Class: Anti-infective/Antiviral Action Inhibits replication of retroviruses including HIV.

Indications Treatment of HIV infected adults and pediatric patients 2 months of age who have experienced clinical and immunological deterioration (used in combination with nucleoside analogs). Indikasi : perlakuan untuk infeksi HIV pada pasien dewasa dan anak-anak yg berumur 2 bulan yang mempunyai pengalaman klinis dan penurunan imunologi (digunakan kombinasi dengan analog nukleosida. Contraindications Standard considerations. (pertimbangan standar) Route/Dosage ADULTS: PO Initial therapy: 200 mg once daily for 14 days. Total daily dose not to exceed 400 mg. Maintenance therapy: 200 mg bid in combination with nucleoside analog. CHILDREN 2 MO to 8 YRS: PO 4 mg/kg once daily for 14 days followed by 7 mg/kg twice daily. Total daily dose not to exceed 400 mg. CHILDREN 8 YRS: PO 4 mg/kg once daily for 14 days followed by 4 mg/kg twice daily. Total daily dose not to exceed 400 mg. Interactions menurunkan level inhibitor protease plasma level hormone dan potensial kontrasepsi Rifampin, rifabutin menurunkan nevirapine di dalam plasma Berinteraksi dengan ketokonazol, menurunkan efeknya. Reaksi yang merugikan CNS: Headache; paresthesia; peripheral neuropathy. DERM: Rash. GI: Nausea; diarrhea; abdominal pain; ulcerative stomatitis. HEPA: increased liver function tests; hepatitis. OTHER: Fever; myalgia. Pencegahan

Pregnancy: Category C. Lactation: Excreted in breast milk. Children: For use in pediatric patients 2 months of age. Nevirapine clearance at least 2-fold greater in children < 8 years of age. Missed doses: Patients who interrupt maintenance dosing for > 7 days should restart the recommended dosing (1 qd for 14 days followed by 1 bid). Skin reactions: Severe and lifethreatening skin reactions have occurred. Discontinue drug if skin rash accompanied by constitutional symptoms (eg, fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches or general malaise) occurs. If rash is mild to moderate in severity and not accompanied by constitutional symptoms, the drug can be continued with close monitoring. If rash develops during first 14 days of therapy, do not increase dose beyond 200 mg qd until rash resolves. Hepatic/Renal function impairment: Use with caution. Hepatotoxicity: Interrupt therapy in patients who develop moderate to severe liver function test abnormalities until liver function tests return to baseline values. Permanently discontinue therapy if liver function abnormalities recur upon readministration. Viral resistance: Always use in combination with at least one additional antiretroviral agent to reduce development of resistance to viral strains. Monitoring: Perform clinical chemistry tests, including liver function tests, prior to initiating therapy and at regular intervals during therapy.

PATIENT CARE CONSIDERATIONS

Administration/Storage

Administer without regard to meals. Always administer in combination with 1 additional antiviral agent as resistant virus emerges rapidly when nevirapine is used as monotherapy. Store at room temperature (59 to 86F) in tightly-closed container. Administer entire measured dose of suspension by using an oral dosing syringe or dosing cup. Assessment/Interventions

Obtain patient history, including drug history and any known allergies. Ensure that clinical chemistry tests, especially liver function tests are performed prior to initiating therapy and at appropriate intervals during therapy. Ensure that at least one additional antiviral agent is being used concurrently. Monitor for rash. A 14day lead-in period of lower dosage has been shown to decrease the frequency of rash. If rash occurs during this period, do not increase the dose until the rash has resolved. The majority of rashes occur during the first 6 weeks of therapy. Carefully monitor during this period. Discontinue nevirapine in patients developing a severe rash or a rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle/joint aches or general malaise.

If any clinical signs, symptoms or laboratory tests suggest moderate or severe liver function abnormalities, treatment should be interrupted until liver function tests return to baseline values. Permanently discontinue if abnormal liver function recurs upon administration. OVERDOSAGE: SIGNS & SYMPTOMS Edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, weight decrease

Patient/Family Education

Advise patient that nevirapine tablets are for oral ingestion only and to take exactly as prescribed. Advise patient to continue with other antiviral agents to reduce chances of viral resistance developing. Instruct patient that if a dose is missed, take the next dose as soon as possible. Do not double the next dose to catch up. Instruct the patient to not take any other medication, including otc medications, without consulting physician. Instruct patient that nevirapine is not a cure for the HIV infection and that opportunistic infections and other complications of HIV infection may continue to develop. Patients should remain under close observation by health care professionals experienced in the treatment of HIV-associated disease. Caution patient or family that long-term effects of nevirapine and results from controlled clinical trials evaluating therapeutic and adverse effects are not known. Any problems should be reported to the primary care provider. Warn patient of the potential adverse effects and drug/drug interactions. Instruct patient to report the following symptoms to physician: Rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, general malaise or signs of infection (eg, sore throat, fever, cough, respiratory congestion). Instruct family to notify physician of changes in neurological status such memory loss or confusion. Explain that the risk of transmission of HIV to others through sexual contact or exposure to the patient's blood is still present. Instruct patient in methods and precautions to prevent transmission of HIV virus. Advise women being treated with nevirapine not to use oral contraceptives or other hormonal contraceptives as a method of contraception since this drug may reduce contraceptive effectiveness. Caution mothers to discontinue nursing if receiving nevirapine, as there is potential for adverse effects from drug in nursing infants as well as transmission of the HIV virus. Caution women to inform physician if pregnant or planning to become pregnant. Advise patient not to share medication and not to exceed the recommended dose.

Instruct patient that if therapy is stopped for > 7 days, it will need to be restarted with the single daily dose for 14 days.

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