

Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that get worse in the sun. Symptoms may improve when you stop Humira.

Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:

• feel very tired
• skin or eyes look yellow
• poor appetite or vomiting
• pain on the right side of your stomach (abdomen).

Psoriasis. Some people using Humira had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Humira. Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Humira may be stopped.

Call your doctor right away if you:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis – confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems – body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome – joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems – numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis – fever with ongoing cough, weight loss (fat or muscle).

What is Humulin N?

Humulin N is a man-made form of a hormone that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin isophane is an intermediate-acting insulin that starts to work within 2 to 4 hours after injection, peaks in 4 to 12 hours, and keeps working for 12 to 18 hours.

Humulin N is used to improve blood sugar control in adults and children with diabetes mellitus.

Humulin N may also be used for purposes not listed in this medication guide.

Warnings

You should not use Humulin N if you are having an episode of low blood sugar.

Never share an injection pen or syringe with another person, even if the needle has been changed.

Hypoglycemia, or low blood sugar, is the most common side effect of Humulin N. Symptoms of low blood sugar may include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Humulin N side effects

Get emergency medical help if you have any signs of an allergic reaction to Humulin N: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, chest tightness, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention – weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humulin N side effects may include:

• low blood sugar;
• weight gain, swelling in your hands or feet;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Before taking this medicine

You should not use Humulin N if you are allergic to insulin isophane, or if you are having an episode of hypoglycemia (low blood sugar).

Do not give Humulin N to a child without a doctor’s advice.

To make sure Humulin N is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Humulin N if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Humulin N?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Humulin N is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Do not give Humulin N with an insulin pump.

Humulin N must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Humulin N if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Humulin N should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject Humulin N. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

If you use an injection pen, use only the injection pen that comes with Humulin N. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, and feeling shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Humulin N is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Humulin N:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) Humulin N:

• Store in a refrigerator or at room temperature as directed in the Instructions for Use provided with your medicine. Do not refrigerate an in-use injection pen.
• In-use Humulin N is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Get your Humulin N prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Humulin N?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin. Some brands of insulin isophane and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect Humulin N?

Humulin N may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low.

What is Humulin R?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Humulin R is a short-acting insulin that starts to work within 30 minutes after injection, peaks in 2 to 3 hours, and keeps working for up to 8 hours.

Humulin R is used to improve blood sugar control in adults and children with diabetes mellitus.

Humulin R may be used for type 1 or type 2 diabetes.

Warnings

You should not use insulin if you are having an episode of hypoglycemia (low blood sugar).

Before taking this medicine

You should not use Humulin R if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humulin R is not approved for use by anyone younger than 2 years old. Humulin R should not be used to treat type 2 diabetes in a child of any age.

To make sure Humulin R is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or
• heart failure.

Taking certain oral diabetes medicines while using Humulin R may increase your risk of serious heart problems. Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Humulin R if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Humulin R?

Use Humulin R exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Humulin R is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself. Humulin R must not be given with an insulin pump. Do not inject Humulin R into a vein or a muscle.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare a Humulin R injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject insulin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using Humulin R, you should eat a meal within 30 minutes.

Never share a syringe with another person, even if the needle has been changed. Sharing syringes can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

Keep Humulin R in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Humulin R:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days shown in your Instructions for Use.

Storing opened (in use) Humulin R:

• Store at room temperature and use within the number of days shown in your Instructions for Use.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Humulin R?

Do not change the brand of insulin or syringe you are using without first talking to your doctor or pharmacist. Some brands of insulin and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how Humulin R will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can interfere with your diabetes treatment.

Humulin R side effects

Get emergency medical help if you have signs of an allergy to Humulin R: redness, swelling, sweating, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humulin R side effects may include:

• low blood sugar;
• swelling in your hands or feet;
• weight gain; or
• thickening or hollowing of the skin where you injected the medicine.

What is concentrated (U-500) insulin?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Concentrated (U-500) insulin is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. U-500 insulin is five times more concentrated than regular U-100 insulin.

U-500 insulin is used to improve blood sugar control in adults and children with diabetes mellitus who have significant daily insulin needs (more than 200 units per day).

U-500 insulin may also be used for purposes not listed in this medication guide.

U-500 insulin side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Humulin R (Concentrated) may cause serious side effects. Call your doctor at once if you have:

• fluid retention–weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of Humulin R (Concentrated) may include:

• low blood sugar;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use Humulin R (Concentrated) if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use U-500 insulin?

U-500 insulin is concentrated and contains 500 units of insulin in each milliliter (mL). This is five times more concentrated than regular U-100 insulin, which contains 100 units per mL. Measure each dose of U-500 insulin carefully. Using too much insulin can lead to insulin shock or death. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

U-500 insulin must not be given with an insulin pump, or mixed with other insulins. Do not inject U-500 insulin into a vein or a muscle.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject U-500 insulin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using U-500 insulin, you should eat a meal within 30 minutes.

If you use an injection pen, use only the injection pen that comes with U-500 insulin. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe. The injection pen has a dial on it that allows you to set your correct doses of U-500 insulin.

If you use U-500 insulin from a vial (bottle), use only a U-500 insulin syringe to inject the medicine. Do not use any other type of syringe.

Do not convert your dose when using a U-500 injection pen or U-500 insulin syringe.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

U-500 insulin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) U-500 insulin:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within 28 days.

Storing opened (in use) U-500 insulin:

• Store the vial in a refrigerator or at room temperature and use within 40 days. Do not shake the vial.
• Store the injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

What happens if I miss a dose?

Follow your doctor’s directions if you miss a dose. To prevent missed doses, keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What is hydralazine?

Hydralazine is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers blood pressure and allows blood to flow more easily through your veins and arteries.

Hydralazine is used to treat high blood pressure (hypertension).

Hydralazine may also be used for purposes not listed in this medication guide.

Hydralazine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Hydralazine may cause serious side effects. Call your doctor at once if you have:

• chest pain or pressure, pain spreading to your jaw or shoulder;
• fast or pounding heartbeats;
• a light-headed feeling, like you might pass out;
• numbness, tingling, or burning pain in your hands or feet;
• painful or difficult urination;
• little or no urination; or
• lupus-like syndrome–joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color.

Common side effects of hydralazine may include:

• chest pain, fast heart rate;
• headache; or
• nausea, vomiting, diarrhea, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use hydralazine if you have coronary artery disease, or rheumatic heart disease affecting the mitral valve.

Before taking this medicine

You should not use hydralazine if you are allergic to it, or if you have:

• coronary artery disease; or
• rheumatic heart disease affecting the mitral valve.

To make sure hydralazine is safe for you, tell your doctor if you have ever had:

• kidney disease;
• systemic lupus erythematosus;
• angina (chest pain); or
• a stroke.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Hydralazine can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

Hydralazine is not approved for use by anyone younger than 18 years old.

How should I take hydralazine?

Follow all directions on your prescription label. Do not take hydralazine in larger or smaller amounts or for longer than recommended.

Your blood pressure will need to be checked often. You may also need frequent blood tests.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include rapid heartbeats, warmth or tingling under your skin, chest pain, or fainting.

What should I avoid while taking hydralazine?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What other drugs will affect hydralazine?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• diazoxide (an injectable blood pressure medication); or
• an MAO inhibitor–isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

What is hydrochlorothiazide?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Hydrochlorothiazide is used to treat high blood pressure (hypertension).

Hydrochlorothiazide is also used to treat fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or kidney disorders, or edema caused by taking steroids or estrogen.

Warnings

You should not use hydrochlorothiazide if you are unable to urinate.

Before using hydrochlorothiazide, tell your doctor if you have liver disease, kidney disease, glaucoma, asthma or allergies, gout, diabetes, or if you are allergic to sulfa drugs or penicillin.

Avoid drinking alcohol, which can increase some of the side effects of hydrochlorothiazide .

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

There are many other drugs that can interact with hydrochlorothiazide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

If you are being treated for high blood pressure, keep using hydrochlorothiazide even if you feel fine. High blood pressure often has no symptoms.

Before taking this medicine

You should not use hydrochlorothiazide if you are allergic to it, or if you are unable to urinate.

To make sure hydrochlorothiazide is safe for you, tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• gout;
• glaucoma;
• low levels of potassium or sodium in your blood;
• high levels of calcium in your blood;
• a parathyroid gland disorder;
• diabetes; or
• an allergy to sulfa drugs or penicillin.

Tell your doctor if you are pregnant or plan to become pregnant. If you take hydrochlorothiazide during pregnancy, your newborn baby may develop jaundice or other problems.

You should not breastfeed while using this medicine.

Hydrochlorothiazide is not approved for use by anyone younger than 18 years old.

How should I take hydrochlorothiazide?

Take hydrochlorothiazide exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking hydrochlorothiazide, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Your blood pressure will need to be checked often. Your blood and urine may be tested if you have been vomiting or are dehydrated.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Keep using hydrochlorothiazide as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture, heat, and freezing. Keep the bottle tightly closed when not in use.

Hydrochlorothiazide dosing information

Usual Adult Dose for Edema:

Usual dose: 25 mg to 100 mg orally once or twice daily

Comments:
-Some patients respond to intermittent therapy, (i.e., administration on alternate days or on 3 to 5 days each week). Excessive response and undesirable electrolyte imbalance are less likely to occur with intermittent dosing.

Usual Adult Dose for Hypertension:

Initial dose: 25 mg orally once daily
Maintenance dose: May increase to 50 mg orally daily, as a single or 2 divided doses

Comments:
-Patients usually do not require doses in excess of 50 mg daily when used concomitantly with other antihypertensive agents.

Usual Adult Dose for Nephrocalcinosis:

Initial: 25 mg orally once daily
Maintenance dose: May increase to 50 mg twice daily

Usual Adult Dose for Diabetes Insipidus:

Initial: 50 mg orally once daily
Maintenance dose: May increase to 100 mg orally daily

Usual Pediatric Dose for Edema:

Less than 6 months: Up to 3 mg/kg/day (up to 1.5 mg/pound) orally in 2 divided doses

Less than 2 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 37.5 mg per day

2 to 12 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 100 mg per day

Usual Pediatric Dose for Hypertension:

Less than 6 months: Up to 3 mg/kg/day (up to 1.5 mg/pound) orally in 2 divided doses

Less than 2 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 37.5 mg per day

2 to 12 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 100 mg per day

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include nausea, dizziness, dry mouth, thirst, and muscle pain or weakness.

What should I avoid while taking hydrochlorothiazide?

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Drinking alcohol with hydrochlorothiazide can cause side effects.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Hydrochlorothiazide side effects

Get emergency medical help if you have signs of an allergic reaction to hydrochlorothiazide (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• a light-headed feeling;
• eye pain, vision problems;
• jaundice (yellowing of the skin or eyes);
• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
• shortness of breath, wheezing, cough with foamy mucus, chest pain;
• dehydration symptoms – feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
• signs of an electrolyte imbalance – increased thirst or urination, confusion, vomiting, constipation, muscle pain, leg cramps, bone pain, lack of energy, irregular heartbeats, tingly feeling.

Common hydrochlorothiazide side effects may include:

• weakness;
• feeling like you might pass out;
• severe pain in your upper stomach spreading to your back, nausea and vomiting;
• fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• electrolyte imbalance.

What is hydrochlorothiazide and lisinopril?

Hydrochlorothiazide is a thiazide diuretic (water pill). Lisinopril is in an ACE inhibitor (ACE stands for angiotensin converting enzyme).

Hydrochlorothiazide and lisinopril is a combination medicine used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack.

Hydrochlorothiazide and lisinopril may also be used for purposes not listed in this medication guide.

Hydrochlorothiazide and lisinopril side effects

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Hydrochlorothiazide and lisinopril may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• eye pain, vision problems;
• little or no urination;
• weakness, drowsiness, or feeling restless;
• fever, chills, sore throat, mouth sores, trouble swallowing;
• jaundice (yellowing of the skin or eyes);
• high potassium–nausea, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• low sodium–headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects of hydrochlorothiazide and lisinopril may include:

• cough;
• headache;
• dizziness; or
• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not use if you are pregnant. If you become pregnant, stop taking hydrochlorothiazide and lisinopril and tell your doctor right away.

You should not use this medicine if you have ever had angioedema, if you are unable to urinate, or if you are allergic to sulfa drugs or to any ACE inhibitor. Do not take hydrochlorothiazide and lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use hydrochlorothiazide and lisinopril together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

You should not use this medicine if you are allergic to hydrochlorothiazide or lisinopril, or if:

• you have hereditary angioedema;
• you are unable to urinate;
• you recently took a heart medicine called sacubitril;
• you have an allergy to sulfa drugs; or
• you have ever had a severe allergic reaction to any ACE inhibitor (benazepril, captopril, enalapril, fosinopril, moexipril, perindopril, quinapril, ramipril, trandolapril).

Do not take hydrochlorothiazide and lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use hydrochlorothiazide and lisinopril together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking hydrochlorothiazide and lisinopril with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• cirrhosis or other liver disease;
• glaucoma;
• heart disease or congestive heart failure;
• asthma or allergies;
• gout;
• lupus;
• an allergy to sulfa drugs or penicillin; or
• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Lisinopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using hydrochlorothiazide and lisinopril.

Hydrochlorothiazide and lisinopril is not approved for use by anyone younger than 18 years old.

How should I take hydrochlorothiazide and lisinopril?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking hydrochlorothiazide and lisinopril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Your blood pressure will need to be checked often, and you may need occasional blood tests.

If you need surgery, tell your surgeon you currently use this medicine.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

Hydrochlorothiazide and lisinopril dosing information

Usual Adult Dose for Hypertension:

Initial dose: Hydrochlorothiazide 12.5 mg-Lisinopril 10 to 20 mg orally once a day, depending on the current monotherapy dose

Maximum dose: Hydrochlorothiazide 50 mg-Lisinopril 80 mg per day

Comments:
-May increase dose every 2 to 3 weeks.
-If blood pressure is controlled with monotherapy hydrochlorothiazide 25 mg per day, but significant potassium loss occurs, then similar or greater blood pressure control without electrolyte disturbance may be achieved with hydrochlorothiazide 12.5 mg-lisinopril 10 mg orally once a day.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking hydrochlorothiazide and lisinopril?

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and lisinopril.

Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

What other drugs will affect hydrochlorothiazide and lisinopril?

Tell your doctor about all your other medicines, especially:

• any other blood pressure medication;
• lithium;
• everolimus, sirolimus, temsirolimus; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is hydrochlorothiazide and losartan?

Hydrochlorothiazide is a diuretic (water pill). Losartan is an angiotensin II receptor antagonist (sometimes called an ARB blocker).

Hydrochlorothiazide and losartan is a combination medicine used to treat high blood pressure (hypertension). It is also used to lower the risk of stroke in certain people with heart disease.

Hydrochlorothiazide and losartan may also be used for purposes not listed in this medication guide.

Hydrochlorothiazide and losartan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Hydrochlorothiazide and losartan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• irregular heartbeats;
• eye pain, vision problems;
• kidney problems–little or no urination, rapid weight gain, swelling in your hands, feet, or ankles;
• new or worsening symptoms of lupus–joint pain, and a skin rash on your cheeks or arms that worsens in sunlight; or
• signs of an electrolyte imbalance–increased thirst or urination, confusion, vomiting, constipation, muscle pain, leg cramps, irregular heartbeats, numbness or tingling, severe weakness, loss of movement, feeling jittery or unsteady.

Common side effects of hydrochlorothiazide and losartan may include:

• dizziness;
• back pain; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use hydrochlorothiazide and losartan if you are unable to urinate.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

If you have diabetes, do not use hydrochlorothiazide and losartan together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

You should not use this medicine if you are allergic to hydrochlorothiazide or losartan, if you are unable to urinate.

If you have diabetes, do not use hydrochlorothiazide and losartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking hydrochlorothiazide and losartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• lupus;
• liver or kidney disease;
• asthma or allergies;
• diabetes;
• gout;
• congestive heart failure;
• glaucoma;
• low or high levels of potassium in your blood;
• high cholesterol or triglyceride levels; or
• an allergy to penicillin or sulfa drugs.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Hydrochlorothiazide and losartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Hydrochlorothiazide and losartan is not approved for use by anyone younger than 18 years old.

How should I take hydrochlorothiazide and losartan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your blood pressure will need to be checked often.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking hydrochlorothiazide and losartan. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using hydrochlorothiazide and losartan.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture, heat, and light.

Hydrochlorothiazide and losartan dosing information

Usual Adult Dose for Hypertension:

HYPERTENSION:
Hydrochlorothiazide 12.5 to 25 mg-Losartan 50 to 100 mg orally once a day

Maximum dose: Hydrochlorothiazide 25 mg-Losartan 100 mg orally once a day

Comments:
-A patient whose blood pressure is not adequately controlled with hydrochlorothiazide or losartan monotherapy may be switched to hydrochlorothiazide 12.5 mg-losartan 50 mg orally once a day.
-May increase dose if blood pressure remains uncontrolled after about 3 weeks.

Use: Treatment of hypertension. This drug is not indicated for initial therapy except when hypertension is severe enough that the benefit of achieving prompt blood pressure control exceeds the risk of initiating combination therapy.

SEVERE HYPERTENSION:
Initial treatment: Hydrochlorothiazide 12.5 mg-Losartan 50 mg orally once a day; if blood pressure remains uncontrolled after 2 to 4 weeks, may initiate maximum dose.

Maximum dose: Hydrochlorothiazide 25 mg-Losartan 100 mg orally once a day

HYPERTENSION WITH LEFT VENTRICULAR HYPERTROPHY:
Initial therapy: Losartan monotherapy; if blood pressure remains uncontrolled, may initiate this drug.

Add-on therapy: Hydrochlorothiazide 12.5 mg-Losartan 50 mg orally once a day; if blood pressure remains uncontrolled, initiate hydrochlorothiazide 12.5 mg-losartan 100 mg orally once a day, followed by hydrochlorothiazide 25 mg-losartan 100 mg orally once a day, if needed.

Use: To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking hydrochlorothiazide and losartan?

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may cause side effects.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids.

What other drugs will affect hydrochlorothiazide and losartan?

If you also take cholestyramine or colestipol, take your hydrochlorothiazide and losartan dose 4 hours before or 4 to 6 hours after you take the other medicine.

Tell your doctor about all your other medicines, especially:

• a diuretic or “water pill”;
• other blood pressure medications;
• lithium; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is hydrochlorothiazide and telmisartan?

Hydrochlorothiazide is a diuretic (water pill). Telmisartan is an angiotensin II receptor blocker (sometimes called an ARB blocker).

Hydrochlorothiazide and telmisartan is a combination medicine is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Hydrochlorothiazide and telmisartan may also be used for purposes not listed in this medication guide.

Hydrochlorothiazide and telmisartan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

• eye pain, vision problems;
• a light-headed feeling, like you might pass out;
• jaundice (yellowing of the skin or eyes);
• swelling in your hands or feet, unusual weight gain;
• easy bruising, unusual bleeding; or
• signs of an electrolyte imbalance–dry mouth, increased thirst, drowsiness, confusion, feeling restless, vomiting, muscle pain or weakness, lack of energy, fast heartbeats, little or no urine, or a seizure.

Common side effects of hydrochlorothiazide and telmisartan may include:

• dizziness, feeling tired;
• nausea, diarrhea;
• back pain; or
• cold or flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

You should not use this medicine if you are unable to urinate.

If you have diabetes, do not use hydrochlorothiazide and telmisartan together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

You should not use hydrochlorothiazide and telmisartan if you are allergic to hydrochlorothiazide or telmisartan, if you are unable to urinate.

If you have diabetes, do not use hydrochlorothiazide and telmisartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking hydrochlorothiazide and telmisartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• glaucoma;
• low or high levels of magnesium or potassium in your blood;
• asthma or allergies;
• lupus;
• diabetes; or
• an allergy to penicillin or sulfa drugs.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Hydrochlorothiazide and telmisartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

How should I take hydrochlorothiazide and telmisartan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take this medicine with or without food.

Your blood pressure will need to be checked often.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking hydrochlorothiazide and telmisartan. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using this medicine.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat. Keep each tablet in its blister pack until you are ready to take it. Gently push the tablet through the foil to remove it.

Hydrochlorothiazide and telmisartan dosing information

Usual Adult Dose for Hypertension:

Hydrochlorothiazide 12.5 to 25 mg-Telmisartan 80 mg orally once a day

Maximum dose: Hydrochlorothiazide 25 mg-Telmisartan 160 mg orally once a day

Comments:
-This drug may be substituted for the individual titrated components.
-If blood pressure remains uncontrolled by hydrochlorothiazide 25 mg orally once a day monotherapy, may switch to hydrochlorothiazide 12.5 to 25 mg-telmisartan 80 mg orally once a day. Reassess after 2 to 4 weeks; may increase up to hydrochlorothiazide 25 mg-telmisartan 160 mg orally once a day.
-If blood pressure is controlled by hydrochlorothiazide 25 mg orally once a day monotherapy, but hypokalemia occurs, may switch to hydrochlorothiazide 12.5 mg-telmisartan 80 mg orally once a day.
-If blood pressure remains uncontrolled by telmisartan 80 mg orally once a day monotherapy, may switch to hydrochlorothiazide 12.5 mg-telmisartan 80 mg orally once a day; may titrate up to hydrochlorothiazide 25 mg-telmisartan 160 mg orally once a day, if necessary.

Use: Treatment of hypertension; not indicated for initial therapy.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include fast or slow heart rate, feeling light-headed, or fainting.

What should I avoid while taking hydrochlorothiazide and telmisartan?

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may cause side effects.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids.

What other drugs will affect hydrochlorothiazide and telmisartan?

If you also take cholestyramine or colestipol, avoid taking these medications within 4 hours before or 4 hours after you take hydrochlorothiazide and telmisartan.

Tell your doctor about all your other medicines, especially:

• any other heart or blood pressure medications;
• digoxin;
• lithium;
• a diuretic or “water pill”;
• insulin or oral diabetes medicine;
• opioid pain medicine;
• a sleeping pill;
• steroid medicine or adrenocorticotrophic hormone (ACTH);
• a barbiturate such as butabarbital, phenobarbital, or secobarbital; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is hydrochlorothiazide and valsartan?

Hydrochlorothiazide is a diuretic (water pill). Valsartan is an angiotensin II receptor blocker (sometimes called an ARB blocker).

Hydrochlorothiazide and valsartan is a combination medicine used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Hydrochlorothiazide and valsartan is given after other blood pressure medicines did not work or have stopped working.

Hydrochlorothiazide and valsartan may also be used for purposes not listed in this medication guide.

Hydrochlorothiazide and valsartan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Hydrochlorothiazide and valsartan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• eye pain, vision problems;
• an unusual skin rash;
• little or no urinating;
• jaundice (yellowing of the skin or eyes);
• easy bruising, unusual bleeding;
• a seizure;
• kidney problems–little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• signs of an electrolyte imbalance–dry mouth, increased thirst, confusion, feeling restless, vomiting, muscle pain or weakness, drowsiness, lack of energy, fast heartbeats, decreased urination.

Common side effects include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• dizziness; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use hydrochlorothiazide and valsartan if you are unable to urinate, or if you are allergic to sulfa drugs.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

If you have diabetes, do not use hydrochlorothiazide and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

You should not use this medicine if you are allergic to valsartan or hydrochlorothiazide, or if you have:

• decreased urination or are unable to urinate; or
• an allergy to sulfa drugs.

If you have diabetes, do not use hydrochlorothiazide and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking hydrochlorothiazide and valsartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• an electrolyte imbalance (such as low levels of potassium or magnesium, or high levels of calcium in your blood);
• liver disease;
• kidney disease;
• gallstones;
• lupus;
• congestive heart failure;
• gout, or high levels of uric acid in your blood;
• asthma or allergies;
• high cholesterol or triglyceride levels;
• an allergy to penicillin;
• glaucoma; or
• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Hydrochlorothiazide and valsartan is not approved for use by anyone younger than 18 years old.

How should I take hydrochlorothiazide and valsartan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take hydrochlorothiazide and valsartan with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and valsartan.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

Hydrochlorothiazide and valsartan dosing information

Usual Adult Dose for Hypertension:

Initial dose: 1 tablet (12.5 mg-160 mg) orally once a day

Maintenance dose: Titrate as necessary (every 1 to 2 weeks) up to a maximum of 25 mg-320 mg orally once a day

Comment:
-Hydrochlorothiazide-valsartan may be substituted for the titrated components.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking hydrochlorothiazide and valsartan?

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may cause side effects.

Avoid driving or hazardous activity until you know how hydrochlorothiazide and valsartan will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What other drugs will affect hydrochlorothiazide and valsartan?

If you also take cholestyramine or colestipol, take your hydrochlorothiazide and valsartan dose 4 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your current medicines. Many drugs can affect hydrochlorothiazide and valsartan, especially:

• cyclosporine, digoxin, digitalis, lithium, or ritonavir;
• all your heart or blood pressure medicines;
• insulin or oral diabetes medicine;
• a diuretic or “water pill”;
• opioid pain medicine;
• a sleeping pill;
• a muscle relaxer;
• an antibiotic–rifabutin, rifampin, rifamycin, rifapentine;
• cancer medicine–cyclophosphamide, methotrexate; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is hydrocodone?

Hydrocodone is an opioid pain medication.

Zohydro ER and Hysingla ER are extended-release forms of hydrocodone that are used for around-the-clock treatment of severe pain.

Extended-release hydrocodone is not for use on an as-needed basis for pain.

Warnings

Hydrocodone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Tell your doctor if you are pregnant. Hydrocodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use hydrocodone if you are allergic to it, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

To make sure hydrocodone is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizures;
• drug or alcohol addiction, or mental illness;
• urination problems;
• liver or kidney disease;
• problems with your gallbladder, pancreas, or thyroid; or
• a heart rhythm disorder called long QT syndrome.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using hydrocodone if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take hydrocodone?

Hydrocodone may be habit-forming, even at regular doses. Follow the directions on your prescription label and read all medication guides. Never use hydrocodone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Your dose needs may be different if you have recently used a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose. Never crush or break a hydrocodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause death.

Do not stop using this medicine suddenly after long-term use, or you could have serious withdrawal symptoms. Ask your doctor how to safely stop using hydrocodone.

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Dosing information

Usual Adult Dose for Chronic Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

As First Opioid Analgesic and For Patients who are NOT Opioid Tolerant:
Extended-Release Capsules (Zohydro(R) ER): Initial dose: 10 mg orally every 12 hours
Extended-Release Tablets (Hysingla(R) ER): Initial dose: 20 mg orally every 24 hours

Comments:
-Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression; monitor patients closely for respiratory depression, especially during the first 24 to 72 hours.
-An opioid tolerant patient is one who has been receiving for 1-week or longer at least: oral morphine 60 mg/day, fentanyl transdermal patch 25 mcg per hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

What happens if I miss a dose?

Since hydrocodone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What to avoid

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how hydrocodone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Hydrocodone side effects

Get emergency medical help if you have signs of an allergic reaction to hydrocodone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using hydrocodone and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• pain or burning when you urinate;
• confusion, tremors, severe drowsiness;
• a light-headed feeling, like you might pass out;
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common hydrocodone side effects may include:

• constipation, nausea, vomiting;
• dizziness, drowsiness, feeling tired;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect hydrocodone?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is hydrocodone and acetaminophen?

Hydrocodone and acetaminophen is a combination medicine used to relieve moderate to severe pain. Hydrocodone is an opioid pain reliever and cough suppressant that belongs to the group of medicines called narcotic analgesics, that work on the central nervous system. Acetaminophen is a non-opioid analgesic used for pain relief and to reduce fever. Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

Hydrocodone and acetaminophen tablets have been marketed under the brand names Norco (discontinued), Vicodin  (discontinued), Lortab (discontinued), Hycet (discontinued), Lorcet (discontinued), Verdrocet (discontinued), Xodol (discontinued), Zamicet (discontinued) and now generic hydrocodone and acetaminophen products are available.

Is hydrocodone with acetaminophen a controlled substance?

Yes, hydrocodone with acetaminophen is a controlled substance. Under the Controlled Substances Act (CSA) hydrocodone (which includes hydrocodone with acetaminophen) is a schedule 2 controlled substance.  This means hydrocodone has a high potential for abuse, it currently has an accepted medical use which may include severe restrictions. Abuse may lead to severe psychological or physical dependence.

What strength is hydrocodone and acetaminophen tablets available as?

Examples of hydrocodone and acetaminophen tablets are:

• hydrocodone and acetaminophen 2.5mg/325mg tablets
• hydrocodone and acetaminophen 5mg/325mg tablets
• hydrocodone and acetaminophen 7.5mg/325mg tablets
• hydrocodone and acetaminophen 10mg/325mg tablets

Sometimes hydrocodone and acetaminophen strengths get abbreviated to hydrocodone acetaminophen 5-325 or hydrocodone acetaminophen 5 325, but is better to use the correct names and strengths (hydrocodone and acetaminophen 5mg/325mg tablets or hydrocodone 5mg and acetaminophen 325mg) to avoid confusion and dosing errors.

Warnings

MISUSE OF HYDROCODONE AND ACETAMINOPHEN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in secure a place where others cannot get to it.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and hydrocodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. See interactions section below for more information on drug interactions.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Stop taking acetaminophen and hydrocodone and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use this medicine if you are allergic to acetaminophen or hydrocodone, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

To make sure acetaminophen and hydrocodone is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• liver disease;
• a drug or alcohol addiction;
• kidney disease;
• a head injury or seizures;
• urination problems; or
• problems with your thyroid, pancreas, or gallbladder.

Pregnancy

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Breastfeeding

Do not breastfeed. Acetaminophen and hydrocodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take hydrocodone and acetaminophen?

Take hydrocodone and acetaminophen exactly as it was prescribed for you. Follow all directions on your prescription label. Never take hydrocodone and acetaminophen in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away hydrocodone and acetaminophen is against the law.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.

You should not stop using this medicine suddenly. Follow your doctor’s instructions about tapering your dose.

Store acetaminophen and hydrocodone at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Dosage

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Adult Dose for Pain:

Hydrocodone 2.5 mg-acetaminophen 325 mg per tablet, Hydrocodone 5 mg-acetaminophen 325 mg per tablet

• Initial dose: 1 to 2 tablets every 4 to 6 hours as needed for pain
• Maximum dose: 8 tablets/24 hours

Hydrocodone 7.5 mg-acetaminophen 325 mg, Hydrocodone 10 mg-acetaminophen 325 mg per tablet:

• Initial dose: 1 tablet every 4 to 6 hours as needed for pain
• Maximum dose: 6 tablets/24 hours

Hydrocodone 7.5 mg-acetaminophen 325 mg per 15 mL oral solution:

• Initial dose: 15 mL every 4 to 6 hours as needed for pain
• Maximum dose: 90 mL/24 hours

Hydrocodone 10 mg-acetaminophen 300 mg per 15 mL oral solution:

• Initial dose: 11.25 mL every 4 to 6 hours as needed for pain
• Maximum dose: 67.5 mL/24 hours

Comments:

• Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
• Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

For more information on hydocodone/acetminophen doses for adults or children, or dosage adjustments required for medical conditions click on the link below.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of acetaminophen and hydrocodone can be fatal.

Acute overdosage with hydrocodone and acetaminophen tablets can cause respiratory depression, sleepiness progressing to near-unconsciousness or coma, floppy muscles, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, slow heartbeat, low blood pressure, partial or complete airway obstruction, unusual snoring, and death. If the patient who has overdosed becomes very low in oxygen pupils may become very dilated instead of constricted pupils. 

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What to avoid

• Avoid driving or operating machinery until you know how hydrocodone and acetaminophen will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
• Do not drink alcohol. Dangerous side effects or death could occur.
• Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen which is sometimes abbreviated as APAP and also known as paracetamol. Taking certain medications together with acetaminophen and hydrocodone can lead to a fatal overdose. 

Side effects of hydrocodone and acetaminophen

Common side effects of hydrocodone acetaminophen include:

• dizziness, drowsiness, feeling tired;
• nausea, vomiting, stomach pain;
• constipation; or headache.

Serious side effects of hydrocodone acetaminophen include:

Get emergency medical help if you have signs of an allergic reaction to acetaminophen and hydrocodone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• liver problems – nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect hydrocodone and acetaminophen?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is hydrocodone and ibuprofen?

Hydrocodone is an opioid pain medicine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This combination medicine is used short-term to relieve severe pain.

Hydrocodone and ibuprofen may also be used for purposes not listed in this medication guide.

Hydrocodone and ibuprofen side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Hydrocodone and ibuprofen may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing, sighing, slow heartbeat, breathing that stops during sleep;
• swelling, rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–loss of appetite, diarrhea, upper stomach pain, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• low cortisol levels–vomiting, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body–agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of hydrocodone and ibuprofen may include:

• dizziness, drowsiness;
• stomach pain, nausea, vomiting, heartburn, gas;
• constipation, diarrhea; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking hydrocodone and ibuprofen during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to hydrocodone or ibuprofen, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizure;
• liver or kidney disease;
• high blood pressure, heart problems, or a heart attack;
• problems with your gallbladder, pancreas, or thyroid;
• urination problems; or
• drug or alcohol addiction, or mental illness.

If you are pregnant, you should not take this medicine unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious problems in the unborn baby and possible complications with your pregnancy. If you take opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using this medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take hydrocodone and ibuprofen?

Follow the directions on your prescription label and read all medication guides. Never use hydrocodone and ibuprofen in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Store at room temperature away from moisture and heat.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Hydrocodone and ibuprofen dosing information

Usual Adult Dose for Pain:

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:
-The lowest effective dose or the longest dosing interval should be sought for each patient.
-Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
-Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Pediatric Dose for Pain:

16 years or older:

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:
-The lowest effective dose or the longest dosing interval should be sought for each patient.
-Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
-Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

What happens if I miss a dose?

Since hydrocodone and ibuprofen is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include black or bloody stools, coughing up blood, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while taking hydrocodone and ibuprofen?

Avoid driving or hazardous activity until you know how hydrocodone and ibuprofen will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

What other drugs will affect hydrocodone and ibuprofen?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids–opioid pain medicine or prescription cough medicine;
• a sedative like Valium–diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
• drugs that make you sleepy or slow your breathing–a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body–a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is hydrocortisone cream?

Hydrocortisone cream is used to treat eczema, dermatitis, psoriasis, hemorrhoids, insect bites or stings, and other skin conditions to help relieve itchy or inflamed skin. It is also available as hydrocortisone ointment, suppositories, gel, and lotion. Hydrocortisone is a steroid medicine that works by decreasing inflammation and reducing an overactive immune system.

Hydrocortisone cream and skin products should only be used on skin conditions that respond to steroids.

Hydrocortisone creams, suppositories, and other topical products may contain other active ingredients, including antibiotics neomycin and polymyxin B sulfate when used for inflamed, infected skin, or hydrocortisone with pramoxine for hemorrhoids.

Hydrocortisone, hydrocortisone butyrate, and hydrocortisone acetate are different medicines. Hydrocortisone butyrate 0.1% (Locoid) is stronger or more potent than hydrocortisone 2.5%, 1% and 0.5%. Hydrocortisone acetate and hydrocortisone are both mild steroids.

Hydrocortisone ointment is used on very dry skin and creates a barrier to lock in moisture. This also helps the active ingredient penetrate the skin, so it is more potent than creams and lotions. Creams are easier to apply to the skin, are absorbed quickly, and help keep the skin moisturized. Lotions are lighter and easier to apply to large areas of the body, hairy areas, or weeping skin. Gels are often used on the scalp because they don’t leave the hair greasy.

Hydrocortisone tablets are used to treat asthma, allergic reactions, arthritis, inflammatory bowel diseases, adrenal insufficiency, lupus, certain cancers, and inflammatory conditions. It works to decrease inflammation, replace cortisol, or improve an overactive immune system.

Hydrocortisone side effects

Common hydrocortisone cream side effects (topical use)

Common hydrocortisone cream side effects are skin redness, itching, stinging, rash, redness or crusting around your hair follicles, burning, dryness, or other irritation of treated skin, itching, or irritation around your mouth, appearance and color changes in treated skin, signs of skin infection (swelling, redness, warmth, oozing), numbness, tingling, or burning pain.

Serious hydrocortisone cream side effects (topical use)

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Hydrocortisone side effects can occur if your skin absorbs topical steroid medicine. Tell your doctor if you have:

• swelling, weight gain (especially in your face or your upper back and torso);
• thinning skin, stretch marks, acne, increased facial hair;
• irregular menstrual periods, changes in sexual function, or
• memory problems, feeling irritable.

Hydrocortisone skin products can cause other serious side effects. Call your doctor at once if you have:

• worsening of your skin condition;
• pain, tenderness, headache;
• blurred vision, eye pain or redness, seeing halos around lights;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor; or
• increased adrenal gland hormones–hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes.

Children can absorb larger amounts of hydrocortisone through the skin and may be more likely to have side effects.

Common hydrocortisone side effects (tablets)

Common hydrocortisone tablet side effects include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.

Serious hydrocortisone side effects (tablets)

Serious hydrocortisone tablet side effects include adrenal crisis, immunosuppression and increased risk of infection, slow growth, Cushing’s syndrome, decrease in bone mineral density, psychiatric side effects, ophthalmic adverse reactions, gastrointestinal adverse reactions, vaccinations and risk of Kaposi’s sarcoma.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Warnings for OTC hydrocortisone cream

Do not use it in the eyes, for diaper rash, or for external genital or feminine itching if you have a vaginal discharge. Do not use more than the recommended daily dosage unless directed by a doctor

Stop using this product and consult a doctor if your condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days, unless prescribed by a doctor).

Stop using this product and consult a doctor if bleeding occurs due to anal itching.

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue; these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.

If a skin infection develops or is present, anti-infective therapy should be started. If it does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.

Warning for hydrocortisone tablets

Hydrocortisone Tablets may suppress the immune system and increase the risk of infection. Corticosteroid-associated infections can be mild but can be severe and, at times, fatal. The rate of infectious complications increases with increasing corticosteroid dosages.

Prolonged use of corticosteroids may cause eye side effects, including posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves. It may also enhance the establishment of secondary ocular infections due to fungi or viruses.

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic condition.

Average and large doses of hydrocortisone or cortisone can elevate blood pressure, cause salt and water retention, and increase potassium excretion.

Vaccinations. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

Before taking this medicine

Hydrocortisone cream

You should not use hydrocortisone topical if you are allergic to it.

Tell your doctor if you have or have ever had:

• any type of skin infection;
• a skin reaction to any steroid medicine;
• cataract or glaucoma;
• thinning of the skin where you will apply hydrocortisone topical;
• problems with your adrenal gland; or
• liver disease.

Steroid medicines can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Pregnancy

Tell your healthcare provider if you are pregnant, plan to become pregnant or become pregnant as it is not known if hydrocortisone topical will harm an unborn baby.

Breastfeeding

Ask your healthcare provider if it is safe to breastfeed while using this medicine.

Hydrocortisone tablets

You should not use hydrocortisone if you are allergic to hydrocortisone or corticosteroids or if you have a systemic fungal infection.

Steroids can weaken your immune system, making it easier to get an infection or worsen an infection you already have. Tell your doctor about any illness or infection you had within the past several weeks.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• tuberculosis;
• kidney disease;
• cirrhosis or other liver disease;
• a thyroid disorder;
• low bone mineral density (osteoporosis);
• stomach ulcers, ulcerative colitis, diverticulitis;
• diabetes;
• a colostomy or ileostomy;
• depression or mental illness;
• glaucoma or cataracts;
• herpes infection of the eyes; or
• a muscle disorder such as myasthenia gravis.

Long-term oral use of steroids may lead to bone loss (osteoporosis), especially if you smoke, do not exercise, do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

Pregnancy

It is not known whether hydrocortisone tablets or capsules will harm an unborn baby. However, using this medicine during pregnancy may cause a hormone deficiency in the newborn. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I use hydrocortisone cream?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Wash your hands before and after applying this medicine unless you are using it to treat a hand condition.

Do not take it by mouth. Topical medicine is for use only on the skin.

Apply a thin layer of hydrocortisone cream, ointment, lotion, or gel to the affected skin and rub it in gently. Do not apply this medicine over a large skin area unless your doctor has told you to.

Apply rectal creams and ointments externally to the anal area; some commercially available creams also may be applied externally to the anogenital areas.

For scalp conditions, part the hair and apply a small amount of lotion or solution directly to the affected area; rub gently into the scalp. Maintain usual hair care, but do not wash out the lotion immediately after application. Alternatively, for scalp dermatoses, apply aerosol to dry scalp after shampooing.

Do not cover treated skin with a bandage unless your doctor tells you to.

For hydrocortisone lotion and spray shake well just before each use.

If you are treating the diaper area, do not use plastic pants or tight-fitting diapers.

You may need medical tests to be sure this medicine is not causing harmful effects.

You may need blood or urine tests while using this medicine.

Stop using OTC hydrocortisone skin products and call your doctor if your symptoms do not improve after using this medicine for 7 days, or if your symptoms get worse or get better, and then come back in a few days.

Store at room temperature, away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

How should I take hydrocortisone tablets or capsules?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with food if hydrocortisone upsets your stomach.

Do not swallow an Alkindi Sprinkle capsule whole. Open the capsule and pour the medicine granules onto the tongue before swallowing. You may also mix the granules with soft food such as yogurt or applesauce (not with liquid). Swallow the mixture right away without chewing.

Drink water right after taking the Alkindi Sprinkle granule mixture. If giving this medicine to a baby, give infant formula or breast milk.

If you have trouble sleeping, you may need to take this medicine early in the day. Follow your doctor’s dosing instructions very carefully.

Your dose needs may change if you have a serious illness, fever or infection, surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Your doctor will need to check your progress on a regular basis.

You should not stop taking hydrocortisone suddenly. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light.

Wear a medical alert tag or carry an ID card to let others know you use steroid medication.

What happens if I miss a dose?

Skin products: Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Tablets or capsules: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medicine.

Skin products: High doses or long-term use of hydrocortisone topical can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Hydrocortisone tablets or capsules:

High doses or long-term use of steroid medicine can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone?

Skin products

• Do not use hydrocortisone topical to treat any skin condition that has not been checked by your doctor.
• Avoid applying hydrocortisone topical to the skin of your face, underarms, or groin area unless your doctor has told you to.
• Avoid using other medications on the areas you treat with hydrocortisone skin products unless your doctor tells you to.
• Do not get hydrocortisone topical in your eyes. If contact does occur, rinse with water.

Hydrocortisone oral products

• Avoid receiving a “live” vaccine. The vaccine may not work as well while you are using hydrocortisone.
• Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using hydrocortisone.

What other drugs will affect hydrocortisone?

Skin products

Medicine used on the skin is not likely to be affected by other drugs you use, but many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.

Hydrocortisone oral products

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect hydrocortisone tablets and capsules, especially:

• birth control pills or hormone replacement therapy;
• heart medication;
• insulin or oral diabetes medicine;
• medicine to treat an infection;
• seizure medication;
• a blood thinner such as warfarin (Coumadin, Jantoven); or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Introduction

Corticosteroid secreted by the adrenal cortex; topical anti-inflammatory agent.

Uses for Hydrocortisone (Topical)

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Nonprescription preparations used for temporary relief of minor skin irritations, itching, and rash caused by eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, or jewelry.

Nonprescription preparations used for temporary relief of itchy anal and/or genital areas.

Nonprescription preparations used for temporary relief of itching and minor scalp irritation caused by scalp dermatitis.

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)

Response may vary from one topical corticosteroid preparation to another.

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.

Infected Dermatoses

Topical treatment of infected dermatoses in combination with topical anti-infectives (e.g., neomycin, polymyxin B) or antifungals.

If a topical corticosteroid is used in combination with a topical anti-infective, weigh benefits against risks.

Oral Lesions

Hydrocortisone acetate paste used as an adjunct for temporary symptomatic relief of oral inflammatory or ulcerative lesions resulting from trauma.

Ulcerative Colitis and Anorectal Disorders

Used rectally as a retention enema for adjunctive treatment of mild or moderate acute ulcerative colitis limited to the rectosigmoid or left colon.

Used rectally as a retention enema for mild acute ulcerative colitis of the transverse or descending colon.

Retention enema usually is effective in mild or moderate acute rectosigmoid ulcerative colitis when response to sulfasalazine (generally considered the maintenance drug of choice) is inadequate or when sulfasalazine cannot be given.

Systemic corticosteroids and/or corticosteroid enemas are more effective than sulfasalazine in acute ulcerative colitis attacks, but if surgery is required, it should not be delayed in favor of corticosteroid therapy.

Hydrocortisone acetate rectal suppositories or suspension (foam), may be effective as adjunctive treatment of rectal ulcerative colitis.

Hydrocortisone acetate rectal suppositories also are used in the treatment of other anorectal inflammatory conditions (e.g., inflamed hemorrhoids, postirradiation or factitial proctitis, cryptitis, pruritus ani).

Fixed-combination preparations of a corticosteroid and local anesthetic may be useful for symptomatic relief of anorectal conditions (e.g., hemorrhoids), but combinations with antihistamines, astringents, keratolytics, and/or vasoconstrictors are of questionable efficacy.

Hydrocortisone (Topical) Dosage and Administration

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.
• Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.
• Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin). Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.
• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercial preparations with another vehicle may decrease effectiveness.
• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol). (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.

Apply creams, lotions, ointments, solutions, and aerosol foams topically to the skin or scalp.

Apply paste topically inside the oral cavity.

Apply rectal creams and ointments externally to the anal area; some commercially available creams also may be applied externally to the anogenital areas.

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.

Apply cream, lotion, ointment, or solution sparingly in a thin film and rub gently into affected area.

For scalp dermatoses, part the hair and apply small amount of lotion or solution directly to the affected area; rub gently into scalp. Maintain usual hair care, but do not wash out lotion immediately after application. Alternatively, for scalp dermatoses, apply aerosol to dry scalp after shampooing.

To dispense foam, shake container well (for 5–10 seconds) immediately prior to use. Hold container upright and press down on container cap until foam appears. Apply a small amount to affected area.

For use in the mouth, press a small amount of paste to the lesion without rubbing until a thin film develops.

After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.

Administration with Occlusive Dressing

Occlusive dressings may be used for severe or resistant dermatoses (e.g., psoriasis). (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film. Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape. For added moisture in dry lesions, apply cream, ointment, or lotion and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.

Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed. Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion. (See Occlusive Dressings under Cautions.)

Rectal Administration

Administer rectally as a retention enema, suppository, or aerosol foam.

Administer retention enema, suppository, or foam carefully according to manufacturer’s instructions.

Dosage

Available as hydrocortisone (dosage expressed in terms of the base) and as hydrocortisone acetate, buteprate, butyrate, and valerate (dosage expressed in terms of the salt).

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy.

Corticosteroid-responsive Dermatoses

Topical

Nonprescription hydrocortisone preparations should not be used in children <2 years of age unless directed and supervised by a clinician.

Children ≥2 years of age: Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.

Adults

Corticosteroid-responsive Dermatoses

Topical

Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.

Apply aerosol foam to affected area 2–4 times daily.

Nonprescription preparations should not be used for self-medication for >7 days.

If the condition worsens or symptoms persist, discontinue and consult a clinician.

Oral Lesions

Topical

Apply a small amount of paste to the lesion 2 or 3 times daily after meals and at bedtime.

If substantial regeneration or repair of oral tissues does not occur after 7 days, further investigate etiology of the lesions.

Ulcerative Colitis and Anorectal Disorders

Rectal (as Retention Enema)

Adjunctive treatment of ulcerative colitis: 100 mg nightly. Some clinicians recommend 100 mg twice daily followed by 100 mg nightly when improvement occurs.

Usually given for 21 days or until clinical and proctologic remissions are achieved.

Lay on left side during and for 30 minutes after administration to distribute drug throughout the left colon. Retain for ≥1 hour, preferably all night.

Symptoms may improve in 3–5 days, followed by proctologic improvement. Discontinue if clinical or proctologic improvement does not occur within 2–3 weeks.

Protologic remission may require 2–3 months of therapy.

Following treatment for >21 days, gradually withdraw use; give every other night for 2–3 weeks, then discontinue.

Rectal (as Foam)

Ulcerative proctitis of the distal rectum: 90 mg (1 applicatorful of a 10% aerosol foam suspension) 1 or 2 times daily for 2–3 weeks. Then, if necessary, every other day until clinical and proctologic improvement.

Symptoms may improve within 5–7 days.

Rectal (as Suppository)

Adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of the anorectum: 25 mg in the morning and at night for 2 weeks.

Severe proctitis: 25 mg 3 times daily or 50 mg twice daily.

Adjunctive treatment of postirradiation or factitial proctitis: 25 mg in the morning and at night for 6–8 weeks (or less if an adequate response is attained).

For internal hemorrhoid symptoms and adjunctive treatment of other anorectal inflammatory conditions: 10 mg in the morning and at night for 2–6 days.

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses

Self-medication

Topical

Maximum 7 days.

Adults

Corticosteroid-responsive Dermatoses

Self-medication

Topical

Maximum 7 days.

Cautions for Hydrocortisone (Topical)

Contraindications

• Known hypersensitivity to hydrocortisone or any ingredient in the formulation.
• Rectal corticosteroid therapy in patients with intestinal obstruction, abscess, impending perforation, peritonitis, extensive fistulas, and fresh intestinal anastomoses or sinus tracts.

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.

General Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression.

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.

HPA-axis function recovery generally is prompt and complete following drug discontinuance.

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.

Systemic Effects

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Adverse systemic effects may occur when corticosteroids are used on large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.

Infants and children may be more susceptible to adverse systemic effects.

Local Effects

Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue; these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.

If irritation occurs, discontinue drug and initiate appropriate therapy.

Skin Infection

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy. If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation. In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.

Do not use occlusive dressings in patients with primary skin infection.

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin); however, most clinicians believe topical corticosteroids may be used with caution if the infection is treated.

Severe Ulcerative Colorectal Disease

Use rectally with caution in severe ulcerative disease and only after adequate proctologic examination; risk of intestinal perforation.

Occlusive Dressings

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly. (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy. (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.

Do not use occlusive dressings in patients with primary skin infection.

Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.

Use plastic occlusive material with care to avoid the risk of suffocation.

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether topical hydrocortisone is distributed into milk. Caution advised if topical hydrocortisone is used.

Pediatric Use

Nonprescription hydrocortisone preparations should not be used in children <2 years of age unless directed and supervised by a clinician.

Tight-fitting diapers or plastic pants should not be used on a child being treated in the diaper area, since such garments may constitute occlusive dressings.

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio, especially when topical corticosteroids are applied to >20% of body surface area. The risk of adrenal suppression appears to increase with decreasing age. (See Systemic Effects under Cautions.)

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.

Children also are at greater risk of glucocorticoid insufficiency during and/or after withdrawal of treatment.

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.

Striae has been reported in children treated inappropriately with topical corticosteroids.

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.

Common Adverse Effects

Burning, stinging, itching, irritation, dry skin, erythema, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.

Drug Interactions

Specific Drugs and Laboratory Tests

Hydrocortisone (Topical) Pharmacokinetics

Absorption

Bioavailability

Percutaneous penetration of corticosteroids following topical application to the skin varies among individuals and may be increased by occlusive dressings, high corticosteroid concentrations, and certain vehicles.

Only minimal amounts of topical corticosteroid reach the dermis and subsequently the systemic circulation after application to most normal skin areas; more absorption occurs from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole.

Absorption is markedly increased by loss of the skin’s keratin layer and by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema).

Occlusive dressings used with hydrocortisone for 96 hours substantially enhance percutaneous penetration; occlusive dressings used for up to 24 hours do not appear to alter penetration.

In healthy individuals, up to 30–90% of hydrocortisone administered rectally as a retention enema may be absorbed. Greater amounts of hydrocortisone may be absorbed if the intestinal mucosa is inflamed.

Distribution

Extent

Not known whether topical hydrocortisone is distributed into milk.

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in the bile.

Stability

Storage

Topical

Creams, Lotions, Ointments, Solutions, Aerosol Foams

Room temperature; consult product information for specific recommendations.

Rectal

Creams, Suspensions for Retention Enemas, Aerosol Foams, Suppositories

Room temperature; consult product information for specific recommendations.

Actions

• Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding.
• Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.
• Anti-inflammatory effects may occur through induction of phospholipase A₂ inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids. Decreased arachidionic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).
• Decreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown.

Advice to Patients

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes. (See Topical Administration under Dosage and Administration.)
• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.
• Importance of informing parents of children receiving the drug that if hydrocortisone is applied in the diaper area, tight-fitting diapers or plastic pants should not be used since they may act as an occlusive dressing.
• Importance of reporting any local adverse reactions, especially those occurring under occlusive dressings, to a clinician.
• Potential for hydrocortisone acetate suppositories to stain fabric; take appropriate precautionary measures.
• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs; other corticosteroid-containing preparations should not be used without first consulting with clinician.
• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.
• Importance of informing patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name