Viramune XR extended-release tablets

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

Severe and sometimes fatal liver problems have occurred in patients taking Viramune XR extended-release tablets. The risk of liver problems is greater 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).

Viramune XR extended-release tablets should only be used in patients who have been diagnosed with HIV. Do not use Viramune XR extended-release tablets 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 Viramune XR extended-release tablets. These reactions may also affect other areas of the body (eg, liver, kidney). 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 Viramune XR extended-release tablets. Be sure to keep all doctor and lab appointments. Take Viramune XR extended-release tablets exactly as prescribed by your doctor. If you develop a liver or skin problem, or if you have a severe allergic reaction to Viramune XR extended-release tablets, you must not take it again.


Viramune XR extended-release tablets is used for:

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

Viramune XR extended-release tablets is a nonnucleoside reverse transcriptase inhibitor (NNRTI). It works by blocking the growth of HIV.

Do NOT use Viramune XR extended-release tablets if:

  • you are allergic to any ingredient in Viramune XR extended-release tablets
  • you have moderate to severe liver problems
  • you have had a serious liver or skin reaction while taking Viramune XR extended-release tablets
  • 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.

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Before using Viramune XR extended-release tablets:

Some medical conditions may interact with Viramune XR extended-release tablets. 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
  • if you have never taken another medicine that contains nevirapine
  • if you have trouble swallowing tablets

Some MEDICINES MAY INTERACT with Viramune XR extended-release tablets. 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 Viramune XR extended-release tablets's side effects
  • Rifamycins (eg, rifampin) or St. John's wort because they may decrease Viramune XR extended-release tablets's effectiveness
  • Anticoagulants (eg, warfarin) or rifabutin because the risk of their side effects may be increased by Viramune XR extended-release tablets
  • 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 Viramune XR extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Viramune XR extended-release tablets 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 Viramune XR extended-release tablets:

Use Viramune XR extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Viramune XR extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Viramune XR extended-release tablets refilled.
  • Take Viramune XR extended-release tablets by mouth with or without food.
  • Swallow Viramune XR extended-release tablets whole. Do not break, crush, chew, or divide before swallowing. If you cannot swallow Viramune XR extended-release tablets whole, tell your doctor.
  • Taking Viramune XR extended-release tablets at the same time each day will help you remember to take it.
  • Continue to take Viramune XR extended-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of Viramune XR extended-release tablets, 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 Viramune XR extended-release tablets 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 Viramune XR extended-release tablets.

Important safety information:

  • Do NOT change your dose or use for longer than prescribed without checking with your doctor.
  • You may sometimes notice something in your stool that looks like Viramune XR extended-release tablets. This is normal and will not affect how your medicine works.
  • Viramune XR extended-release tablets 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 Viramune XR extended-release tablets, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Viramune XR extended-release tablets 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 Viramune XR extended-release tablets. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Viramune XR extended-release tablets 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 Viramune XR extended-release tablets.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Viramune XR extended-release tablets. 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 Viramune XR extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Viramune XR extended-release tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Viramune XR extended-release tablets while you are pregnant. Viramune XR extended-release tablets is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Viramune XR extended-release tablets to the baby.

Possible side effects of Viramune XR extended-release tablets:

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 Viramune XR extended-release tablets:

Store Viramune XR extended-release tablets 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 Viramune XR extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Viramune XR extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Viramune XR extended-release tablets 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 Viramune XR extended-release tablets 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 Viramune XR extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Viramune XR extended-release tablets. 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 Viramune XR extended-release tablets.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
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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