Viramune

DRUG DESCRIPTION

VIRAMUNE is the brand name for nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTT) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.

The chemical name of nevirapine is 1 l-cyclopropyl-5,1 l-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][l,4] diazepin-6-one. Nevirapine is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C15H14N4O. Nevirapine has the following structural formula:

Viramune®
  (nevirapine) Structural Formula Illustration

VIRAMUNE Tablets are for oral administration. Each tablet contains 200 mg of nevirapine and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate.

VIRAMUNE Oral Suspension is for oral administration. Each 5 mL of VIRAMUNE suspension contains 50 mg of nevirapine (as nevirapine hemihydrate). The suspension also contains the following excipients: carbomer 934P, methylparaben, propylparaben, sorbitol, sucrose, polysorbate 80, sodium hydroxide and purified water.

What are the possible side effects of nevirapine (Viramune)?

Get emergency medical help if you have any of these signs of an allergic reaction: tired feeling, joint or muscle pain, muscle weakness, skin rash, bruising, severe tingling, numbness, mouth sores, trouble breathing, or swelling of your face, lips, tongue, or throat.

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

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the...

Read All Potential Side Effects and See Pictures of Viramune »

What are the precautions when taking nevirapine (Viramune)?

Before taking nevirapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C, cirrhosis), kidney dialysis, lactose or galactose intolerance.

Rarely, this drug may make some people drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex...

Read All Potential Precautions of Viramune »


Viramune Consumer (continued)

SIDE EFFECTS: See also Warning and How to Use sections.

Tiredness, nausea, vomiting, or diarrhea may occur. Drowsiness may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Nevirapine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. See the Warning section for more details.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking nevirapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C, cirrhosis), kidney dialysis, lactose or galactose intolerance.

Rarely, this drug may make some people drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Nevirapine may be part of that treatment. Discuss the risks and benefits with your doctor.

Nevirapine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Viramune Patient Information Including Side Effects

Brand Names: Viramune

Generic Name: nevirapine (Pronunciation: ne VYE ra peen)

  • What is nevirapine (Viramune)?
  • What are the possible side effects of nevirapine (Viramune)?
  • What is the most important information I should know about nevirapine (Viramune)?
  • What should I discuss with my healthcare provider before taking nevirapine (Viramune)?
  • How should I take nevirapine (Viramune)?
  • What happens if I miss a dose (Viramune)?
  • What happens if I overdose (Viramune)?
  • What should I avoid while taking nevirapine (Viramune)?
  • What other drugs will affect nevirapine (Viramune)?
  • Where can I get more information?

What is nevirapine (Viramune)?

Nevirapine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Nevirapine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Nevirapine is not a cure for HIV or AIDS.

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

What are the possible side effects of nevirapine (Viramune)?

Get emergency medical help if you have any of these signs of an allergic reaction: tired feeling, joint or muscle pain, muscle weakness, skin rash, bruising, severe tingling, numbness, mouth sores, trouble breathing, or swelling of your face, lips, tongue, or throat.

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

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild nausea, vomiting, or stomach pain;
  • headache, tired feeling; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 at 1-800-FDA-1088.

What is the most important information I should know about nevirapine (Viramune)?

Nevirapine can cause severe or life-threatening effects on the liver. Call your doctor at once if you have any of these liver symptoms while taking nevirapine: skin rash, nausea, stomach pain, loss of appetite, low fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Nevirapine may also cause severe or life-threatening skin reactions. Contact your doctor if you have any type of skin rash. Even a minor skin rash could be an early sign of a serious reaction. Later signs include fever, sore throat, and headache with a severe blistering, peeling, and red skin rash. This type of reaction is a medical emergency.

There are many other medicines that can interact with nevirapine, or make it less effective. 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.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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