Generic Viramune, tablets

Chemical Name: NEVIRAPINE


Common uses

This medicine is a non-nucleoside reverse transcriptase inhibitor used to treat human immunodeficiency virus infection (HIV). This medicine is not a cure for HIV. It must be used in combination with other proven anti-HIV medicines. If this medicine is taken alone to treat HIV infection, it may stop working. Contact your doctor for more information. It may also be used to treat other conditions as determined by your doctor.

Before using

Warning: this medicine has caused severe, sometimes fatal, skin reactions, including stevens-johnson syndrome, toxic epidermal necrolysis, and allergic reactions. Women may have a greater risk for these side effects. If you develop any type of rash; blistering or peeling skin; mouth sores; inflammation, redness, or discharge of the eye; sore throat or fever; unusual fatigue or tiredness; muscle or joint aches; swelling of the face; or change in amount of urine while using this medicine, stop using this medicine and notify your doctor immediately. This medicine has caused severe, sometimes fatal, liver problems, including fulminant and cholestatic hepatitis, liver necrosis, and liver failure. In some cases, these side effects have persisted even when this medicine was stopped. Patients with higher cd4 counts and women are at a higher risk for these liver side effects. Women with cd4 counts higher than 250 cells/mm3, including pregnant women on chronic HIV treatment, are at considerably higher risk for these liver side effects. If you develop a rash, fever, unusual fatigue or tiredness, abdominal or stomach pain, nausea, loss of appetite, dark urine, light or clay-colored stools, or yellowing of the skin or eyes, seek immediate medical attention. The risk of both skin and liver side effects is highest during the first 18 weeks of therapy, but these side effects can happen at any time. It is important to be frequently monitored by your doctor for the entire time that you are taking this medicine.

Do not take this medicine if you are also taking ketoconazole or st. John's wort. This medicine will decrease the effectiveness of birth control pills. You must use an additional form of birth control while using this medicine. Additional monitoring of your dose or condition may be needed if you are taking "blood thinners" such as warfarin, HIV protease inhibitors (such as indinavir, lopinavir, ritonavir, or saquinavir), efavirenz, narcotic pain medicines (such as methadone or fentanyl), certain antifungal medicines (such as fluconazole or itraconazole), clarithromycin, rifampin, rifabutin, certain medicines for irregular heartbeat (such as amiodarone, disopyramide, or lidocaine), seizure medicines (such as carbamazepine, clonazepam, phenytoin, phenobarbital, or ethosuximide), calcium channel blockers (such as diltiazem, nifedipine, or verapamil), cyclophosphamide, ergotamine, cisapride, cyclosporine, or tacrolimus or sirolimus.

Do not start or stop any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of kidney problems, liver problems, dialysis, swelling of the abdomen (ascites), skin problems (such as rash), allergies, pregnancy, or breast-feeding. Use of this medicine is not recommended if you have a history of severe liver disease; hepatitis; abnormal liver function test results; or have had skin reactions, liver reactions, or allergic reactions associated with this medicine. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

Directions

Follow the directions for taking this medicine provided by your doctor. Follow the dosing schedule closely. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. Store this medicine at room temperature at 77 degrees F (25 degrees c), in a tightly closed container away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same times each day will help you to remember. Continue to take this medicine even if you feel well. It is important not to miss doses of this medicine. If you miss a dose of this medicine, 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 stop taking this medicine for more than seven days, contact your doctor before you begin taking it again.

Cautions

Do not take this medicine if you have had an allergic reaction to it or are allergic to any ingredient in this product. If you have a question about whether you are allergic to this medicine, contact your doctor or pharmacist. Follow your treatment plan closely. Because HIV can quickly become resistant to this medicine when used alone, this medicine must be used with at least 1 other anti-HIV medicine. Your doctor may change your treatment plan if this medicine stops working well. Do not exceed the recommended dose of this medicine without checking with your doctor. Exceeding the recommended dose of this medicine may not provide additional benefits, and may increase the risks of side effects. Do not stop using this medicine without first checking with your doctor. Laboratory and/or medical tests, including liver function tests and cd4 counts, may be done to monitor your progress or to check for side effects. It is important to be monitored frequently by your doctor while you are taking this medicine. Keep all doctor and laboratory appointments while you are taking this medicine. Do not stop taking this medicine without first checking with your doctor. This medicine will not prevent you from spreading HIV through your blood or through sexual contact. If you have any questions concerning how to prevent the spreading of HIV, ask your doctor, nurse, or pharmacist. This medicine may not prevent other infections. If your health changes, check with your doctor. Changes in body fat may occur while you are taking this medicine (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-tem effects of these changes are unknown. Discuss any concerns with your doctor.

Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist.

For women taking birth control pills: this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control. Caution is advised when using this medicine in children because they may be more sensitive to the effects of this medicine.

For women: if you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. This medicine is excreted in breast milk. Do not breast-feed while taking this medicine.

Possible side effects

Side effects, that may go away during treatment, include headache or diarrhea. If they continue or are bothersome, check with your doctor. Contact your doctor immediately if you develop a rash; fever; blistering or peeling skin; mouth sores; redness, irritation, or discharge of the eye; sore throat or fever; unusual fatigue or tiredness; swelling (including swelling of the face); muscle or joint aches or discomfort; abdominal or stomach pain; nausea; loss of appetite; yellowing of the skin or eyes; dark urine; change in the amount of urine; or pale or clay-colored stools. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

If you take too much

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of an overdose may include swelling of the hands and feet, rash, fever, fatigue, trouble sleeping, dizziness, nausea, vomiting, and unexplained weight loss.

Additional information

If you have any questions concerning how to prevent the spreading of HIV, ask your doctor, nurse, or pharmacist. Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children. If using this medicine for an extended period of time, obtain refills before your supply runs out.

Drug interactions

Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking.


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