VIRAMUNE ORAL SUSPENSION Dosage & Rx Info

Viramune Oral Suspension Generic Name & Formulations

Legal Class

General Description

Nevirapine (as hemihydrate) 50mg/5mL.

Pharmacological Class

Non-nucleoside reverse transcriptase inhibitor.

How Supplied

Tabs—contact supplier; Susp—240mL; XR 100mg—90; 400mg—30

Manufacturer

Boehringer Ingelheim Pharmaceuticals

Viramune Oral Suspension Indications

Indications

HIV-1 infection.

Limitations of Use

Adult females with CD4+ counts >250cells/mm³ or males with CD4+ counts >400cells/mm³: do not initiate unless benefit outweighs risk.

Viramune Oral Suspension Dosage and Administration

Adult

≥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.

Children

<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.

Viramune Oral Suspension Contraindications

Contraindications

Moderate to severe (Child-Pugh B or C) hepatic impairment. Use as part of occupational or non-occupational post-exposure prophylaxis regimens.

Viramune Oral Suspension Boxed Warnings

Boxed Warning

Life-threatening (including fatal) hepatotoxicity and skin reactions.

Viramune Oral Suspension Warnings/Precautions

Warnings/Precautions

Risk of severe, life-threatening hepatotoxicity (eg, hepatic necrosis and failure, cholestatic hepatitis) or skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity). Monitor liver function (at baseline, intensively during 1^st 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.

Viramune Oral Suspension Pharmacokinetics

See Literature

Viramune Oral Suspension Interactions

Interactions

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.

Viramune Oral Suspension Adverse Reactions

Adverse Reactions

Rash, nausea, headache, abnormal liver function tests, fatigue, fever, vomiting, myalgia, abdominal pain; fat redistribution, immune reconstitution syndrome. Children: also granulocytopenia.

Viramune Oral Suspension

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