Monograph Details
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Infections & Infestations
> Viral infections
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VIRAMUNE ORAL SUSPENSION |
| Manufacturer |
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Boehringer Ingelheim Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Non-nucleoside reverse transcriptase inhibitor. |
| Generic Name |
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Nevirapine (as hemihydrate) 50mg/5mL. |
| Also |
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• VIRAMUNE
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| Indications |
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HIV-1 infection. |
| Children |
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<2 months: not recommended. 2months–8yrs: initially 4mg/kg once daily for 14 days; if no rash occurs increase to 7mg/kg twice daily; if mild rash occurs, continue and monitor; if severe rash occurs, discontinue. ≥8yrs: initially 4mg/kg once daily for 14 days; if no rash occurs increase to 4mg/kg twice daily; if mild rash occurs, continue and monitor; if severe rash occurs, discontinue. Max 400mg/day. Retitrate if stopped for >7days. Hemodialysis: see literature. |
| Adults |
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Initially 200mg once daily for 14 days. If no rash occurs, increase to 200mg twice daily; if mild rash occurs, continue and monitor; if severe rash occurs, discontinue. Retitrate if stopped for >7days. Hemodialysis: see literature. |
| Contraindications |
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Severe hepatic impairment. Women with CD4 counts >250cells/mm3 or men with CD4 counts >400cells/mm3 (increased risk of rash-associated hepatic events): usually not recommended (see literature). See Interactions. |
| Precautions |
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Monitor liver function (at baseline and during 1st 18 weeks). Suspend if moderate to severe liver dysfunction, severe rash, or rash with constitutional symptoms (eg, fever, blistering, oral lesions, conjunctivitis, swelling, muscle/joint aches or general malaise) occurs; do not restart if these occur during 1st 18 weeks, or if hepatitis, severe liver dysfunction, or severe rash occurs at any time. Discontinue if severe rash occurs or if liver dysfunction occurs on rechallenge. Renal dysfunction. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Antagonizes ketoconazole, oral contraceptives: not recommended (use nonhormonal contraception). Antagonized by St. John's wort, rifampin: not recommended. May antagonize methadone (monitor for withdrawal symptoms; increase methadone dose if needed), or drugs metabolized by CYP3A4 or CYP2B6. Monitor warfarin, rifabutin, other CYP450 substrates. |
| Adverse Reactions |
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Potentially severe, life-threatening hepatotoxicity (eg, hepatic necrosis, cholestatic hepatitis) or skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis); nausea, headache, abnormal liver function tests, fatigue, fever, vomiting, myalgia, abdominal pain, fat redistribution. Children: also granulocytopenia. |
| Extra Text |
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Note: Register pregnant patients exposed to nevirapine by calling (800) 258-4263. |
| How Supplied |
Tabs—60
Susp—240mL |
| Additional Resources |
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• Related Prescribing Note |
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