Select therapeutic use:
Indications for VIRAMUNE ORAL SUSPENSION:
Limitations Of use:
Adult females with CD4+ counts >250cells/mm3 or males with CD4+ counts >400cells/mm3: do not initiate unless benefit outweighs risk.
≥16yrs: Initially 200mg once daily for 14 days. If no rash occurs, increase to 200mg twice daily. If mild-to-moderate rash occurs during the 14-day lead in period, do not give twice-daily regimen until rash has resolved; lead-in dosing regimen should not be continued beyond 28 days, consider alternative regimen. If severe rash or hepatic event occurs, discontinue permanently. Max 400mg/day. Retitrate if stopped for >7days. Hemodialysis: give additional nevirapine 200mg dose after dialysis.
<15 days: not recommended. For oral susp: use dosing syringe or cup: ≥15 days: Initially 150mg/m2 once daily for 14 days; if no rash occurs increase to 150mg/m2 twice daily. If mild-to-moderate rash occurs during the 14-day lead in period, do not give twice-daily regimen until rash has resolved; lead-in dosing regimen should not be continued beyond 28 days, consider alternative regimen. If severe rash or hepatic event occurs, discontinue permanently. Max 400mg/day. Retitrate if stopped for >7 days.
Moderate-to-severe (Child-Pugh B or C) hepatic impairment. Use as part of occupational or non-occupational post-exposure prophylaxis regimens.
Risk of severe, life-threatening hepatotoxicity (eg, hepatic necrosis and failure, cholestatic hepatitis) or skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). Monitor liver function (at baseline, intensively during 1st 18 weeks, and throughout therapy). Suspend and discontinue permanently if signs/symptoms of hepatitis, elevated transaminases combined with rash or other systemic symptoms (eg, fever, blistering, oral lesions, conjunctivitis, swelling, muscle/joint aches or general malaise) occurs; do not restart after recovery. Co-infected with hepatitis B or C. Hepatitis fibrosis or cirrhosis; monitor. Renal dysfunction. Elderly. Pregnancy. Nursing mothers: not recommended.
Possible increased adverse reactions with concomitant efavirenz: not recommended. Concomitant other NNRTIs: not recommended. Potentiated by fluconazole (monitor). Antagonizes atazanavir, fosamprenavir without ritonavir, ketoconazole, itraconazole, boceprevir, telaprevir: not recommended, clarithromycin (consider alternative). Antagonized by St. John's wort, rifampin: not recommended. Antagonizes methadone (monitor for withdrawal symptoms; increase methadone dose if needed), oral contraceptives (use nonhormonal contraception; monitor). May antagonize other drugs metabolized by CYP3A4 or CYP2B6. Do not give lopinavir/ritonavir tabs or oral soln once daily with nevirapine (see full labeling). Monitor warfarin, carbamazepine, clonazepam, ethosuximide, rifabutin (caution), other CYP450 substrates.
Non-nucleoside reverse transcriptase inhibitor.
Rash, nausea, headache, abnormal liver function tests, fatigue, fever, vomiting, myalgia, abdominal pain; fat redistribution, immune reconstitution syndrome. Children: also granulocytopenia.
Register pregnant patients exposed to nevirapine by calling (800) 258-4263.
Tabs—60; Susp—240mL; XR 100mg—90; 400mg—30