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Viramune Xr Generic Name & Formulations
Legal Class
Rx
General Description
Nevirapine 100mg, 400mg; ext-rel tabs.
Pharmacological Class
Non-nucleoside reverse transcriptase inhibitor.
See Also
How Supplied
Tabs—contact supplier; Susp—240mL; XR 100mg—90; 400mg—30
Manufacturer
Viramune Xr 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 Xr Dosage and Administration
Adult
Swallow whole. ≥18yrs: Initially Viramune 200mg once daily for 14 days, then Viramune XR 400mg once daily. If mild-to-moderate rash develops during the 14-day lead in period, do not start Viramune XR until rash has resolved. Lead-in period not necessary if patient already on a regimen of immediate-release Viramune twice daily. Total duration of once daily lead-in period should not exceed 28 days; consider alternative regimen. If severe rash or hepatic event occurs, discontinue permanently. Retitrate if stopped for >7 days.
Children
<6yrs: not recommended. Swallow whole. ≥6–<18yrs: Initially 150mg/m2 Viramune oral susp or immediate-release tabs once daily for 14 days; max 200mg/day, then Viramune XR dose based on BSA: 0.58–0.83m2: 200mg once daily; 0.84–1.16m2: 300mg once daily; ≥1.17m2: 400mg once daily. All: max 400mg/day. If mild-to-moderate rash develops during the 14-day lead in period, do not start Viramune XR until rash has resolved. Lead-in period not necessary if patient already on a regimen of immediate-release Viramune twice daily. Total duration of once daily lead-in period should not exceed 28 days; consider alternative regimen. If severe rash or hepatic event occurs, discontinue permanently. Retitrate if stopped for >7 days.
Viramune Xr 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 Xr Boxed Warnings
Boxed Warning
Life-threatening (including fatal) hepatotoxicity and skin reactions.
Viramune Xr 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 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.
Viramune Xr Pharmacokinetics
See Literature
Viramune Xr 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 Xr 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 Xr Clinical Trials
See Literature
Viramune Xr Note
Notes
Register pregnant patients exposed to nevirapine by calling (800) 258-4263.
Viramune Xr Patient Counseling
See Literature
