Nevirapine

(ne vye' ra peen)

Brand Name(s): Viramune®, Viramune® XR¶; also available generically

IMPORTANT WARNING:

Nevirapine can cause severe, life-threatening liver damage. Tell your doctor if you have or have ever had liver disease. Your doctor will probably tell you not to take nevirapine. If you experience any of these symptoms, stop taking nevirapine and call your doctor immediately: excessive tiredness; lack of energy or general weakness; nausea; vomiting; loss of appetite; dark (tea colored) urine; pale stools; yellowing of the skin or eyes; pain in the upper right part of the stomach; or flu-like symptoms.

Nevirapine can cause severe, life-threatening skin reactions and allergic reactions. Tell your doctor if you have a rash or other skin condition before you start taking nevirapine. If you experience any of these symptoms, stop taking nevirapine and call your doctor immediately: rash, fever; sore throat, chills, or other signs of infection; flu-like symptoms; muscle or joint aches; blisters; mouth sores; red or swollen eyes; hives; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness; or difficulty breathing or swallowing.

If your doctor tells you to stop taking nevirapine because you had a serious skin or liver reaction, you should never take nevirapine again.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to nevirapine.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with nevirapine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking nevirapine.

WHY is this medicine prescribed?

Nevirapine is used to treat human immunodeficiency virus (HIV) infection.Nevirapine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood.

Although nevirapine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses.Taking these medications and making other life-style changes may decrease the risk of giving the HIV virus to other people.

Are there OTHER USES for this medicine?

Nevirapine is also sometimes used to prevent unborn babies whose mothers have HIV or AIDS from becoming infected with HIV during birth.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Nevirapine comes as a tablet, an extended-release tablet, and a suspension (liquid) to take by mouth with or without food.The tablet and suspension are usually taken once a day for 2 weeks and then twice a day after the first 2 weeks. The extended-release tablet is usually taken once a day, following at least two weeks of treatment with regular nevirapine tablets or suspension.

Take nevirapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

Shake the liquid gently before each use to mix the medication evenly. Use an oral dosing cup or dosing syringe to measure your dose. It is best to use a dosing syringe, especially if your dose is less than 5 mL (1 teaspoon). If you use a dosing cup, first drink all of the medication that you measured in the dosing cup. Then fill the dosing cup with water and drink the water to be sure that you get your full dose.

Continue to take nevirapine even if you feel well. Do not stop taking nevirapine without talking to your doctor. If you miss doses or stop taking nevirapine, your condition may become more difficult to treat.

If you do not take nevirapine for 7 days or longer, do not start taking it again without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking nevirapine,

  • tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking while taking nevirapine. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.

  • The following herbal product may interact with nevirapine: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking nevirapine. Do not start this medication while taking nevirapine without discussing with your healthcare provider.

  • tell your doctor if you have or have ever had kidney disease, especially if you are being treated with dialysis (treatment to clean the blood outside the body when the kidneys are not working well).

  • tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking nevirapine, call your doctor.

  • tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking nevirapine.

  • you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of taking this medication if you have concerns about fertility.

  • you should know that your body fat may increase or move to other areas of your body such as your waist, upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.

  • you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with nevirapine, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Nevirapine may cause side effects. Tell your doctor if either of these symptoms is severe or does not go away:

  • headache
  • diarrhea
  • stomach pain

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

  • swelling of the hands, feet, ankles, or lower legs
  • painful red bumps on the skin
  • excessive tiredness
  • fever
  • headache
  • difficulty falling asleep or staying asleep
  • nausea
  • vomiting
  • rash
  • dizziness

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

If you are taking the extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This branded product is no longer on the market. Generic alternatives may be available.

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