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Viramune oral suspension is a white to off-white preserved suspension containing 50 mg nevirapine as nevirapine hemihydrate in each 5 ml.

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The dose must be strictly adhered toespecially the 14-days lead-in periodsee section 4.2

Severe and life-threatening hepatotoxicityincluding fatal fulminant hepatitishas occurred in patients treated with nevirapineThe first 18 weeks of treatment is a critical period which requires close monitoringThe risk of hepatic reactions is greatest in the first 6 weeks of therapyHowever the risk continues past this period and monitoring should continue at frequent intervals throughout treatment.

Rhabdomyolysis has been observed in patients experiencing skin and/or liver reactions associated with nevirapine use.

Howeverapproximately 15of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ml2 fold the usual mean troughPatients with hepatic impairment should be monitored carefully for evidence of medicinal product induced toxicity.

Viramune tablets and oral suspension have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg.

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