What is labetalol?

Labetalol is a beta-blocker that is used to treat hypertension (high blood pressure). Labetalol oral is sometimes given with other blood pressure medications.

Labetalol injection is used when hypertension is severe.

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

Labetalol 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.

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

• a light-headed feeling, like you might pass out;
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• severe headache, blurred vision, pounding in your neck or ears; or
• liver problems–loss of appetite, stomach pain (upper right side), flu-like symptoms, itching, dark urine, jaundice (yellowing of the skin or eyes).

Severe dizziness or fainting may be more likely in older adults.

Common side effects of labetalol may include:

• dizziness, drowsiness, tiredness;
• nausea, vomiting;
• sudden warmth, skin redness, sweating;
• numbness; or
• tingly feeling in your scalp.

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 labetalol if you are allergic to it, or if you have:

• asthma;
• “AV block” (2nd or 3rd degree);
• uncontrolled heart failure;
• very low blood pressure;
• slow heartbeats that have caused you to faint; or
• if your heart cannot pump blood properly.

Tell your doctor if you have ever had:

• congestive heart failure;
• angina (chest pain);
• liver disease;
• emphysema, chronic bronchitis, or other breathing problems;
• pheochromocytoma (tumor of the adrenal gland);
• diabetes;
• coronary artery bypass surgery (sometimes called “CABG”);
• kidney disease; or
• allergies.

Labetalol can affect your pupils. If you need eye surgery, tell the surgeon about your use of labetalol, even if you no longer take it.

Labetalol may cause low blood pressure, low blood sugar, slow heartbeats, or breathing problems in a newborn if the mother uses labetalol during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

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

Not approved for use by anyone younger than 18 years old.

How should I use labetalol?

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.

Labetalol oral is taken by mouth.

Labetalol injection is given in a vein by a healthcare provider when hypertension is severe. After the injection you may need to remain lying down for up to 3 hours. You may feel light-headed when you first stand up.

Your blood pressure will need to be checked often, and you may need other medical tests. If you have diabetes, check your blood sugar regularly.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms.

Labetalol can cause false results with certain lab tests of the urine, including a drug-screening urine test. Tell the laboratory staff that you use labetalol.

Tell your doctor if you have a planned surgery.

You should not stop using labetalol suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture and heat.

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 slow heart rate, wheezing, chest tightness, trouble breathing, extreme dizziness, seizure, or fainting.

What should I avoid while using labetalol?

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of labetalol.

What other drugs will affect labetalol?

Tell your doctor about all your other medicines, especially:

• any other blood pressure medicine;
• aminophylline, theophylline;
• cimetidine;
• heart medication;
• insulin or oral diabetes medicine;
• an antidepressant–amitriptyline, doxepin, desipramine, imipramine, nortriptyline, and others; or
• a bronchodilator–albuterol, formoterol, levalbuterol, metaproterenol, olodaterol, salmeterol, and others.

What is lactulose?

Lactulose is used to treat chronic constipation.

Lactulose is sometimes used to treat or prevent certain conditions of the brain that are caused by liver failure. These conditions can lead to confusion, problems with memory or thinking, behavior changes, tremors, feeling irritable, sleep problems, loss of coordination, and loss of consciousness.

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

Lactulose 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.

Stop using lactulose and call your doctor at once if you have severe or ongoing diarrhea.

Common side effects of lactulose may include:

• bloating, gas;
• stomach pain;
• diarrhea; or
• nausea, vomiting.

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 lactulose if you are on a special diet low in galactose (milk sugar).

Tell your doctor if you have ever had:

• diabetes; or
• if you need to have any type of intestinal test using a scope (such as a colonoscopy).

Tell your doctor if you are pregnant or breastfeeding.

How should I take lactulose?

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

Mix lactulose powder with at least 4 ounces of water, milk, or fruit juice.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Lactulose should produce a bowel movement within 24 to 48 hours.

If you use lactulose long-term, you may need frequent medical tests.

Tell your doctor if you have a planned colonoscopy or proctoscopy procedure.

Store tightly closed at room temperature, away from moisture and heat. Avoid freezing.

The liquid may turn darker in color, but this will not affect the medicine. Do not use the medicine if it becomes very dark or gets thicker or thinner in texture.

Lactulose dosing information

Usual Adult Dose for Constipation — Chronic:

15 mL orally once a day.

Usual Adult Dose for Constipation — Acute:

Initial dose: 15 mL orally once a day. Therapy should be continued until normal bowel function resumes.

Usual Adult Dose for Hepatic Encephalopathy:

Initial dose: 30 mL orally 3 times a day or
300 mL in 700 mL water or normal saline as an enema retained for 30 to 60 minutes every 4 to 6 hours.
Maintenance dose: 30 to 45 mL orally 3 times a day.

Usual Pediatric Dose for Hepatic Encephalopathy:

Infants: 1.7 to 6.7 g/day (2.5 to 10 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

Children: 26.7 to 60 g/day (40 to 90 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

Usual Pediatric Dose for Constipation — Chronic:

Children: 0.7 to 2 g/kg/day (1 to 3 mL/kg/day) orally in divided doses daily; generally recommended not to exceed the adult maximum of 40 g/day (60 mL/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 may cause nausea, vomiting, diarrhea, and stomach cramps, or symptoms of low blood potassium or low blood sodium (confusion, weakness, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling).

What should I avoid while taking lactulose?

Ask your doctor before taking any other laxative or an antacid, and take only the type your doctor recommends.

What is Lamictal?

Lamictal is an anti-epileptic medication, also called an anticonvulsant.

Lamictal is used alone or with other medications to treat epileptic seizures in adults and children. Lamictal is also used to delay mood episodes in adults with bipolar disorder (manic depression).

Immediate-release Lamictal can be used in children as young as 2 years old for seizure treatment as an add-on treatment to other seizure medication. However, this form should not be used as a single medication in a child or teenager who is younger than 16 years old.

Extended-release Lamictal XR is for use only in adults and children who are at least 13 years old.

Warnings

Lamictal may cause a severe or life-threatening skin rash, especially in children and in people who take a very high starting dose, or those who also take valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if you have a skin rash, hives, blistering, peeling, or sores in your mouth or around your eyes.

Call your doctor at once if you have signs of other serious side effects, including: fever, swollen glands, severe muscle pain, bruising or unusual bleeding, yellowing of your skin or eyes, headache, neck stiffness, vomiting, confusion, or increased sensitivity to light.

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

Do not stop taking Lamictal without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using this medicine suddenly. Contact your doctor if your seizures get worse or you have them more often while taking this medicine. Taking this medication during early pregnancy can increase the risk of the baby being born with cleft lip or cleft palate. Tell your doctor if you are pregnant or if you become pregnant during treatment.

Before taking this medicine

You should not take Lamictal if you are allergic to lamotrigine.

Lamictal may cause a severe or life-threatening skin rash, especially in children and in people who take a very high starting dose, or those who also take valproic acid (Depakene) or divalproex (Depakote).

Tell your doctor if you have ever had:

• a rash or allergic reaction after taking another seizure medication;
• kidney or liver disease;
• heart problems such as heart block or irregular heartbeats;
• depression, suicidal thoughts or actions; or
• meningitis (inflammation of the tissue that covers the brain and spinal cord) after taking Lamictal.

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

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

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

Birth control pills can make lamotrigine less effective, resulting in increased seizures. Tell your doctor if you start or stop using birth control pills. Your lamotrigine dose may need to be changed.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take Lamictal?

Take Lamictal 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.

Taking too much Lamictal at the start of treatment may increase your risk of a severe life-threatening skin rash.

You may need frequent blood tests to help your doctor make sure you are taking the right dose.

Extended-release and immediate-release Lamictal may be used for different conditions. Always check your refills to make sure you have received the correct size, color, and shape of tablet. Avoid medication errors by using only the form and strength your doctor prescribes.

If you switch to Lamictal from another seizure medicine, carefully follow your doctor’s instructions about the timing and dosage of your medicine.

Lamictal tablets should be swallowed whole. Do not crush, chew, or break it.

Lamictal chewable dispersible tablets may be swallowed whole, chewed, or mixed with water or diluted fruit juice.

Read and carefully follow any Instructions for Use provided with the orally disintegrating or dispersible tablets. Ask your doctor or pharmacist if you do not understand these instructions.

Do not stop using this medicine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

In case of emergency, wear or carry medical identification to let others know you use seizure medication.

Lamotrigine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use lamotrigine.

Store at room temperature away from light and moisture.

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.

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.

Overdose symptoms may include blurred vision, problems with coordination, increased seizures, feeling light-headed, or fainting.

What to avoid

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

Lamictal side effects

Get emergency medical help if you have signs of an allergic reaction to Lamictal (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).

If you have to stop taking lamotrigine because of a serious skin rash, you may not be able to take it again in the future.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• fast, slow, or pounding heartbeats or fluttering in your chest;
• chest pain, shortness of breath;
• fever, swollen glands, weakness, severe muscle pain;
• any skin rash, especially with blistering or peeling;
• painful sores in your mouth or around your eyes;
• headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness;
• jaundice (yellowing of the skin or eyes); or
• pale skin, cold hands and feet, easy bruising, unusual bleeding.

Common Lamictal side effects may include:

• headache, dizziness;
• blurred vision, double vision;
• tremor, loss of coordination;
• dry mouth, nausea, vomiting, stomach pain, diarrhea;
• fever, sore throat, runny nose;
• drowsiness, tired feeling;
• back pain; or
• sleep problems (insomnia).

What is lanadelumab?

Lanadelumab (Takhzyro) is used to prevent hereditary angioedema (HAE), lanadelumab helps to reduce the number and severity of hereditary angioedema attacks. Lanadelumab works by lowering the activity of a protein called kallikrein which helps to prevent the swelling and related symptoms of HAE. Lanadelumab is usually given every two weeks as an injection under the skin using a ready-to-use, prefilled syringe. The dose depends on age and can change to every 4 weeks if symptoms have improved.

Hereditary angioedema is a rare condition that causes rapid attacks of swelling in areas under the skin around the face, arms, legs, and also the throat, which can be life-threatening if it blocks off the airways. People with hereditary angioedema have high levels of a protein called bradykinin, which makes fluid leak fluid into the surrounding tissue, causing swelling attacks. Lanadelumab-flyo works by blocking another protein in the blood called ‘kallikrein’, which in turn reduces the level of bradykinin, which helps to prevent the swelling and symptoms of angioedema.

Lanadelumab approval by the FDA was originally on February 3, 2023, and it is now approved to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. FDA approval was supported by data from HELP Study, the HELP OLE Study and the Phase 3 SPRING Study (NCT SHP643-301).

Lanadelumab is a plasma kallikrein inhibitor (monoclonal antibody).

Before taking this medicine

You should not use lanadelumab if you are allergic to it or any of the inactive ingredients. For a full list of ingredients in Takhzyro see the Ingredients section at the bottom of this page.

Lanadelumab is not approved for use by anyone younger than 2 years old.

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

Pregnancy

• If you are pregnant or planning to become pregnant. It is not known if lanadelumab can harm your unborn baby.
• Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

• If you are breastfeeding or plan to breastfeed. It is not known if lanadelumab passes into your breastmilk.
• Talk to your healthcare provider about the best way to feed your baby while using this medicine.

How should I use lanadelumab?

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

Your healthcare provider should show you or your caregiver, how to prepare and inject your dose of lanadelumab before you inject yourself for the first time. Do not try to inject this medicine unless you have been trained by your healthcare provider.

• Take the medicine out of the refrigerator and let it reach room temperature for 15 minutes before injecting your dose.
• Do not shake.
• If using the Single-Dose Vial (bottle) prepare your injection only when you are ready to give it within the next 2 hours.
• Lanadelumab is given as an injection under your skin (subcutaneous) by healthcare provider, a caregiver or yourself.
• For detailed instructions with diagrams on how to use the prefilled syringe or single-dose glass vial
• Each Single-Dose Vial of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside.
• 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.

Lanadelumab dosing information

Usual dose for adult and pediatric patients 12 years and older for hereditary angioedema:

• Initial dose: 300 mg subcutaneously once every 2 weeks.
• Maintenance dose: a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

Usual dose for pediatric patients 6 years to less than 12 years old for hereditary angioedema:

• Initial dose: 150 mg subcutaneously once every 2 weeks.
• Maintenance dose: a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

Usual dose for pediatric patients 2 years to less than 6 years old dose for hereditary angioedema:

• Dose: 150 mg administered subcutaneously every 4 weeks.
• Self-injection is not recommended in children 2 years to less than 12 years.

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 .

Lanadelumab side effects

The most common lanadelumab side effects are:

• injection site reactions (pain, redness, and bruising)
• upper respiratory infections
• headache
• rash
• dizziness
• diarrhea
• muscle aches.

Lanadelumab may cause serious side effects, including allergic reactions. Allergic reactions may happen with lanadelumab. Call your healthcare provider or get emergency help right away if you have any of the following symptoms of allergic reactions:

• wheezing
• difficulty breathing
• chest tightness
• fast heartbeat
• faintness
• rash
• hives

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 lanadelumab?

Other drugs may affect lanadelumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Lanadelumab Package Insert

Review the Takhzyro Package Insert for more detailed information about lanadelumab. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Ingredients

Active Ingredient: lanadelumab-flyo

Inactive Ingredients: citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and sodium phosphate, dibasic, dihytrate.

Storage

• Store the prefilled syringes and vials refrigerated at 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Do not shake.
• Keep the prefilled syringe and vial in the original carton to protect from light.’

Manufacturer

• Takeda Pharmaceuticals U.S.A., Inc.
• Lexington, MA 02421.

Lanadelumab 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 is 1 for lanadelumab.Takhzyro (lanadelumab-flyo) – Takeda Pharmaceuticals U.S.A., Inc.

What is lansoprazole?

Lansoprazole is a proton pump inhibitor. Lansoprazole decreases the amount of acid produced in the stomach.

Lansoprazole is used to treat and prevent stomach and intestinal ulcers, erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome.

Over-the-counter lansoprazole (Prevacid OTC) is used to treat frequent heartburn that happens 2 or more days per week. This medicine is not for the immediate relief of heartburn symptoms.

Warnings

Lansoprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

This medicine can cause diarrhea, which may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Lansoprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

If you also take sucralfate (Carafate), avoid taking it at the same time you take this medicine. Sucralfate can make it harder for your body to absorb lansoprazole. Wait at least 30 minutes after taking this medicine before you take sucralfate.

Before taking this medicine

You should not use lansoprazole if you are allergic to it, or if you take any medicine that contains rilpivirine (Edurant, Complera, Odefsey).

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

Tell your doctor if you have ever had:

• liver disease;
• lupus;
• low levels of magnesium in your blood; or
• osteoporosis or low bone mineral density (osteopenia).

Do not use over-the-counter lansoprazole (Prevacid OTC) without the advice of a doctor if you have:

• trouble or pain with swallowing;
• bloody or black stools; vomit that looks like blood or coffee grounds;
• heartburn that has lasted for over 3 months;
• frequent chest pain, heartburn with wheezing;
• unexplained weight loss;
• nausea or vomiting, stomach pain; or
• an electrolyte imbalance or metabolic disorder.

Some forms of lansoprazole may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Some conditions are treated with a combination of lansoprazole and antibiotics. Use all medications as directed by your doctor

Do not give lansoprazole to a child younger than 1 year old. Prevacid OTC is not approved for use by anyone younger than 18 years old.

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

How should I take lansoprazole?

Use lansoprazole exactly as directed on the label, or as prescribed by your doctor and read all medication guides or instruction sheets.

Lansoprazole is usually taken before eating. Prevacid OTC should be taken in the morning before you eat breakfast.

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

Shake the lansoprazole oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Swallow the lansoprazole capsule whole and do not crush, chew, break, or open it.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Use lansoprazole for the full prescribed length of time, even if your symptoms quickly improve.

Prevacid OTC should be taken only once daily for 14 days. It may take up to 4 days for full effect. Allow at least 4 months to pass before you start another 14-day treatment with Prevacid OTC.

Call your doctor if your symptoms do not improve or if they get worse while you are taking lansoprazole. If you take Prevacid OTC, call your doctor if your heartburn gets worse over the 14-day treatment, or if you need treatment more than once every 4 months.

Some conditions are treated with a combination of lansoprazole and antibiotics. Use all medications as directed.

If you use lansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

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

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 to avoid

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Lansoprazole side effects

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

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• new or unusual pain in your wrist, back, hip, or thigh;
• a seizure (convulsions);
• kidney problems – fever, nausea, little or no urination, blood in your urine, swelling, rapid weight gain;
• low magnesium – dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
• new or worsening symptoms of lupus – joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking lansoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use lansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common lansoprazole side effects may include:

• nausea, stomach pain;
• diarrhea, constipation; or
• headache.

What is Lantus?

Lantus is a man-made form of a hormone (insulin) that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

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

Lantus is for use in adults with type 1 or type 2 diabetes, and in children at least 6 years old with type 1 diabetes.

For type 1 diabetes, Lantus is used together with a short-acting insulin given before meals.

Some brands of insulin glargine are for use only in adults. Carefully follow all instructions for the brand of insulin glargine you are using.

Warnings

You should not use Lantus if you are having an episode of hypoglycemia (low blood sugar), or if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

Never share a Lantus SoloStar pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Not all insulin glargine brands are equal in dosing. Follow your doctor’s instructions when changing from one brand to another. If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change.

Lantus 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.

Before taking this medicine

You should not use Lantus if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

Lantus is not approved for use by anyone younger than 6 years old, and some brands are for use only in adults. Do not use this medicine to treat type 2 diabetes in a child of any age.

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

• liver or kidney disease; or
• heart failure or other heart problems.

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 this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

How should I use Lantus?

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

Lantus is injected under the skin, usually once per day at the same time of day.

When treating type 1 diabetes, use your short-acting insulin before meals as directed by your doctor.

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

Ask your doctor or pharmacist if you don’t understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject Lantus. Do not inject into the same place two times in a row.

Avoid injecting into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

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

Never share an injection pen, even if you changed the needle. Sharing these devices can pass infections from person to person.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

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) Lantus:

• Refrigerate and use until expiration date; or
• Store at room temperature (below 86 degrees Fahrenheit) and use within 28 days.

Storing opened (in use) Lantus:

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the Lantus SoloStar injection pen at room temperature (do not refrigerate) and use within 28 days.

Do not store an injection pen with the needle attached. Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Wear a medical alert tag or carry an ID card to let others know you have diabetes.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Do not use more than one dose in a 24-hour period unless your doctor tells you to.

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 severe 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 Lantus?

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

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

Avoid drinking alcohol or using medicines that contain alcohol. It may interfere with your diabetes treatment.

Lantus side effects

Get emergency medical help if you have any signs of an allergic reaction to Lantus: 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:

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

Common Lantus side effects may include:

• low blood sugar;
• swelling, weight gain;
• allergic reaction, itching, rash; or
• thickening or hollowing of the skin where you injected the medicine.

What is Lasix?

Lasix is a loop diuretic (water pill) that prevents your body from absorbing too much salt, causing it to be passed in your urine. Lasix treats fluid retention (edema) in people with congestive heart failure, liver disease, or kidney disorders such as nephrotic syndrome.

Lasix is also used to treat high blood pressure (hypertension).

Warnings

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

Using more than your recommended dose will not make this medicine more effective. High doses of furosemide may cause irreversible hearing loss.

Before using Lasix, tell your doctor if you have kidney disease, enlarged prostate, urination problems, cirrhosis or other liver disease, an electrolyte imbalance, high cholesterol, gout, lupus, diabetes, or an allergy to sulfa drugs.

Tell your doctor if you have recently had an MRI (magnetic resonance imaging) or any type of scan using a radioactive dye that is injected into your veins. Do not take more of this medication than is recommended.

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

Tell your doctor about all your other medicines. Some drugs should not be used with Lasix.

Before taking this medicine

You should not use Lasix if you are allergic to furosemide, if you are unable to urinate or have hepatic cirrhosis.

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

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• enlarged prostate, bladder obstruction, or other urination problems;
• gout;
• lupus;
• diabetes;
• an allergy to sulfa drugs;
• kidney disease; or
• cirrhosis or other liver disease.

Tell your doctor if you have an MRI (magnetic resonance imaging) or any type of scan using a radioactive dye that is injected into a vein. Contrast dyes and furosemide can harm your kidneys.

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

It may not be safe to breastfeed while using Lasix. Ask your doctor about any risk. Lasix may slow breast milk production.

How should I use Lasix?

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

Do not use more than your recommended dose. High doses of furosemide may cause irreversible hearing loss.

Doses are based on weight in children and teenagers. Your child’s dose may change if the child gains or loses weight.

Lasix will make you urinate more often and you may get dehydrated easily. Follow your doctor’s instructions about using potassium supplements or getting enough salt and potassium in your diet.

Your blood pressure will need to be checked often and you may need other medical tests.

If you have high blood pressure, keep using Lasix even if you feel well. High blood pressure often has no symptoms.

If you need surgery, tell the surgeon ahead of time that you are using Lasix.

Store at room temperature away from moisture, heat, and light.

Dosing Information

Usual Adult Dose of Lasix for Ascites:

Oral: Initial dose: 20 to 80 mg orally once; may repeat with the same dose or increase by 20 or 40 mg no sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
Maintenance dose: Administer the dose that provided the desired diuretic effect once or twice a day (e.g., at 8 am and 2 pm).

Usual Adult Dose of Lasix for Congestive Heart Failure:

Oral: Initial dose: 20 to 80 mg orally once; may repeat with the same dose or increase by 20 or 40 mg no sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
Maintenance dose: Administer the dose that provided the desired diuretic effect once or twice a day (e.g., at 8 am and 2 pm).

Usual Adult Dose of Lasix for Edema:

Oral: Initial dose: 20 to 80 mg orally once; may repeat with the same dose or increase by 20 or 40 mg no sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
Maintenance dose: Administer the dose that provided the desired diuretic effect once or twice a day (e.g., at 8 am and 2 pm).

Usual Adult Dose of Lasix for Nephrotic Syndrome:

Oral: Initial dose: 20 to 80 mg orally once; may repeat with the same dose or increase by 20 or 40 mg no sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
Maintenance dose: Administer the dose that provided the desired diuretic effect once or twice a day (e.g., at 8 am and 2 pm).

Usual Adult Dose of Lasix for Renal Failure:

Oral: Initial dose: 20 to 80 mg orally once; may repeat with the same dose or increase by 20 or 40 mg no sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
Maintenance dose: Administer the dose that provided the desired diuretic effect once or twice a day (e.g., at 8 am and 2 pm).

Usual Adult Dose of Lasix for Liver Cirrhosis:

Oral: Initial dose: 20 to 80 mg orally once; may repeat with the same dose or increase by 20 or 40 mg no sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
Maintenance dose: Administer the dose that provided the desired diuretic effect once or twice a day (e.g., at 8 am and 2 pm).

Comments:
-Edema may be most efficiently and safely mobilized by giving this drug on 2 to 4 consecutive days each week.
-When doses greater than 80 mg/day are given for prolonged periods of time, careful clinical observation and laboratory monitoring are particularly advisable.

Usual Adult Dose of Lasix for Pulmonary Edema:

Oral: Initial dose: 80 mg/day, usually divided into 40 mg orally twice a day

Use: Treatment of hypertension alone or in combination with other antihypertensive agents.

Maximum Adult dose: 600 mg/day in patients with clinically severe edematous states.

Usual Pediatric Dose for Edema:

Oral: Initial dose: 2 mg/kg orally once; if the diuretic response to the initial dose is not satisfactory, may increase by 1 or 2 mg/kg and administer no sooner than 6 to 8 hours after the previous dose.
Maintenance dose: Adjust to minimum effective dose.

Maximum dose: 6 mg/kg

Use: Treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome, especially when an agent with greater diuretic potential is desired.

What happens if I miss a dose?

Lasix is sometimes used only once, so you may not be on a dosing schedule. If you are using the medication regularly, 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include feeling very thirsty or hot, heavy sweating, hot and dry skin, extreme weakness, or fainting.

What should I avoid while using Lasix?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming dehydrated. Follow your doctor’s instructions about the type and amount of liquids you should drink while you are using Lasix.

Drinking alcohol with this medicine can cause side effects.

Lasix could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

If you have high blood pressure, ask a doctor or pharmacist before taking any medicines that can raise your blood pressure, such as diet pills or cough-and-cold medicine.

Lasix side effects

Get emergency medical help if you have signs of an allergic reaction to Lasix (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).

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

• a light-headed feeling, like you might pass out;
• ringing in your ears, hearing loss;
• muscle spasms or contractions;
• pale skin, easy bruising, unusual bleeding;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• kidney problems – swelling, urinating less, feeling tired or short of breath
• signs of liver or pancreas problems – loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of an electrolyte imbalance – increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest.

Common Lasix side effects may include:

• diarrhea, constipation, loss of appetite;
• numbness or tingling;
• headache, dizziness; or
• blurred vision.

Uses for latanoprost

Latanoprost eye drops is used to treat certain kinds of glaucoma. It is also used to treat a condition called hypertension of the eyealone or together with other medicines to lower pressure inside the eye that is caused by open-angle glaucoma or ocular (eye) hypertension. Latanoprost appears to work by increasing the outflow of fluid from the eye. This lowers the pressure in the eye.

This medicine is available only with your doctor’s prescription.

Before using latanoprost

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of latanoprost eye drops in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of latanoprost eye drops in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aphakia (no lens in the eyes) or
• Eye inflammation (eg, iritis or uveitis), history of or
• Herpes simplex eye infection, history of or
• Patients with torn artificial lenses—Use with caution. May make these conditions worse.
• Eye infection or inflammation, active—Should not be used in patients with this condition.

Proper use of latanoprost

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use if for a longer time than your doctor ordered. To do so may increase the chance of side effects.

To use the eye drops:

• Wash your hands with soap and water before and after you use this medicine.
• Shake well just before each use.
• Tilt your head back. Press your finger gently on the skin just beneath the lower eyelid and pull it away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.

You should not use this medicine if you have contact lenses in your eyes. Remove your contact lenses before using it. Wait at least 15 minutes after you use the medicine before putting the contact lenses back in.

If you will be using latanoprost with other eye medicines, use them at least 5 minutes apart from each other.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic emulsion dosage form (eye drops):
  • For glaucoma or hypertension of the eye:
    • Adults—One drop in the affected eye once a day in the evening.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Xalatan®: Store the unopened bottle in the refrigerator. You may keep the opened bottle in the refrigerator or at room temperature for up to 6 weeks.

Precautions while using latanoprost

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you are allergic to this medicine.

This medicine may cause blurred vision or other vision problems. If these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these eye changes are bothersome, check with your doctor.

While you are using latanoprost, the iris (colored part) of your treated eye may slowly become more brown in color. This is more likely to happen if you have blue-brown, gray-brown, green-brown, or yellow-brown eyes. You may notice this change usually within several months or years from the start of treatment. You may also have darkening of the eyelid skin color or longer, thicker, and darker eyelashes. These changes to the iris, eyelid, and lashes may be permanent even if you stop using latanoprost. However, any of these changes will affect only the eye being treated with latanoprost. Check with your doctor if you have any concerns about this.

Side Effects of latanoprost

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Eye pain or stinging

Less common

• Decreased vision
• painful irritation of the clear front part of the eye
• swelling or redness of the eye and the lining of the eyelid

Incidence not known

• Arm, back, or jaw pain
• blistering, peeling, or loosening of the skin
• blurred vision or other change in vision
• burning, dry, or itching eyes
• chest pain or discomfort
• chest tightness or heaviness
• chills
• cough
• diarrhea
• difficulty breathing
• discharge, excessive tearing
• fast, irregular, pounding, or racing heartbeat or pulse
• itching
• joint or muscle pain
• noisy breathing
• red skin lesions, often with a purple center
• sensitivity of the eye to light
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• tearing
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Drainage from the eyes
• longer and thicker eyelashes

Less common

• Eyelash discoloration
• feeling of having something in the eye

Incidence not known

• Darkening of the eyelid skin color
• dizziness
• headache

What is Latuda?

Latuda is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Latuda is used to treat schizophrenia in adults and teenagers who are at least 13 years old.

Latuda is also used to treat episodes of depression associated with bipolar disorder (bipolar depression) in adults and children who are at least 10 years old.

Warnings

Latuda is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related psychosis.

Some young people have thoughts about suicide when taking Latuda. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before you take Latuda, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, heart rhythm problems, a history of heart attack or stroke, high cholesterol or triglycerides, low white blood cell (WBC) counts, seizures, diabetes, Parkinson’s disease, trouble swallowing, or a history of breast cancer or suicidal thoughts.

Some medicines can interact with lurasidone and should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

While you are taking Latuda, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Latuda may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. 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.

Drinking alcohol can increase certain side effects of lurasidone. Stop using this medicine and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or pounding heartbeats, feeling like you might pass out, tremors, or twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Before taking this medicine

You should not use Latuda if you are allergic to lurasidone.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lurasidone. Your doctor may change your treatment plan if you also use:

• antifungal medicine such as ketoconazole or voriconazole;
• an antibiotic such as clarithromycin or rifampin;
• an antiviral such as ritonavir;
• St. John’s wort; or
• seizure medicine such as carbamazepine or phenytoin.

Latuda is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related conditions.

Tell your doctor if you have ever had:

• heart disease or a stroke;
• high or low blood pressure;
• high cholesterol or triglycerides (a type of fat in the blood);
• diabetes or high blood sugar (in you or your family);
• a seizure;
• liver or kidney disease;
• low white blood cell (WBC) counts;
• abnormal hormone function tests (thyroid, pituitary gland);
• breast cancer; or
• suicidal thoughts or actions.

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

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking lurasidone without your doctor’s advice.

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

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

Latuda is not approved for schizophrenia in anyone younger than 13 years old. Latuda is not approved for depression in anyone younger than 10 years old.

How should I take Latuda?

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

Latuda should be taken with food (at least 350 calories).

You may need frequent blood tests.

It may take several weeks before your symptoms improve. Keep using the medication as directed. Call your doctor if your symptoms do not improve, or if they get worse while using Latuda.

You should not stop using this medicine suddenly. Stopping suddenly may cause other problems.

It is easier to become dangerously overheated and dehydrated while you are taking Latuda. Drink plenty of fluids, especially in hot weather and during exercise. You may also be more sensitive to temperature extremes (hot or cold).

Store at room temperature away from moisture and heat.

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.

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 .

What to avoid

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Grapefruit and grapefruit juice may interact with lurasidone and lead to unwanted side effects. Avoid the use of grapefruit products while taking Latuda.

Latuda side effects

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

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), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of Latuda can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you use lurasidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

• any new or unusual muscle movements you cannot control;
• a light-headed feeling, like you might pass out;
• a seizure (convulsions);
• (in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;
• (in men) breast swelling, impotence;
• trouble swallowing;
• manic episodes – racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• low white blood cell counts – fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing;
• high blood sugar – increased thirst, increased urination, hunger, dry mouth, fruity breath odor; 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 Latuda side effects may include:

• drowsiness;
• weight gain;
• tremors, muscle stiffness, slow muscle movement;
• feeling restless or being unable to sit still;
• nausea, vomiting;
• runny nose; or
• sleep problems (insomnia).

What is leflunomide?

Leflunomide affects the immune system and reduces swelling and inflammation in the body.

Leflunomide is used to treat the symptoms of rheumatoid arthritis.

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

Leflunomide 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.

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

• signs of infection–sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;
• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• numbness, tingling, or burning pain in your hands or feet;
• liver problems–nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of leflunomide may include:

• nausea, diarrhea, stomach pain;
• headache;
• abnormal liver function tests;
• thinning hair;
• back pain;
• weakness;
• rash; or
• high blood pressure.

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 leflunomide if you are pregnant, and stop taking leflunomide if you think you might be pregnant. Use birth control to prevent pregnancy while you are taking leflunomide, and until you complete a “drug elimination” procedure.

Leflunomide can cause severe or fatal liver damage. Tell your doctor if you have a history of liver disease or if you also use other medicines such as: pain or arthritis medicine (including aspirin, Tylenol, and Advil/Motrin), medicines to treat tuberculosis or other infections, seizure medication, hormonal birth control or hormone replacement therapy, chemotherapy, cholesterol-lowering medicine, heart medication, or blood pressure medicine.

Your liver function will need to be tested often, and you may need to stop taking leflunomide based on the results of these tests.

Before taking this medicine

You should not use this medicine if you are allergic to leflunomide or teriflunomide, or if:

• you are pregnant (you will need to have a negative pregnancy test before starting this treatment);
• you have severe liver disease; or
• you are also using teriflunomide.

Do not use leflunomide if you are pregnant or may become pregnant. Avoid getting pregnant until after you stop taking leflunomide and undergo a “drug elimination” procedure to help rid your body of this medicine. Stop taking leflunomide and call your doctor right away if you miss a period or think you might be pregnant.

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

• a history of liver disease or hepatitis (leflunomide can cause severe liver problems);
• a severe or uncontrolled infection;
• kidney disease;
• nerve problems, such as neuropathy caused by diabetes;
• a history of tuberculosis;
• a weak immune system or bone marrow disorder; or
• if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).

Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking leflunomide, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

Ask your doctor if you should use a barrier form of birth control (condom or diaphragm with spermicide). Using hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may increase your risk of liver damage while taking leflunomide.

It is not known whether leflunomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take leflunomide?

Before you start treatment with leflunomide, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use leflunomide in larger or smaller amounts or for longer than recommended.

Your blood pressure will need to be checked often.

Leflunomide can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your leflunomide treatment may be stopped for a short time based on the results of these tests.

Your liver function will also need to be tested often, and you may need to stop taking leflunomide based on the results of these tests.

After you stop taking leflunomide, you may need to be treated with other medicines to help your body eliminate leflunomide quickly. If you do not undergo this drug elimination procedure, leflunomide could stay in your body for up to 2 years. Follow your doctor’s instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking leflunomide.

Arthritis is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store at room temperature away from moisture, heat, and light.

Leflunomide dosing information

Usual Adult Dose for Rheumatoid Arthritis:

Loading dose: 100 mg orally once a day for 3 days
Maintenance: 20 mg orally once a day (If not well tolerated, the dose may be decreased to 10 mg orally once a day)

Comment:
-Hematology parameters and liver enzymes should be monitored.

Use:
For the treatment of active rheumatoid arthritis (RA):
-To reduce signs and symptoms
-To inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
-To improve physical function

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 diarrhea, stomach pain, pale skin, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes).

What should I avoid while taking leflunomide?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using leflunomide, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect leflunomide?

Leflunomide can cause severe or fatal liver damage. This effect is increased when you also use certain other medicines, including:

• acetaminophen (Tylenol), aspirin, gout or arthritis medication (including gold injections); an NSAID (non-steroidal anti-inflammatory drug)–ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
• an antibiotic, antifungal medicine, or sulfa drug; tuberculosis medicine; antiviral or HIV/AIDS medication; medicine to treat mental illness; seizure medication–carbamazepine, phenytoin, valproic acid, and others;
• birth control pills or hormone replacement therapy; anabolic steroids–methyltestosterone, “performance-enhancing drugs”; cancer medication; or
• cholesterol-lowering medication–Crestor, Lipitor, Vytorin, Zocor, and others; heart or blood pressure medication.

What is letrozole?

Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years.

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

Letrozole 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.

Common side effects of letrozole may include:

• hot flashes, warmth or redness in your face or chest;
• headache, dizziness, weakness;
• bone pain, muscle or joint pain;
• swelling, weight gain;
• increased sweating; or
• increased cholesterol in your blood.

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 letrozole if you are pregnant.

Before taking this medicine

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

letrozole is for use only in women who can no longer get pregnant. Letrozole can harm an unborn baby. Do not use if you are pregnant. Use effective birth control if you are not past menopause. Keep using birth control for at least 3 weeks after your last dose of letrozole. Tell your doctor if you think you may be pregnant.

Tell your doctor if you have ever had:

• liver disease (especially cirrhosis);
• osteoporosis, osteopenia (low bone mineral density);
• high cholesterol; or
• if you also take tamoxifen.

You should not breastfeed while you are using letrozole and for at least 3 weeks after your last dose.

How should I take letrozole?

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

You may take letrozole with or without food.

You will need frequent medical tests, and your bone mineral density may also need to be checked.

Store at room temperature away from moisture and heat.

Letrozole dosing information

Usual Adult Dose for Breast Cancer:

2.5 mg orally once a day

Duration of therapy:
-Adjuvant and extended adjuvant settings: Optimal duration is unknown; discontinue therapy at relapse.
-Advanced disease: Until tumor progression is evident.

Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
-Extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy
-First-line treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or unknown locally advanced or metastatic breast cancer; second-line treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy

Usual Adult Dose for Breast Cancer — Adjuvant:

2.5 mg orally once a day

Duration of therapy:
-Adjuvant and extended adjuvant settings: Optimal duration is unknown; discontinue therapy at relapse.
-Advanced disease: Until tumor progression is evident.

Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
-Extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy
-First-line treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or unknown locally advanced or metastatic breast cancer; second-line treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen 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.

What should I avoid while taking letrozole?

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

What is Leukeran?

Leukeran is used to treat several types of cancer, including Hodgkin’s disease and certain types of leukemia or lymphoma.

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

Leukeran 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 eyes, skin pain, red or purple skin rash with blistering and peeling).

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

• a seizure;
• an unusual mass or lump;
• severe vomiting or diarrhea;
• new or worsening cough;
• bone marrow suppression–dizziness, pale lips or fingernail beds, fast heart rate, getting easily tired or short of breath;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of Leukeran may include:

• bone marrow suppression;
• low blood cell counts;
• missed menstrual periods;
• nausea, vomiting, diarrhea; or
• sores or white patches in or around your mouth.

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

Leukeran can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, weakness).

Before taking this medicine

You should not be treated with Leukeran if you are allergic to it, or if you have received this medicine in the past without successful treatment of your condition.

You may not be able to receive Leukeran if you’ve ever had an allergic reaction to another cancer drug such as bendamustine, busulfan, carmustine, dacarbazine, ifosfamide, lomustine, mechlorethamine, melphalan, streptozocin, or temozolomide.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• a seizure;
• a head injury or brain tumor; or
• if you have received radiation or chemotherapy within the past 4 weeks.

Taking Leukeran may increase your risk of developing other types of cancer. Talk to your doctor about your specific risk.

Do not use Leukeran if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using Leukeran.

This medicine may affect fertility (ability to have children) in both men and women. However, women should still use birth control to prevent pregnancy because Leukeran can harm an unborn baby.

You should not breastfeed while using this medicine.

How should I take Leukeran?

You must remain under the care of a doctor while you are using Leukeran.

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.

Leukeran is usually taken for 3 to 6 weeks. Follow your doctor’s dosing instructions very carefully.

Leukeran can increase your risk of bleeding or infection. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

What is leuprolide?

Leuprolide injection (Eligard, Lupron Depot) is used to treat the symptoms associated with advanced prostate cancer.

Leuprolide injection (Lupron Depot-PED, Fensolvi) is used in children 2 years of age or older to treat central precocious puberty (CPP; a condition causing girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics).

Leuprolide injection (Lupron Depot) is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms).

Leuprolide injection (Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus).

Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body.

Leuprolide side effects

Get emergency medical help if you have signs of an allergic reaction to leuprolide (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 seizure, unusual changes in mood or behavior (crying spells, irritability, restlessness, anger, aggression), severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Your symptoms may become temporarily worse when you first start using leuprolide, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

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

• bone pain, loss of movement in any part of your body;
• swelling, rapid weight gain;
• a seizure;
• unusual changes in mood or behavior (crying spells, anger, feeling irritable);
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• painful or difficult urination;
• pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;
• muscle weakness or loss of muscle use, loss of bladder or bowel control;
• problems with your pituitary gland – sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
• high blood sugar – increased thirst, increased urination, hunger, dry mouth, fruity breath odor;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• signs of a stroke – sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance.

Common leuprolide side effects may include:

• pituitary gland problems;
• acne, itching, rash, white scales (seborrhea);
• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
• fractures, ligament sprain;
• fever, tiredness, not feeling well;
• stomach pain, nausea, vomiting, diarrhea, constipation;
• wheezing, chest tightness, trouble breathing;
• breast tenderness, hot flashes, sweating;
• dizziness, sleep problems, mood changes;
• headache, general pain;
• vaginal swelling, itching, or discharge;
• weight changes;
• decreased testicle size;
• irregular menstrual periods, decreased interest in sex; or
• redness, pain, swelling, or oozing where the medicine was injected.

Leuprolide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using leuprolide.

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

Your symptoms may become temporarily worse when you first start using leuprolide, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

Call your doctor at once if you have a seizure, unusual changes in mood or behavior, severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Do not use leuprolide if you are pregnant. Use effective birth control. Do not use if you have abnormal vaginal bleeding that has not been checked by a doctor.

Before taking this medicine

You should not use this medicine if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

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

• depression, mental illness, or psychosis;
• seizures or epilepsy;
• a blood vessel disorder;
• a brain tumor or spinal cord injury;
• heart disease, congestive heart failure, long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Call your doctor if your periods continue while you are being treated with leuprolide.

Leuprolide may cause birth defects. Do not use leuprolide if you are pregnant. Tell your doctor if you become pregnant.

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

How should I use leuprolide?

Uae leuprolide as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

There are many brands, strengths, or forms of leuprolide used to treat different conditions. Avoid medication errors by using only the medicine your doctor prescribes.

Leuprolide is usually administered by a healthcare provider.

Leuprolide is injected under the skin or into a muscle, once every month or once every 3 to 6 months. A healthcare provider may teach you how to properly use the medication by yourself.

Your symptoms may become temporarily worse as your hormones adjust to leuprolide. A child using this medicine may have increased signs of puberty (such as vaginal bleeding) during the first weeks of treatment.

You may need frequent medical tests while using leuprolide.

Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Follow all storage instructions provided with leuprolide. Your pharmacist can provide more information about how to store this medicine.

Dosing Information

Usual Adult Dose for Endometriosis:

3.75 mg IM once a month for up to 6 months
OR
11.25 mg depot every 3 months

Comments:
-In women receiving this drug for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms.

Uses: Management of endometriosis (including pain relief and reduction of endometriotic lesions), preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata

Usual Adult Dose for Prostate Cancer:

Eligard: administered by subcutaneous injection and provides continuous release of leuprolide acetate over a one, three, four, or six-month period:

• One 7.5 mg injection every month; or
• One 22.5 mg injection every 3 months; or
• One 30 mg injection every 4 months; or
• One 45 mg injection every 6 months,

Viadur: one implant inserted for 12 months. Each implant contains 65 mg leuprolide. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of leuprolide for 12 months of hormonal therapy.

Usual Pediatric Dose for Precocious Puberty:

IM Injection:
2 years and older:
One month depot injection: 25 kg or less: 7.5 mg IM once a month. Greater than 25 kg to 37.5 kg: 11.25 mg IM once a month. Greater than 37.5 kg: 15 mg IM once a month
Three month depot injection: 11.25 mg or 30 mg IM every 3 months

Comments:
-Doses should be titrated to the individual.
-Hormone levels should be tested after 1 to 2 months of therapy and with each dose change to ensure adequate pituitary gonadotropin suppression.
-Once a dose that results in adequate hormonal suppression has been determined, it can often be maintained for the duration of therapy in most children; however, hormonal suppression should be verified as weight can increase significantly while on therapy.
-Therapy should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.

Subcutaneous injection:
2 years and older:
Fensolvi (long acting formulation): 45 mg subcutaneously every 6 months
NOTE: The short-acting formulation has been replaced with long-acting formulations.

Comments:
-The dosage should be adjusted for weight changes.
-Discontinuation of therapy be considered before age 11 for females and before age 12 for males.

Use: Treatment of children with central precocious puberty (CPP); CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years in girls and 9 years in boys) associated with pubertal pituitary gonadotropin activation; it may show a significantly advanced bone age that can result in diminished adult height

Uses for levalbuterol

Levalbuterol is used to prevent or treat bronchospasm in patients with asthma and other lung diseases.

Levalbuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor’s prescription.

Before using levalbuterol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of levalbuterol solution and solution concentrate in children younger than 6 years of age, and levalbuterol aerosol in children younger than 4 years of age. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levalbuterol in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving levalbuterol.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Albuterol
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Arotinolol
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Butriptyline
• Carteolol
• Carvedilol
• Celiprolol
• Clomipramine
• Desipramine
• Dibenzepin
• Dilevalol
• Dothiepin
• Doxepin
• Epinephrine
• Esmolol
• Fenoterol
• Hexoprenaline
• Imipramine
• Iprindole
• Labetalol
• Landiolol
• Levobunolol
• Lofepramine
• Melitracen
• Mepindolol
• Methacholine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propizepine
• Propranolol
• Protriptyline
• Sotalol
• Talinolol
• Tertatolol
• Tianeptine
• Timolol
• Trimipramine
• Tulobuterol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart disease or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Seizures, history of—Use with caution. May make these conditions worse.
• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of levalbuterol

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any other asthma medicine that you are taking without telling your doctor. To do so may increase the chance for breathing problems.

The levalbuterol inhalation solution and inhalation solution concentrate should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution or solution concentrate in the nebulizer:

• Open the pouch and remove one vial.
• Check the liquid in the vial. It should be clear or colorless. Do not use it if is discolored.
• Open the vial and place the inhalation solution in the medicine reservoir or nebulizer cup on the machine. If you are using the solution concentrate, mix it first with sterile normal saline before placing it on the reservoir.
• Connect the nebulizer to the face mask or mouthpiece.
• Use the face mask or mouthpiece to breathe in the medicine.
• Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.
• Clean all the parts of the nebulizer after each use.
• Do not use if solution becomes cloudy.
• Do not mix another inhalation medicine with levalbuterol in the nebulizer, unless told to do so by your doctor.

For patients using levalbuterol inhalation aerosol:

• The levalbuterol aerosol canister provides about 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness.
• When you use the inhaler for the first time, or if you have not used it in a while, the inhaler may not deliver the right amount of medicine with the first puff. Test or prime the inhaler before using it.
• Shake the inhaler well immediately before each use.
• Take the cap off the actuator (or mouthpiece). Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use.
• Prime the inhaler by releasing 4 test sprays in the air, away from your face. The inhaler will now be ready to provide the right amount of medicine when you use it.
• Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding the inhaler in the mouthpiece-down position and closing your lips around it.
• While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Immediately after the puff is delivered, release your finger from the canister and remove the inhaler from your mouth.
• Hold your breath for 10 seconds, if possible.
• If your doctor has prescribed more than a single inhalation/puff, wait 1 minute between inhalations. Then, shake the inhaler well and repeat.
• Replace the cap on the mouthpiece after each use.
• Clean the actuator or mouthpiece at least once a week.
• Wash the actuator through the top and bottom with warm running water for 30 seconds at least once a week.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For preventing or treating bronchospasm:
  • For inhalation aerosol dosage form:
    • Adults and children 4 years of age and older—Two puffs every 4 to 6 hours. In some patients one puff every 4 hours may be enough.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
  • For inhalation solution dosage form (used with a nebulizer):
    • Adults and children 12 years of age and older—At first, 0.63 milligrams (mg) in the nebulizer 3 times a day, every 6 to 8 hours per day. Some patients may need to start at 1.25 mg in the nebulizer 3 times a day.
    • Children 6 to 11 years of age—0.31 mg in the nebulizer 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 0.63 mg 3 times a day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If your dosing schedule is different from all of the above and you miss a dose of this medicine, or if you have any questions about this, check with your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep the inhalation solution in the foil pouch until you are ready to use it. The rest of the vials in the pouch should be used within 2 weeks after the foil pouch has been opened.

Use the inhalation solution concentrate vial right away after opening the foil pouch.

Throw away the canister after either 200 sprays have been used. Ask your pharmacist if you are not sure. Do not place the canister in water to see if the canister is full (float test).

Precautions while using levalbuterol

If you will be using this medicine for a long time, it is important that your doctor check your or your child’s progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other similar inhaled medicines, such as albuterol (Accuneb®), isoproterenol (Isuprel®), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if:

• Your or your child’s symptoms do not improve or they become worse after using this medicine.
• Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Levalbuterol may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, trouble breathing, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Side Effects of levalbuterol

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Fast heartbeat

Less common

• Chest pain or tightness
• dizziness
• feeling “faint”
• lightheadedness
• troubled breathing

Incidence not known

• Confusion
• cough
• difficult or labored breathing
• difficulty swallowing
• drowsiness
• extra heartbeat
• fainting
• fast, pounding, slow, or irregular heartbeat or pulse
• hives, welts, itching, or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• nausea
• noisy breathing
• rapid, deep breathing
• redness of the skin
• restlessness
• stomach cramps
• unusual tiredness or weakness
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Chest pain
• dizziness
• dry mouth
• general feeling of discomfort or illness
• headache
• impaired consciousness
• irregular or fast heartbeat
• lightheadedness
• nausea
• nervousness
• seizures
• sleeplessness
• sweating
• tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Accidental injury (in children 4 to 11 years of age)
• anxiety
• body aches or pain
• chills
• congestion
• cough
• dryness or soreness of the throat
• fever
• general aches and pains
• headache
• hoarseness
• increased cough
• leg cramps
• loss of appetite
• migraines or other headaches
• muscle tightness
• nervousness
• runny or stuffy nose

Less common

• Abnormal growth filled with fluid or semisolid material
• blemishes on the skin
• blood in the urine
• bloody nose
• burning, dry, or itching eyes
• burning or stinging of the skin
• cough producing mucus
• cramps
• diarrhea
• difficulty having a bowel movement
• discharge from the eye
• dry mouth or throat
• ear pain
• excessive tearing
• eye itch
• heavy menstrual bleeding
• muscle pain
• night sweats
• numbness or decreased sensitivity of the hand
• pain
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pimples
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• stomach pain
• tingling sensation in the arms or legs
• vaginal yeast infection
• weight loss

What is Levaquin?

Levaquin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.

Levaquin is used to treat different types of bacterial infections. Levofloxacin is also used to treat people who have been exposed to anthrax or certain types of plague.

Fluoroquinolone antibiotics can cause serious or disabling side effects.

Levaquin should be used only for infections that cannot be treated with a safer antibiotic.

Warnings

Levaquin can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using this medicine and call your doctor at once if you have symptoms such as: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, levofloxacin may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Levaquin may cause swelling or tearing of a tendon. Stop taking levofloxacin and call your doctor at once if you have sudden pain, swelling, bruising, tenderness, stiffness, or movement problems in any of your joints.

Before taking this medicine

You should not use Levaquin if you are allergic to levofloxacin or other fluoroquinolones (ciprofloxacin, gemifloxacin, moxifloxacin, norfloxacin, ofloxacin, and others).

Levaquin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles’ tendon of the heel. This can happen during treatment or up to several months after you stop taking levofloxacin. Tendon problems may be more likely in certain people (children and older adults, or people who use steroid medicine or have had an organ transplant).

Tell your doctor if you have ever had:

• tendon problems, bone problems, arthritis or other joint problems (especially in children);
• blood circulation problems, aneurysm, narrowing or hardening of the arteries;
• heart problems, high blood pressure;
• a genetic disease such as Marfan syndrome or Ehler’s-Danlos syndrome;
• diabetes;
• a muscle or nerve disorder, such as myasthenia gravis;
• kidney disease;
• seizures or epilepsy;
• a head injury or brain tumor;
• long QT syndrome (in you or a family member); or
• low levels of potassium in your blood (hypokalemia).

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

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

You should not breast-feed while using this medicine.

How should I take Levaquin?

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

Take this medicine with water, at the same time each day. Drink extra fluids to keep your kidneys working properly while taking this medicine.

You may take Levaquin tablets with or without food.

Take levofloxacin oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Levaquin will not treat a viral infection such as the flu or a common cold.

Do not share Levaquin with another person.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use levofloxacin.

Store at room temperature away from moisture and heat. 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 to avoid

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

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Levofloxacin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Tell your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Levaquin 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).

Levaquin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

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

• low blood sugar – headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
• nerve symptoms in your hands, arms, legs, or feet – numbness, weakness, tingling, burning pain;
• serious mood or behavior changes – nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
• signs of tendon rupture – sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, levofloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Stop taking Levaquin and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• the first sign of any skin rash, no matter how mild;
• muscle weakness, breathing problems;
• seizure (convulsions);
• increased pressure inside the skull – severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• liver problems – upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, constipation, diarrhea;
• headache, dizziness; or
• trouble sleeping.

What is levocetirizine?

Levocetirizine is an antihistamine that may be used to reduce allergy symptoms such as red, itchy, or watery eyes; a runny nose; sneezing; rashes; or reactions to insect bites or stings.

Levocetirizine works by reducing the effects of a natural chemical in the body called histamine. Histamine can produce symptoms such as a runny nose or hives.

Levocetirizine is used to treat symptoms of year-round (also called perennial) allergies in adults and children who are at least 6 months old.

Levocetirizine is also used to treat itching and swelling caused by chronic (long-lasting) urticaria (hives) in adults and children who are at least 6 months old.

Levocetirizine was FDA approved in 2007.

Warnings

Follow all the directions on your levocetirizine label and package. Tell all your healthcare providers that you take levocetirizine.

Before taking this medicine

You should not use levocetirizine if you are allergic to levocetirizine or cetirizine (Zyrtec).

You should not take levocetirizine if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take levocetirizine.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• urination problems (caused by conditions such as enlarged prostate or spinal cord lesion); or
• gallbladder problems.

Levocetirizine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or intending to become pregnant.

You should not breast-feed while taking levocetirizine.

Levocetirizine is not approved for use by anyone younger than 6 months old.

How should I take levocetirizine?

Take levocetirizine exactly as directed on the label and read all medication guides or instruction sheets about levocetirizine.

A child’s dose of levocetirizine is based on the age of the child. Follow your doctor’s dosing instructions very carefully.

Do not give a child more than the prescribed dose of levocetirizine. A child’s body absorbs twice as much of the same dose of levocetirizine as an adult’s body.

Taking more levocetirizine than instructed will not make it more effective, and may cause severe drowsiness.

Levocetirizine is usually taken in the evening, with or without food.

Measure liquid levocetirizine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Store levocetirizine at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose of levocetirizine, take the missed dose as soon as you can. 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 levocetirizine?

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

Drinking alcohol with levocetirizine can cause side effects such as drowsiness.

Levocetirizine side effects

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

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

• worsening allergy or urticaria symptoms;
• painful or difficult urination;
• little or no urination;
• a light-headed feeling, like you might pass out;
• fever; or
• signs of an ear infection–ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child.

Common side effects of levocetirizine may include:

• drowsiness, tiredness;
• sinus pain;
• ear infection;
• cough;
• fever;
• nosebleed;
• vomiting, diarrhea, constipation;
• dry mouth; or
• weight gain.

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.

Levocetirizine dosing information

Usual Adult Dose for Urticaria:

5 mg orally once a day in the evening

Comments: Some patients may be adequately controlled on 2.5 mg orally once a day in the evening.

Usual Adult Dose for Allergic Rhinitis:

Seasonal Allergic Rhinitis (OTC): 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Usual Pediatric Dose for Allergic Rhinitis:

Perennial Allergic Rhinitis:
6 months to 2 years: 1.25 mg orally once a day in the evening

Comments: The recommended dose in pediatric patients 6 months to 2 years should not be exceeded.
Seasonal Allergic Rhinitis (OTC):
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Comments: Avoid use in patients less than 6 years.

Usual Pediatric Dose for Urticaria:

6 months to 5 years: 1.25 mg orally once a day in the evening
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

What is levodopa inhalation?

Levodopa inhalation is used to treat symptoms of Parkinson’s disease that come back (OFF episodes) while you are taking another medicine called carbidopa and levodopa.

Levodopa inhalation is not to be used in place of any medicine you take daily for Parkinson’s disease.

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

Levodopa inhalation 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.

Stop using levodopa inhalation and call your doctor or seek emergency medical attention if you have a wheezing, chest tightness, or trouble breathing after inhaling levodopa inhalation.

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

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• nausea, sweating, and a light-headed feeling (like you might pass out);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• confusion, paranoia, hallucinations (seeing or hearing things that are not real);
• unusual thoughts or behavior;
• trouble sleeping, or increased dreaming;
• agitation, aggression; or
• increased sexual urges, unusual urges to gamble, or other intense urges.

Some people using this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. This side effect has occurred up to 1 year after the start of treatment with levodopa inhalation. Tell your doctor if you have any problems with daytime drowsiness.

Common side effects of levodopa inhalation may include:

• cough;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• nausea; or
• sweat, urine, or saliva that appears dark in color.

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

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.

Before taking this medicine

Do not use levodopa inhalation if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have ever had:

• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• glaucoma;
• involuntary muscle movements;
• a sleep disorder that causes daytime sleepiness;
• dizziness, nausea, or fainting spells when standing from a sitting or lying position;
• mental illness or psychosis; or
• an intense urge or compulsive behavior (such as sexual urges, binge eating, gambling, or spending money).

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

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I use levodopa inhalation?

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

Levodopa inhalation is for use only in people who are currently taking carbidopa and levodopa. Do not stop taking your daily Parkinson’s medications or change your dosing schedule without your doctor’s advice.

For best results, use levodopa inhalation when an “off episode” begins (when your Parkinson’s symptoms start to return). Do not use levodopa inhalation more than 5 times per day.

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

Levodopa inhalation (Inbrija) is a powder that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load 2 capsules (one at a time) into the inhaler device each time you use the medicine. Pushing the handle of the device onto the mouthpiece will pierce the capsule and release the medicine into the inhaler.

Do not swallow a levodopa inhalation capsule. It is for use only in the Inbrija inhaler device.

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

Do not stop using levodopa inhalation suddenly after long-term regular use, or you could have unpleasant withdrawal symptoms (fever, confusion, muscle stiffness, changes in breathing and heart rate). Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you ready to load the inhaler device. Do not store capsules inside the device.

Throw away the device when your capsules run out. Always use the inhaler device that comes with each new prescription.

Levodopa inhalation dosing information

Usual Adult Dose for Parkinson’s Disease:

84 mg via oral inhalation as needed when OFF period starts to return; may dose up to 5 times a day
Maximum dose per OFF period: 84 mg
Maximum daily dose: 420 mg

Comments:
-Therapy should be taken when symptoms of an OFF period start to return.
-This drug has shown efficacy only in combination with levodopa/carbidopa therapy.
-Oral inhalation capsules should only be used with the Inbrija(R) inhaler; capsules should not be swallowed whole as the intended effect will not be obtained.

Use: For the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa.

What happens if I miss a dose?

Since levodopa inhalation is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s 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.

Overdose symptoms may include muscle pain or weakness, fever, dark colored urine, little or no urination, fast heartbeats, or fainting.

What should I avoid while using levodopa inhalation?

Avoid driving or hazardous activity until you know how levodopa inhalation will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect levodopa inhalation?

Using levodopa inhalation 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:

• isoniazid;
• metoclopramide;
• risperidone or other antipsychotic medication;
• iron medication, such as ferrous fumarate, ferrous gluconate, or ferrous sulfate;
• a multivitamin or mineral supplement that contains iron; or
• other medicines to treat Parkinson’s disease.

What is levofloxacin?

Levofloxacin is an antibiotic that that may be used to treat different types of bacterial infections. Levofloxacin may also be used to treat people who have been exposed to anthrax or certain types of plague.

Levofloxacin is usually only used for bacterial infections that cannot be treated with safer antibiotics. This is because levofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic and fluoroquinolone antibiotics can cause serious or disabling side effects.

Levofloxacin was FDA approved in 1996.

Warnings

Levofloxacin can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using levofloxacin and call your doctor at once if you have symptoms such as: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, levofloxacin may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Before taking this medicine

You should not use levofloxacin if you are allergic to it or other fluoroquinolones (such as ciprofloxacin, gemifloxacin, moxifloxacin, norfloxacin, ofloxacin, and others).

Levofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles’ tendon of the heel. This can happen during treatment or up to several months after you stop taking levofloxacin. Tendon problems may be more likely in certain people (children and older adults, or people who use steroid medicine or have had an organ transplant).

Tell your doctor if you have ever had:

• tendon problems, bone problems, arthritis or other joint problems (especially in children);
• blood circulation problems, aneurysm, narrowing or hardening of the arteries;
• heart problems, high blood pressure;
• a genetic disease such as Marfan syndrome or Ehler’s-Danlos syndrome;
• diabetes;
• a muscle or nerve disorder, such as myasthenia gravis;
• kidney disease;
• seizures or epilepsy;
• a head injury or brain tumor;
• long QT syndrome (in you or a family member); or
• low levels of potassium in your blood (hypokalemia).

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

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

You should not breast-feed while using levofloxacin.

How should I take levofloxacin?

Follow all directions on your prescription label and read all medication guides or instruction sheets about levofloxacin.

Take levofloxacin with water, at the same time each day. Drink extra fluids to keep your kidneys working properly while taking levofloxacin.

You may take levofloxacin tablets with or without food.

Take levofloxacin oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Use levofloxacin for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Levofloxacin will not treat a viral infection such as the flu or a common cold.

Do not share levofloxacin with another person.

Levofloxacin may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you are taking it.

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

What happens if I miss a dose?

Take levofloxacin 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 levofloxacin?

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

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Levofloxacin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Tell your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Levofloxacin side effects

Get emergency medical help if you have signs of an allergic reaction to levofloxacin (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).

Levofloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

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

• low blood sugar – headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
• nerve symptoms in your hands, arms, legs, or feet – numbness, weakness, tingling, burning pain;
• serious mood or behavior changes – nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
• signs of tendon rupture – sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, levofloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Stop taking levofloxacin and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• the first sign of any skin rash, no matter how mild;
• muscle weakness, breathing problems;
• seizure (convulsions);
• increased pressure inside the skull – severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• liver problems – upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of levofloxacin may include:

• nausea, constipation, diarrhea;
• headache, dizziness; or
• trouble sleeping.

What is levothyroxine?

Levothyroxine is used in adults and children to treat hypothyroidism (underactive thyroid – a condition where the thyroid gland does not produce enough thyroid hormone).

Levothyroxine is also used in adults along with surgery and radioactive iodine therapy to treat a certain type of thyroid cancer.

Levothyroxine injection is used in adults to treat myxedema coma.

Levothyroxine belongs to a class of medications called hormones. It works by replacing thyroid hormone that is normally produced by the body.

Without thyroid hormone, your body cannot function properly, which may result in poor growth, slow speech, lack of energy, excessive tiredness, constipation, weight gain, hair loss, dry, thick skin, increased sensitivity to cold, joint and muscle pain, heavy or irregular menstrual periods, and depression. When taken correctly, levothyroxine reverses these symptoms.

Levothyroxine side effects

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

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

• sudden pain or trouble moving your hip, wrist, or back;
• fast or irregular heartbeats;
• chest pain, pain spreading to your jaw or shoulder;
• wheezing;
• fever, swollen glands, itching, joint pain, or not feeling well;
• nausea, vomiting, or diarrhea; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

Common levothyroxine side effects may include:

• fever, hot flashes, increased sweating;
• tiredness;
• skin rash, hair loss;
• chest pain, fast or irregular heartbeats, shortness of breath;
• headache, leg cramps, muscle pain or weakness;
• tremors, feeling nervous or irritable, sleep problems (insomnia);
• increased or change in appetite;
• weight loss or weight gain;
• changes in your menstrual periods; or
• vomiting, diarrhea.

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 may not be able to use levothyroxine if you have certain medical conditions. Tell your doctor if you have an untreated or uncontrolled adrenal gland disorder or any heart problems such as a recent heart attack.

Levothyroxine should not be used to treat obesity or weight problems. Dangerous side effects or death can occur from the misuse of this medicine, especially if you are taking any other weight-loss medications or appetite suppressants.

Taking more than your recommended dose will not make this medicine more effective, and may cause serious side effects.

Before taking this medicine

You should not use levothyroxine if you are allergic to glycerin or edetate disodium, or if you have an untreated or uncontrolled adrenal gland disorder.

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

• a thyroid nodule;
• thyroiditis (inflammation of thyroid gland);
• heart problems such as a heart attack, stroke;
• a blood clot or a blood clotting disorder;
• diabetes (your diabetes medicine may need to be adjusted);
• anemia (low red blood cells);
• weak bones (osteoporosis), or low bone mineral density;
• problems with your pituitary or adrenal gland;
• an allergy to any food or drugs;
• recently received radiation therapy with iodine (such as I-131); or
• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant. Having hypothyroidism during pregnancy may increase the risk of premature birth or other complications. The benefit of treating hypothyroidism may outweigh any risks to the baby. Your dose needs may be different during pregnancy.

Tell your doctor if you are breastfeeding. Your dose needs may be different while you are nursing.

You may be more likely to have a broken bone while using levothyroxine. Talk with your doctor about ways to keep your bones healthy.

How should I use levothyroxine?

Take levothyroxine 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.

Some brands of levothyroxine have different dosage instructions and/or recommendations of how soon you need to take them before eating food. Always check the instructions on the label.

Oral levothyroxine

Oral levothyroxine is taken by mouth and is available as tablets, capsules, and an oral solution.

• Keep using this medicine even if you feel well. You may not fully benefit from this medicine for several weeks.
• You will need frequent medical tests, and your next dose may be delayed based on the results.
• This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.
• Tell your doctor if you have a planned surgery or dental procedure.
• Taking more than your recommended dose will not make this medicine more effective, and may cause serious side effects.

Tablets and capsules

Take levothyroxine tablets and capsules on an empty stomach, at least 30 to 60 minutes before breakfast with a full glass of water. Take the medicine at the same time each day.

• Swallow the capsule whole and do not crush, chew, break, or open it. Tell your doctor if your child cannot swallow a capsule whole.
• If you cannot swallow a tablet whole, crush the tablet, and mix it with 1 or 2 teaspoons of water; give the mixture right away. Do not save it for later use.
• Keep each tablet or capsule in the blister pack until you are ready to take one.
• Store at room temperature away from moisture, heat, and light.

Oral solution (liquid medicine)

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

• Dosages are based on weight in children and teenagers. Your child’s dose may change if the child gains or loses weight.
• Your dose needs may change if you switch to a different brand, strength, or form of levothyroxine. Avoid medication errors by using only the medicine your doctor prescribes.
• Tirosint-Sol oral solution can be administered 15 minutes before eating breakfast. Use it within 3 months after opening the pouch.
• Ermeza and Thyquidity liquids should be taken on an empty stomach, at least 30 to 60 minutes before breakfast. Store them in their original bottle. Use Ermeza within 90 days and Thyquidity within 8 weeks of opening the bottle.
• Store at room temperature away from moisture, heat, and light.

Intravenous levothyroxine

This is given as an injection into a vein by a healthcare provider and should only be used to treat myxedema coma.

What happens if I miss a dose?

In a medical setting, you are not likely to miss a dose of levothyroxine injection.

Take the missed oral levothyroxine dose as soon as you remember, and then go back to your regular schedule. 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 can be fatal.

Overdose symptoms may include headache, leg cramps, tremors, feeling nervous or irritable, chest pain, shortness of breath, fast or pounding heartbeats, stroke, and coma.

What should I avoid while using levothyroxine?

Avoid the following food products within 1 hour of taking oral levothyroxine or the medication will not be as effective: grapefruit juice, infant soy formula, soybean flour, cotton seed meal, walnuts, and high-fiber foods.

What is Lexapro?

Lexapro (escitalopram) is an antidepressant from the group of drugs called selective serotonin reuptake inhibitors (SSRIs) and is used to treat certain types of depression and anxiety. It is not known how Lexapro works, but it is thought to block the reuptake of serotonin by nerves. This results in an increase in serotonin concentrations in the nerve synapse (the space between two nerves).

Lexapro was FDA-approved on August 14, 2002.

Lexapro side effects

Common side effects of Lexapro may include:

• painful urination;
• dizziness, drowsiness, tiredness, weakness;
• feeling anxious or agitated;
• increased muscle movements, feeling shaky;
• sleep problems (insomnia);
• sweating, dry mouth, increased thirst, loss of appetite;
• nausea, constipation;
• yawning;
• nosebleed, heavy menstrual periods; or
• decreased sex drive, impotence, or difficulty having an orgasm.

Serious side effects

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

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), more depressed, or have thoughts about suicide or hurting yourself.

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

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• racing thoughts, unusual risk-taking behavior, feelings of extreme happiness or sadness;
• pain or burning when you urinate;
• (in a child taking Lexapro) slow growth or weight gain;
• low levels of sodium in the body – headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

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.

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 Lexapro if you also take pimozide or citalopram (Celexa).

Do not use Lexapro within 14 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Young adults are at higher risk of having thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Parents or caregivers should report any new or worsening mood symptoms in their child to their doctor. Also, be alert for signs of mania (excessively happy or active behavior).

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.

SSRIs, including Lexapro, may cause sexual problems. Symptoms in males may include delayed ejaculation or inability to have an ejaculation, decreased sex drive, and problems getting or keeping an erection. Symptoms in females may include decreased sex drive, delayed orgasm, or inability to have an orgasm. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Lexapro. There may be treatments your healthcare provider can suggest.

Do not give Lexapro to anyone under 12 years old.

Do not stop using Lexapro without first asking your doctor.

Before taking this medicine

You should not use Lexapro if you are allergic to escitalopram or citalopram (Celexa), or if:

• you also take pimozide.

Do not use Lexapro within 14 days before or 14 days after you have used an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with escitalopram and cause a serious condition called serotonin syndrome.

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

• liver or kidney disease;
• seizures;
• low levels of sodium in your blood;
• heart disease, high blood pressure;
• a stroke;
• bleeding problems;
• sexual problems;
• bipolar disorder (manic depression); or
• drug addiction or suicidal thoughts.

Tell your healthcare provider if you are pregnant, intending to become pregnant, or breastfeeding.

Some young people have thoughts about suicide when first taking an antidepressant. 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.

Lexapro is not approved for use by anyone younger than 12 years old.

Pregnancy

Ask your doctor about taking this medicine if you are pregnant. Taking an SSRI antidepressant during late pregnancy may cause serious medical complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking Lexapro without your doctor’s advice.

If you are pregnant, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. You can register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

There is a less than 2-fold increased risk for severe bleeding after delivery (postpartum hemorrhage) in mothers exposed to SSRIs, particularly in the month before delivery.

Breastfeeding

If you are breastfeeding, tell your doctor if you notice drowsiness, agitation, feeding problems, or poor weight gain in the nursing baby.

How should I take Lexapro?

Take Lexapro 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.

Take the medicine at the same time each day, with or without food.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Your doctor will need to check your progress on a regular basis. A child taking Lexapro should be checked for height and weight gain.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using Lexapro suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose.

Store Lexapro at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Generalized Anxiety Disorder:

Initial dose: 10 mg orally once a day; increase if necessary after at least 1 week of treatment to 20 mg once a day
Maintenance dose: 10 to 20 mg orally once a day
Maximum dose: 20 mg orally once a day

Comment: Treatment should be periodically reassessed to determine the need for ongoing treatment; efficacy beyond 8 weeks has not been systematically studied.

Use: Acute treatment of generalized anxiety disorder

Usual Adult Dose for Depression:

Initial dose: 10 mg orally once a day; increase if necessary after at least 1 week of treatment to 20 mg once a day
Maintenance dose: 10 to 20 mg orally once a day
Maximum dose: 20 mg orally once a day

Comments:
-Acute episodes may require several months or longer of sustained pharmacological therapy beyond response to the acute episode.
-Patients should be periodically reassessed to determine the need for maintenance treatment.

Use: Acute and maintenance treatment of major depressive disorder

Usual Geriatric Dose for Depression:

Recommended dose: 10 mg orally once a day

Use: Acute and maintenance treatment of major depressive disorder

Usual Pediatric Dose for Depression:

12 years and older:
-Initial dose: 10 mg orally once a day; increase if necessary after at least 3 weeks of treatment to 20 mg once a day
-Maintenance dose: 10 to 20 mg orally once a day
-Maximum dose: 20 mg orally once a day

Comments:
-Acute episodes may require several months or longer of sustained pharmacological therapy beyond response to the acute episode.
-Patients should be periodically reassessed to determine the need for maintenance treatment.

Use: Acute and maintenance treatment of major depressive disorder

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 to avoid

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Lexapro may cause you to bruise or bleed easily.

Avoid alcohol.

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

What is Lexette?

Lexette foam is a super high potency, Class I corticosteroid foam that is applied to the skin to reduce inflammation and itching caused by plaque psoriasis in adults aged 18 years and older. Lexette contains halobetasol propionate 0.05%.

The foam is applied as a thin layer to the affected areas of the skin for a maximum of 2 consecutive weeks. Lexette foam is flammable, and you should avoid heat, open flames, or smoking while using this product. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

Lexette foam was FDA approved on May 24, 2018.

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.

Lexette foam 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 use more than 50 grams per week. Periodic monitoring for HPA suppression may be required.

Before taking this medicine

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

Lexette foam 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. Lexette foam is not approved for use by young adults and children under the age of 18.

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

How do I use Lexette foam?

Use Lexette foam 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 it gets in your eyes or mouth.

• Wash your hands before and after using Lexette foam unless you are using this medicine to treat the skin on your hands.
• Shake the foam before each use.
• Press down on the actuator to dispense a small amount of foam into your hand.
• Apply a thin layer of Lexette foam to the affected area 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.

Lexette foam is for short-term use only up to 2 weeks. 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, 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 Lexette foam 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 Lexette foam?

• Avoid heat, flame, or smoking during and right after applying Lexette to your skin, because it is flammable.
• Avoid applying Lexette foam to your face, scalp, underarms, or groin area.
• Do not use Lexette foam 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 Lexette foam unless your doctor tells you to.

What are the side effects of Lexette foam?

Get emergency medical help if you have signs of an allergic reaction to Lexette foam, 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 Lexette side effects may include:

• headache
• pain where the foam was applied.

Other side effects reported with topical corticosteroids include:

• burning, stinging, itching, or dryness of treated skin
• redness or crusting around your hair follicles
• stretch marks
• spider veins.

What is Lialda?

Lialda affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Lialda is used to treat mild to moderate active ulcerative colitis in adults and children who weight at least 24kg.

Lialda is also used in adults as a maintenance treatment to prevent the symptoms of ulcerative colitis from recurring.

Warnings

Stop using Lialda and call your doctor at once if you have severe stomach pain, stomach cramping, bloody diarrhea (may occur with fever, headache, and skin rash).

Before taking this medicine

You should not use Lialda if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

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

• a kidney stone or kidney disease;
• liver disease;
• a blockage in your stomach or intestines (such as pyloric stenosis); or
• a skin condition such as eczema.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether mesalamine will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy may cause complications such as low birth weight or premature birth. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

It may not be safe to breastfeed while using Lialda. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

How should I take Lialda?

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

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

Lialda should be taken with a meal.

Drink plenty of liquids to help prevent kidney stones.

Swallow the Lialda tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet.

Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse.

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

You may need frequent blood tests to check your blood cells or kidney function.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Lialda for Ulcerative Colitis — Active:

1200 mg tablets: 2.4 to 4.8 g (two to four tablets) orally once a day with food.

Usual Adult Dose of Lialda for Ulcerative Colitis — Maintenance:

1200 mg tablets: 2.4 g (two tablets) orally once a day with food.

Usual Pediatric Dose of Lialda for Ulcerative Colitis — Active:

Patient weight – 24 kg to 35 kg: from week 0 to week 8, two 1.2 g tablets once daily. After week 8, one 1.2 g tablet once daily.
Greater than 35 kg to 50 kg: from week 0 to week 8, three 1.2 g tablets once daily. After week 8, two 1.2 g tablets once daily.
Greater than 50 kg: from week 0 to week 8, four 1.2 g tablets once daily. After week 8, two 1.2 g tablets once daily.

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 Lialda?

If you have a skin condition such as eczema, mesalamine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Lialda side effects

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

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

• severe stomach pain, stomach cramping, bloody diarrhea;
• fever, headache, general ill feeling;
• rash, itching, eye redness;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• low white blood cell counts – fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
• signs of a kidney stone – severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine;
• kidney problems – increased or decreased urination, swelling, weight gain; or
• liver problems – loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Low white blood cell counts may be more likely in older adults.

Common Lialda side effects may include:

• burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas;
• dizziness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• back pain;
• headache;
• rash; or
• abnormal liver function tests.

Uses for Lidex

Fluocinonide topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor’s prescription.

Before using Lidex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluocinonide topical in the pediatric population. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully. For Vanos® cream, safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Vanos® cream in the elderly. However, elderly patients are more likely to have age-related medical problems, which may require caution in patients receiving Vanos® cream.

No information is available on the relationship of age to the effects of fluocinonide topical in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing’s syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—Vanos® cream should not be used in patients with these conditions.

Proper use of Lidex

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

If you are using the Vanos® cream:

• Do not use it on the face, groin, or underarms unless directed to do so by your doctor.
• Do not use it for more than 2 weeks unless your doctor tells you otherwise.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream, gel, ointment, or solution):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin two to four times per day.
    • Children—Apply to the affected area of the skin two to four times per day.
• For topical dosage form (cream):
  • For atopic dermatitis:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin once a day.
    • Children younger than 12 years of age—Use is not recommended.
  • For psoriasis:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin one to two times per day.
    • Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Lidex

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Side Effects of Lidex

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Fever
• headache
• muscle aches
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Incidence not known

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

What is Liletta?

Liletta (levonorgestrel) is an intrauterine device (IUD) used to prevent pregnancy and also to treat heavy periods (menstrual bleeding).  Liletta is an IUD which is a small, flexible, T-shaped plastic device that is placed in the uterus, where it slowly releases the hormone levonorgestrel.  

The Liletta IUD works to prevent pregnancy by thickening the mucus at the entrance to the uterus to prevent sperm from entering, thinning the lining of the uterus, and preventing sperm from moving and surviving in the uterus. Liletta works to treat heavy periods by levonorgestrel effect on the uterus. Liletta works to treat heavy periods by controlling the monthly development of the uterus lining so there is less bleeding each month.

Liletta contains levonorgestrel which is a progestin hormone; it does not contain estrogen. It should not be used as emergency birth control and does not protect you from sexually transmitted infections or human immunodeficiency virus (HIV).

How long does Liletta IUD last?

Liletta can be used for up to 8 years to prevent pregnancy and for 5 years when used for heavy periods and as a contraceptive. It can be replaced at the time of removal with a new device if continued contraceptive protection is wanted. You can stop using the IUD at any time by asking your healthcare provider to remove it.

When does Liletta start working?

If you are currently not using hormonal or intrauterine contraception:

• Liletta IUD will start working immediately as a contraceptive if it is inserted within the first seven days of your period or immediately after a first-trimester abortion or miscarriage. However, if you choose to have Liletta inserted at any other time during your monthly cycle, you will need to use an additional birth control method (like condoms) for the first week, as at this stage of your cycle, it takes seven days after the insertion of Liletta for it to provide full protection against pregnancy.

For information on when Liletta starts working when switching from oral, transdermal, vaginal hormonal contraceptive or injectable progestin contraceptive, see the dosing information link below.

How well does Liletta work?

Liletta IUD is very effective at preventing pregnancy with a low chance of becoming pregnant, with less than 1 in 100 patients becoming pregnant in one year.

Liletta IUD works well to reduce heavy menstrual bleeding with 80% of patients having their blood loss reduced by half after 6 months.

Liletta side effects

Common Liletta side effects may include:

• pelvic pain, painful or irregular menstrual periods, changes in bleeding patterns or flow;
• vaginal swelling, itching or infection;
• temporary pain, bleeding, or dizziness during insertion of the IUD;
• ovarian cysts (pelvic pain that disappears within 3 months);
• stomach pain, nausea, vomiting, bloating;
• headache, migraine, depression, mood changes;
• back pain, breast tenderness or pain;
• weight gain, acne, oily skin, changes in hair growth, loss of interest in sex; or
• puffiness in your face, hands, ankles, or feet.

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

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy.

The IUD may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Serious Liletta side effects may include:

Call your doctor at once if you have:

• severe cramps or pelvic pain, pain during sexual intercourse;
• extreme dizziness or light-headed feeling;
• severe migraine headache;
• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
• pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;
• jaundice (yellowing of the skin or eyes); or
• sudden numbness or weakness (especially on one side of the body), confusion, problems with vision, sensitivity to light.

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 Liletta during pregnancy. Tell your doctor right away if you become pregnant.

Before using this medicine

An IUD can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about this risk.

You should not use Liletta if you are allergic to levonorgestrel, or other materials in this device. For a full list of ingredients, click here Liletta ingredients.

You should not use Liletta if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;
• an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
• endometriosis or a serious pelvic infection following a pregnancy or abortion in the past 3 months;
• pelvic inflammatory disease (PID), unless you had a normal pregnancy after the infection was treated and cleared;
• uterine fibroid tumors or conditions that affect the shape of the uterus;
• past or present cancer of the breast, cervix, or uterus;
• liver disease or liver tumor (benign or malignant);
• a condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;
• if you have another intrauterine device (IUD) in place;
• if you had an abortion or miscarriage in the past 6 weeks; or
• if you gave birth to a baby in the past 6 weeks.

Tell your doctor if you have ever had:

• high blood pressure, heart problems, a heart attack, or a stroke;
• bleeding problems;
• migraine headaches; or
• a vaginal infection, pelvic infection, or sexually transmitted disease.

Pregnancy

Do not use during pregnancy. If left in place during pregnancy, Liletta could cause severe infection, miscarriage, premature birth, or death of the mother. The hormone Liletta may also cause unwanted effects in a female newborn.

Tell your doctor right away if you become pregnant. If you continue the pregnancy, watch for signs such as fever, chills, cramps, vaginal bleeding, or discharge.

Breastfeeding

Tell your doctor if you are breastfeeding. You may use Liletta when breastfeeding as it is not likely to affect the quality or amount of breast milk; however, a small number of patients who have taken progestin-only birth control pills report a decrease in the amount of milk produced. There is also an increased risk of Liletta becoming attached or going through the wall of the uterus when breastfeeding.

How is Liletta used?

The Liletta IUD is inserted through the vagina and placed into the uterus by a healthcare professional. You may feel pain or dizziness during insertion of the IUD, and you may have minor vaginal bleeding. Tell your doctor if these symptoms last longer than 30 minutes.

Your doctor should check Liletta after a few weeks to make sure it is still in place. You will also need annual pelvic exams and Pap smears.

Liletta should not interfere with sexual intercourse, wearing a tampon or menstrual cup, or using other vaginal medications.

The IUD may come out by itself. After each menstrual period, make sure you can still feel the removal threads at the opening of your cervix. At the lower end of the Liletta device, there are two treads which are the only part of the device that you can feel when the IUD is in your uterus; however, unlike a tampon string, the threads do not extend outside your body.

Call your doctor at once if you cannot feel the strings or if you think Liletta has slipped lower or has come out of your uterus, especially if you also have pain or bleeding. Use a non-hormone method of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy until your doctor is able to replace the IUD.

You may have irregular periods for 3 to 6 months. Your flow may be lighter or heavier, and your periods may stop after several months. Tell your doctor if you do not have a period for 6 weeks or if you think you might be pregnant.

If you need to have an MRI (magnetic resonance imaging), tell your healthcare providers ahead of time that you have an IUD in place.

Liletta may be removed at any time you decide to stop using birth control. Liletta must be removed at the end of the 8-year wearing time when used as a contraceptive and for 5 years when used for heavy periods and as a contraceptive. 

If you decide to use a different method of birth control, you may need to start using it a week before Liletta is removed.

Only your doctor should remove the IUD. Do not attempt to remove the device yourself.

Dosing information

Liletta contains levonorgestrel 52 mg, which initially has a release rate of 20 mcg/day and declines to 6.5 mcg/day after 8 years. The average release rate of levonorgestrel is approximately 13.5 mcg/day over a period of 8 years. The T-shaped plastic frame is 32mm by 32 mm.

Liletta should be removed at the end of the 8-year wearing time when used as a contraceptive and for 5 years when used for heavy periods and as a contraceptive. It can be replaced at the time of removal with a new device if continued contraceptive protection is wanted.

If pregnancy is not desired, Liletta can be removed at any time; however, another contraception method should be started at least 7 days before removal of the device. There is a risk of pregnancy if there has been intercourse in the week prior to removal without the use of a backup contraceptive method. 

What happens if I miss a dose?

Since the IUD continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

What happens if I overdose?

An overdose of levonorgestrel released from the intrauterine system is very unlikely to occur.

What should I avoid while using Liletta?

The IUD can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted diseases. Liletta will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom may help protect from these diseases.

Call your doctor if your sex partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Antibacterial; oxazolidinone.

Uses for Linezolid

Respiratory Tract Infections

Treatment of community-acquired pneumonia (CAP), including infections associated with concurrent bacteremia, caused by susceptible Streptococcus pneumoniae.

Treatment of CAP caused by susceptible Staphylococcus aureus (methicillin-susceptible [oxacillin-susceptible] strains only). Also recommended for treatment of CAP caused by methicillin-resistant S. aureus^{† [off-label]} (MRSA; also known as oxacillin-resistant S. aureus or ORSA).

Treatment of nosocomial pneumonia caused by susceptible S. aureus (including MRSA) or S. pneumoniae.

Not indicated for treatment of respiratory tract infections caused by gram-negative bacteria. It is imperative that an anti-infective active against gram-negative bacteria be used concomitantly if documented or presumed pathogens include gram-negative bacteria.

Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections caused by susceptible S. aureus (methicillin-susceptible [oxacillin-susceptible] strains only) or S. pyogenes (group A β-hemolytic streptococci, GAS).

Treatment of complicated skin and skin structure infections (including diabetic foot infections), without concurrent osteomyelitis, caused by susceptible S. aureus (including MRSA), S. pyogenes, or S. agalactiae (group B streptococci, GBS).

Not evaluated for use in the treatment of decubitus ulcers.

Not indicated for treatment of skin and skin structure infections caused by gram-negative bacteria. It is imperative that an anti-infective active against gram-negative bacteria be used concomitantly if the documented or presumed pathogens include gram-negative bacteria.

Vancomycin-resistant Enterococcus faecium Infections

Treatment of infections caused by susceptible vancomycin-resistant Enterococcus faecium, including infections associated with concurrent bacteremia.

Has been used for treatment of native valve or prosthetic valve infective endocarditis^{† [off-label]} caused by vancomycin-resistant or multidrug-resistant E. faecium. AHA recommends that patients with infective endocarditis attributable to enterococci resistant to penicillins, aminoglycosides, and vancomycin be managed by a team of specialists in infectious disease, cardiology, cardiovascular surgery, clinical pharmacy, and, if necessary, pediatrics.

Tuberculosis

Used in multiple-drug regimens for treatment of multidrug-resistant (MDR) tuberculosis^{† [off-label]} caused by Mycobacterium tuberculosis (i.e., caused by M. tuberculosis resistant to isoniazid and rifampin). ATS, CDC, and IDSA state that linezolid is one of various options that can be considered for inclusion in multiple-drug regimens used for treatment of MDR tuberculosis. WHO recommends that linezolid be included in multiple-drug regimens used for longer-term treatment (≥18 months) of multidrug- or rifampin-resistant (MDR/RR) tuberculosis.

Used in a 3-drug combination regimen that includes bedaquiline and pretomanid for treatment of extensively drug resistant (XDR) pulmonary tuberculosis (i.e., caused by M. tuberculosis resistant to isoniazid, rifampin, any fluoroquinolone, and at least one injectable antituberculosis agent) or treatment-intolerant or non-responsive MDR pulmonary tuberculosis. WHO states that the 3-drug regimen of pretomanid, bedaquiline, and linezolid (also known as BPaL) may be used for treatment of MDR tuberculosis in patients who have not previously received either bedaquiline or linezolid (or received the drugs for ≤2 weeks) and have documented evidence that the MDR strain also is resistant to a fluoroquinolone.

Patients with MDR or XDR tuberculosis are at high risk for treatment failure and acquisition of further drug resistance. ATS, CDC, and IDSA recommend that such patients be referred to or that consultation be obtained from a specialized treatment center as identified by local or state health departments or the CDC.

For additional information on treatment of MDR and XDR tuberculosis, consult current guidelines from ATS/CDC/IDSA and WHO.

Linezolid Dosage and Administration

Administer orally or by IV infusion.

When clinically appropriate, IV route may be switched to oral without dosage adjustment.

Avoid large quantities of foods or beverages with high tyramine content during linezolid treatment. (See Monoamine Oxidase Inhibition under Cautions.)

Oral Administration

Administer orally without regard to meals.

Reconstitution

Reconstitute powder for oral suspension at time of dispensing by adding amount of water specified on bottle to provide a suspension containing 100 mg/5 mL. After tapping bottle gently to loosen the powder, add water in 2 portions and agitate well after each addition.

Prior to administration of each dose, gently mix suspension by inverting bottle 3–5 times; do not shake.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Single-use containers of linezolid injection for IV infusion should be administered without further dilution. Do not use the containers in series connections; do not introduce additives into the solution.

Rate of Administration

Administer by IV infusion over 30–120 minutes.

Dosage

Manufacturer states safety and efficacy of >28 days of linezolid treatment not evaluated in controlled clinical trials. The drug is administered for longer durations when used in multiple-drug regimens for treatment of MDR tuberculosis.

Pediatric Patients

General Dosage for Neonates

Oral or IV

Neonates: Manufacturer recommends 10 mg/kg every 12 hours initially in premature neonates <7 days of age; may consider 10 mg/kg every 8 hours in those with inadequate response. Manufacturer recommends 10 mg/kg every 8 hours in all neonates ≥7 days of age.

Neonates ≤7 days of age: AAP recommends 10 mg/kg every 12 hours in those with gestational age <34 weeks and 10 mg/kg every 8 hours in those with gestational age ≥34 weeks.

Neonates 8–28 days of age: AAP recommends 10 mg/kg every 8 hours, regardless of gestational age.

Respiratory Tract Infections

Community-acquired or Nosocomial Pneumonia

Oral or IV

Children 7 days through 11 years of age: 10 mg/kg every 8 hours for 10–14 days.

Adolescents ≥12 years of age: 600 mg every 12 hours for 10–14 days.

Skin and Skin Structure Infections

Uncomplicated Skin and Skin Structure Infections

Oral

Children 7 days through 4 years of age: 10 mg/kg every 8 hours for 10–14 days.

Children 5 through 11 years of age: 10 mg/kg every 12 hours for 10–14 days.

Adolescents ≥12 years of age: 600 mg every 12 hours for 10–14 days.

Complicated Skin and Skin Structure Infections

Oral or IV

Children 7 days through 11 years of age: 10 mg/kg every 8 hours for 10–14 days.

Adolescents ≥12 years of age: 600 mg every 12 hours for 10–14 days.

Vancomycin-resistant Enterococcus faecium Infections

Oral or IV

Children 7 days through 11 years of age: 10 mg/kg every 8 hours for 14–28 days.

Adolescents ≥12 years of age: 600 mg every 12 hours for 14–28 days.

Adults

Respiratory Tract Infections

Community-acquired or Nosocomial Pneumonia

Oral or IV

600 mg every 12 hours for 10–14 days.

Skin and Skin Structure Infections

Uncomplicated Skin and Skin Structure Infections

Oral

400 mg every 12 hours for 10–14 days.

Complicated Skin and Skin Structure Infections

Oral or IV

600 mg every 12 hours for 10–14 days.

Vancomycin-resistant Enterococcus faecium Infections

Oral or IV

600 mg every 12 hours for 14–28 days.

Active Tuberculosis

XDR or Treatment-intolerant or Non-responsive MDR Pulmonary Tuberculosis

Oral

1.2 g daily for 26 week. Adjustment of dosage to 600 mg daily with further reductions to 300 mg daily or interruption of linezolid therapy may be required if myelosuppression, peripheral neuropathy, or optic neuropathy occurs.

Must administer in conjunction with oral pretomanid (200 mg once daily for 26 weeks) and bedaquiline (400 mg once daily for 2 weeks followed by 200 mg 3 times weekly [with at least 48 hours between doses] for 24 weeks).

The 3-drug combination regimen should be continued for 26 weeks, but may be extended beyond 26 weeks if necessary.

Special Populations

Hepatic Impairment

Mild to moderate hepatic impairment (Child-Pugh class A or B): Dosage adjustments not needed.

Severe hepatic impairment: Pharmacokinetics not evaluated.

Renal Impairment

Dosage adjustments not needed. Consider that linezolid metabolites may accumulate in patients with renal impairment; clinical importance unknown. (See Renal Impairment under Cautions.)

Hemodialysis patients: Administer linezolid doses after dialysis session.

Geriatric Patients

Dosage adjustments not needed.

Cautions for Linezolid

Contraindications

• Known hypersensitivity to linezolid or any ingredient in the formulation.
• Current or recent (within the last 2 weeks) treatment with drugs that inhibit MAO A or B (e.g., isocarboxazid, phenelzine). (See Specific Drugs under Interactions.)

Warnings/Precautions

Hematologic Effects

Myelosuppression (anemia, leukopenia, pancytopenia, thrombocytopenia) reported.

Toxicity studies in adult and juvenile dogs and rats indicate myelosuppression (bone marrow hypocellularity/decreased hematopoiesis; decreased extramedullary hematopoiesis in spleen and liver; decreased levels of circulating erythrocytes, leukocytes, and platelets) and lymphoid depletion in thymus, lymph nodes, and spleen.

Monitor CBCs weekly during linezolid treatment, especially in those receiving the drug for >2 weeks and in those who have preexisting myelosuppression, are receiving concomitant drugs associated with bone marrow suppression, or have a chronic infection that was or is being treated with concomitant anti-infective therapy.

Consider discontinuing linezolid if myelosuppression develops or worsens. Hematologic parameters generally have increased toward pretreatment values following discontinuance of the drug.

Peripheral and Optic Neuropathy

Peripheral and optic neuropathies reported in adults and children receiving linezolid, principally in those receiving the drug for >28 days. Optic neuropathy progressing to loss of vision reported when linezolid used for >28 days. Blurred vision reported in some patients who received the drug for <28 days.

If patient experiences symptoms of visual impairment (e.g., changes in visual acuity or color vision, blurred vision, visual field defect), promptly perform an ophthalmic evaluation. Monitor visual function in all patients receiving linezolid for extended periods of time (i.e., ≥3 months). In addition, monitor visual function in all patients reporting a new visual symptom, regardless of length of linezolid treatment.

If peripheral or optic neuropathy occurs, weigh potential benefits versus risks of continued linezolid treatment.

Serotonin Syndrome

Serotonin syndrome (including some fatalities) reported in patients receiving linezolid concomitantly with serotonergic drugs. Signs and symptoms of serotonin syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering, shaking, diarrhea, loss of coordination, and/or fever.

Most reported cases occurred in patients receiving linezolid concomitantly with SSRIs or SNRIs. FDA has not concluded whether concomitant use of linezolid with other drugs with lesser degrees of serotonergic activity (e.g., tricyclic antidepressants, MAO inhibitors) is associated with a risk comparable to that reported with SSRIs or SNRIs.

Unless considered clinically appropriate and patients can be carefully monitored for signs and/or symptoms of serotonin syndrome or neuroleptic malignant syndrome-like (NMS-like) reactions, do not use linezolid in patients with carcinoid syndrome or in patients receiving SSRIs, tricyclic antidepressants, serotonin 5-HT₁ receptor agonists (triptans), meperidine, bupropion, or buspirone. (See Specific Drugs under Interactions.)

In cases when patient is already receiving a serotonergic antidepressant or buspirone and urgent treatment with linezolid is required (e.g., life-threatening infection caused by MRSA or vancomycin-resistant E. faecium) and alternatives to linezolid are not available and potential benefits of the drug outweigh risks of serotonin syndrome or NMS-like reactions, stop the serotonergic antidepressant promptly and administer linezolid. Monitor for manifestations of serotonin syndrome or NMS-like reactions (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes that include extreme agitation progressing to delirium and coma) for 2 weeks (5 weeks if fluoxetine was taken) or until 24 hours after last linezolid dose, whichever comes first. Also monitor for symptoms associated with discontinuance of the antidepressant.

Mortality

In an investigational study in seriously ill patients with intravascular catheter-related infections^{† [off-label]}, mortality was higher in patients receiving linezolid than in patients receiving a comparator anti-infective (vancomycin, oxacillin, dicloxacillin); patients also could receive concomitant therapy for gram-negative infection. There was no difference in mortality between linezolid and comparator regimens in patients with only gram-positive bacteria identified in the baseline culture; mortality was higher in linezolid-treated patients with gram-negative bacterial infections, mixed gram-positive and gram-negative infections, or no pathogen identified at baseline. Causality not established.

Not approved by FDA for treatment of catheter-related bacteremia or catheter-site infections; not approved for treatment of gram-negative bacterial infections.

Monoamine Oxidase Inhibition

Linezolid is a weak, nonselective, reversible inhibitor of MAO, and potentially may interact with MAO inhibitors and adrenergic and serotonergic agents. (See Specific Drugs under Interactions.)

Significant pressor response reported when tyramine doses >100 mg were used in adults receiving linezolid. Instruct patients to avoid large quantities of foods or beverages with high tyramine content during linezolid treatment. Foods high in tyramine content include those that may have undergone protein changes by aging, fermentation, pickling, or smoking to improve flavor (e.g., aged cheeses, fermented or air-dried meat, sauerkraut, soy sauce, tap beer, red wine). Consider that tyramine content of any protein-rich food may be increased if stored for long periods or improperly refrigerated.

Risk of Hypertension

Unless monitored for potential increases in BP, do not use linezolid in patients with uncontrolled hypertension, pheochromocytoma, or thyrotoxicosis or in patients receiving direct- or indirect-acting sympathomimetic agents (e.g., pseudoephedrine), vasopressor agents (e.g., epinephrine, norepinephrine), or dopaminergic agents (e.g., dopamine, dobutamine). (See Specific Drugs under Interactions.)

Lactic Acidosis

Lactic acidosis, characterized by recurrent nausea and vomiting, reported. Patients who develop recurrent nausea and vomiting, unexplained acidosis, or a low bicarbonate concentration while receiving linezolid should undergo immediate medical evaluation.

Seizures

Seizures reported; history of seizures or risk factors for seizures noted in some cases.

Hypoglycemia

Symptomatic hypoglycemia reported in patients with diabetes mellitus receiving linezolid concomitantly with insulin or oral hypoglycemic agents.

Although causal relationship between linezolid and hypoglycemia not established, caution patients with diabetes mellitus about potential for hypoglycemia during linezolid treatment.

If hypoglycemia occurs, dosage reduction of insulin or oral antidiabetic agents or discontinuance of linezolid, insulin, or oral antidiabetic agents may be necessary.

Sensitivity Reactions

Anaphylaxis, angioedema, and bullous skin disorders, including severe cutaneous adverse reactions (SCAR) such as toxic epidermal necrolysis and Stevens-Johnson syndrome, reported.

Tooth Discoloration

Superficial tooth discoloration and tongue discoloration reported. In cases with known outcome, tooth discoloration was removable with professional dental cleaning (manual descaling).

Phenylketonuria

Oral suspension contains aspartame, which is metabolized in the GI tract to provide 20 mg of phenylalanine per 5 mL of suspension.

Linezolid tablets do not contain aspartame and should be used in individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine.

Superinfection/Clostridioides difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms. Monitor carefully; institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides difficile (formerly Clostridium difficile).

C. difficile infection (CDI) andC. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including linezolid, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to the development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as ≥2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. Initiate appropriate anti-infective therapy directed against C. difficile (e.g., fidaxomicin, vancomycin, metronidazole), supportive therapy (e.g., fluid and electrolyte management, protein supplementation), and surgical evaluation as clinically indicated.

Selection and Use of Anti-infectives

Linezolid is indicated only for treatment of certain infections caused by certain gram-positive bacteria. The drug has no clinical activity against gram-negative bacteria and is not indicated for treatment of infections caused by gram-negative bacteria.

It is imperative that an anti-infective active against gram-negative bacteria be used concomitantly if documented or presumptive pathogens also include gram-negative bacteria. (See Uses.)

Safety and efficacy of linezolid given for >28 days not evaluated in controlled clinical trials. (See Dosage under Dosage and Administration.)

To reduce development of drug-resistant bacteria and maintain effectiveness of linezolid and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

Information on test methods and quality control standards for in vitro susceptibility testing of antibacterials and specific interpretive criteria for such testing recognized by FDA is available at [Web]. For most antibacterials, including linezolid, FDA recognizes the standards published by the Clinical and Laboratory Standards Institute (CLSI).

Specific Populations

Pregnancy

Available data from published and postmarketing case reports regarding use of linezolid in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

In mice, rats, and rabbits, linezolid was not teratogenic; however, embryofetal toxicities reported (e.g, post-implantational embryo death, decreased fetal body weights, increased incidence of costal cartilage fusion, reduced ossification).

Lactation

Distributed into human milk; not known whether the drug affects the breast-fed infant or affects milk production.

Consider benefits of breast-feeding and the importance of linezolid to the woman along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

If used in a nursing woman, manufacturer recommends monitoring breast-fed infant for diarrhea and vomiting since these are the most common adverse reactions reported in infants being treated with linezolid.

Males of Reproductive Potential

Based on findings from animal studies, linezolid may reversibly impair fertility in males.

In adult male rats, reversible decrease in fertility and reproductive performance reported. The effects on fertility were mediated through altered spermatogenesis; affected spermatids contained abnormally formed and oriented mitochondria and were nonviable. Epithelial cell hypertrophy and hyperplasia in the epididymis observed in conjunction with decreased fertility.

Pediatric Use

Safety and efficacy for treatment of CAP, nosocomial pneumonia, complicated skin and skin structure infections, and vancomycin-resistant E. faecium infections in pediatric patients are supported by adequate and well-controlled studies in adults, pharmacokinetic studies in pediatric patients, and additional data from a comparator-controlled study of gram-positive infections in neonates and children through 11 years of age. Safety and efficacy for treatment of CAP in pediatric patients also is supported by evidence from an uncontrolled study in patients 8 months through 12 years of age.

Safety and efficacy for treatment of uncomplicated skin and skin structure infections in pediatric patients established in a comparator-controlled study in pediatric patients 5–17 years of age.

In children with a suboptimal response to linezolid, especially those with infections caused by pathogens with linezolid MICs of 4 mcg/mL, consider inadequate systemic exposure, site and severity of infection, and underlying medical conditions.

Manufacturer states not recommended for empiric treatment of CNS infections in pediatric patients. (See Distribution under Pharmacokinetics.)

Geriatric Use

Pharmacokinetic, safety, and efficacy profiles similar to those in younger adults. Possibility of greater sensitivity in some older individuals cannot be ruled out.

Hepatic Impairment

Mild or moderate hepatic impairment (Child-Pugh class A or B): Pharmacokinetics not altered.

Severe hepatic impairment: Pharmacokinetics not evaluated.

Renal Impairment

Although clinical importance not determined, the 2 principal metabolites of linezolid may accumulate in patients with impaired renal function; amount of accumulation increases with severity of renal impairment. Weigh potential benefits against potential risks of accumulation of linezolid metabolites. (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (diarrhea, nausea, vomiting, localized or generalized abdominal pain, loose stools), headache, rash, dizziness, anemia, thrombocytopenia.

Drug Interactions

Minimally metabolized; possibly by CYP isoenzymes.

Does not inhibit CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A4. Does not induce CYP isoenzymes.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Potent inducers of hepatic enzymes: Possible reduced linezolid concentrations.

Specific Drugs

Linezolid Pharmacokinetics

Absorption

Bioavailability

Rapidly and extensively absorbed after oral administration. Absolute oral bioavailability is approximately 100%.

Peak plasma concentrations attained within 1–2 hours following oral administration.

Food

Time to peak concentrations is delayed and peak concentration decreased when administered with high-fat meal; extent of absorption not affected. Not considered clinically important.

Distribution

Extent

Readily distributed into well-perfused tissues.

Adults with CNS infections: IV administration of linezolid (600 mg twice daily) resulted in steady-state mean peak CSF concentrations 36–58% of mean peak plasma concentrations; time to peak CSF concentrations was approximately 3–4 hours after a dose.

Pediatric patients with ventriculoperitoneal shunts: Therapeutic concentrations not consistently achieved or maintained in CSF after single or multiple doses.

Distributed into human milk.

Plasma Protein Binding

Approximately 31%.

Elimination

Metabolism

Principally metabolized by oxidation of the morpholine ring to 2 inactive metabolites (metabolites A and B). Minimally metabolized; possibly mediated by CYP enzyme system.

Elimination Route

Approximately 65% of a dose eliminated via nonrenal clearance. At steady state, approximately 30% of dose eliminated in urine as unchanged drug, 10% as metabolite A, and 40% as metabolite B. Mean renal clearance is 40 mL/minute, suggesting net tubular reabsorption.

Almost no linezolid is found in feces as unchanged drug; approximately 3 and 6% of a dose is eliminated in feces as metabolites A and B, respectively.

Linezolid and its metabolites removed by hemodialysis. Approximately 30% of linezolid dose removed by 3-hour hemodialysis session started 3 hours after the dose.

Not known whether linezolid or its metabolites removed by peritoneal dialysis.

Half-life

Adults: Mean elimination half-life is 4.3–6.4 hours.

Neonates: Mean elimination half-life is 5.6 hours in preterm neonates <1 week of age, 3 hours in full-term neonates <1 week of age, and 1.5 hours in neonates 1 week to 28 days of age.

Infants and children: Mean elimination half-life is 1.8 hours in infants >28 days through 2 months of age and 2.9 hours in children 3 months through 11 years of age.

Adolescents 12 through 17 years of age: Mean elimination half-life is 4.1 hours.

Special Populations

Geriatric adults ≥65 years of age: Pharmacokinetics similar to younger adults.

Pediatric patients: Clearance varies with age and there is wide intraindividual variability. Excluding neonates <7 days of age, clearance is most rapid in the youngest age groups (i.e., those 7 days to 11 years of age); as children age, clearance of linezolid decreases and clearance in adolescents is similar to that observed in adults.

Pharmacokinetics of linezolid not affected by mild or moderate hepatic impairment (Child-Pugh class A or B); not evaluated in severe hepatic impairment.

Pharmacokinetics of linezolid not affected by renal impairment, but the 2 principal metabolites accumulate; amount of accumulation increases with increasing severity of renal impairment.

Stability

Storage

Oral

Tablets

25°C. Protect from light and moisture.

For Suspension

25°C. Protect from light and moisture. After reconstitution, store at room temperature and use within 21 days.

Parenteral

Injection, for IV Infusion

25°C; do not freeze. Protect from light and moisture.

Compatibility

Parenteral

Solution Compatibility1 HID

Drug Compatibility

Actions and Spectrum

• Oxazolidinone anti-infective agent.
• Binds to a site on the bacterial 23S ribosomal RNA of the 50S subunit and prevents formation of a functional 70S initiation complex.
• Bacteriostatic in vitro against susceptible enterococci and staphylococci; bactericidal against susceptible streptococci.
• Active in vitro against Staphylococcus aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA]), Streptococcus agalactiae (group B streptococci, GBS), S. pneumoniae, and S. pyogenes (group A β-hemolytic streptococci, GAS). Although clinical importance unknown, also active in vitro against S. epidermidis (including methicillin-resistant [oxacillin-resistant] strains), S. haemolyticus, viridans group streptococci, group G streptococci, Corynebacterium, and Pasteurella multocida.
• Active in vitro against vancomycin-resistant Enterococcus faecium. Although clinical importance unknown, also active in vitro against E. faecium (vancomycin-susceptible strains) and E. faecalis (including vancomycin-resistant strains).
• Active in vitro against Mycobacterium tuberculosis, including some multiple-drug resistant (MDR) and extensively drug-resistant (XDR) strains. Also has activity in vitro against some strains of M. chelonaei, M. fortuitum, M. gilvum, M. gordonae, M. kansasii, M. mucogenicum, and M. simiae.
• Resistance to linezolid has been produced in vitro by serial passage of MRSA or enterococci (i.e., E. faecalis, E. faecium) in the presence of increasing concentrations of the drug and has emerged in patients receiving the drug for treatment of infections caused by MRSA or enterococci.
• Linezolid resistance generally associated with point mutations in 23S rRNA. However, linezolid resistance in staphylococci mediated by the chloramphenicol-florfenicol (cfr) gene located on a plasmid has been reported and such resistance is transferable between staphylococci.
• Cross-resistance between linezolid and other oxazolidinones (e.g., tedizolid) reported. Bacteria resistant to linezolid because of mutations in chromosomal genes encoding the 23S rRNA or ribosomal proteins (L3 and L4) generally cross-resistant to other oxazolidinones (e.g., tedizolid) and vice versa. In vitro data indicate presence of cfr gene in S. aureus that results in resistance to linezolid does not necessarily result in cross-resistance to tedizolid in the absence of chromosomal mutations.
• Cross-resistance between linezolid and non-oxazolidinone anti-infectives unlikely.

Advice to Patients

• Advise patients that antibacterials (including linezolid) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).
• Importance of completing full course of therapy, even if feeling better after a few days.
• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with linezolid or other antibacterials in the future.
• Advise patients that linezolid may be taken orally without regard to meals.
• If using the oral suspension, importance of not shaking the bottle vigorously and gently inverting the bottle 3–5 times to resuspend the drug prior to administration of each dose.
• Advise patients of the potential risk of serotonin syndrome, particularly if linezolid is used concomitantly with MAO inhibitors, SSRIs, SNRIs, tricyclic antidepressants, or other serotonergic drugs. Importance of immediately contacting clinician if signs and symptoms of serotonin syndrome develop (e.g., confusion, hyperactivity, memory problems, muscle twitching, excessive sweating, shivering, shaking, diarrhea, loss of coordination, fever). Importance of not discontinuing serotonergic drugs without first consulting clinician.
• Advise patients, particularly those with diabetes mellitus, that hypoglycemic reactions (diaphoresis and tremulousness) and low blood glucose concentrations may occur during linezolid treatment. Importance of contacting a clinician to obtain proper treatment if such reactions occur.
• Importance of avoiding large quantities of foods or beverages with high tyramine content during linezolid treatment; this includes foods or beverages that have been aged, fermented, pickled, or smoked to improve flavor (e.g., aged cheeses, fermented or air-dried meats, sauerkraut, soy sauce, tap beer, red wine). Consider that tyramine content of any protein-rich food may be increased if stored for long periods or improperly refrigerated.
• Advise individuals with phenylketonuria that the oral suspension contains aspartame, which is metabolized in the GI tract to provide 20 mg of phenylalanine per 5 mL of suspension.
• Importance of notifying clinician of any history of hypertension or seizures.
• Importance of notifying clinician if any change in vision occurs.
• Importance of notifying clinicians if recurrent nausea and vomiting occurs.
• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.
• Importance of informing clinicians of existing or contemplated concomitant therapy including prescription drugs (e.g., antidepressants) and OTC drugs (e.g., pseudoephedrine), as well as any concomitant illnesses.
• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
• Importance of advising patients of other important precautionary information. (See Cautions.)

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

What is Linzess?

Linzess is a prescription medicine used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults.

Linzess is also used to treat functional constipation (FC) in children and adolescents 6 to 17 years of age.

Linzess contains linaclotide which belongs to the class of drugs called guanylate cyclase-C agonists. The guanylate cyclase type-C (GC-C) receptor is located on the luminal surface of the intestine. Linaclotide works to treat IBS-C, CIC, and FC by stimulating the GC-C receptor to increase fluid secretion, which softens stools and stimulates bowel movements.

What is Linzess used to treat?

Linzess is used to treat certain types of constipation. Constipation is a condition in which you may have fewer bowel movements than expected, or you may have stools that are hard, dry, lumpy, or painful or difficult to pass.

Linzess is used in adults to treat irritable bowel syndrome with constipation (IBS-C). IBS-C is constipation that is associated with abdominal symptoms such as pain, discomfort and bloating.

Linzess is used in adults to treat chronic idiopathic constipation (CIC). CIC is constipation that keeps coming back or lasts for three months or more, with no known cause.

Linzess is also used in children and adolescents 6 to 17 years of age to treat functional constipation (FC). FC is constipation with no known cause.

Warnings

You should not use Linzess if you have a blockage in your intestines.

Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal. Do not crush, chew, break, or open a capsule. Swallow it whole.

Stop using this medicine and call your doctor at once if you have severe or ongoing diarrhea, severe stomach pain, or black, bloody, or tarry stools.

Before taking this medicine

You should not use Linzess:

• if you are allergic to linaclotide, or
• if you have a blockage in your intestines (bowel obstruction).

It is not known if this medicine is safe and effective in children less than 6 years of age with functional constipation, or in children less than 18 years of age with IBS-C.

Linzess should not be given to a child younger than 2 years of age. Linaclotide can cause severe diarrhea and fatal dehydration in children who are younger than 2 years of age.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Linzess?

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

Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce or bottled water. Swallow the mixture right away without chewing. Do not save it for later use.

Even if you have taken this medicine with applesauce, wait at least 30 minutes before eating a full meal.

If needed, medicine from the Linzess capsule may be given through a nasogastric (NG) or gastronomy tube.

Carefully follow instructions for mixing medicine from the capsule with applesauce or water, or giving the medicine through a feeding tube. Ask your doctor or pharmacist if you have any questions.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Keep this medicine out of the reach of children. Linaclotide can be fatal to a child who accidentally swallows this medicine. Seek emergency medical attention if this happens.

Dosing information

Usual Adult Dose for Irritable Bowel Syndrome with Constipation (IBS-C):

290 mcg orally once a day

Use: Treatment of irritable bowel syndrome with constipation (IBS-C)

Usual Adult Dose for Chronic Idiopathic Constipation (CIC):

145 mcg orally once a day

Use: Treatment of chronic idiopathic constipation (CIC)

Usual Pediatric Dose for Functional Constipation (FC):

72 mcg orally once a day

Use: Treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Linzess side effects

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

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

• severe or ongoing diarrhea; or
• diarrhea with dizziness or a light-headed feeling (like you might pass out).

Common Linzess side effects may include:

• diarrhea;
• stomach pain;
• gas; or
• bloating or full feeling in your stomach.

What is Lipitor?

Lipitor is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

Lipitor is also used to lower the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol (‘bad cholesterol’) and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol (‘good cholesterol’) in the blood.

Lipitor may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally).

Lipitor (atorvastatin) belongs to a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with Lipitor has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Warnings

You should not take Lipitor if you have liver disease or cirrhosis.

Lipitor can cause the breakdown of muscle tissue, which can lead 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 urine.

Serious drug interactions can occur when certain medicines are used together with Lipitor. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Avoid eating foods that are high in fat or cholesterol. Lipitor will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Lipitor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Before taking this medicine

You should not use Lipitor if you are allergic to atorvastatin, or if you have liver failure or cirrhosis.

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

• muscle pain or weakness;
• diabetes;
• stroke;
• a thyroid disorder;
• a habit of drinking more than 2 alcoholic beverages per day; or
• kidney disease.

Lipitor can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Atorvastatin may harm an unborn baby. Tell your doctor if you are pregnant.

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

How should I take Lipitor?

Take Lipitor 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.

Do not change your dose or stop taking any of your medications without your doctor’s advice.

Lipitor is usually taken once per day. Follow your doctor’s instructions.

You may take Lipitor tablets with or without food.

It may take up to 2 weeks before your cholesterol levels improve, and you may need frequent blood tests. Even if you have no symptoms, tests can help your doctor determine if Lipitor is effective.

Your treatment may also include diet, exercise, weight control, and blood tests.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the 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 Lipitor?

Avoid eating foods high in fat or cholesterol, or Lipitor will not be as effective.

Drinking alcohol may increase your risk of liver damage.

Grapefruit may interact with atorvastatin and cause side effects. Avoid consuming grapefruit products and drinking more than 1.2 liters of grapefruit juice each day.

Lipitor side effects

Get emergency medical help if you have signs of an allergic reaction to Lipitor (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).

Lipitor can cause the breakdown of muscle tissue, which can lead 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 urine.

Muscle problems may be more likely in older adults and those who have kidney problems, thyroid problems, or take certain other medicines.

Also call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing;
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

Common Lipitor side effects may include:

• pain in your bones, spine, joints, or muscles;
• pain and burning when you urinate, painful urination;
• muscle spasms;
• upset stomach;
• trouble with sleeping;
• stuffy nose, runny nose, sore throat;
• diarrhea, nausea; or
• pain in arms or legs (limbs).

What is liraglutide?

Liraglutide is used to improve blood sugar control in adults and children 10 years and older with type 2 diabetes (alongside dietary changes); to reduce cardiovascular risk in adults with type 2 diabetes; or for weight loss in adults and children 12 and older.

• Liraglutide comes in 3 FDA-approved forms: Saxenda, Victoza, and generic liraglutide injection.
• Victoza and generic liraglutide are used to lower blood sugar (glucose) in type 2 diabetes.
• Only Saxenda is specifically approved for weight loss, although Victoza/ liraglutide injection may cause weight loss as a side effect

Liraglutide’s mechanism of action involves mimicking a natural hormone called GLP-1, that your body makes after eating. GLP-1 helps control blood sugar in type 2 diabetes by increasing insulin when needed, reducing glucose production in the liver, slowing digestion, and decreasing appetite. When used in people with excess weight, liraglutide reduces appetite by slowing down digestion which tells your brain you are full, so you eat less. Over time, eating less leads to weight loss.

• Unlike your body’s natural GLP-1 which works for minutes, liraglutide lasts for 24 hours, which means liraglutide injections only need to be given 1 time a day.

Liraglutide belongs to the drug class called glucagon-like peptide-1 (GLP-1) receptor agonists, which includes other medications such as Ozempic, Wegovy, Ryebelsus, Trulicity, and Byetta.

Liraglutide first gained FDA approval on January 25, 2010, under Victoza, for type 2 diabetes, and Saxenda for weight loss. A Victoza generic, called liraglutide injection, was FDA-approved on December 23, 2024. This generic is only FDA-approved to improve blood sugar control in people with Type 2 diabetes.

Liraglutide uses

Liraglutide comes in 3 FDA-approved forms:

• Saxenda: Approved for weight loss treatment only
• Victoza: Approved for diabetes treatment only (improve blood sugar control/reduce cardiovascular risk)
• Liraglutide injection: Approved for diabetes treatment only (improve blood sugar control).

FDA-approved Saxenda uses

Saxenda is used for adults who are obese or overweight with weight-related medical problems, and children with obesity aged 12 to 17 years with a body weight above 132 pounds (60 kg) to help them lose weight and keep the weight off.

• Saxenda should be used with a reduced-calorie diet and increased physical activity.
• Saxenda and Victoza have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines.
• It is not known if Saxenda is safe and effective when taken with other prescription, over-the counter medicines, or herbal weight loss products.
• It is not known if Saxenda is safe and effective in children under 12 years of age.

FDA-approved Victoza/ generic liraglutide injection uses

Victoza/  liraglutide injection is used to lower blood sugar (glucose) in type 2 diabetes in adults and children who are 10 years of age and older along with diet and exercise.

Victoza is also approved to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Victoza/ liraglutide injection is not for use in people with type 1 diabetes.

They should not be used with other medicines that contain liraglutide.

It is not known if Victoza/ liraglutide injection is safe and effective in lowering blood sugar (glucose) in children under 10 years of age

Liraglutide side effects

The most common side effects of liraglutide (Victoza/ liraglutide injection) when used in people with type 2 diabetes are:

• nausea
• diarrhea
• vomiting
• decreased appetite
• indigestion and constipation.

The most common side effects of liraglutide (Saxenda) when used for weight loss are:

• nausea
• injection site reaction
• tiredness (fatigue)
• diarrhea
• low blood sugar (hypoglycemia)
• dizziness
• constipation
• headache
• stomach pain
• vomiting
• upset stomach (dyspepsia)
• changes in enzyme (lipase) levels in your blood.

Additional common side effects of liraglutide used for weight loss in children (Saxenda) include fever and gastroenteritis.

Serious side effects and warnings

Liraglutide carries a Boxed Warning for thyroid C-cell tumors in rats and mice, but it is unknown whether liraglutide would cause this type of cancer in humans.

Possible thyroid tumors, including cancer. liraglutide and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if liraglutide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

• Do not use liraglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath. These may be symptoms of thyroid cancer.

Inflammation of your pancreas (pancreatitis). Stop using liraglutide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia). Your risk of getting low blood sugar may be higher if you use liraglutide with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:

• dizziness or light-headedness
• sweating
• confusion or drowsiness
• headache
• blurred vision
• slurred speech
• shakiness
• fast heartbeat
• anxiety, irritability, or mood changes
• hunger
• weakness
• feeling jittery.

Serious allergic reactions. Stop using liraglutide and get medical help right away if you have any symptoms of a serious allergic reaction including:

• swelling of your face, lips, tongue or throat
• problems breathing or swallowing
• severe rash or itching
• fainting or feeling dizzy
• very rapid heartbeat.

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.

Gallbladder problems. Gallbladder problems including gall stones have happened in some people who take liraglutide. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:

• pain in your upper stomach (abdomen)
• fever
• yellowing of skin or eyes (jaundice)
• clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). liraglutide may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking liraglutide before you are scheduled to have surgery or other procedures.

Pancreatitis associated with liraglutide has been reported in post-marketing reports. Stop taking liraglutide and talk to your healthcare provider immediately if you experience symptoms such as pain in your upper abdomen that spreads to your back, a swollen or tender abdomen, fever, or nausea and vomiting.

Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Victoza is not for type 1 diabetes.

Do not use Saxenda and Victoza/ liraglutide injection together. Do not use liraglutide with other GLP-1 agonists, such as Ozempic, Wegovy, Ryebelsus, Trulicity, or Byetta.

These are not all the possible side effects of liraglutide. Tell your healthcare provider if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking

You should not use liraglutide if you are allergic to liraglutide, Saxenda, Victoza, or any of the inactive ingredients in liraglutide. In addition, do not use if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands)
• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer).

Tell your healthcare provider about all your medical conditions before starting liraglutide, including if you:

• are taking certain medicines called GLP-1 receptor agonists such as Ozempic, Wegovy, Ryebelsus, Trulicity, or Byetta
• have or have had problems with your pancreas, kidneys or liver
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis), problems with digesting food, or severe stomach problems
• have type 1 diabetes
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Liraglutide is not approved for use by anyone younger than 10 years old with type 2 diabetes (Victoza/ liraglutide injection), or for anyone younger than 12 years for weight loss (Saxenda). For cardiovascular risk reduction, it is only approved for adults 18 years and older with type 2 diabetes (Victoza/ liraglutide injection).

Pregnancy

It is not known if liraglutide will harm an unborn baby. Tell your healthcare provider if you become pregnant while using liraglutide.

Breastfeeding

It is not known if liraglutide passes into your breast milk. You and your healthcare provider should decide if you should breastfeed while taking liraglutide.

How should I use liraglutide?

Read the Instructions for Use that come with the brand of liraglutide your healthcare provider has prescribed. Use liraglutide exactly as your healthcare provider tells you to. See the:

• Saxenda Instructions for Use
• Victoza Instructions for Use
• Liraglutide injection Instructions for Use.

Inject liraglutide 1 time each day, at any time of the day.

• Liraglutide may be taken with or without food.

Liraglutide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject liraglutide into a muscle (intramuscularly) or a vein (intravenously).

• Change (rotate) your injection site with each daily injection. Do not use the same site for each injection.
• Your healthcare provider will teach you how to inject liraglutide yourself, or you can have a caregiver give it to you.

If you are also prescribed insulin, do not mix insulin and liraglutide in the same injection.

• You may give an injection of insulin in the same body area as liraglutide (such as your stomach area), but not right next to each other.

Liraglutide dosing information

Usual Adult Liraglutide Dose for Diabetes Type 2 for Glycemic Control (Victoza, generic liraglutide injection) or Cardiovascular Risk Reduction (Victoza only)

Initial dose: liraglutide 0.6 mg subcutaneously 1 time daily for 1 week then increase to 1.2 mg daily.

• If additional glycemic control is needed, increase the dose to 1.8 mg daily after 1 week of treatment with the 1.2 mg daily dose.

Maintenance dose: 1.2 to 1.8 mg subcutaneously 1 time a day.

Maximum dose: 1.8 mg subcutaneously 1 time a day.

Note: The 0.6 mg liraglutide dose is intended to reduce gastrointestinal symptoms and is not an effective dose for glycemic control.

Usual Child 10 years and Older Liraglutide Dose for Diabetes Type 2 for Glycemic Control (Victoza, generic liraglutide injection)

Initial dose: liraglutide 0.6 mg subcutaneously 1 time daily for at least 1 week.

• If additional glycemic control is needed, increase the dose to 1.2 mg daily, and if additional glycemic control is still required, increase to 1.8 mg daily after at least 1 week of treatment with the 1.2 mg daily dose.

Maintenance dose: 0.6 to 1.8 mg subcutaneously 1 time a day.

Maximum dose: 1.8 mg subcutaneously 1 time a day.

Usual Adult and Child 12 and older Liraglutide Dose for Weight Loss (Saxenda)

Saxenda is started at a low dose initially then gradually increased over 5 weeks to the full dose of Saxenda 3 mg.

• Week 1: Saxenda 0.6 mg for 1 week.
• Week 2: Saxenda 1.2 mg for 1 week.
• Week 3: Saxenda 1.8 mg for 1 week.
• Week 4: Saxenda 2.4 mg for 1 week.
• Week 5: Saxenda 3 mg for 1 week.

After this initial dosing schedule, do not change the dose of Saxenda unless your healthcare provider tells you to.

Children 12 and older may reduce their dose to 2.4 mg daily if the maximum dose is not tolerated.

What happens if I miss a dose of liraglutide?

If you miss a dose of liraglutide, take the missed dose at the next scheduled dose. Do not take 2 doses of liraglutide at the same time.

What happens if I take too much liraglutide?

If you take too much liraglutide, call your healthcare provider right away. Taking too much liraglutide may cause severe nausea, severe vomiting, and low blood sugar (hypoglycemia).

What happens if I develop low blood sugar on liraglutide?

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.

Blood sugar levels can be affected by other medications (such as insulin or sulfonylureas for diabetes), stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

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

What should I avoid while using liraglutide?

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

What other drugs will affect liraglutide?

Other drugs may interact with liraglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin
• oral diabetes medicine – Glucotrol, Metaglip, Amaryl, Avandaryl, Duetact, DiaBeta, Micronase, Glucovance, and others.

Liraglutide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

How do I store liraglutide?

Store unopened liraglutide in a refrigerator between 36-46°F (2-8°C), away from the cooling element and do not freeze.

After opening, you can store the pen for 30 days either at room temperature (59-86°F/15-30°C) or in the fridge. Always keep the cap on and protect it from heat and sunlight.

For injections, use a fresh needle each time, removing and discarding it after use. Store the pen without an injection needle attached to prevent contamination, leakage, or infection.

Liraglutide ingredients

Victoza brand

Active ingredient: liraglutide.
Inactive ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection, hydrochloric acid or sodium hydroxide may be added to adjust pH.

Victoza injection is available as a 6 mg/mL solution in a pre-filled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg.

Saxenda brand

Active ingredient: liraglutide.

Inactive ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust the pH.

Saxenda injection is available as a 6 mg/mL solution in a 3 mL pre-filled, single, patient-use pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg.

Generic liraglutide injection (Hikma Pharmaceuticals PLC)

Active ingredient: liraglutide.

Inactive ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection.

Generic liraglutide injection is available as a 6 mg/mL solution in a pre-filled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg.

Who makes liraglutide?

Novo Nordisk makes liraglutide under the brand name Victoza.

Novo Nordisk makes liraglutide under the brand name Saxenda.

Hikma Pharmaceuticals PLC makes generic liraglutide injection. 

What is lisdexamfetamine?

Lisdexamfetamine is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) in adults and in children who are at least 6 years old.

Lisdexamfetamine is also used to treat moderate to severe binge eating disorder in adults. lisdexamfetamine is not to be used for obesity or weight loss.

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

Lisdexamfetamine 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.

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

• signs of heart problems–chest pain, trouble breathing, pounding heartbeats or fluttering in your chest, feeling like you might pass out;
• signs of psychosis–hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia; or
• signs of circulation problems–numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes.

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.

Lisdexamfetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects of lisdexamfetamine may include:

• dry mouth, loss of appetite, weight loss;
• sleep problems (insomnia);
• fast heart rate, feeling jittery;
• dizziness, feeling anxious or irritable; or
• nausea, vomiting, stomach pain, diarrhea, constipation.

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

Lisdexamfetamine may be habit-forming, and lisdexamfetamine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use lisdexamfetamine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Lisdexamfetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems–chest pain, feeling light-headed or short of breath; signs of psychosis–paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems–unexplained wounds on your fingers or toes.

What should I discuss with my doctor before taking lisdexamfetamine?

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

Do not use lisdexamfetamine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• kidney disease;
• coronary artery disease (clogged arteries);
• blood circulation problems in the hands or feet; or
• drug or alcohol addiction.

Some medicines can interact with lisdexamfetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

It is not known whether this medicine will harm an unborn baby. However, taking the medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Lisdexamfetamine can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.

Lisdexamfetamine is not approved to treat ADHD in a child younger than 6 years old. Lisdexamfetamine is not approved to treat binge eating disorder in anyone younger than 18 years old.

How should I take lisdexamfetamine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take lisdexamfetamine in larger or smaller amounts or for longer than recommended.

Lisdexamfetamine may be habit-forming. Never share lisdexamfetamine 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. Selling or giving away this medicine is against the law.

Take lisdexamfetamine with or without food, first thing in the morning.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

The chewable tablet must be chewed before you swallow it.

Do not crush, chew, break, or divide a lisdexamfetamine capsule. Swallow it whole.

To make swallowing easier, you may open the lisdexamfetamine capsule and sprinkle the medicine into a glass of water or orange juice, or mix it with yogurt. After the medicine has dissolved, drink or eat the mixture right away. Do not save for later use.

While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. Lisdexamfetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Throw away unused or expired lisdexamfetamine in a sealed container or bag. Ask your pharmacist where to locate a community pharmaceutical take back disposal program.

Lisdexamfetamine dosing information

Usual Adult Dose for Attention Deficit Disorder:

Initial dose: 30 mg orally once a day in the morning
Maintenance dose: 30 mg to 70 mg per day; may adjust dosage in increments of 10 mg or 20 mg at approximately weekly intervals.
Maximum dose: 70 mg per day

Comments: Prior to treatment, assess for the presence of cardiac disease and the risk of abuse.

Use: Attention Deficit Hyperactivity Disorder (ADHD)

Usual Adult Dose for Eating Disorder:

Initial dose: 30 mg orally once a day in the morning
Maintenance dose: 50 mg to 70 mg per day; titrate dose in increments of 20 mg at approximately weekly intervals.
Maximum dose: 70 mg per day

Comments: Discontinue this drug if binge eating does not improve.

Use: Moderate to Severe Binge Eating Disorder

Usual Pediatric Dose for Attention Deficit Disorder:

Age 6 to 17 Years:
Initial dose: 30 mg orally once a day in the morning
Maintenance dose: 30 mg to 70 mg per day; may adjust dosage in increments of 10 mg or 20 mg at approximately weekly intervals.
Maximum dose: 70 mg per day

Comments: Prior to treatment, assess for the presence of cardiac disease and the risk of abuse.

Use: Attention Deficit Hyperactivity Disorder (ADHD)

What happens if I miss a dose?

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. 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 . An overdose of lisdexamfetamine can be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.

What should I avoid while taking lisdexamfetamine?

Lisdexamfetamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What is lisinopril?

Lisinopril is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older.

Lisinopril is also used in adults to treat congestive heart failure and to improve survival after a heart attack.

Lisinopril belongs to a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Warnings

Do not use lisinopril if you are pregnant. It could harm the unborn baby. Stop using this medicine and tell your doctor right away if you become pregnant.

You should not use this medicine if you have ever had angioedema. Do not take lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use lisinopril together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

You may also need to avoid taking lisinopril with aliskiren if you have kidney disease.

Before taking this medicine

You should not use lisinopril if you are allergic to it or to any other ACE (angiotensin converting enzyme) inhibitor such as captopril, fosinopril, enalapril, benazepril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

Do not take lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not take lisinopril with any medication that contains aliskiren (a blood pressure medicine).

Do not take lisinopril if you have a history of angioedema (severe allergic reaction).

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

• heart disease, heart problems such as a recent heart attack;
• low blood pressure;
• low white blood cell count;
• stomach pain;
• if you are on a low-salt diet;
• diabetes;
• liver disease; or
• kidney disease (or if you are on dialysis).

You may also need to avoid taking lisinopril with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Lisinopril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

How should I take lisinopril?

Take lisinopril 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..

You may take lisinopril with or without food.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your blood pressure will need to be checked often and you may need frequent blood tests.

Tell your doctor if you have a planned surgery.

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 lisinopril. This can lead to very low blood pressure, an electrolyte imbalance, or kidney failure.

If you have high blood pressure, keep using lisinopril even if you feel well. High blood pressure often has no symptoms.

Store tightly closed at room temperature, away from moisture and heat. Do not freeze.

Dosing information

Usual Adult Dose for Hypertension:

Initial dose: 10 mg orally once a day; 5 mg orally once a day
Maintenance dose: 20 to 40 mg orally once a day
Maximum dose: 80 mg orally once a day

Comments:
-The initial dose is 5 mg orally once a day in patients receiving a diuretic.
-The 80 mg dose is used but does not appear to give greater effect.
-If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 2.5 to 5 mg orally once a day
Maintenance dose: Dosage should be increased as tolerated
Maximum dose: 40 mg orally once a day

Comments:
-The diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension. The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug.

Usual Adult Dose for Myocardial Infarction:

Initial dose: 5 mg orally (within 24 hours of the onset of acute myocardial infarction)
Subsequent doses: 5 mg orally after 24 hours, then 10 mg orally after 48 hours.
Maintenance dose: 10 mg orally once a day. Dosing should continue for at least 6 weeks.

Comments:
-Therapy should be initiated at 2.5 mg in patients with a low systolic blood pressure (less than or equal to 120 mm Hg and greater than 100 mmHg) during the first 3 days after the infarct. If prolonged hypotension occurs (systolic blood pressure less than 90 mmHg for more than 1 hour) therapy should be withdrawn.

Uses: Reduction of mortality in acute myocardial infarction

Usual Adult Dose for Diabetic Nephropathy:

Initial dose: 10 to 20 mg orally once a day
Maintenance dose: 20 to 40 mg orally once a day
Dosage may be titrated upward every 3 days

Comments:
-Not an approved indication.

Usual Geriatric Dose for Hypertension:

Initial dose: 2.5 to 5 mg orally once a day
Maintenance dose: Dosages should be increased at 2.5 mg to 5 mg per day at 1 to 2 week intervals.
Maximum dose: 40 mg orally once a day

Usual Pediatric Dose for Hypertension:

Pediatric patients greater than or equal to 6 years of age:
Initial dose: 0.07 mg/kg orally once a day (Maximum initial dose is 5 mg once a day)
Maintenance dose: Dosage should be adjusted according to blood pressure response at 1 to 2 week intervals.
Maximum dose: Doses above 0.61 mg/kg or greater than 40 mg have not been studied in pediatric patients

Comments:
-This drug is not recommended in pediatric patients less than 6 years old or in pediatric patients with glomerular filtration rate less than 30 mL/min.

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 lisinopril?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

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.

Lisinopril side effects

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

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

• a light-headed feeling, like you might pass out;
• high blood potassium – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough;
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common lisinopril side effects may include:

• headache, dizziness;
• low blood pressure, cough; or
• chest pain.