Generic Name: nevirapine (Oral route)
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 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 nevirapine 200 mg daily dosing .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiretroviral Agent
Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor
Nevirapine is used with other medicines in 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. Nevirapine will be used together with other medicines for HIV .
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:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nevirapine in children. However, safety and efficacy have not been established in infants less than 15 days of age .
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 liver, kidney, or heart problems which may require an adjustment of dose in patients receiving nevirapine .
|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.|
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.
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.
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.
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.
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:
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 stop taking this medicine without checking with your doctor first.
Keep taking nevirapine for the full time of treatment, even if you 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 the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day. If you are taking two doses a day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.
Nevirapine may be taken with or without food, and with water, milk, or soda .
If you are taking the oral solution, 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 rinse to make sure you get all of the medicine. If your dose is less than 5 mL (one teaspoonful), use the dosing syringe.
If you stop taking this medicine for more than seven days, ask your doctor how much to take before you start taking it again .
This medicine comes with patient instructions. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.
Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.
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.
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.
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.
It is very important that your doctor check your progress 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. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; fever; 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 .
Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: blistering, peeling, or loosening of the skin; itching; joint or muscle pain; rash; red skin lesions; sore throat; or sores, ulcers, or white spots in the mouth or on the lips .
Do not use this medicine if you are also taking ketoconazole (Nizoral®) or rifampin (Rifadin®, Rifamate®, or Rifater®). Taking any of them together with this medicine may increase the chance of serious side effects .
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 .
When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately .
This medicine may cause you to have excess body fat. Tell your doctor right away if you 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 .
You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk .
This medicine may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g. condoms, a diaphragm, or a contraceptive foam or jelly) while using nevirapine.
This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone .
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
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of Overdose
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.
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