Viramune O/S

Generic Name: nevirapine (Oral route)

ne-VIR-a-peen

Oral route(Tablet;Tablet, Extended Release;Suspension)

Severe, life-threatening, in some cases fatal, hepatotoxicity and skin reactions (eg, Stevens-Johnson syndrome; toxic epidermal necrolysis; and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction) have been reported. Women, including pregnant women, and/or patients with higher CD4+ cell counts are at higher risk of hepatotoxicity. Permanently discontinue nevirapine following severe hepatic, skin, or hypersensitivity reactions. Monitor patients intensively during the first 18 weeks of therapy with nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. Strictly follow the 14-day lead-in period with immediate-release nevirapine 200 mg daily dosing .

Commonly used brand name(s)

In the U.S.

  • Viramune
  • Viramune O/S
  • Viramune XR

Available Dosage Forms:

  • Tablet, Extended Release
  • Tablet
  • Elixir
  • Suspension

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

Uses For Viramune O/S

Nevirapine is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by lowering the amount of HIV in the blood.

Slideshow: Flashback: FDA Drug Approvals 2013

Nevirapine will not cure HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Nevirapine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, nevirapine is used in certain patients with the following medical condition:

  • Mother-to-child transmission of HIV during labor and at birth (prevention).

Before Using Viramune O/S

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nevirapine suspension or tablets in children. However, safety and efficacy have not been established in infants younger than 15 days of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nevirapine extended-release tablets in children 6 to 17 years of age. However, use is not recommended in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nevirapine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving nevirapine.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Carbamazepine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amprenavir
  • Artemether
  • Atazanavir
  • Avanafil
  • Boceprevir
  • Bosutinib
  • Clozapine
  • Cobicistat
  • Cyclophosphamide
  • Delavirdine
  • Dexamethasone
  • Dolutegravir
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Elvitegravir
  • Enzalutamide
  • Etravirine
  • Fluconazole
  • Fosamprenavir
  • Hydrocodone
  • Ifosfamide
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Nifedipine
  • Piperaquine
  • Quinine
  • Rifampin
  • Rifapentine
  • Rilpivirine
  • Simeprevir
  • St John's Wort
  • Telaprevir
  • Tolvaptan
  • Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Caspofungin
  • Cisapride
  • Clarithromycin
  • Clonazepam
  • Cyclosporine
  • Dalfopristin
  • Diltiazem
  • Disopyramide
  • Ergotamine
  • Ethosuximide
  • Fentanyl
  • Indinavir
  • Lopinavir
  • Methadone
  • Nelfinavir
  • Ospemifene
  • Quinupristin
  • Rifabutin
  • Saquinavir
  • Sirolimus
  • Tacrolimus
  • Verapamil
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hepatitis B or
  • Hepatitis C—Use with caution. May cause side effects to become worse.
  • Liver disease, moderate or severe—Should not be used in patients with this conditions.

Proper Use of nevirapine

This section provides information on the proper use of a number of products that contain nevirapine. It may not be specific to Viramune O/S. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a Medication Guide. Read and follow these instructions carefully before starting nevirapine treatment and each time you refill your prescription. Ask your doctor if you have any questions.

Nevirapine may be taken with or without food, and with water, milk, or soda.

If you or your child are taking the oral liquid, shake it gently before use. Use an oral dosing syringe or dosing cup to measure the right dose. After drinking the medicine, rinse the dosing cup with water and drink the water to make sure you get all of the medicine. If your dose is less than 5 mL (one teaspoonful), use the dosing syringe.

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

Keep taking nevirapine for the full time of treatment, even if you or your child begin to feel better.

It is important to take nevirapine as part of a combination treatment. Take all other medicines your doctor has prescribed at the right time of the day. This will make your medicines work better.

This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. For example, if you or your child are taking one dose per day, try to take it at the same time each day. If you are taking two doses per day, the doses should be spaced about 12 hours apart. If you need help planning the best times to take your medicine, check with your doctor.

Do not take more than one dosage form of nevirapine at the same time. Talk to your doctor if you have any questions.

If you stop taking this medicine for more than 7 days, ask your doctor how much to use before you start taking it again. .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For treatment of HIV infection:
    • For oral dosage form (extended-release tablets):
      • Adults—At first, one 200 milligrams (mg) Viramune® immediate-release tablet once a day for 2 weeks. This is followed by one 400 mg Viramune® XR® once a day, together with other HIV medicines.
      • Children 6 to 17 years of age—Dose is based on body size and must be determined by your doctor. The starting dose is 150 milligrams (mg) per square meter (m[2]) of Viramune® oral suspension or tablets for the first 2 weeks. This is followed by 200 to 400 mg of Viramune® XR® once a day, together with other HIV medicines.
      • Children younger than 6 years of age—Use is not recommended.
    • For oral dosage forms (suspension or tablets):
      • Adults—200 milligrams (mg) once a day for 2 weeks, followed by 200 mg two times per day, together with other medicines.
      • Children and infants 15 days of age and older—Dose is based on body size and must be determined by your doctor.
      • Infants younger than 15 days of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Viramune O/S

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Liver problems may occur while you are using this medicine. Check with your doctor right away if you or your child are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools, dark urine, a fever, a headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Tell your doctor if you or your child get any type of skin rash, even a mild rash. Stop using this medicine and call your doctor right away if you or your child have a rash with blisters, a fever, mouth sores, red or irritated eyes, swelling of the face, muscle or joint pain, or muscle weakness.

Your immune system may get stronger, when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, including an increased amount of body fat in your neck or upper back, face, around your chest, or stomach area. You might also lose fat from your legs, arms, or face.

This medicine may decrease the effects of some birth control pills. To avoid getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include a condom, a diaphragm, contraceptive foam or jelly.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Viramune O/S Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • diarrhea
  • fever
  • general tiredness and weakness
  • itching
  • joint or muscle pain
  • light-colored stools
  • lower back or side pain
  • nausea and vomiting
  • painful or difficult urination
  • pale skin
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • shortness of breath
  • skin rash
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes and skin
Less common
  • Decreased appetite
  • hives
  • loss of appetite
  • swelling of the feet or lower legs
Rare
  • Abdominal or stomach pain
  • pain, numbness, or tingling of the hands, arms, legs, or feet
  • sleepiness or unusual drowsiness
  • tingling, burning, or prickly sensations

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Chest pain
  • cough
  • decrease in weight
  • dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • headache
  • pain in the ankles or knees
  • painful, red lumps under the skin, mostly on the legs
  • sensation of spinning
  • trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Difficulty with moving
  • muscle pain or stiffness
  • pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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