Nevirapine suspension

Generic Name: nevirapine (ne-VIR-a-peen)
Brand Name: Viramune

Severe and sometimes fatal liver problems have occurred in patients taking nevirapine suspension. The risk of liver problems is greatest during the first 18 weeks of therapy but may occur at any time during treatment. This may occur in men and women, but the risk may be greater in women and in patients with a high CD4 cell count at the start of treatment. Certain pregnant women and women with a CD4 cell count higher than 250 have the greatest risk. Contact your doctor right away if you develop a rash or symptoms of liver problems (eg, dark urine, yellowing of the eyes or skin, pale stools, stomach pain, nausea, loss of appetite, unusual tiredness).

Nevirapine suspension should only be used in patients who have been diagnosed with HIV. Do not use nevirapine suspension to prevent HIV infection if you have been exposed to the virus.

Serious and sometimes fatal skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and allergic reactions have been reported in some patients taking nevirapine suspension. These reactions may also affect other areas of the body (eg, liver, kidneys). The risk of skin reactions is greatest during the first 6 weeks of therapy but may occur at any time during treatment. Contact your doctor right away if you develop blisters or sores in the mouth; fever; general ill feeling; muscle or joint aches; rash, including red, swollen, blistered, or peeling skin; red or swollen eyes; severe tiredness; trouble breathing; swelling of the mouth or face; change in the amount of urine produced; or symptoms of liver problems.

Your doctor will check for side effects and perform lab tests, including liver function, while you use nevirapine suspension. Be sure to keep all doctor and lab appointments. Take nevirapine suspension exactly as prescribed by your doctor. If you develop a liver or skin problem, or if you have a severe allergic reaction to nevirapine suspension, you must not take it again.


Nevirapine suspension is used for:

Treating HIV infection. It must be used along with other HIV medicines.

Nevirapine suspension is a nonnucleoside reverse transcriptase inhibitor (NNRTI). It works by blocking the growth of HIV.

Do NOT use nevirapine suspension if:

  • you are allergic to any ingredient in nevirapine suspension
  • you have moderate to severe liver problems
  • you have had a serious liver or skin reaction while taking nevirapine suspension
  • you have not been diagnosed with HIV
  • you are taking another medicine that contains nevirapine
  • you are taking artemether/lumefantrine, bosutinib, cabazitaxel, delavirdine, efavirenz, etravirine, certain HIV protease inhibitors (eg, atazanavir, fosamprenavir), itraconazole, ketoconazole, lurasidone, rifampin, rilpivirine, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using nevirapine suspension:

Some medical conditions may interact with nevirapine suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems (eg, cirrhosis, hepatic fibrosis, hepatitis), abnormal liver function tests, or certain skin problems (eg, growths, rash)
  • if you have kidney problems or are receiving dialysis
  • if you have a high CD4 cell count

Some MEDICINES MAY INTERACT with nevirapine suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Prednisone because the risk of severe skin rash may be increased
  • Fluconazole because it may increase the risk of nevirapine suspension's side effects
  • Rifamycins (eg, rifampin) or St. John's wort because they may decrease nevirapine suspension's effectiveness
  • Anticoagulants (eg, warfarin) or rifabutin because the risk of their side effects may be increased by nevirapine suspension
  • Antiarrhythmics (eg, amiodarone, disopyramide, lidocaine), artemether/lumefantrine, azole antifungals (eg, itraconazole, ketoconazole), bosutinib, cabazitaxel , calcium channel blockers (eg, diltiazem, nifedipine, verapamil), carbamazepine, cisapride, clarithromycin, clonazepam, cyclophosphamide, cyclosporine, delavirdine, efavirenz, ergot alkaloids (eg, ergotamine), ethosuximide, etravirine, exemestane, fentanyl, hormonal contraceptives (eg, birth control pills), hormone replacement therapy (eg, estradiol), lurasidone, methadone, protease inhibitors (eg, boceprevir, ritonavir), rilpivirine, sirolimus, tacrolimus, tyrosine kinase receptor inhibitors (eg, dasatinib), or ulipristal because their effectiveness may be decreased by nevirapine suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if nevirapine suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use nevirapine suspension:

Use nevirapine suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Nevirapine suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get nevirapine suspension refilled.
  • Take nevirapine suspension by mouth with or without food.
  • Shake gently before each use.
  • Use an oral dosing syringe or a dosing cup to take nevirapine suspension. Ask your pharmacist for help if you are unsure of how to measure your dose. If you are using a dosing cup, rinse it with water after you take your dose. Swallow the rinse water to be sure you receive the entire dose of medicine. If your dose is less than 1 teaspoon (5 mL), use a dosing syringe.
  • Taking nevirapine suspension at the same time each day will help you remember to take it.
  • Continue to take nevirapine suspension even if you feel well. Do not miss any doses.
  • If you miss a dose of nevirapine suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking nevirapine suspension for more than 7 days, contact your doctor before you start to take it again.

Ask your health care provider any questions you may have about how to use nevirapine suspension.

Important safety information:

  • Do NOT change your dose or use for longer than prescribed without checking with your doctor.
  • Nevirapine suspension is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking nevirapine suspension, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Nevirapine suspension does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items such as toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking nevirapine suspension. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Nevirapine suspension may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start nevirapine suspension.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using nevirapine suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including liver and heart function, complete blood cell counts, and CD4 cell counts, may be performed while you use nevirapine suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Nevirapine suspension should be used with extreme caution in CHILDREN younger than 15 days old; safety and effectiveness in these children have not been confirmed.
  • Caution is advised when using nevirapine suspension in CHILDREN; they may be more sensitive to its effects, especially anemia.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking nevirapine suspension while you are pregnant. Nevirapine suspension is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or nevirapine suspension to the baby.

Possible side effects of nevirapine suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild nausea or stomach pain; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; eye irritation, pain, redness, or swelling; fever, chills, or persistent sore throat; flu-like symptoms or general feeling of being unwell; mouth sores; muscle or joint aches or pain; red, swollen, peeling, or blistered skin (with or without fever); swollen lymph glands; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; loss of appetite; pale stools; severe, persistent, or unusual nausea or stomach pain); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of nevirapine suspension:

Store nevirapine suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep nevirapine suspension out of the reach of children and away from pets.

General information:

  • If you have any questions about nevirapine suspension, please talk with your doctor, pharmacist, or other health care provider.
  • Nevirapine suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take nevirapine suspension or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about nevirapine suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to nevirapine suspension. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using nevirapine suspension.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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