What is Ninlaro?

Ninlaro is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Ninlaro is used in adults to treat multiple myeloma (bone marrow cancer), in combination chemotherapy with lenalidomide and dexamethasone.

This combination is usually given after treatment with at least one other cancer medicine has failed.

Ninlaro should not be used to treat people who are receiving maintenance treatment, or who have been newly diagnosed with multiple myeloma, except if they are participants in a controlled clinical trial.

Warnings

Do not use Ninlaro with lenalidomide if you are pregnant, or if you are a man and your sexual partner is pregnant. Lenalidomide is known to cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

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

You should not use Ninlaro if you are allergic to ixazomib.

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

• liver disease; or
• kidney disease (or if you are on dialysis).

Ixazomib may harm an unborn baby. Both men and women should use effective birth control to prevent pregnancy while taking Ninlaro, and for at least 90 days after the last dose.

If you are a woman also taking dexamethasone: If you use birth control pills or other hormonal contraception (injections, implants, skin patches, vaginal rings), also use a barrier form of birth control such as a condom, diaphragm, cervical cap, or contraceptive sponge.

Ninlaro is used together with lenalidomide. Do not use Ninlaro with lenalidomide if you are pregnant, or if you are a man and your sex partner is pregnant. Lenalidomide is known to cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Carefully follow all instructions about the use of birth control while using Ninlaro with lenalidomide, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using these medicines.

Do not breastfeed while using Ninlaro, and for at least 90 days after your last dose.

How should I take Ninlaro?

Take Ninlaro 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.

Your combination chemotherapy will be given in a 28-day treatment cycle. You will take Ninlaro once per week on the same day of the week during the first 3 weeks of each cycle. Your other medicines may be taken daily or only once per week throughout the cycle.

If you’ve ever had chickenpox or shingles, taking Ninlaro can cause this virus to become active again. You may be given antiviral medication to prevent shingles.

Carefully follow your doctor’s dosing instructions for taking all your medications.

Take Ninlaro at the same time each day on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not take your dexamethasone dose at the same time you take Ninlaro. Dexamethasone should be taken with food and Ninlaro should be taken without food.

Swallow the Ninlaro capsule whole and do not crush, chew, break, or open it. Take with a full glass of water.

If you vomit shortly after taking Ninlaro, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Do not use a broken capsule. The medicine inside the capsule can be dangerous if it gets in your eyes or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water. Ask your pharmacist how to safely dispose of a broken pill.

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

Store at room temperature away from moisture and heat. Do not freeze. Keep each capsule in the blister pack until you are ready to take a dose.

Dosing information

Usual Adult Dose for Multiple Myeloma:

Starting dose: 4 mg orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-Limitations of Use: This drug is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.
-The recommended starting dose of lenalidomide is 25 mg orally daily on Days 1 through 21 of a 28-day treatment cycle; the recommended starting dose of dexamethasone is 40 mg orally on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
-The manufacturer product information for lenalidomide and dexamethasone should each be consulted.

Use: In combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 72 hours (3 days). 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

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

Ninlaro side effects

Get emergency medical help if you have signs of an allergic reaction to Ninlaro (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, mouth sores, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Ixazomib can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Call your doctor at once if you have:

• severe ongoing nausea, vomiting, diarrhea, or constipation;
• a new or worsening skin rash;
• blurred vision, dry or red eyes;
• back pain;
• fluid retention – swelling in your hands or feet, rapid weight gain;
• liver problems – upper stomach pain, jaundice (yellowing of the skin or eyes);
• low levels of platelets in your blood – easy bruising, unusual bleeding, purple or red spots under your skin;
• low white blood cell counts – fever, cold or flu symptoms, cough, sore throat, swollen gums, mouth sores, skin sores;
• nerve problems – numbness, tingling, pain, burning feeling in your hands or feet, weakness in your arms or legs; or
• signs of shingles – flu-like symptoms, tingly or painful blistering rash on one side of your body.

What is nitazoxanide?

Nitazoxanide is an antiprotozoal medicine that treats infections caused by protozoa (single-cell parasites that live in moist places such as lakes, streams, and soil).

Nitazoxanide is used to treat diarrhea caused by Giardia or Cryptosporidium. These conditions are sometimes called “Traveler’s diarrhea.” Nitazoxanide is used in adults and children who are at least 1 year old.

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

Nitazoxanide 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 nitazoxanide may include:

• nausea, stomach pain;
• headache; or
• discolored urine.

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

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

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

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

• liver or kidney disease;
• HIV or AIDS; or
• a weak immune system.

The tablet form of nitazoxanide should not be given to a child younger than 12 years old. Children ages 1 to 11 years should use only the oral suspension (liquid) form of nitazoxanide.

Nitazoxanide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant.

It is not known whether nitazoxanide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take nitazoxanide?

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

Take nitazoxanide with food.

Nitazoxanide is usually taken once every 12 hours for 3 days. Follow your doctor’s dosing instructions very carefully.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid after 7 days.

Nitazoxanide dosing information

Usual Adult Dose for Cryptosporidiosis:

500 mg orally every 12 hours for 3 days

Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum

Usual Adult Dose for Giardiasis:

500 mg orally every 12 hours for 3 days

Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum

Usual Pediatric Dose for Cryptosporidiosis:

1 to 3 years: 100 mg orally every 12 hours
4 to 11 years: 200 mg orally every 12 hours
12 years or older: 500 mg orally every 12 hours

Duration of Therapy: 3 days

Use: For the treatment of diarrhea due to G lamblia or C parvum

Usual Pediatric Dose for Giardiasis:

1 to 3 years: 100 mg orally every 12 hours
4 to 11 years: 200 mg orally every 12 hours
12 years or older: 500 mg orally every 12 hours

Duration of Therapy: 3 days

Use: For the treatment of diarrhea due to G lamblia or C parvum

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 .

What should I avoid while taking nitazoxanide?

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

What other drugs will affect nitazoxanide?

Other drugs may interact with nitazoxanide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is nitrofurantoin?

Nitrofurantoin is an antibiotic that fights bacteria in the body.

Nitrofurantoin is used to treat urinary tract infections.

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

Warnings

You should not take nitrofurantoin if you have severe kidney disease, urination problems, or a history of jaundice or liver problems caused by nitrofurantoin.

Do not take this medicine if you are in the last 2 to 4 weeks of pregnancy.

Before taking this medicine

You should not take nitrofurantoin if you are allergic to it, or if you have:

• severe kidney disease;
• a history of jaundice or liver problems caused by taking nitrofurantoin;
• if you are urinating less than usual or not at all; or
• if you are in the last 2 to 4 weeks of pregnancy.

Do not take nitrofurantoin if you are in the last 2 to 4 weeks of pregnancy.

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

• kidney disease;
• anemia;
• diabetes;
• an electrolyte imbalance or vitamin B deficiency;
• glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
• any type of debilitating disease.

FDA pregnancy category B. This medicine is not expected to be harmful to an unborn baby during early pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Nitrofurantoin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medicine.

Nitrofurantoin should not be given to a child younger than 1 month old.

How should I take nitrofurantoin?

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

Take nitrofurantoin with food.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

You may mix your liquid dose with water, milk, or fruit juice to make it easier to swallow. Drink the entire mixture right away.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Nitrofurantoin will not treat a viral infection such as the common cold or flu.

Nitrofurantoin is usually given for up to 3 to 7 days.

If you use this medicine long-term, you may need frequent medical tests at your doctor’s office.

Nitrofurantoin can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using nitrofurantoin.

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

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 .

What to avoid

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid using antacids without your doctor’s advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb nitrofurantoin.

Nitrofurantoin side effects

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

Call your doctor at once if you have:

• diarrhea that is watery or bloody;
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• new or worsening cough, trouble breathing;
• fever, chills, body aches, tiredness, unexplained weight loss;
• numbness, tingling, or pain in your hands or feet;
• liver problems–nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• lupus-like syndrome–joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Common nitrofurantoin side effects may include:

• headache, dizziness;
• gas, upset stomach;
• mild diarrhea; or
• vaginal itching or discharge.

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

Dosing information

Usual Adult Dose for Cystitis:

Regular release: 50 to 100 mg orally 4 times a day for 1 week or for at least 3 days after urine sterility is obtained
Dual release: 100 mg orally twice a day for 7 days

Usual Adult Dose for Cystitis Prophylaxis:

Regular release: 50 to 100 mg orally once a day at bedtime

Usual Pediatric Dose for Cystitis:

Regular release:
1 month or older: 5 to 7 mg/kg/day (up to 400 mg/day) orally in 4 divided doses

Dual release:
Greater than 12 years: 100 mg orally twice a day for 7 days

Usual Pediatric Dose for Cystitis Prophylaxis:

Regular release:
1 month or older: 1 to 2 mg/kg/day (up to 100 mg/day) orally in 1 to 2 divided doses

What other drugs will affect nitrofurantoin?

Other drugs may interact with nitrofurantoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is nivolumab?

Nivolumab (brand name Opdivo) is an immunotherapy treatment that treats multiple types of cancer by interfering with the growth and spread of cancer cells in the body. It is given as an intravenous infusion (infusion into your vein; IV) over 30 minutes, every 2 to 4 weeks, depending on the type of cancer you have. Nivolumab can be used alone or with other medicines, such as ipilimumab (Yervoy) or chemotherapy.

Nivolumab was first approved by the FDA in 2014, under the brand Opdivo. There are no generics or biosimilars.

Types of cancer treated with nivolumab

Nivolumab is FDA-approved to treat the following cancers, either alone or in combination with other treatments such as ipilimumab (Yervoy):

• Melanoma
• Bladder cancer (urothelial carcinoma)
• Cancer of the stomach and esophagus
• Classical Hodgkin lymphoma (cHL)
• Gastric cancer, gastroesophageal junction cancer, and esophageal cancer
• Kidney cancer (renal cell carcinoma)
• Malignant pleural mesothelioma (cancer that affects the lining of the lungs and chest wall)
• Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer, including cases that have progressed following prior treatment for metastatic disease
• Non-small cell lung cancer (NSCLC)
• Squamous cell cancer of the head and neck
• Unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.

For some cancers, such as melanoma and colorectal cancer, nivolumab is approved for children aged 12 years and older. .

Nivolumab is sometimes given only if laboratory testing shows specific genetic markers or DNA mutations associated with your cancer.

Common combination therapies

Primary combination: ipilimumab (Yervoy)

Nivolumab and ipilimumab are commonly used together to improve survival for people with the following cancers:

• Metastatic melanoma
• Advanced renal cell carcinoma
• Non-small cell lung cancer
• Malignant pleural mesothelioma
• Colorectal cancer
• Hepatocellular carcinoma.

Clinical trials have shown nivolumab and ipilimumab work better when taken together for some types of cancer .

Chemotherapy combinations

Nivolumab is used with various chemotherapy treatments for:

• Non-small cell lung cancer
• Gastric cancer
• Esophageal cancer
• Pleural mesothelioma

Other targeted therapy combinations

Clinical trials have also reported enhanced benefits when nivolumab is used with:

• Cabometyx for kidney cancer
• Herceptin for certain gastric cancers.

Treatment selection factors

The choice of the combination treatment depends on:

• Cancer type and stage
• Biomarker testing results
• Patient’s overall health
• Prior treatments
• Side effect considerations.

Specific combinations will be determined by your oncologist based on individual factors and current FDA approvals.

How does nivolumab work?

Nivolumab works through a sophisticated mechanism called immune checkpoint inhibition:

• It blocks the PD-1 protein found on T cells
• This prevents PD-1 from interacting with PD-L1 on cancer cells
• This inhibition helps prevent cancer cells from “hiding” from the immune system, enhancing our immune system’s response against cancer.

Nivolumab belongs to the drug class called immune checkpoint inhibitors. It may also be called a monoclonal antibody or a PD-1-blocking antibody.

Side effects

The most common side effects of nivolumab when used alone are:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• mouth sores, altered sense of taste;
• itching, rash, redness, or blisters on your hands or feet;
• hormonal problems;
• liver problems;
• numbness, tingling, or burning pain in your hands or feet;
• fever, body aches;
• feeling weak, tired, or short of breath;
• cold symptoms such as runny or stuffy nose, cough, sore throat;
• headache, dizziness, increased blood pressure; or
• weight loss.

The most common side effects of nivolumab and ipilimumab in combination are:

• constipation
• cough
• decreased appetite
• decreased weight
• diarrhea
• dizziness
• feeling tired
• fever
• headache
• itching
• low thyroid hormone levels (hypothyroidism)
• nausea
• pain in muscles, bones, and joints
• rash
• shortness of breath
• stomach-area (abdominal) pain
• upper respiratory tract infection
• vomiting.

Serious side effects and warnings

Nivolumab can cause serious, sometimes life-threatening, side effects in many different parts of your body. Some side effects may need to be treated with other medicines, and your cancer treatments may be delayed.

Immune system problems. Nivolumab is a medicine that may treat certain cancers by working with your immune system. Nivolumab can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended and may be more common when nivolumab is used in combination with other treatments. Call or see your healthcare provider right away if you develop any new or worsening symptoms, including:

• Lung problems
  • new or worsening cough
  • shortness of breath
  • chest pain.
• Intestinal problems
  • diarrhea (loose stools) or more bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness.
• Liver problems
  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • severe nausea or vomiting
  • bleeding or bruising more easily than normal
  • pain on the right side of your stomach area (abdomen).
• Hormone gland problems
  • headaches that will not go away or unusual headaches
  • urinating more often than usual
  • hair loss
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased
  • sex drive, irritability, or forgetfulness
  • feeling more hungry or thirsty than usual.
• Kidney problems
  • decrease in your amount of urine
  • swelling in your ankles
  • blood in your urine
  • loss of appetite.
• Skin problems
  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in your mouth or in your nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes.

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with nivolumab. Call or see your healthcare provider right away for new or worsening symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising.

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Nivolumab. Your healthcare provider will monitor you for these complications.

Nivolumab can cause severe infusion-related reactions. Tell your healthcare provider right away if you experience chest tightness, wheezing, shortness of breath, facial flushing, itching, hives, swelling, or any other allergic reaction.

Get emergency medical help if you have signs of an allergic reaction to nivolumab (hives, difficulty 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).

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with nivolumab. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with nivolumab if you have severe side effects.

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

Nivolumab may cause harm to an unborn baby. Females who can get pregnant should use an adequate form of contraception while being treated with nivolumab.

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

Before taking this medicine

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

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have liver disease
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past and have received other medicines that are similar to nivolumab
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Pregnancy

Nivolumab may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving nivolumab and for at least 5 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if nivolumab passes into your breast milk. Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is nivolumab administered?

Nivolumab is given as an infusion into a vein (IV infusion) by a healthcare provider. This medicine must be given slowly over 30 minutes.

• Nivolumab is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.
• The dosage of nivolumab depends on the cancer being treated and the patient’s age.
• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving nivolumab.
• Nivolumab can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.

What happens if I miss a dose?

Call your doctor for instructions if you miss a chemotherapy appointment.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving nivolumab?

Follow your doctor’s instructions about restricting food, beverages, or activity.

What other drugs will affect nivolumab?

Other drugs may interact with Nivolumab, 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.

Should not be given to patients with multiple myeloma who also take thalidomide medication in combination with dexamethasone unless they are part of a controlled clinical trial.

Storage

Your healthcare provider will store Nivolumab refrigerated at 2°C to 8°C (36°F to 46°F) and protect it from light by storing it in the original package until the time of use.

Nivolumab should not be frozen or shaken.

Nivolumab ingredients

Active ingredient: nivolumab

Inactive ingredients: mannitol, pentetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection. May contain hydrochloric acid and/or sodium hydroxide.

Who makes nivolumab?

Nivolumab is only available under the brand name Opdivo, which is made by Bristol Myers Squibb (BMS), headquartered in New York City.

Nivolumab 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 nivolumab.Opdivo (nivolumab) – Bristol-Myers Squibb Company

What is Norco?

Norco contains a combination of acetaminophen and hydrocodone. Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

Norco is used to relieve moderate to moderately severe pain.

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

Warnings

Hydrocodone can slow or stop your breathing. Never use Norco in larger amounts, or for longer than prescribed. Opioid pain medicine may be habit-forming, even at regular doses. Never share Norco with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not use Norco if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Stop taking Norco and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use Norco if you are allergic to acetaminophen (Tylenol) or hydrocodone, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use Norco if you have taken a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Some medicines can interact with hydrocodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take 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.

You should not use this medicine if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

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

• breathing problems, sleep apnea (breathing stops during sleep);
• liver disease;
• a drug or alcohol addiction;
• kidney disease;
• a head injury or seizures;
• urination problems; or
• problems with your thyroid, pancreas, or gallbladder.

Norco is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

If you use narcotic medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take Norco?

Take Norco exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Norco is against the law.

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Norco.

Store Norco at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor.

Dosing information

Usual Adult Dose of Norco for Pain:

Tablets:
Recommended dose:
Acetaminophen-hydrocodone 300 mg-5 mg: 1 to 2 tablets orally every 4 to 6 hours as needed
Maximum dose:
Acetaminophen-hydrocodone 300 mg-5 mg: 8 tablets daily
Comments:
Dosage should be adjusted according to severity of the pain and the response of the patient. Tolerance to hydrocodone can develop with continued use and the incidence of side effects is dose related.

Approved indication: For the relief of moderate to moderately severe pain

What happens if I miss a dose?

Since Norco is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What to avoid

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Norco will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Norco side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• confusion, unusual thoughts or behavior;
• seizure (convulsions);
• easy bruising or bleeding;
• infertility, missed menstrual periods;
• impotence, sexual problems, loss of interest in sex;
• liver problems – nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Norco side effects include:

• drowsiness, headache;
• upset stomach, constipation;
• blurred vision; or
• dry mouth.

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

What other drugs will affect Norco?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Norco can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is nortriptyline?

Nortriptyline is a tricyclic antidepressant. It affects chemicals in the brain that may be unbalanced in people with depression.

Nortriptyline is used to treat symptoms of depression.

Nortriptyline is not recommended for use in children.

Warnings

You should not use nortriptyline if you recently had a heart attack.

Do not use nortriptyline if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine and others.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms.

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.

Before taking this medicine

You should not use nortriptyline if:

• you are allergic to it or similar medicines (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, protriptyline, trimipramine);
• you are allergic to certain seizure medications (carbamazepine, eslicarbazepine, oxcarbazepine, rufinamide); or
• you recently had a heart attack.

Do not use nortriptyline 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, tranylcypromine, and others.

Tell your doctor 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. An interaction with nortriptyline could cause a serious condition called serotonin syndrome.

Tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

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

• unexplained fainting spells;
• a genetic heart condition called Brugada syndrome;
• a family history of unexplained death at younger than 45 years old;
• heart disease;
• a heart attack or stroke;
• a seizure;
• bipolar disorder (manic-depression);
• schizophrenia or other mental illness;
• a thyroid disorder;
• problems with urination;
• narrow-angle glaucoma; or
• if you are receiving electroshock treatment.

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.

Tell your doctor if you are pregnant or breastfeeding.

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

How should I take nortriptyline?

Take nortriptyline 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.

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

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

You may have unpleasant withdrawal symptoms if you stop using nortriptyline suddenly. Ask your doctor how to safely stop using this medicine.

It may take a few 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 bottle tightly closed when not in use.

Dosing information

Usual Adult Dose for Depression:

25 mg orally 3 to 4 times per day
-Maximum dose: 150 mg/day

Comments:
-The total daily dosage may be given once a day.
-Patients should be started at lower doses, and the doses should be gradually increased.
-When doses above 100 mg per day are given, plasma levels should be monitored and maintained in the optimum range of 50 to 150 ng/mL.

Use: Relief of symptoms of depression

Usual Geriatric Dose for Depression:

30 to 50 mg orally per day, in divided doses

Comments:
-The total daily dosage may be given once a day.
-Patients should be started at lower doses, and the doses should be gradually increased.

Use: Relief of symptoms of depression

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include irregular heartbeats, severe drowsiness, vision problems, confusion, hallucinations, agitation, stiff muscles, overactive reflexes, vomiting, feeling hot or cold, feeling like you might pass out, seizures, or coma.

What to avoid

Do not drink alcohol. Dangerous side effects or death could occur.

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

Nortriptyline 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.

Nortriptyline side effects

Get emergency medical help if you have signs of an allergic reaction to nortriptyline: hives; difficult 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.

Call your doctor at once if you have:

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• restless muscle movements in your eyes, tongue, jaw, or neck;
• a light-headed feeling, like you might pass out;
• seizure (convulsions);
• new or worsening chest pain, pounding heartbeats or fluttering in your chest;
• sudden numbness or weakness, problems with vision, speech, or balance;
• fever, sore throat, easy bruising, unusual bleeding;
• painful or difficult urination; or
• jaundice (yellowing of the skin or eyes).

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.

Common nortriptyline side effects may include:

• increased blood pressure;
• numbness or tingling in your hands or feet;
• dry mouth, nausea, vomiting, loss of appetite;
• blurred vision;
• rash, itching; or
• breast swelling (in men or women).

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 nortriptyline?

Using nortriptyline 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:

• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl, Sudafed, and others);
• a stimulant medicine, such as diet pills or ADHD medicine;
• medicine to treat Parkinson’s disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• bronchodilator asthma medication.

What is Norvasc?

Norvasc (amlodipine) belongs to a class of medications called calcium channel blockers. Amlodipine lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard.

Norvasc is used to treat certain types of angina (chest pain) and other conditions caused by coronary artery disease (narrowing of the blood vessels that supply blood to the heart).

Norvasc controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain.

Norvasc is also used alone or in combination with other medicines to treat high blood pressure (hypertension) in adults and children at least 6 years old. Lowering blood pressure may lower your risk of a stroke or heart attack.

Warnings

Before taking Norvasc, tell your doctor if you have congestive heart failure or liver disease.

Drinking alcohol can further lower your blood pressure within the first 12 hours and may increase certain side effects of amlodipine.

If you are being treated for high blood pressure, keep using Norvasc even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Norvasc is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Tell your doctor about all other heart or blood pressure medications you are taking.

Your chest pain may become worse when you first start taking Norvasc or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Before taking this medicine

You should not take Norvasc if you are allergic to amlodipine.

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

• severe narrowing of a certain valve in your heart (aortic stenosis), or other heart problems;
• coronary artery disease (clogged arteries); or
• liver disease.

It is not known if amlodipine will harm an unborn baby. However, having high blood pressure during pregnancy may cause complications or medical problems in both mother and baby. The benefit of treating hypertension may outweigh any risks to the baby.

Tell your doctor if you are breastfeeding.

How should I take Norvasc?

Take Norvasc 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.

Norvasc is usually taken once per day.

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

Your blood pressure will need to be checked often.

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

Do not change your doses or stop taking any of your medications without your doctor’s advice.

Your treatment may also include diet, exercise, weight control, and blood tests.

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

Dosing information

Usual Adult Dose of Norvasc for Hypertension:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day.

Usual Adult Dose of Norvasc for Angina Pectoris:

Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day.

Usual Adult Dose of Norvasc for Coronary Artery Disease:

Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day.

Usual Geriatric Dose for Hypertension:

Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 10 mg orally once a day
Maximum dose: 10 mg/day.</.p>

Usual Geriatric Dose for Angina Pectoris:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day.

Usual Pediatric Dose for Hypertension:

6 to 17 years:
Maintenance dose: 2.5 to 5 mg orally once a day
Maximum dose: 5 mg/day.

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 .

Overdose symptoms may include rapid heartbeats, redness or warmth in your arms or legs, or fainting.

What should I avoid while taking Norvasc?

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

Norvasc side effects

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

In rare cases, when you first start taking Norvasc, your chest pain may get worse or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

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

• worsening chest pain; or
• a light-headed feeling, like you might pass out.

Common Norvasc side effects may include:

• dizziness, drowsiness;
• swelling of your legs or ankles;
• irregular heartbeat;
• pounding heartbeats or fluttering in your chest;
• muscle stiffness;
• uncontrolled muscle movements;
• feeling tired;
• stomach pain, nausea; or
• flushing (sudden warmth, redness, or tingly feeling).

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

What other drugs will affect Norvasc?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may interact with amlodipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is Novolin N?

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

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

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

Novolin N side effects

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

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

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

Common side effects of Novolin N may include:

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

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

Warnings

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

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

Before taking this medicine

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

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

Tell your doctor if you have ever had:

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

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

Tell your doctor if you are pregnant or breastfeeding.

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

How should I use Novolin N?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Storing unopened (not in use) Novolin N:

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

Storing opened (in use) Novolin N:

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

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

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

What happens if I miss a dose?

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

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

What happens if I overdose?

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

What should I avoid while using Novolin N?

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

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

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

What other drugs will affect Novolin N?

Novolin N may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.

What is NovoLog?

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

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

This medicine is sometimes used together with a long-acting or intermediate-acting insulin.

Novolog is available as:

• NovoLog 10‑mL vial
• NovoLog FlexPen
• NovoPen Echo

NovoLog side effects

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

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

Common NovoLog side effects may include:

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

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

Warnings

NovoLog is a fast-acting insulin that begins to work very quickly. After using it, you should eat a meal within 5 to 10 minutes.

Never share an injection 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.

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

Before taking this medicine

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

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

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

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

Tell your doctor if you are pregnant or breastfeeding.

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

How should I use NovoLog?

Use NovoLog exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

NovoLog is injected under the skin, or into a vein through an IV. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

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

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

After using NovoLog, you should eat a meal within 5 to 10 minutes.

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

If you use this medicine with an insulin pump, do not mix or dilute NovoLog with any other insulin. Infusion pump tubing, catheters, and the needle location on your skin should be changed every 3 days. Change the medicine in the reservoir every 6 days.

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

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

Use a disposable needle or syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

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

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

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

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

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

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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

What happens if I miss a dose?

Since NovoLog is used before meals, you may not be on a timed dosing schedule. Whenever you use NovoLog, be sure to eat a meal within 5 to 10 minutes. Do not use extra insulin to make up a missed dose.

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

What happens if I overdose?

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

What should I avoid while using NovoLog?

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

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

Avoid drinking alcohol or using medicines that contain alcohol. Alcohol can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect NovoLog?

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

NovoLog and Medicare

Because of the prescription drug law, known as the Inflation Reduction Act, Medicare is able to negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs.

NovoLog is one of 10 drugs covered under Medicare Part D that were selected in 2024 for the first cycle of negotiation based on Total Expenditures under Part D and other criteria as required by the law. Negotiations with participating drug companies are ongoing, and any negotiated prices for the first cycle of negotiation is effective from 2026.

Storage

Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused insulin in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze insulin and do not use insulin if it has been frozen. Do not expose insulin to excessive heat or light. Do not withdraw insulin into a syringe and store for later use.

Always remove and discard the needle after each injection from the NovoLog FlexPen or NovoLog FlexTouch and store without a needle attached.

The storage conditions are summarized in the following table:

Storage Conditions for vial, PenFill cartridges, NovoLog FlexPen, and NovoLog FlexTouch

*For insulin pump use, the total in-use time is 19 days, including 7 days pump in-use time.

Storage in External Insulin Pump:

Change the Novolog in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 37°C (98.6°F).

Company

Manufactured by: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536

Novolog 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 Novolog.Fiasp (insulin aspart) – Novo Nordisk Inc.

What is desiccated thyroid?

Desiccated (dried) thyroid is a combination of hormones that are normally produced by your thyroid gland to regulate the body’s energy and metabolism. Desiccated thyroid is given when the thyroid does not produce enough of this hormone on its own.

Desiccated thyroid treats hypothyroidism (low thyroid hormone). Desiccated thyroid is also used to treat or prevent goiter (enlarged thyroid gland), and is also given as part of a medical tests for thyroid disorders.

Desiccated thyroid should not be used to treat obesity or weight problems.

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

Desiccated thyroid 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 may include temporary hair loss (especially in children).

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

Warnings

You may not be able to use NP Thyroid if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

Call your doctor if you have signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.

Before taking this medicine

Since thyroid hormone occurs naturally in the body, almost anyone can take desiccated thyroid. However, you may not be able to use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

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

• heart disease, angina (chest pain);
• coronary artery disease;
• congestive heart failure;
• any type of diabetes; or
• problems with your adrenal gland.

Desiccated thyroid is not expected to be harmful to an unborn baby, but your dose needs may be different during pregnancy. Tell your doctor if you become pregnant while taking this medicine.

Small amounts of desiccated thyroid can pass into breast milk, but this is not expected to harm a nursing baby. However, do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take desiccated thyroid?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use NP Thyroid in larger or smaller amounts or for longer than recommended.

While using desiccated thyroid, you may need frequent blood tests.

Keep using this medicine as directed, even if you feel well. You may need to take thyroid medication for the rest of your life.

Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.

If you need surgery, tell the surgeon ahead of time that you are using desiccated thyroid. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking desiccated thyroid?

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking these medications within 4 hours before or after you take desiccated thyroid.

Avoid taking an antacid within 4 hours before or after you take desiccated thyroid. Some antacids can make it harder for your body to absorb desiccated thyroid.

What other drugs will affect desiccated thyroid?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with desiccated thyroid, especially:

• birth control pills or hormone replacement therapy;
• a blood thinner such as warfarin, Coumadin, Jantoven;
• insulin or diabetes medication you take by mouth;
• medications that contain iodine (such as I-131);
• salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate; or
• steroids such as prednisone and others.

What is Nubeqa?

Nubeqa is a prescription androgen receptor inhibitor used to treat prostate cancer.

Nubeqa is used to treat prostate cancer that has not spread to other parts of your body and no longer responds to a medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC).

Nubeqa is also used to treat prostate cancer that has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (metastatic castration-sensitive prostate cancer or mCSPC). It can be used alone or in combination with docetaxel. 

It is not known if Nubeqa is safe and effective in children or in females.

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

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

• liver or kidney disease.

Darolutamide may harm an unborn baby or cause a miscarriage. Nubeqa is not for use by women. Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while you are using Nubeqa.

It may be harder for you to get a woman pregnant while you are using Nubeqa. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Nubeqa is not for use by women or by anyone younger than 18 years old.

How should I take Nubeqa?

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

Take with food.

Swallow the tablet whole and do not crush, chew, or break it.

If you have not had castration surgery (to lower the amount of testosterone in your body), your doctor may also prescribe a gonadotropin-releasing hormone (GnRH) medicine such as Eligard, Lupron, Trelstar, Zoladex, or Vantas. Keep using your GnRH as directed.

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

Dosing information

Usual Adult Dose for Prostate Cancer:

• 600 mg (2 x 300 mg tablets) orally 2 times a day.
• Swallow tablets whole.
• Take with food.
  
  Comments:
  – Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
  – For patients with mCSPC treated with Nubeqa in combination with docetaxel, administer the first cycle of docetaxel within 6 weeks after the start of Nubeqa treatment.

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

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

Nubeqa side effects

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

Call your doctor at once if you have:

• severe ongoing nausea or diarrhea;
• painful or difficult urination;
• blood in your urine;
• severe headache, blurred vision, pounding in your neck or ears;
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a lung infection – fever, chills, cough with mucus, chest pain, shortness of breath.

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

Common Nubeqa side effects may include:

• feeling tired;
• pain in your arms, hands, legs, or feet;
• rash;
• low white blood cells; or
• abnormal liver function tests.

When used in combination with docetaxel in mCSPC, the most common side effects of Nubeqa are:

• constipation
• rash
• decreased appetite
• hemorrhage
• increased weight
• high blood pressure
• laboratory test abnormalities, such as anemia, high blood glucose levels, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and low calcium levels. 

What is Nucala?

Nucala is used to treat severe eosinophilic asthma, eosinophilic COPD, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It is self-administered by injection subcutaneously (under the skin) every 4 weeks, or a healthcare provider or caregiver can give it.

Nucala autoinjector is approved for adults and children 12 years and older, while the prefilled syringe can be used for children as young as 6.

Nucala (mepolizumab) gained FDA approval on November 4, 2015. There is no generic or biosimilar.

FDA approvals and indications

Nucala is approved for: 

• Severe asthma with an eosinophilic phenotype in adults and children aged 6 years and older as an add-on maintenance treatment. It is not a rescue medicine for acute bronchospasm or status asthmaticus 
• Inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype in adults as an add-on maintenance treatment
•  Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults aged 18 years and older whose disease is not controlled with nasal corticosteroids, as an add-on maintenance treatment. Nucala helps reduce symptoms (such as nasal congestion, nasal discharge, mucus in the throat, and loss of smell) and may help prevent surgery for nasal polyps
• Eosinophilic granulomatosis with polyangiitis (EGPA) in adults
• Hypereosinophilic syndrome [HES] in adults and children 12 years and older that has been present for 6 months or longer without an identifiable non-hematologic secondary cause.

Mechanism

Nucala works by reducing levels of eosinophils in the blood. Eosinophils are a type of white blood cell that are involved in inflammation. The mechanism of action of Nucala involves targeting and preventing the immune system protein interleukin-5 (IL-5) from interacting with its receptor on eosinophils, reducing eosinophil levels and inflammation.

Nucala belongs to the drug class interleukin inhibitors. It may also be called a monoclonal antibody or a biologic.

Side effects

The most common side effects of Nucala are:

• headache
• feeling tired
• mouth or throat pain
• back pain, joint pain
• pain, swelling, redness, burning, or itching where the medicine was injected.

Serious side effects and warnings

Nucala can cause the following serious side effects:

• Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen hours or days after you get your Nucala injection. Get emergency medical help if you have signs of an allergic reaction such as hives, a rash, wheezing, chest tightness, difficulty breathing, feeling like you might pass out, or swelling of your face, lips, tongue, or throat.
• Herpes zoster infections. Herpes zoster infections, which can cause shingles, have happened in
  people who received Nucala. Call your doctor if you have symptoms of herpes zoster, such as skin sores or blisters, itching, tingling, burning pain, or a rash on your face or torso. 

If you also use an oral or inhaled steroid medication, do not stop using it suddenly. Talk to your healthcare provider about this.

Nucala injection is not approved for use in:

• HES in a child younger than 12
• Asthma in a child younger than 6
• COPD, EPGA, or CRSwNP in adolescents and children younger than 18.

This is not a complete list of side effects, and others may occur. See the Nucala Prescribing Information for a full list, or call your doctor for more information.

Before using

Do not use Nucala if you are allergic to mepolizumab, Nucala, or any inactive ingredients in the injection.

Before receiving Nucla, tell your healthcare provider about all your medical conditions, including if you have ever:

• used an oral or inhaled steroid medicine
• had herpes zoster (also called shingles)
• had an infection caused by helminths (worm-like parasites).

Tell your doctor if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

You may be given a zoster (shingles) vaccine before starting your Nucala injection.

Pregnancy

It is not known if Nucala may harm your unborn baby. Tell your doctor if you become pregnant while using this medicine. Your name may be added to a pregnancy registry to track the effects of Nucala on the baby.

Breastfeeding

You and your healthcare provider should decide if you will use Nucala and breastfeed. You should not do both without talking with your healthcare provider first.

How is Nucala administered?

Nucala is injected under the skin, usually once every 4 weeks.

• It can be given under the skin of your thigh or stomach (abdomen) or a caregiver can administer it under the skin of the back of your upper arm.
• A healthcare provider can teach you how to use the medication before you give it to yourself. Or your healthcare provider can give it to you every 4 weeks.
• The single-dose prefilled autoinjector is for use by people 12 years and older, and the single-dose prefilled syringe is for children 6 years and older, to be administered by a caregiver.
• Each Nucala prefilled syringe or autoinjector is for one use only. Throw it away after one use, even if there is still medicine left inside.

Read the Instructions for Use in the Nucala Package Insert that comes with Nucala or contact the MyNucala Patient Support Program for more details about self-administration.

Nucala is not a rescue medicine for asthma attacks. Use only a fast-acting bronchodilator such as albuterol for an asthma attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Dosing information

Dose of Nucala for severe eosinophilic asthma

• Adults and children 12 years and older: 100 mg SC 1 time every 4 weeks.
• Children aged 6 to 11 years: 40 mg SC 1 time every 4 weeks.

Dose of Nucala for chronic obstructive pulmonary disease (COPD) in adults

• 100 mg SC 1 time every 4 weeks.

Dose of Nucala for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults

• 100 mg SC 1 time every 4 weeks.

Dose of Nucala for eosinophilic granulomatosis with polyangiitis (EGPA) in adults

• 300 mg (as 3 separate 100mg injections) SC every 4 weeks.

Dose of Nucala for hypereosinophilic syndrome (HES)

• Adults and children aged 12 and older: 300 mg (as 3 separate 100mg injections) SC every 4 weeks.

What happens if I miss a dose?

If you miss a dose, inject a dose as soon as possible. Then continue (resume) your injection on your regular dosing schedule.

If you do not notice that you have missed a dose until it is time for your next scheduled dose, then inject the next scheduled dose as planned. Do not use two doses at one time.

If you are not sure when to inject Nucala, call your healthcare provider.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Nucala?

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

• oral or inhaled steroid medicines.

Other drugs may interact with Nucala, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using. Formal drug interaction trials have not been performed with Nucala.

Storage

Store the Nucala prefilled syringe or Nucala autoinjector in the original carton in a refrigerator. Do not freeze or shake the medicine.

• After removing the medicine from the carton, you must use it within 8 hours.

You may store the prefilled syringe or autoinjector in the unopened carton at room temperature for up to 7 days.

• Throw away a syringe or autoinjector left out of the refrigerator for longer than 7 days.

Safely throw away medicine that is out of date or no longer needed.

Keep out of the reach of children.

Ingredients

Active Ingredient: mepolizumab.

Inactive Ingredients (vials): polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Inactive Ingredients (prefilled autoinjectors and prefilled syringes): citric acid monohydrate, EDTA, disodium dihydrate, polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Nucala for injection is available as:

• 100 mg of lyophilized powder in a single-dose vial for reconstitution
• 100 mg/mL single-dose prefilled autoinjector/syringe
• 40 mg/0.4 mL single-dose prefilled syringe. 

Who makes Nucala?

Nucala (mepolizumab) is a prescription medication manufactured by GlaxoSmithKline (GSK), a multinational pharmaceutical company. GSK’s global headquarters are located in Brentford, London, United Kingdom. The company was formed through the merger of Glaxo Wellcome and SmithKline Beecham in 2000.

Nucala 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 Nucala.Nucala (mepolizumab) – GlaxoSmithKline LLC

What is Nurtec ODT?

Nurtec ODT (rimegepant) is used to treat acute migraine attacks (with or without aura) and is also used to prevent episodic migraines.

Nurtec ODT is a calcitonin gene-related peptide (CGRP) receptor blocker, so it works by blocking CGRP receptors in the brain to reduce migraine symptoms of headache, nausea, vomiting, light sensitivity, and sound sensitivity, and it also can be taken regularly prevent as many as episodic migraines from happening. 

Nurtec is an orally disintegrating tablet (ODT) that dissolves on the tongue or under the tongue, without the need to take it with a glass of water. Because Nurtec ODT dissolves in the mouth, it gets absorbed into the bloodstream very quickly.  Nurtec ODT starts working within one hour to relieve pain from migraine, and in 2 hours 59.3% of migraine patients had pain relief, according to clinical trials.

Nurtec ODT was first approved by the FDA on February 27, 2020.

What is Nurtec used for?

Nurtec is FDA approved to be used to treat adults with acute migraines that occur with or without aura, and it is also FDA approved for the preventive treatment of episodic migraine in adults.

Warnings

It is not known if it is safe to take Nurtec ODT for more than 15 migraine headaches in 30 days.

Nurtec ODT can be taken once a day as needed, to treat an acute migraine. You should not take more than 1 tablet in 24 hours. Nurtec ODT can be taken every second day to prevent episodic migraine. The safety of using more than 18 doses in a 30-day period has not been established.

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 Nurtec ODT

Allergies: You should not take Nurtec ODT if you are:

• allergic to rimegepant or any of the other ingredients contained in the orally disintegrating tablets. See the end of this page for a complete list of ingredients.

Kidney or Liver disease: To make sure Nurtec is safe for you, tell your doctor if you have ever have or every had:

• liver disease; or
• kidney disease (or if you are on dialysis).

Age: Rimegepant is not approved for use by anyone younger than 18 years old.

Nurtec ODT and Pregnancy:

Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Having migraine headaches may cause complications during pregnancy such as dangerously high blood pressure (preeclampsia) that can lead to medical problems in both mother and baby. Your healthcare provider or doctor will help you decide whether the benefit of treating your migraine outweighs any risk to your baby.

There is a pregnancy exposure registry for women who take Nurtec ODT during pregnancy. The study is named MONITOR (Migraine Observational NURTEC Pregnancy Registry). A registry is a study. The purpose of this registry is to collect information about your health and the health of your baby. You may enroll yourself, or your healthcare provider can help you enroll in this registry.

Nurtec ODT and Breastfeeding:

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Very small amounts of this medicine will pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Nurtec ODT.

How should I take Nurtec ODT?

Nurtec ODT comes as an orally disintegrating tablet (a tablet that dissolves quickly in the mouth) that is place under or onto the tongue to dissolve.

Remove the tablet from the package only when you are ready to take the medicine.

• It is important to have dry hands when opening the blister pack.

• Peel the foil covering from the blister and remove the tablet.  Do not try to push the orally disintegrating tablet through the foil packaging as you may damage it.
• Immediately place the tablet on or under your tongue. 
• The tablet will quickly dissolve and can be swallowed with saliva. No water is needed to swallow disintegrating tablets.
• Swallow several times as the tablet dissolves.

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

Call your doctor if your headaches do not get better or occur more frequently after taking this medicine

Dosing information

Acute treatment of migraine (with or without aura) when migraine occurs:

• One tablet (75mg) as needed when you have a migraine.
• Maximum of one tablet in a 24-hour period.
• The safety of using more than 18 doses in a 30-day period is currently not known.

Preventative treatment of episodic migraine:

• One tablet (75mg) every other day (every 48 hours)

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Nurtec ODT side effects

Nurtec ODT can cause an allergic reaction which can be serious. If you experience any of the following symptoms, you should immediately call your doctor or get emergency medical treatment:

• difficulty breathing
• shortness of breath
• swelling of the throat, tongue, mouth, lips, face or eyes
• hives
• rash
• Itching

An allergic reaction called delayed hypersensitivity reactions may occur days after you have taken this medicine and can be severe.

The most common side effect of Nurtec is nausea, when it is used for acute treatment of migraine attacks.

When Nurtec ODT is used as a preventive treatment of episodic migraine, its most common side effects are nausea, indigestion and stomach pain.

What is Nuvigil?

Nuvigil (armodafinil) is an oral prescription medicine that may be used to improve wakefulness in adults who are very sleepy due to narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

• Nuvigil is taken in combination with other treatments for sleep disorders.
• Use of Nuvigil does not replace using your CPAP machine or other treatments that your doctor has prescribed for OSA. Continue to use these treatments.
• Nuvigil is not a cure. It may help the sleepiness caused by these conditions, but it may not stop all your sleepiness and does not take the place of getting enough sleep. Follow your doctor’s advice about good sleep habits and using other treatments.

Nuvigil’s mechanism of action is thought to involve dopamine transporter (DAT) inhibition, although the exact way it works for sleep disorders is not known. While similar to stimulants like amphetamine and methylphenidate, Nuvigil has a different chemical structure. Nuvigil belongs to the drug class called CNS stimulants. 

Nuvigil is classified as a Schedule IV (4) controlled substance due to its potential for misuse and dependence. Misuse is illegal and harmful and you should always keep it in a safe place and never share it with others. Tell your doctor if you have a history of substance abuse.

Nuvigil gained FDA approval on June 15, 2007. A Nuvigil generic is available under the name armodafinil.

Nuvigil side effects

The most common side effects of Nuvigil are:

• headache
• dizziness
• nausea
• sleep problems (insomnia).

Serious side effects and warnings

Nuvigil may cause serious side effects including a serious rash or serious allergic reactions including anaphylaxis, angioedema, and multiorgan hypersensitivity. These may need to be treated in a hospital and may be life-threatening. Stop taking Nuvigil and call your doctor right away or get emergency help if you have any of these symptoms:

• a severe skin reaction that spreads and causes blistering and peeling
• a skin rash, hives, or sores in your mouth
• fever, sore throat, or burning in your eyes
• swelling of your face, eyes, lips, tongue, throat, or lymph nodes
• trouble swallowing, breathing, or hoarseness
• shortness of breath, flu-like symptoms, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine.

Stop taking Nuvigil and seek urgent medical attention at the first sign of rash, no matter how minor it is, unless the rash is not drug-related. These rashes usually occur within 1 to 5 weeks after the first dose. 

Nuvigil may cause the following other serious side effects. 

Mental (psychiatric) symptoms. Symptoms such as depression, anxiety, agitation, nervousness, and irritability, some of which resulted in people stopping Nuvigil, have been reported. May not be suitable for people with a history of psychosis, depression, or mania. Tell your healthcare provider immediately if you develop symptoms such as:

• depression or thoughts of suicide
• hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• feeling anxious
• an extreme increase in activity and talking (mania)
• aggressive behavior.

Persistent sleepiness. Nuvigil may not return a person’s levels of wakefulness to normal and persistent sleepiness may continue despite taking Nuvigil. Tell your healthcare provider if you continue to be sleepy during the day and avoid driving or any other potentially dangerous activity. 

Cardiovascular events have been reported with Nuvigil including chest pain, high blood pressure, palpitations or abnormal heartbeats, shortness of breath, and ECG changes. Some of these patients had preexisting heart disease.  Seek urgent medical attention if you develop symptoms of a heart problem, including chest pain, abnormal heartbeats, or trouble breathing.

It is not known if Nuvigil is safe and effective in children under the age of 18 and it is not approved for use in children.

These are not all the possible side effects of Nuvigil. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Nuvigil if you have ever had a rash or allergic reaction caused by armodafinil, Nuvigil, modafinil (Provigil), or any of the inactive ingredients in Nuvigil tablets.

To make sure Nuvigil is safe for you, tell your doctor about all your medical conditions, including if you have ever had:

• liver or kidney disease
• heart disease or a heart muscle or valve disorder such as mitral valve prolapse
• high blood pressure, heart disease, or prior heart attack
• mental illness or psychosis
• drug or alcohol addiction.

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

Pregnancy

It is not known whether Nuvigil will harm an unborn baby. Nuvigil has been reported to be associated with growth restriction (small fetus) and miscarriage. Tell your doctor if you are pregnant or plan to become pregnant. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not work while you take Nuvigil. Women who use one of these methods of birth control may have a higher chance of getting pregnant while taking Nuvigil and for 1 month after stopping. Use effective birth control while taking Nuvigil and for 1 month after your final dose. Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

There is a registry for women who become pregnant during treatment with Nuvigil. The purpose of this registry is to collect information about the safety of Nuvigil during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106.

Breastfeeding

It is not known whether Nuvigil passes into breast milk or if it could affect the nursing baby. Talk to
your doctor about the best way to feed your baby if you take Nuvigil.

How should I take Nuvigil?

Take Nuvigil exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Ask your doctor or pharmacist if you have any questions.

Nuvigil is usually taken 1 time a day.

• Nuvigil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.
• You may take this medicine with or without food.
• Do not change the time of day you take Nuvigil unless you have talked to your doctor. If you take Nuvigil too close to your bedtime, you may find it harder to go to sleep.
• Nuvigil is usually given for up to 12 weeks. Follow your doctor’s instructions.

Nuvigil may be habit-forming. Never share Nuvigil with another person, especially someone with a history of drug abuse or addiction. Selling or giving away this medicine is against the law because Nuvigil is a federally controlled substance.

• Keep track of the amount of medicine used from each new bottle. Nuvigil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Nuvigil for OSA

When Nuvigil is used for people with OSA it is usually prescribed with other medications and a CPAP machine.

• A CPAP (continuous positive airway pressure) machine is an air pump connected to the mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
• When you start Nuvigil, do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and Nuvigil may be necessary to best treat your condition.
• Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking this medicine.
• Nuvigil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Nuvigil dosage

Adult Dosage for OSA or Narcolepsy: Nuvigil 150 mg to 250 mg once a day in the morning

Adult Dosage for Shift Work Disorder (SWD): Nuvigil 150 mg once a day, taken approximately one hour before starting your work shift. 

• Liver disease: Reduce the dose of Nuvigil in patients with severe liver disease.
• Geriatric patients: consider a lower dose of Nuvigil.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours.

• If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of Nuvigil. 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 .

Symptoms of an overdose of Nuvigil may include:

• Trouble sleeping
• Confusion
• Feeling excited
• Nausea and diarrhea
• Chest pain
• Anxiety
• Restlessness
• Feeling disoriented
• Hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• A fast or slow heartbeat
• Shortness of breath.

What to avoid

Do not drive a car or do other dangerous activities until you know how Nuvigil affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.

Avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking Nuvigil.

What other drugs will affect Nuvigil?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Nuvigil and many other medicines can interact with each other, sometimes causing side effects. Nuvigil may affect the way other medicines work, and other medicines may affect how it works. Your dose of Nuvigil or certain other medicines may need to be changed.

Especially, tell your doctor if you use or take hormonal birth control, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs).

• Hormonal birth control methods may not work while you take Nuvigil.
• Women who use one of these methods of birth control may have a higher chance of getting pregnant while taking Nuvigil and for 1 month after stopping.
• Use effective birth control while taking Nuvigil and for 1 month after your final dose.
• Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

Taking Nuvigil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

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

• birth control pills, rings, patches, or other types of hormones
• cyclosporine
• heartburn or antacid medications, such as omeprazole
• seizure medications including phenytoin, diazepam, and others
• antidepressant medications
• blood thinners, such as warfarin (Coumadin, Jantoven)
• beta-blockers, including propranolol, and others.

What is pantoprazole?

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

Pantoprazole is used to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old. Pantoprazole is usually given for up to 8 weeks at a time while your esophagus heals.

Pantoprazole is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.

Warnings

Pantoprazole is not for the immediate relief of heartburn symptoms.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Long-term treatment with pantoprazole may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Talk with your doctor if you need long-term pantoprazole treatment and you have concerns about vitamin B-12 deficiency.

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

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Pantoprazole 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.

Before taking this medicine

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.

You should not use this medicine if:

• you also take medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey);
• if you had breathing problems, kidney problems, or a severe allergic reaction after taking pantoprazole in the past; or
• you are allergic to pantoprazole or similar medicines (lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, and others).

Tell your doctor if you have ever had:

• low levels of magnesium in your blood;
• lupus; or
• osteoporosis or low bone mineral density.

You may be more likely to have a broken bone while using pantoprazole long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy, especially if you are an adult over 50.

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

You should not breast-feed while using this medicine.

Pantoprazole is not approved for use by anyone younger than 5 years old.

How should I use pantoprazole?

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

Use the lowest dose for the shortest amount of time needed to treat your condition.

Pantoprazole is taken by mouth (oral) or given as an infusion into a vein (injection). A healthcare provider may teach you how to properly use the injection by yourself.

Pantoprazole tablets are taken by mouth, with or without food. The oral granules should be taken 30 minutes before a meal.

Do not crush, chew, or break the tablet. Swallow it whole.

The oral granules should be mixed with applesauce or apple juice and given either by mouth or through a nasogastric (NG) tube.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have any questions.

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

Call your doctor if your symptoms do not improve or if they get worse while you are using this medicine.

Pantoprazole can cause false results with certain medical tests. Tell the doctor or laboratory staff that you are using this medicine.

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

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

Dosing information

Usual Adult Dose for Erosive Esophagitis:

Treatment of Erosive Esophagitis:
40 mg orally once a day for up to 8 weeks; however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Maintenance of Healing of Erosive Esophagitis:
40 mg orally once a day. Controlled studies have been limited to 12 months of pantoprazole therapy.

Usual Adult Dose for Gastroesophageal Reflux Disease:

Parenteral: 40 mg once a day for 7 to 10 days, administered via intravenous infusion over a period of 15 minutes. Intravenous therapy should be discontinued as soon as the patient is able to resume oral therapy.

Oral: 40 mg orally once a day, for short-term administration (up to 8 weeks); however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Usual Adult Dose for Duodenal Ulcer:

Study (n=54)
40 mg orally once a day, dose was increased every 12 weeks by 40 mg increments to a maximum of 120 mg per day, for 28 weeks. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete duodenal ulcer healing in up to 87% and 94% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Gastric Ulcer:

40 mg orally once a day. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete gastric ulcer healing in up to 87% and 97% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Helicobacter pylori Infection:

Study (n=242) – Triple therapy:
40 mg orally twice daily for 7 days, commonly in conjunction with clarithromycin and either amoxicillin or metronidazole to eradicate Helicobacter pylori, followed with 40 mg pantoprazole orally once daily until day 28. Triple therapy has resulted in eradication rates of greater than 95%.

The QUADRATE Study (n=405) – Quadruple therapy:
40 mg orally twice daily for 7 days, concomitantly with bismuth subcitrate and tetracycline, both four times daily, and metronidazole 200 mg three times daily and 400 mg at bedtime. Helicobacter Pylori eradication was achieved in 82% of patients.

Usual Adult Dose for Zollinger-Ellison Syndrome:

Parenteral: 80 mg every 12 hours, administered by 15-minute infusion. Daily doses higher than 240 mg administered in equally divided doses by 15-minute infusion, or administered for more than 6 days have not been studied.

Oral: 40 mg twice daily, to a maximum of 240 mg per day. Some patients have received treatment with pantoprazole for more than 2 years.

Usual Adult Dose for Stress Ulcer Prophylaxis:

Study (n=21) – Stress Ulcer bleeding prophylaxis in the Critical Care Setting:
80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Study (n=20 ) – Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting:
80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

Usual Adult Dose for Peptic Ulcer:

Study (n=21) – Stress Ulcer bleeding prophylaxis in the Critical Care Setting:
80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Study (n=20 ) – Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting:
80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using pantoprazole?

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. Do not use anti-diarrhea medicine unless your doctor tells you to.

Pantoprazole side effects

Get emergency medical help if you have signs of an allergic reaction to pantoprazole: 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;
• sudden pain or trouble moving your hip, wrist, or back;
• bruising or swelling where intravenous pantoprazole was injected;
• kidney problems – fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, 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 pantoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use pantoprazole 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 pantoprazole side effects may include:

• headache, dizziness;
• stomach pain, gas, nausea, vomiting, diarrhea;
• joint pain; or
• fever, rash, or cold symptoms (most common in children).

What is paracetamol?

Paracetamol (Panadol, Calpol, Alvedon) is an analgesic and antipyretic drug that is used to temporarily relieve mild-to-moderate pain and fever. It is commonly included as an ingredient in cold and flu medications and is also used on its own.

Paracetamol is exactly the same drug as acetaminophen (Tylenol). Paracetamol is the drug’s name assigned using the International Nonproprietary Name (INN) generic name system. Paracetamol is the name used for the drug in places such as Europe, Australia, New Zealand and India. Acetaminophen is the generic name assigned using the United States Adopted Names (USAN) system. Acetaminophen is the name used in countries such as the US, Canada and Japan. Usually the INN and USAN generic names for a drug are the same and don’t differ between countries.

It is not clear exactly how paracetamol works. However, it is thought to work by blocking chemical messengers in the brain that let us know when we’re in pain and by affecting the chemical messengers that regulate our body temperature. The evidence suggests that paracetamol inhibits the production of prostaglandins, which are made by the body to deal with illness and injury. It’s also thought to act on the serotonergic, opioid, nitric oxide and cannabinoid pathways.

Paracetamol was first made in 1878, but only became more widely used in the 1950s. Today paracetamol is one of the most widely used painkillers in the world. Branded and generic versions of this drug are available.

What is paracetamol used for?

Paracetamol is available over-the-counter (OTC) and also as a prescription medication. It is used for the relief of:

• Headache
• Tension headache
• Migraine
• Backache
• Rheumatic and muscle pain
• Mild arthritis/osteoarthritis
• Toothache
• Period pain (dysmenorrhea)
• Colds and flu symptoms
• Sore throat
• Sinus pain
• Post-operative pain
• Fever (pyrexia)

Important information

Paracetamol (acetaminophen) is found in many different OTC cold and flu medications. Do not take paracetamol if you are taking any other prescription or non-prescription medications containing paracetamol or acetaminophen.

Who should not take paracetamol?

Do not take medications containing paracetamol if you are allergic to it or any of the other ingredients in the paracetamol product you are taking.

What should I tell my doctor before taking paracetamol?

Before you take paracetamol, tell your healthcare provider about all of your medical conditions, including:

• if you suffer from mild arthritis and need to take pain relief every day
• have liver or kidney problems
• are underweight or malnourished
• regularly drink alcohol. You may be more open to the side effects of paracetamol if you drink large amounts of alcohol.
• have a severe infection as this may increase you risk of metabolic acidosis. Signs of metabolic acidosis include:
  • deep, rapid, difficult breathing
  • feeling sick (nausea)
  • being sick (vomiting)
  • loss of appetite
    Contact your doctor immediately if you get a combination of these symptoms. You may need to avoid or limit paracetamol.
• have glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency)
• suffer from asthma and are sensitive to aspirin
• have hemolytic anemia (abnormal breakdown of red blood cells)

How should I take paracetamol?

• Always use exactly as your doctor or pharmacist tells you to
• Always read the instructions on your medication before taking it
• Do not take more than the recommended dose. Check the instructions for the paracetamol product you have. The strength and recommended dose among for different paracetamol-containing products.
• Paracetamol may be taken every 4 to 6 hours. Leave at least 4 hours between doses.
• Do not take more than four doses in 24 hours.
• Do not take for more than 3 days, unless your doctor tells you to
• Contact your healthcare professional if your symptoms get worse or do not improve

Paracetamol 500mg tablets and capsules

• Swallow tablets or capsules whole with a glass of water

Paracetamol 120 mg/5 ml, 250 mg/5 ml oral suspension

• Always use the oral syringe or measuring spoon that comes with your paracetamol suspension to make sure you are giving the correct dose. The recommended dose will depend on your child’s age and weight.
• Shake the bottle for 10 seconds then remove the cap
• Insert the syringe and draw up the recommended dose
• Place the syringe inside the child’s mouth against the inside of their cheek and press the plunger slowly to release the medicine
• Replace the cap on the paracetamol bottle and wash and dry the syringe

* Only for use of relief of fever after the 2 month immunizations in children weighing more than 4 kg who were born after 37 weeks. If your child still has a fever after 2 doses consult your doctor.

Paracetamol 60 mg, 125 mg and 250 mg suppositories

• Your child’s bowels need to be empty when you give them this medication. If they need to go to the toilet, make sure they do this before you give then a suppository.
• Position your child lying on their front or side on a bed to administer the suppositories. Or select another position that is comfortable for your child.
• Wash your hands and unwrap the suppository, taking care not to break it
• Gently push the pointed end of the suppository into your child’s rectum (back passage), then wash your hands
• Try and keep your child still for 1 to 2 minutes. Add a second suppository if another one is required. Wash your hands.
• Try and keep your child still for another 1 to 2 minutes after the full dose is administered

#Check with your doctor or pharmacist about the correct dose for your child, which will be based on their age and weight. Do not guess the dose.

*One dose can be given to babies who develop a fever after their immunizations at 2 months of age. Otherwise do not use in babies less than 3 months old unless your doctor tells you to.

Paracetamol 650 mg oral powder

• Check the sachet is not broken before use
• Empty the content of 1 sachet into a glass. Fill with freshly boiled water and stir under dissolved
• Allow the solution to cool and then drink it
• Adults and children aged 12 years and over can take 1 sachet every 4 hours if required. Do not take more than 4 sachets in 24 hours.
• Do not give to children under 12 years of age.

Paracetamol 250 mg orally disintegrating tablets

• Remove the orally disintegrating tablet from the foil using your fingernail, pressing along the dotted line before pressing it out
• Tablets can be sucked gently on the tongue until they melt into a paste which is easily swallowed
• Tablets can also be dissolved in water or milk if preferred

Paracetamol 500 mg effervescents tablets

• Place the paracetamol effervescent tablet(s) in a full glass of water and allow to dissolve completed before swallowing

* Do not give to children younger than 12 years old.

#Maximum 2 tablets per dose. Maximum 8 tablets in 24 hours.

Paracetamol 10 mg/ml solution for infusion

• This form of paracetamol comes in vials and is administered via intravenous (IV) infusion – an injection in your arm – over 15 minutes.
• The dose you need will depend on your age and weight and how well your kidneys work. Your healthcare provider will work out the dose you need.

What happens if I miss a dose?

If you miss a dose of paracetamol, give the next dose when needed as long as it’s been more than 4 hours since your last dose. Do not give a double dose or exceed the maximum daily dose.

What happens if I overdose?

If you or your child takes too much paracetamol, get medical help or contact a Poison Control Center right away (1-800 222-1222). Quick medical attention is critical for adults and children even if they seem well.

Paracetamol can caused delayed, serious liver damage. There may be no symptoms of overdose during the first 24 hours although paleness, nausea, sweating, vomiting, loss of appetite and abdominal pain may occur.

Dosing information

See “How should I take paracetamol?” above for information about paracetamol dosing. For further details read the full prescribing information.

What are the side effects of paracetamol?

Serious side effects of paracetamol include:

• Allergic reactions, which may be severe and include:
  • Skin rashes, itching or hives
  • Swelling of the throat, tongue or face
  • Shortness of breath or wheezing
• Skin rash or peeling, or mouth ulcers
• Breathing problems. This is more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
• Unexplained bruising or bleeding or becoming unusually tired. Getting more infections than usual.
• Liver problems. Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin can occur
  
  If you get any of the rare side effects listed above, stop taking the medicine and contact your doctor immediately.

Common side effect of paracetamol suppositories include:

• Redness or soreness in or around the rectum

Everyday, long-term use (several months or more) of paracetamol can cause liver or kidney damage. People taking this medication in the usual way for shorter periods of time have not had these problems.

These are not all of the possible side effects of this medication.

Call your doctor for medical advice about side effects.

Interactions

Tell your doctor or pharmacist about all the medicines you take, including prescription and OTC medicines, vitamins, and herbal supplements before taking this medication. Especially tell your doctor if you take:

• Blood thinning medications (anticoagulants) such as warfarin and you need to take a pain reliever daily. Occasional doses of paracetamol can be taken with anticoagulants
• Medications to help relieve nausea (metoclopramide or domperidone)
• Medications to treat high cholesterol (cholestyramine)
• Medications to treat epilepsy (lamotrigine)
• Medications to treat tuberculosis (isoniazide)
• Medication to treat fever or mild pain (aspirin, salicylamide)
• Barbiturate and tricyclic antidepressants to treat depression (amitriptyline)
• A medication to treat gout called probenecid
• A medication used to treat bacterial infections called chloramphenicol
• A medication used in HIV infections and AIDS called zidovudine
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment, and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Paracetamol may affect the results of laboratory tests for uric acid and blood sugar levels.

Paracetamol can be taken with oral contraceptives, but it may not work as well to lower your pain or fever.

Pregnancy and breastfeeding

Tell your healthcare provider if you are pregnant or plan to become pregnant. If necessary, paracetamol can be used during pregnancy. Paracetamol can be taken if you are breastfeeding. Small amounts of paracetamol pass into breast milk.

Use the lowest possible dose that reduces your pain and/or fever and use it for the shorted time possible. Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take this medicine more often.

Storage

• Keep out of sight and reach of children
• Do not use the medicine after the expiry date
• Store below 77°F (25°C) unless instructed otherwise
• Store paracetamol suppositories in a cool, dry place below 77°F (25°C) and out of direct sunlight
• Store paracetamol effervescent tablets below 86 7°F (30°C). Use within 1 month of first opening the tube. Do not use the effervescent tablets if you notice visible signs of deterioration, such as brown or black spots on the tablets, or bulging or discolored tablets.
• Store paracetamol solution for infusion below 86 7°F (30°C). Do not refrigerate or freeze. Store in the original package and protect from light.

What are the ingredients in paracetamol?

Active ingredient: paracetamol

Inactive ingredients:

Inactive ingredients will vary among the different brands and formulations. Check the product label for your formulation and strength of paracetamol for the list of inactive ingredients.

Zentiva paracetamol capsules: maize starch and magnesium stearate. The capsule is made of gelatine and sodium lauryl sulfate coloured with titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172) and indigo carmine (E132). The ink used to print on the capsules contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone and titanium dioxide.

Panadol original tablets: maize starch, potassium sorbate (E 202), purified talc, stearic acid, povidone, starch pregelatinised, hypromellose, triacetin and carnauba wax.

Effervescent tablets: anhydrous citric acid, Sodium hydrogen carbonate, Sorbitol E420, Sodium carbonate anhydrous, Povidone K25 (E1201), Simethicone, Saccharin sodium, Lemon flavour (containing maize maltodextrin, acacia gum (E 414), alpha-tocopherol (E 307), Macrogol 6000

Accord intravenous (IV) infusion: cysteine hydrochloride monohydrate, disodium phosphate dihydrate, hydrochloric acid (1M) (for pH-adjustment), sodium hydroxide (1M) (for pH-adjustment), mannitol, water for injections.

Calpol SixPlus Fastmelts orally disintegrating tablets: mannitol (E421), crospovidone, aspartame (E951), magnesium stearate, basic butylated methacrylate copolymer, polyacrylate dispersion 30% and colloidal anhydrous silica. The flavoring is strawberry (containing benzyl alcohol and glucose).

Boots Cold & Flu Relief Powders – Lemon flavor: sucrose, sodium citrate, citric acid, tartaric acid, sodium cyclamate, ascorbic acid, starch, natural colour (E100), spray dried lemon juice, lemon aroma

Calpol 120 mg/5 ml infant oral suspension: sucrose, sorbitol liquid (E420), glycerol, polysorbate 80, asulfame potassium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethyl parahydroxybenzoate (E214), microcrystalline cellulose and carmellose sodium, xanthan gum and purified water. The flavoring is strawberry (containing propylene glycol (E1520)) and coloring is carmoisine (E122). Each 5 ml of this product contains 2.2 g of sucrose.

Alvedon paracetamol suppositories: hard fat (Witepsol H12)

Panadol is marketed by GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. Calpol is marketed by McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK. Alvedon is marketed by Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berkshire, SL6 6PT, UK.

What is Paragard?

Paragard is a copper IUD (intrauterine device) used to prevent pregnancy for up to 10 years. Paragard IUD prevents pregnancy by continuously releasing copper, which interferes with sperm transport, fertilization of an egg, and possibly prevention of implantation. When Paragard IUD is inserted it can provide up to 10 years of contraception, and can be removed by a healthcare provider at any time if you decide you want to get pregnant.

Paragard IUD is a small, flexible plastic “T” shaped device with copper wrapped around the stem and placed on arms of the “T”. Two thin white threads are attached to the stem (lower end) of the device. The device is inserted into the space inside the uterus, with the threads protruding from the cervix into the vagina. The threads are the only part of Paragard you can feel when it is in your uterus.

Paragard does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Paragard is an IUD contraceptive used by women who want birth control that is:

• long term as it works continuously for up to 10 years
• immediately reversible when removed
• 99% effective at preventing pregnancy
• low maintenance
• hormone free.

Paragard side effects

Common Paragard side effects

Common Paragard side effects may include anemia (low red blood cell count), backache, painful periods, pain during sex, expulsion (complete or partial), vaginal discharge, prolonged periods, spotting, pain and cramping, and vaginal irritation.

Serious Paragard side effects

Paragard can cause serious side effects including:

• ectopic pregnancy and intrauterine pregnancy risks: There are risks if you become pregnant while using Paragard (see “What if I become pregnant while using Paragard?”).
• life-threatening infection: Life-threatening infection can occur within the first few days after the IUD is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after it is placed.
• pelvic inflammatory disease (PID) or endometritis: Some IUD users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. PID and endometritis are usually sexually transmitted. You have a higher chance of getting PID and endometritis if you or your partner has sex with other partners. PID and endometritis can cause serious problems such as infertility, ectopic pregnancy, and pelvic pain that does not go away. PID and endometritis are usually treated with antibiotics. More serious cases of PID or endometritis may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death.
  
  Tell your healthcare provider right away if you have any of these signs of PID or endometritis: low abdominal (stomach area) or pelvic pain, pelvic tenderness, painful sex, unusual or bad smelling vaginal discharge, chills, long-lasting or heavy bleeding, fever, genital lesions or sores.
• embedment: Paragard may become attached to (embedded) the wall of the uterus. This may make it hard to remove the device. Surgery may sometimes be needed to remove Paragard.
• perforation: Paragard may go through the wall of the uterus. This is called perforation. If this occurs, the IUD may no longer prevent pregnancy. If perforation occurs, the IUD may move outside the uterus and cause internal scarring, infection, damage to other organs, pain, or infertility and you may need surgery to have Paragard removed. Excessive pain or vaginal bleeding during placement of Paragard, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with perforation. You are not protected from pregnancy if Paragard moves outside the wall of the uterus. The risk of perforation is increased in breastfeeding women.
• expulsion: Paragard may partially or completely fall out of the uterus by itself. This is called expulsion. Expulsion occurs in about 2 out of 100 women. Excessive pain, vaginal bleeding during placement of the IUD, pain that gets worse, bleeding after placement, or not being able to feel the threads may happen with expulsion. You are not protected from pregnancy if Paragard is expelled.
• changes in menstrual bleeding: You may have heavier and longer periods with spotting in between. Sometimes the bleeding is heavier than usual at first. Call your healthcare provider if the bleeding remains heavier or longer and spotting continues.
• reactions after placement or removal: Some women have had reactions such as dizziness (syncope), slowed heart rate (bradycardia), or seizures, immediately after Paragard was placed or removed. This happened especially in women who have had these conditions before.

This is not a complete list of possible side effects you may have with Paragard. For more information, ask your healthcare provider. Tell your healthcare provider about any side effect that bothers you or does not go away.
Call your doctor for medical advice about side effects.

Who should not use Paragard?

Do not use this IUD if you:

• are or think you might be pregnant
• your uterus cavity (the space inside your uterus) is an abnormal shape for example due to large fibroid tumors
• have an untreated pelvic infection called pelvic inflammatory disease (PID) or you can get infections easily due problems with your immune system or current behaviors that may put you at risk eg multiple sexual partners or you use or abuse intravenous drugs
• have had an infection in your uterus after a pregnancy or abortion in the past 3 months
• have or suspect you might have cancer of the uterus or cervix
• have unexplained bleeding from your vagina
• have an untreated lower genital infection now in your cervix
• have Wilson’s disease (a disorder in how the body handles copper)
• have an allergy to copper, polyethylene, or barium sulfate
• have an intrauterine system (IUD) in your uterus already

Before having Paragard placed

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

• any of the conditions listed above
• slow heart beat (bradycardia)
• dizziness (syncope)
• seizures
• recently had a baby or if you are breastfeeding
• have AIDS, HIV, or any other sexually transmitted infection

How should I receive Paragard?

How is Paragard inserted? Paragard is placed in your uterus during an in-office visit. It can be inserted anytime during a normal menstrual cycle.

First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then cleanse your vagina and cervix with an antiseptic solution and measure your uterus. Your healthcare provider will then slide a plastic tube containing Paragard into your uterus. The tube is removed, leaving IUD inside your uterus. Two white threads will extend into your vagina. The threads will be trimmed so they are just long enough for you to feel with your fingers when you are doing a self-check.

When Paragard is inserted, you may feel cramping or pinching, and you may have some bleeding. Some women feel faint, nauseated, or dizzy for a few minutes afterward. Your healthcare provider may ask you to lie down until you are feeling better and to get up slowly.

You should return to your healthcare provider for a follow-up appointment after your first period after you have had IUD is placed to make sure that it is in the right position.

Should I check my Paragard is still in place?

You should check that Paragard is in the proper position by feeling the threads. It is a good habit to do once a month. Your healthcare provider should teach you how to check that it is in place.

First, wash your hands with soap and water. You can check by reaching up to the top of your vagina with clean fingers to feel the 2 threads. Do not pull on the threads.
If you feel changes in the length of the 2 threads, you cannot feel the threads, or you can feel any other part of the device other than the threads, it may not be in the right position and may not prevent pregnancy. If you feel that your IUD is not in the correct position you should use back-up birth control (such as condoms or spermicide) and ask your healthcare provider to check that Paragard is still in the right place.

If your Paragard is accidentally removed you may be at risk of becoming pregnant and should talk to a healthcare provider.

How long does Paragard last?

Once Paragard is inserted it can provide up to 10 years of contraception, and can be removed by a healthcare provider at any time if you decide you want to get pregnant. Paragard must be removed on or before 10 years from the date it was inserted.

After 10 years when you are having your Paragard removed if you want to continue using this form of contraception your healthcare provider can place your new Paragard at the same appointment.

What if I become pregnant while using Paragard?

You should call your healthcare provider right away if you think you may be pregnant. If you get pregnant while using this IUD you may have an ectopic pregnancy, which is a pregnancy that is not in your uterus. Signs of ectopic pregnancy are unusual vaginal bleeding or abdominal pain, especially with missed periods.

An ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility and even death.

If you get pregnant while using Paragard and the pregnancy is in the uterus, there are risks of severe infection, miscarriage, premature delivery, and even death if the pregnancy continues with the intrauterine device (IUD) still in place. Because of these risks, your healthcare provider may try to remove the device, even though removing it may cause a miscarriage. If Paragard cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy.

If you continue your pregnancy you will need see your healthcare provider regularly. Call your healthcare provider right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.

It is not known if Paragard can cause long-term effects on the fetus if it stays in place during a pregnancy.

General Paragard Information

Will Paragard interfere with sexual intercourse?

You and your partner should not feel Paragard during intercourse as it is placed in the uterus, not in the vagina. Sometimes your partner may feel the threads. If this occurs, or if you or your partner experience pain during sex, talk with your healthcare provider.

How will Paragard change my periods?

Your period may become heavier and longer. You may also have frequent spotting between periods.

Is it safe to breastfeed while using Paragard?

You may use Paragard when you are breastfeeding. The risk of the device becoming attached to (embedded) or going through the wall of the uterus is increased if it is placed while you are breastfeeding.

Can I have an MRI with Paragard in place?

Paragard can be safely scanned with MRI only under specific conditions. Before you have an MRI, tell your healthcare provider that you have Paragard, an intrauterine device (IUD), in place.

Before you have a medical procedure using heat therapy tell your healthcare provider that you have Paragard in place.

What is paroxetine?

Paroxetine is an antidepressant that belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Paroxetine works by increasing levels of serotonin, which helps reduce symptoms of depression and improves mood, anxiety, and other disorders.

Paroxetine is used to treat depression (major depressive disorder), panic disorder (PD), obsessive-compulsive disorder (OCD), anxiety (generalized anxiety disorder, GAD), social anxiety disorder (SAD), post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), and hot flushes due to menopause, in adults.

Paroxetine is usually taken once daily in the morning, with or without food.

Paroxetine brand names are Paxil, Paxil CR, Brisdelle, and generic paroxetine is also available. Not all products are FDA-approved for the same conditions.

Warnings

Boxed warning for suicidal thoughts and behaviors. Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor. See full prescribing information for complete boxed warning.

You should not use paroxetine if you are also taking pimozide or thioridazine.

Do not use paroxetine 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.

Seek medical attention right away if you have symptoms such as: agitation, hallucinations, muscle stiffness, twitching, loss of coordination, dizziness, warmth or tingly feeling, nausea, vomiting, diarrhea, fever, sweating, tremors, racing heartbeats, or a seizure (convulsions).

Do not stop using paroxetine without first asking your doctor.

Paroxetine side effects

Common paroxetine side effects may include:

• vision changes;
• weakness, drowsiness, dizziness, tiredness;
• sweating, anxiety, shaking;
• sleep problems (insomnia);
• loss of appetite, nausea, vomiting, diarrhea, constipation;
• dry mouth, yawning;
• infection;
• headache; or
• decreased sex drive, impotence, abnormal ejaculation, or difficulty having an orgasm.

Serious paroxetine side effects

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

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.

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

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• unusual bone pain or tenderness, swelling or bruising;
• changes in weight or appetite;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or
• low levels of sodium in the body – headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.

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.

Before taking this medicine

You should not use this medicine if you are allergic to paroxetine, or if you are also taking pimozide or thioridazine.

Do not use an MAO inhibitor within 14 days before or 14 days after you take paroxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking paroxetine you must wait at least 14 days before you start taking an MAO inhibitor.

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

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

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 paroxetine and cause a serious condition called serotonin syndrome.

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.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other 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 this medicine without your doctor’s advice.

Do not use Brisdelle if you are pregnant.

You should not breastfeed while using this medicine.

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

How should I take paroxetine?

Take paroxetine 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.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Shake the oral suspension (liquid) before you measure a dose. 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.

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 paroxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using paroxetine. Follow your doctor’s instructions about tapering your dose.

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 it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

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

What to avoid

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

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 paroxetine may cause you to bruise or bleed easily.

Drinking alcohol with this medicine can cause side effects.

What is Paxil?

Paxil is an antidepressant that belongs to group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may be unbalanced in people with depression, anxiety, or other disorders.

Paxil is used to treat depression, including major depressive disorder.

Paxil is also used to treat panic disorder, obsessive-compulsive disorder (OCD), anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Warnings

You should not use Paxil if you are also taking pimozide or thioridazine.

Do not use Paxil 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.

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

Seek medical attention right away if you have symptoms such as: agitation, hallucinations, muscle stiffness, twitching, loss of coordination, dizziness, warmth or tingly feeling, nausea, vomiting, diarrhea, fever, sweating, tremors, racing heartbeats, or a seizure (convulsions).

Do not stop using Paxil without first asking your doctor.

Before taking this medicine

You should not use Paxil if you are allergic to paroxetine, or if you are also taking pimozide or thioridazine.

Do not use an MAO inhibitor within 14 days before or 14 days after you take paroxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking Paxil you must wait at least 14 days before you start taking an MAO inhibitor.

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

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

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 paroxetine and cause a serious condition called serotonin syndrome.

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.

Taking an SSRI antidepressant such as Paxil during pregnancy may cause serious lung problems or other 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 this medicine without your doctor’s advice.

You should not breastfeed while using this medicine.

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

How should I take Paxil?

Take Paxil 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.

Swallow the Paxil CR extended-release tablet whole and do not crush, chew, or break the tablet.

Shake the Paxil oral suspension (liquid) before you measure a dose. 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.

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 Paxil suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine. Follow your doctor’s instructions about tapering your dose.

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 it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

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

What to avoid

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

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 Paxil may cause you to bruise or bleed easily.

Drinking alcohol with this medicine can cause side effects.

Paxil side effects

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

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.

Call your doctor at once if you have:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• unusual bone pain or tenderness, swelling or bruising;
• changes in weight or appetite;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or
• low levels of sodium in the body – headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.

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.

Common Paxil side effects may include:

• vision changes;
• weakness, drowsiness, dizziness, tiredness;
• sweating, anxiety, shaking;
• sleep problems (insomnia);
• loss of appetite, nausea, vomiting, diarrhea, constipation;
• dry mouth, yawning;
• infection;
• headache; or
• decreased sex drive, impotence, abnormal ejaculation, or difficulty having an orgasm.

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

What other drugs will affect Paxil?

Using Paxil 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:

• cimetidine (Tagamet), digoxin, St. John’s wort, tamoxifen, theophylline, tryptophan (sometimes called L-tryptophan), warfarin (Coumadin, Jantoven);
• a diuretic or “water pill”;
• heart rhythm medicine;
• HIV or AIDS medications;
• certain medicines to treat narcolepsy or ADHD – amphetamine, atomoxetine, dextroamphetamine, Adderall, Dexedrine, Evekeo, Vyvanse, and others;
• narcotic pain medicine – fentanyl, tramadol;
• medicine to treat anxiety, mood disorders, thought disorders, or mental illness – such as buspirone, lithium, other antidepressants, or antipsychotics;
• migraine headache medicine – sumatriptan, rizatriptan, zolmitriptan, and others; or
• seizure medicine – phenobarbital, phenytoin.

What is Paxlovid?

Paxlovid is an antiviral treatment for COVID-19 used to lower the risk of severe COVID-19, including hospitalization or death. Paxlovid contains nirmatrelvir tablets and ritonavir packaged together. 

Paxlovid is an FDA-approved medicine for adults with mild-to-moderate COVID-19 patients who are at high risk of severe COVID-19, including hospitalization or death.

Paxlovid has Emergency Use Authorisation (EUA) to treat patients 12 to 18 years old for mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death.

People who are at high risk of severe COVID-19 are patients with:

• heart disease, diabetes, lung disease, cancer, blood disorders, immune disorders, mental health conditions, disabilities or other conditions
• being overweight or obese
• 50 years or older
• lifestyle factors, such as smoking
• physical, mental, and developmental disabilities.

Paxlovid works as nirmatrelvir blocks an enzyme (SARS-CoV-2-3CL protease) that the coronavirus needs to replicate. By preventing the virus from reproducing itself, nirmatrelvir reduces the severity of symptoms and decreases the number of hospitalizations and deaths in high-risk patients. Ritonavir is a medication that helps nirmatrelvir stay in the body longer and at a higher concentration, making nirmatrelvir a more effective antiviral.

You should start taking Paxlovid as soon as possible after COVID diagnosis and within the first 5 days that you have had symptoms. The usual Paxlovid dose is two nirmatrelvir tablets and one ritonavir tablet taken together twice daily for 5 days. The dose needs to be changed if you have kidney problems, and if you are taking certain medicines, Paxlovid is not suitable for some patients.

Paxlovid is not approved for use as a pre-exposure or post-exposure prophylaxis to prevent COVID-19 or for the prevention of long COVID.

Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions.

Paxlovid side effects

Common Paxlovid side effects

Common Paxlovid side effects include a bad taste or change in taste (5%) and diarrhea (3%) in the EPIC-HR clinical trial. Other Paxlovid side effects, including abdominal pain, nausea, vomiting, high blood pressure, headache, generally feeling unwell (malaise), allergic reaction, and hypersensitivity reactions, occurred in Paxlovid Emergency Use Authorization Experience. 

The Paxlovid side effect of bad taste or change in taste (dysgeusia) is the most common side effect, it is often described as a metallic taste or bitter taste and usually goes when you have finished the course. If you get this side effect, you may want to try gum, mints, or mouthwash for temporary relief.

Serious Paxlovid side effects

Paxlovid may cause serious side effects, including allergic reactions, hypersensitivity reactions, and liver problems.

Allergic reactions: Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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).

Liver problems: Call your doctor at once if you have:

• liver problems symptoms include loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Ritonavir side effects

Ritonavir, one of the active ingredients in Paxlovid, affects your immune system, which may cause certain side effects (even weeks or months after you’ve taken nirmatrelvir and ritonavir). Tell your doctor if you have:

• signs of a new infection–fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

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

Warnings

Paxlovid Drug Interactions: Paxlovid can interact with other medicines, causing severe or life-threatening side effects or death. It is important to know the medicines that should not be taken with Paxlovid. See the Interactions section below and check the interactions checker.

Hypersensitivity Reactions: Anaphylaxis, serious skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome), and other hypersensitivity reactions have been reported with this medicine. Do not take this medicine if you are allergic to nirmatrelvir, ritonavir, or any of the ingredients in Paxlovid. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately stop taking Paxlovid and start appropriate medications and/or supportive care. 

Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir, one of the active ingredients in Paxlovid.

HIV-1 Drug Resistance: Using Paxovid may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors if you have uncontrolled or undiagnosed HIV-1 infection. 

Paxlovid rebound and COVID rebound

COVID rebound is when COVID symptoms return between 2 and 8 days after finishing treatment; symptoms are mild, transient, and usually clear up in 1 to 3 days. COVID rebound can happen in some people who are vaccinated, unvaccinated, Paxlovid treated, and people who have not been treated with Paxlovid. When COVID-19 symptoms return in Paxlovid-treated patients, some people have called it Paxlovid rebound.

The CDC states that “There is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARS-CoV-2 therapies in cases where COVID-19 rebound is suspected.”

Before taking this medicine

You should not use Paxlovid if you are allergic to the active ingredients nirmatrelvir and ritonavir or any of the inactive ingredients. A list of ingredients is at the bottom of this page.

Some drugs have drug interactions with Paxlovid, and they should not be used with Paxlovid, such as those listed below.

• alfuzosin, colchicine;
• sildenafil (Revatio) when used to treat pulmonary arterial hypertension (PAH);
• pain medicine – pethidine, piroxicam, propoxyphene;
• heart medicine – amiodarone, dronedarone, flecainide, propafenone, quinidine, ranolazine;
• antipsychotic medicine – lurasidone, pimozide, clozapine;
• ergot medicine – dihydroergotamine, ergotamine, methylergonovine;
• cholesterol-lowering medicine – lovastatin, simvastatin; or
• a sedative – riazolam, oral midazolam.

Paxlovid should not be started immediately after discontinuation of any of the following drugs:

• rifampin;
• St. John’s Wort;
• a cancer medicine – apalutamide; or
• seizure medicine – carbamazepine, phenobarbital, phenytoin.

Not all possible interactions are listed here. Also, see the Interactions section below and check the interactions checker.

Tell your doctor if:

• you have liver problems or a liver disease such as hepatitis;
• you have kidney problems;
• you have an HIV-1 infection;
• you are pregnant or breastfeeding, or
• you have any serious or chronic disease.

Pregnancy

Tell your healthcare provider right away if you are or if you become pregnant. It is not known if Paxlovid can harm your unborn baby. Ritonavir can make birth control pills or birth control skin patches less effective. Ask your doctor about other birth control options such as an injection, implant, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.

Breastfeeding

Tell your healthcare provider you are breastfeeding or plan to breastfeed. It is not known if Paxlovid can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

How should I take Paxlovid?

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

Paxlovid Instructions

Take nirmatrelvir together with ritonavir (two tablets of nirmatrelvir and one tablet of ritonavir) twice a day for 5 consecutive days. If you have kidney disease, talk to your healthcare provider, as you may need to take a different dose.

Take Paxlovid as soon as possible after diagnosis of COVID-19 and within 5 days of when symptoms first appear.

You may take Paxlovid with or without food.

Swallow the tablets whole and do not crush, chew, or break them.

General Information

You may need frequent blood tests to check your liver function.

If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or Human Immunodeficiency Virus (HIV), you should continue to take your medicine as prescribed by your healthcare provider.

Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days.

If you have kidney disease, your prescriber may prescribe you a lower dose. Talk to your healthcare provider to make sure you receive the correct Dose Pack.

Paxlovid Dosage information

Usual Paxlovid Dosing for Adult COVID-19 (FDA-approved)

Nirmatrelvir: 300 mg orally twice a day for 5 days
Ritonavir: 100 mg orally twice a day for 5 days

Usual Paxlovid Dosing for 12 to 18 Year Old COVID-19 (EUA)

For investigational use only
Use: Patients 12 to 18 years old weighing at least 40 kg:
Nirmatrlvir 300 mg orally twice a day for 5 days
Ritonavir 100 mg orally twice a day for 5 days

Usual Paxlovid Dosing for Renal Impairment

Use: Patients with moderate renal impairment (eGFR ≥30 to <60 mL/min)
Nirmatrelvir 150 mg twice daily for 5 days
Ritonavir 100 mg twice daily for 5 days 
No dosage adjustment is recommended in patients with mild renal impairment (eGFR ≥60 to <90 mL/min)

General Paxlovid Dosing information:

• If you have kidney disease, your healthcare provider may prescribe a lower dose. Talk to your healthcare provider to make sure you receive the correct Dose Pack.
• Nirmatrelvir must be coadministered with ritonavir. Prescriptions should specify the numeric dose of each active component within this product.
• This product should be started as soon as possible after COVID-19 has been diagnosed and within 5 days of symptom onset.
• If hospitalization is required due to severe/critical COVID-19 after starting treatment with this product, the patient should complete the full 5-day treatment course per health care provider’s discretion.

What happens if I miss a dose?

If you miss a dose of Paxlovid within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of Paxlovid at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Paxlovid?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can affect Paxlovid and some drugs should not be used at the same time. Paxlovid can interact with other medicines causing severe or life-threatening side effects or death. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Paxlovid Drug Interactions

Do not take Paxlovid if you are taking any of the following medicines: alfuzosin, amiodarone, apalutamide, carbamazepine, colchicine, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, finerenone, flecainide, flibanserin, ivabradine, lomitapide, lovastatin, lumacaftor/ivacaftor, lurasidone, methylergonovine, midazolam (oral), naloxegol, phenobarbital, phenytoin, pimozide, primidone, propafenone, quinidine, ranolazine, rifampin, rifapentine, St. John’s Wort (hypericum perforatum), sildenafil (Revatio®, Liqrev®) for pulmonary arterial hypertension, silodosin, simvastatin, tolvaptan, triazolam, ubrogepant, voclosporin.

These are not the only medicines that may cause serious or life-threatening side effects if taken with Paxlovid. It is very important to tell your healthcare provider about all of the medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with this Paxlovid. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines.

Not all possible interactions are listed in this medication guide. Use the Paxlovid interaction checker below to check for more interaction information.

Ingredients

Nirmatrelvir 150 mg tablets

Active ingredient: nirmatrelvir
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate. The following are the ingredients in the film coating: hydroxy propyl methylcellulose, iron oxide red, polyethylene glycol, and titanium dioxide.

Ritonavir 100 mg tablets

Active ingredient: ritonavir
Inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The following are the ingredients in the film coating: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, and titanium dioxide.

What is pegcetacoplan?

Intravitreal pegcetacoplan (Syfovre) is used to treat geographic atrophy (GA), the dry, advanced form of age-related macular degeneration (AMD). It is given as an injection into each affected eye by a qualified healthcare provider every 25 to 60 days.

Pegcetacoplan for injection into the eye gained FDA approval on February 17, 2023, under the brand name Syfovre. It is manufactured by Apellis Pharmaceuticals Inc. There is no generic.

• A formulation of pegcetacoplan given by infusion (Empaveli) is used to treat paroxysmal nocturnal hemoglobinuria (PNH).

How does intravitreal pegcetacoplan work?

Pegcetacoplan works by targeting an overactive immune response that can harm cells in the retina. It focuses on a protein called C3 which is part of the complement system – an immune system component that, when too active, can damage retinal cells and accelerate GA progression.

By inhibiting the C3 protein, intravitreal pegcetacoplan helps:

• Protect retinal cells from further immune system damage
• Reduce the expansion of GA lesions in the eye
• Help preserve vision for a longer period by slowing disease progression.

Pegcetacoplan belongs to the drug class called complement inhibitors.

How effective is intravitreal pegcetacoplan?

Clinical trials, including two Phase 3 clinical trials, OAKS and DERBY, which followed 1,258 patients over 24 months reported:

• Slowing of GA lesions by 18 to 22% (-0.72 mm² to -0.87 mm²/24 months) with monthly pegcetacoplan injections
• Slowing of GA lesions by 17 to 18% (-0.70 mm² to -0.72 mm²/24 months) with pegcetacoplan injections every 2 months.

Pegcetacoplan side effects

The most common side effects of pegcetacoplan injections into the eye are:

• Eye discomfort, such as pain, irritation, or a feeling that something is in your eye
• Development of wet macular degeneration 
• Seeing flashes of light or “floaters” in vision (vitreous floaters)
• Minor eye bleeding (conjunctival bleeding)
• Inflammation of the cornea (clear outer layer at the front of the eye) and other parts of the eye
• Vitreous detachment (when a gel-like substance within the eye separates from the retina)
• Retinal bleeding
• Clouding of the eye’s lens capsule (posterior capsule opacification)
• Increased eye pressure.

Serious pegcetacoplan injection side effects

Intravitreal pegcetacoplan can cause the following serious side effects.

Eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, small specks floating in your vision, or flashing lights.

Severe inflammation of the vessels in the retina that may result in severe vision loss. Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, or flashing lights

Risk of developing wet AMD. You should be monitored for signs of wet AMD and you should report if you have any change in vision including blurred, wavy/distorted vision, black spots, or loss of central vision to your healthcare provider.

Episodes of eye inflammation. You should report any symptoms including eye redness, light sensitivity, eye pain, specks floating in your vision, or any changes in vision to your healthcare provider.

Increase in eye pressure within minutes of the injection. Your healthcare provider will monitor this after each injection.

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

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

Before receiving

Do NOT receive a pegcetacoplan injection if you:

• have an infection in or around your eye
• have any active swelling around or in your eye that may include pain and redness
• are allergic to the active ingredient or inactive ingredients.

Before receiving this medicine, tell your healthcare provider about all your medical conditions, including if you:

• Have a history of seeing flashes of light or specks floating in your vision and notice a sudden increase in the size and number of these specks
• Have high pressure in the eye or glaucoma
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed.

Pregnancy

Females who can become pregnant should use effective contraception methods to prevent pregnancy during treatment with this medicine and for 40 days after the last dose. The use of this medicine may be considered following an assessment of the risks and benefits.

Breastfeeding

Ask your doctor for advice before taking this medicine. If you are breastfeeding or planning to breastfeed, your doctor will talk to you about the best way to feed your baby.

How is pegcetacoplan administered?

Pegcetacoplan is given as an injection into the soft gel (vitreous) in the middle of your eye by a qualified healthcare provider. This is called an intravitreal injection.

• The injection is given into each affected eye 1 time every 25 to 60 days.
• Your healthcare provider will decide how often you receive your injections.

You will need frequent eye examinations before and after receiving this injection.

Pegcetacoplan dosing information

Before giving you the eye injection, your healthcare provider will numb (anesthetize) your eye and use a broad-spectrum antibiotic eye drop to disinfect the periocular skin, eyelid, and ocular surface prior to the injection.

Adult Dose for GA caused by AMD: Pegcetacoplan 15 mg (0.1 mL of a 150 mg/mL solution).

• Administer a single dose into each affected eye.
• Dispose of any excess volume.

After the eye injection

• Your healthcare provider will monitor you for any increase in eye pressure.

What should I avoid while receiving this medicine?

Pegcetacoplan injection may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Storage

Your healthcare provider will store pegcetacoplan in the refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

• The vial should not be shaken or used beyond the expiration date on the carton.

What is Pentasa?

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

Pentasa is used to treat mild to moderate ulcerative colitis in adults. Ucerative colitis is associated with inflammation, ulcers and sores in the bowel causing bleeding, stomach pain, and diarrhoea.

Pentasa is also used off-label in the USA as a treatment for Crohn’s disease. Use of Pentasa to treat Crohn’s disease is officially approved in some other countries.

Warnings

Stop using Pentasa 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 Pentasa 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 Pentasa 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 this medicine. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

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

How should I take Pentasa?

Take Pentasa 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 mesalamine.

Drink plenty of liquids to help prevent kidney stones.

Pentasa can be taken with or without food.

Swallow the capsule whole and do not chew or crush the contents of the capsule. Tell your doctor if you have trouble swallowing the capsule.

If you cannot swallow a Pentasa capsule whole, open it and sprinkle the medicine into a spoonful of yogurt or applesauce. Swallow all of the mixture immediately without chewing. Do not save it for later use.

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 mesalamine.

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 for Ulcerative Colitis — Active:

250 and 500 mg extended-release capsules: 1 g orally 4 times a day
Duration of therapy: Up to 8 weeks.

Uses: Treatment of mildly to moderately active ulcerative colitis and induction of remission of ulcerative colitis.

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 Pentasa?

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.

Pentasa side effects

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

Stop using Pentasa 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 Pentasa 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.

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

What other drugs will affect Pentasa?

Mesalamine can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• azathioprine or 6-mercaptopurine.

What is Pepcid?

Pepcid is a histamine-2 blocker that works by decreasing the amount of acid the stomach produces.

Pepcid is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome.

Pepcid also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Warnings

Before taking Pepcid, tell your doctor if you have kidney or liver disease, a history of Long QT syndrome, stomach cancer or other problems, or asthma, COPD, or other breathing problems.

Pepcid may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor’s instructions very closely.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use Pepcid if you are allergic to famotidine or similar medicines such as ranitidine (Zantac), cimetidine (Tagamet), or nizatidine (Axid).

Before taking this medicine

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.

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

• kidney disease;
• liver disease;
• cancer stomach; or
• long QT syndrome (in you or a family member).

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

How should I take Pepcid?

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

You may take this medicine with or without food.

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

Most ulcers heal within 4 weeks of famotidine treatment, but it may take up to 8 weeks of using this medicine before your ulcer heals. Keep using the medication as directed.

Call your doctor if the condition you are treating with famotidine does not improve, or if it gets worse.

Pepcid may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow all instructions of your doctor or dietitian.

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

Throw away any unused liquid that is older than 30 days.

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

Drinking alcohol may increase the risk of damage to your stomach.

Avoid taking other stomach acid reducers unless your doctor has told you to. However, you may take an antacid (such as Maalox, Mylanta, Gaviscon, Milk of Magnesia, Rolaids, or Tums) with famotidine.

Pepcid side effects

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

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

• confusion, hallucinations, agitation, lack of energy;
• a seizure;
• fast or pounding heartbeats, sudden dizziness (like you might pass out); or
• unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Some side effects may be more likely in older adults and in people who have severe kidney disease.

Common Pepcid side effects may include:

• headache;
• dizziness; or
• constipation or diarrhea.

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

What other drugs will affect Pepcid?

Famotidine can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor if you are taking:

• cefditoren;
• dasatinib;
• delavirdine;
• fosamprenavir; or
• tizanidine (if you are taking famotidine liquid).

What is Percocet?

Percocet contains a combination of acetaminophen and oxycodone. Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Percocet is used to relieve moderate to severe pain.

Due of the risks of addiction, abuse, and misuse, even at recommended doses, Percocet is only prescribed when treatment with non-opioid pain relieving medication has not been tolerated or has not provided adequate pain relief.

Warnings

You should not use Percocet if you have recently used alcohol, sedatives, tranquilizers, or other opioid medications. Do not use Percocet if you have used a MAO Inhibiter in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine, or have received a methylene blue injection.

Oxycodone can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share Percocet with another person.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not take more Percocet than is recommended. An overdose of oxycodone or acetaminophen (both present in Percocet) can cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Oxycodone (present in Percocet) may cause life-threatening withdrawal symptoms in a newborn if the mother has taken Percocet during pregnancy.

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Fatal side effects can occur if you use Percocet with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not use Percocet if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.

Before taking this medicine

You should not use Percocet if you are allergic to any of its components including acetaminophen or oxycodone, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

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

• breathing problems, sleep apnea;
• liver disease;
• a drug or alcohol addiction;
• kidney disease;
• a head injury or seizures;
• urination problems; or
• problems with your thyroid, pancreas, or gallbladder.

If you use Percocet while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

If you become pregnant while taking oxycodone, do not stop your medication suddenly without talking to your doctor. You may need to decrease your medicine gradually.

Do not breastfeed. Oxycodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby. Tell your doctor if you are breastfeeding before using oxycodone.

How should I take Percocet?

Take Percocet exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away Percocet is against the law.

If you need surgery or medical tests, tell the doctor ahead of time that you are using Percocet.

You should not stop using Percocet suddenly. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

What happens if I miss a dose?

Since Percocet is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include nausea, vomiting, sweating, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What to avoid

Avoid driving or operating machinery until you know how Percocet will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.

Percocet side effects

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

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen or Tylenol in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Oxycodone can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• slow heartbeat or week pulse;
• cold, clammy skin;
• a light-headed feeling, like you might pass out;
• weakness, tiredness, fever, unusual bruising or bleeding;
• confusion, unusual thoughts or behavior;
• seizure (convulsions);
• problems with urination;
• signs of liver problems including nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Percocet side effects include:

• dizziness, drowsiness, feeling tired;
• headache;
• constipation, nausea, vomiting, stomach pain;
• blurred vision;
• itching, red eyes, or flushing;
• feelings of extreme happiness or sadness; or
• dry mouth

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

What other drugs will affect Percocet?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is perindopril?

Perindopril is an ACE inhibitors. ACE stands for angiotensin converting enzyme.

Perindopril is used to treat high blood pressure (hypertension) and to prevent heart attack in people with coronary artery disease.

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

Perindopril side effects

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

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

• a light-headed feeling, like you might pass out;
• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• little or no urination;
• swelling, rapid weight gain;
• high potassium–nausea, slow or unusual heart rate, weakness, loss of movement;
• pale skin, easy bruising or bleeding; or
• jaundice (yellowing of the skin or eyes).

Common side effects of perindopril may include:

• dizziness;
• back pain; or
• cough.

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

Warnings

Do not use if you are pregnant. If you become pregnant, stop taking perindopril and tell your doctor right away.

You should not use perindopril if you have ever had angioedema. Do not take perindopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use perindopril together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

You should not use this medicine if you are allergic to perindopril or if:

• you have hereditary angioedema;
• you recently took a heart medicine called sacubitril; or
• you are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, or trandolapril.

Do not take perindopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use perindopril together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking perindopril with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• liver disease;
• heart disease or congestive heart failure;
• diabetes; or
• a connective tissue disease such as Marfan syndrome, Sjogren’s syndrome, lupus, scleroderma, or rheumatoid arthritis.

Do not use if you are pregnant, and tell your doctor right away if you become pregnant. Perindopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

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

How should I take perindopril?

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

Take each dose with a full glass of water. Drink plenty of liquids while you are taking perindopril.

You may take perindopril with or without food.

Your blood pressure will need to be checked often. Your kidney or liver function may also need to be checked.

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 perindopril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

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

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

Perindopril dosing information

Usual Adult Dose for Coronary Artery Disease:

Initial dose: 4 mg orally once a day for 2 weeks, then increase to maintenance dose as tolerated.
Maintenance dose: 8 mg orally once a day

Use: Treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction.

Usual Adult Dose for Hypertension:

Initial dose: 4 mg orally once a day
Maintenance dose: 4 to 8 mg orally per day in 1 or 2 divided doses
Maximum dose: 16 mg/day

Comments: In patients treated with a diuretic, consider reducing the diuretic dose prior to starting this drug.

Usual Geriatric Dose for Coronary Artery Disease:

Greater than 70 Years:
Initial dose:
-Week 1: 2 mg orally once a day
-Week 2: 4 mg orally once a day, then increase to maintenance dose as tolerated.
Maintenance dose: 8 mg orally once a day

Use: Treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction.

Usual Geriatric Dose for Hypertension:

Initial dose: 4 mg orally per day in 1 or 2 divided doses

Comments: Experience with doses above 8 mg is limited; administer with careful blood pressure monitoring and dose titration.

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 perindopril?

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.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

What other drugs will affect perindopril?

Tell your doctor about all your other medicines, especially:

• lithium;
• a diuretic or “water pill”;
• gold injections to treat arthritis; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is phenazopyridine?

Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Phenazopyridine is used to treat urinary symptoms such as pain or burning, increased urination, and increased urge to urinate. These symptoms can be caused by infection, injury, surgery, catheter, or other conditions that irritate the bladder.

Phenazopyridine will treat urinary symptoms, but this medication will not treat a urinary tract infection.. Take any antibiotic that your doctor prescribes to treat an infection.

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

Phenazopyridine side effects

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

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

• little or no urinating;
• swelling, rapid weight gain;
• confusion, loss of appetite, pain in your side or lower back;
• fever, pale or yellowed skin, stomach pain, nausea and vomiting; or
• blue or purple appearance of your skin.

Common side effects of phenazopyridine may include:

• headache;
• dizziness; or
• upset stomach.

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

Warnings

You should not use phenazopyridine if you have kidney disease.

Before taking this medicine

You should not use phenazopyridine if you are allergic to it, or if you have kidney disease.

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

• liver disease;
• diabetes; or
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

FDA pregnancy category B. Phenazopyridine is not expected to harm an unborn baby. Do not use phenazopyridine without a doctor’s advice if you are pregnant.

It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

How should I take phenazopyridine?

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

Take phenazopyridine after meals.

Drink plenty of liquids while you are taking phenazopyridine.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not harmful. Darkened urine may also cause stains to your underwear that may be permanent.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

This medication can cause unusual results with urine tests. Tell any doctor who treats you that you are using phenazopyridine.

Store at room temperature away from moisture and heat.

Phenazopyridine dosing information

Usual Adult Dose for Dysuria:

190 to 200 mg orally 3 times a day

Comments:
-Take this drug after a meal.
-Take this drug with a full glass of water.
-This drug should not be used longer than 2 days concomitantly with an antibacterial, because of the lack of evidence that the combined administration of this drug and an antibacterial provides greater benefit than the antibacterial alone after 2 days.

Use: For the symptomatic relief of pain, burning, urgency, frequency, and other discomfort arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters

Usual Pediatric Dose for Dysuria:

12 years and older:
190 to 195 mg orally 3 times a day

Comments:
-Take this drug after a meal.
-Take this drug with a full glass of water.
-This drug should not be used longer than 2 days concomitantly with an antibacterial, because of the lack of evidence that the combined administration of this drug and an antibacterial provides greater benefit than the antibacterial alone after 2 days.

Use: For the symptomatic relief of pain, burning, urgency, frequency, and other discomfort arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters

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 .

What should I avoid while taking phenazopyridine?

Do not use this medication while wearing soft contact lenses. Phenazopyridine can permanently discolor soft contact lenses.

What is Phenergan?

Phenergan belongs to a group of drugs called phenothiazines. It works by changing the actions of chemicals in your brain. Promethazine also acts as an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

Phenergan is used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes.

Phenergan also prevents motion sickness, and treats nausea and vomiting or pain after surgery. It is also used as a sedative or sleep aid.

Phenergan is not for use in treating symptoms of asthma, pneumonia, or other lower respiratory tract infections.

Warnings

Stop using Phenergan and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Phenergan should not be given to a child younger than 2 years old. Phenergan can cause severe breathing problems or death in very young children. Carefully follow your doctor’s instructions when giving this medicine to a child of any age.

Phenergan can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase some of the side effects of Phenergan. There are many other medicines that can interact with promethazine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Before taking this medicine

Phenergan should not be given to a child younger than 2 years old. Phenergan can cause severe breathing problems or death in very young children. Carefully follow your doctor’s instructions when giving this medicine to a child of any age.

You should not take Phenergan if you are allergic to promethazine or to similar medicines such as chlorpromazine, fluphenazine, mesoridazine, perphenazine, prochlorperazine, thioridazine, or trifluperazine.

You should not take Phenergan if you have asthma or another lower respiratory tract disorder.

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

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a sulfite allergy;
• a history of seizures;
• a weak immune system (bone marrow depression);
• glaucoma;
• enlarged prostate or problems with urination;
• stomach ulcer or obstruction;
• heart disease or high blood pressure;
• liver disease;
• adrenal gland tumor (pheochromocytoma);
• low levels of calcium in your blood (hypocalcemia); or
• if you have ever had a serious side effect while using promethazine or any other phenothiazine.

It is not known whether Phenergan will affect an unborn baby. Animal studies have not shown any effects. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether promethazine passes into breast milk or if it could affect a nursing baby. Tell your doctor if you are nursing prior to using Phenergan.

How should I take Phenergan?

Take Phenergan exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Phenergan is often taken at bedtime or before meals. For motion sickness, Phenergan is usually started within 1 hour before traveling. When used for surgery, Phenergan is usually taken the night before the surgery.

How often you take Phenergan and the timing of your dose will depend on the condition being treated.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Phenergan doses are based on weight in children, and any changes may affect your child’s dose.

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

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

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

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 overactive reflexes, loss of coordination, severe drowsiness or weakness, fainting, dilated pupils, weak or shallow breathing, or seizure (convulsions).

What to avoid

This medicine 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 Phenergan. Do not drink alcohol while taking this medication.

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

Phenergan side effects

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

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

• severe drowsiness, weak or shallow breathing;
• a light-headed feeling, like you might pass out;
• confusion, agitation, hallucinations, nightmares;
• seizure (convulsions);
• fast or slow heartbeats;
• jaundice (yellowing of the skin or eyes);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• easy bruising or bleeding (nosebleeds, bleeding gums);
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing; or
• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Side effects such as confusion and severe drowsiness may be more likely in older adults.

Common Phenergan side effects may include:

• drowsiness, dizziness;
• ringing in your ears;
• double vision;
• feeling nervous;
• dry mouth; or
• tired feeling, sleep problems (insomnia).

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

What other drugs will affect Phenergan?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with Phenergan and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines.

Also tell your doctor if you are using any of the following medicines:

• lithium (Eskalith, Lithobid);
• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• blood pressure medication such as guanadrel (Hylorel), guanethidine (Ismelin), propranolol (Inderal), and others;
• a blood thinner such as warfarin (Coumadin);
• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), and others;
• a MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) or methylene blue injection; or
• medicines to treat Parkinson’s disease, restless leg syndrome, or pituitary gland tumor (prolactinoma); or
• medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine).

What is phenobarbital?

Phenobarbital is a barbiturate (bar-BIT-chur-ate). Phenobarbital slows the activity of your brain and nervous system.

Phenobarbital is used to treat or prevent seizures. Phenobarbital is also used short-term as a sedative to help you relax.

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

Phenobarbital side effects

Phenobarbital may cause a severe allergic reaction. Stop taking phenobarbital and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, eyes, lips, tongue, or throat.

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

• weak or shallow breathing;
• unusual pain anywhere in your body (especially in the neck, shoulder, or arms);
• a red blood cell disorder–pale skin, muscle weakness, diarrhea, weight loss, rapid heart rate, tongue swelling, numbness or tingling in your hands or feet, feeling short of breath; 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.

Side effects such as confusion, depression, or excitement may be more likely in older adults and those who are ill or debilitated.

Common side effects of phenobarbital may include:

• drowsiness, lack of energy;
• dizziness or spinning sensation;
• depressed mood;
• feeling restless or excited (especially in children or older adults);
• drunk feeling; or
• “hangover” effect (drowsiness the day after taking phenobarbital).

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

Warnings

You should not use phenobarbital if you have severe liver disease, severe asthma or COPD, a personal or family history of porphyria, or a history of addiction to drugs similar to phenobarbital.

Before taking this medicine

You should not take phenobarbital if you are allergic to phenobarbital or other barbiturates (Nembutal, Seconal, and others), or if you have:

• severe asthma, chronic obstructive pulmonary disorder (COPD), or other breathing disorder;
• a personal or family history of porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• severe liver disease; or
• a history of addiction to phenobarbital or similar medicines (Valium, Xanax, Ativan, and others).

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

• liver disease;
• temporary or chronic pain;
• a pituitary gland disorder;
• pheochromocytoma (tumor of the adrenal gland);
• kidney disease;
• a food or drug allergy;
• a condition for which you take a blood thinner (warfarin, Coumadin, Jantoven).

Follow your doctor’s instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor’s advice, and tell your doctor right away if you become pregnant.

Phenobarbital can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

It is not known whether phenobarbital passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take phenobarbital?

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

Phenobarbital may be habit-forming. Never share phenobarbital 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.

Do not change your phenobarbital dose without your doctor’s advice. Tell your doctor if the medicine does not seem to work as well in treating your condition.

If you are taking phenobarbital to treat seizures, keep taking the medicine even if you feel fine.

Do not stop using suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using phenobarbital.

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

Keep track of the amount of medicine used from each new bottle. Phenobarbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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 . An overdose of phenobarbital can be fatal.

Overdose symptoms may include slow or shallow breathing, weak pulse, cold or clammy skin, little or no urination, pinpoint pupils, feeling cold, or fainting.

What should I avoid while taking phenobarbital?

Drinking alcohol with phenobarbital can cause side effects.

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

What other drugs will affect phenobarbital?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking phenobarbital with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

What is phentermine?

Phentermine is used to speed weight loss in overweight people. It is used together with diet and exercise to treat obesity, especially in people with risk factors such as high blood pressure, high cholesterol, or diabetes.

Phentermine is similar to an amphetamine. It stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.

Phentermine belongs to a class of medications called anorectics. It works by reducing your appetite.

Warnings

Do not use phentermine if you are pregnant or breastfeeding a baby.

You should not use phentermine if you have glaucoma, overactive thyroid, severe heart problems, uncontrolled high blood pressure, advanced coronary artery disease, extreme agitation, or a history of drug abuse.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. A dangerous drug interaction could occur.

Before taking this medicine

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

• a history of heart disease (coronary artery disease, heart rhythm problems, congestive heart failure, stroke);
• severe or uncontrolled high blood pressure;
• overactive thyroid;
• glaucoma;
• extreme agitation or nervousness;
• a history of drug abuse; or
• if you take other diet pills.

Do not use phentermine 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.

Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Do not use phentermine if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

You should not breast-feed while using this medicine.

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

• heart disease or coronary artery disease;
• a heart valve disorder;
• high blood pressure;
• diabetes (your diabetes medication dose may need to be adjusted); or
• kidney disease.

Phentermine is not approved for use by anyone younger than 16 years old.

How should I take phentermine?

Take phentermine 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.

Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. Follow your doctor’s dosing instructions very carefully.

Never use phentermine in larger amounts, or for longer than prescribed. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects.

This medicine is for short-term use only. The effects of appetite suppression may wear off after a few weeks.

Phentermine may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Call your doctor at once if you think this medicine is not working as well, or if you have not lost at least 4 pounds within 4 weeks.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

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

Dosing information

Usual Adult Dose for Obesity:

8 mg orally 3 times a day 30 minutes before meals, OR
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.

Use: Short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity in patients with an initial body mass index (BMI) of 30 kg/m2 or greater, or BMI of 27 kg/m2 or greater in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Usual Pediatric Dose for Obesity:

Age 17 Years and Older:
8 mg orally 3 times a day 30 minutes before meals, OR
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.

Use: Short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity in patients with an initial body mass index (BMI) of 30 kg/m2 or greater, or BMI of 27 kg/m2 or greater in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is late in the day. Do not take two doses at one time.

What happens if I overdose?

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

Overdose symptoms may include confusion, panic, hallucinations, extreme restlessness, nausea, vomiting, diarrhea, stomach cramps, feeling tired or depressed, irregular heartbeats, weak pulse, seizure, or slow breathing (breathing may stop).

What to avoid

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

Drinking alcohol with this medicine can cause side effects.

Phentermine side effects

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

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

• feeling short of breath, even with mild exertion;
• chest pain, feeling like you might pass out;
• swelling in your ankles or feet;
• pounding heartbeats or fluttering in your chest;
• tremors, feeling restless, trouble sleeping;
• unusual changes in mood or behavior; or
• increased blood pressure – severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Common side effects of phentermine may include:

• itching;
• dizzinessheadache;
• dry mouth;
• unpleasant taste;
• diarrhea;
• constipation;
• stomach pain; or
• increased or decreased interest in sex.

What is phenylephrine?

Oral and nasal phenylephrine are used as nasal decongestants to temporarily unblock a nose or relieve sinus pressure in people with nasal and sinus congestion caused by colds, allergies, or hay fever. While phenylephrine can provide some symptom relief, it doesn’t treat the underlying cause or speed recovery.

Injectable phenylephrine may be used in a hospital setting to increase blood pressure in adults with significantly low blood pressure caused primarily by vasodilation (a widening of the blood vessels), as a result of septic shock or anesthesia.

Phenylephrine works by directly stimulating receptors in the blood vessels of the nose and other parts of the body (called alpha-1 adrenergic receptors), causing vasoconstriction (narrowing of the blood vessels). This reduces nasal congestion by preventing fluid from draining from the blood vessels into the tissues lining the nasal passages. At higher dosages, phenylephrine increases blood pressure and reduces heart rate and cardiac output (particularly in people with preexisting heart disease).

Phenylephrine has been available for over 60 years, which means it wasn’t subject to the same rigorous scrutiny by the FDA as newer medicines.

Phenylephrine side effects

The most common side effects of phenylephrine include:

• flushing (warmth, redness, or tingly feeling)
• loss of appetite
• feeling restless or excited (especially in children).

Serious side effects and warnings

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

Do not use if you are taking a monoamine oxidase inhibitor (MAOI) or have used one in the past 14 days (2 weeks). MAOIs include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine, and these are typically used for depression, psychiatric or emotional conditions, or Parkinson’s disease, or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this phenylephrine.

Other reported side effects of phenylephrine include:

• Cardiac disorders: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia
• Gastrointestinal disorders: Nausea, vomiting
• General disorders and administrative site conditions: Chest pain, extravasation
• Immune system disorders: Sulfite sensitivity
• Nervous system disorders: Headache, nervousness, paresthesia, tremor
• Psychiatric disorders: Excitability
• Respiratory: Pulmonary edema, rales
• Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation
• Vascular disorders: Hypertensive crisis.

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

• fast, pounding, or irregular heartbeat
• severe dizziness or nervousness
• sleep problems (insomnia)
• increased blood pressure. Symptoms may include a severe headache, blurred vision, and pounding in your neck or ears.

Liquid phenylephrine

The liquid form of this medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

Injectable phenylephrine

Some injectable preparations of phenylephrine contain sodium metabisulfite, a sulfite that may cause allergic reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

This is not a complete list of side effects.

Before taking

Do not use phenylephrine 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.

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

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• heart disease or high blood pressure
• diabetes
• a thyroid disorder
• an enlarged prostate and urination problems
• any drug allergies.

If you are pregnant or breastfeeding, ask a health professional before use.

The liquid form of this medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

Pregnancy

It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if needed.

Use of phenylephrine during labor and delivery

The most common side effects reported in mothers receiving phenylephrine during neuraxial anesthesia during cesarean delivery include nausea and vomiting, which are commonly associated with low blood pressure, slow heartbeat, reactive high blood pressure, and short-lasting arrhythmias. Phenylephrine does not appear to cause a decrease in perfusion of the placenta that is significant enough to affect the baby’s Apgar score or blood gas levels.

Breastfeeding

It is not known if phenylephrine is excreted in human milk.

How should I take phenylephrine?

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

• Cold medicine is only for short-term use until your symptoms clear up.
• Always follow directions on the medicine label about giving cold medicine to a child.
• You must chew the phenylephrine chewable tablet before you swallow it.
• Measure phenylephrine liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
• Remove an orally disintegrating phenylephrine 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.

Stop taking phenylephrine and ask a doctor if nervousness, dizziness, or sleeplessness occur or symptoms do not improve within 7 days or occur with a fever, rash, or headaches.

If you need surgery, tell your surgeon if you are currently using phenylephrine.

Phenylephrine dosage

When using phenylephrine do not exceed recommended dose.

• The safety and effectiveness of using phenylephrine in children have not been established.
• The dosage of phenylephrine may need adjusting for liver or kidney disease.

Phenylephrine dosage for nasal congestion

• Adults and children 12 years and older. 10mg every 4 hours. Do not take more than 6 tablets in 24 hours.
• Children under 12 years. Ask a doctor.

Phenylephrine dosage for low blood pressure

Perioperative dosing (adults undergoing surgery with neuraxial or general anesthesia):

• Initial dose: 50 to 250 mcg by intravenous bolus (most common doses: 50 to 100 mcg)
• Maintenance dose: 0.5 to 1.4 mcg/kg/min by intravenous continuous infusion (titrate to blood pressure goal)

Septic or Other Vasodilatory Shock

• Adults: 0.5 to 6 mcg/kg/min by intravenous continuous infusion (titrate to blood pressure goal)
• No bolus
• Doses over 6 mcg/kg/min do not show significant incremental blood pressure increases.

Usual Adult Dose for Shock. Perioperative dosing (patients undergoing surgery with neuraxial or general anesthesia):

• Initial dose: 50 to 250 mcg by intravenous bolus (most common doses: 50 to 100 mcg)
• Maintenance dose: 0.5 to 1.4 mcg/kg/min by intravenous continuous infusion (titrate to blood pressure goal)

Does phenylephrine work?

Recently, an FDA advisory panel concluded that phenylephrine is not effective as an oral decongestant and does not significantly improve symptoms compared to a placebo (an inactive pill).

Phenylephrine has been available for more than six decades but it came into use before the FDA developed a stringent approval process for new medicines back in the 1970s and received marketing authorization based on pre-existing use.

A reason for phenylephrine’s lack of effectiveness includes the fact that, even though it is well absorbed from the stomach, it undergoes extensive metabolism in the gut wall. This means only about 40% of a dose reaches the bloodstream and only 3% is excreted unchanged.

Phenylephrine is currently allowed by the FDA as a medicine based on in-house studies provided by pharmaceutical companies, not as a result of clinical trials. These unpublished studies ranged from mild successes to total failures, and a recommendation that phenylephrine should not be accepted as an oral nasal decongestant was made in 1994 but ignored. However, the efficacy of phenylephrine as a nasal spray for nasal congestion is supported by several studies.

On September 14, 2023, the FDA Drug Advisory Committee concluded that current data does not support the effectiveness of phenylephrine as an oral nasal decongestant, although there were no concerns about any toxicity at recommended dosages.

What happens if I miss a dose?

Phenylephrine for nasal symptoms is usually taken as needed according to the recommended dose so if you miss a dose, just go back to your regular dosing schedule. Do not double up the dose or take extra to make up for the next dose.

What happens if I overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

An overdose of phenylephrine can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, high blood pressure, reflex slow heart rate, and cardiac arrhythmias, which may cause a sensation of fullness in the head and tingling of the hands and feet.

Storage

Store phenylephrine tablets and nasal spray between 20-25°C (68-77°F).

Do not use it if the blister unit is torn or broken.

Keep out of reach of children.

Phenylephrine ingredients

Active: phenylephrine

Inactive. Inactive ingredients in phenylephrine tablets, nasal sprays, and injections, vary depending on the manufacturer. See the phenylephrine package insert for each particular manufacturer for a list of inactive ingredients.

What other drugs will affect phenylephrine?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Phenylephrine and other medicines can affect each other causing side effects.

Drugs that cause the uterus to contract (oxytocic drugs) can strengthen the blood pressure-increasing effect (pressor effect) of phenylephrine.

The blood vessel narrowing (vasoconstrictive) effects of phenylephrine are increased in patients receiving:

• Monoamine oxidase inhibitors (MAOI), such as selegiline.
• β-adrenergic blockers
• α-2 adrenergic agonists, such as clonidine
• Steroids
• Tricyclic antidepressants
• Norepinephrine transport inhibitors, such as atomoxetine
• Ergot alkaloids, such as methylergonovine maleate
• Centrally-acting sympatholytic agents, such as guanfacine or reserpine
• Atropine sulfate.

α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine.

Know the medications you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the phenylephrine package insert for a full list of interactions.