<p><strong>Pediatric Use</strong>: The safety, pharmacokinetic profile, and virologic and immunologic responses of Nevirapine have been evaluated in HIV-1 infected pediatric subjects age 3 months to 18 years. The safety and pharmacokinetic profile of Nevirapine has been evaluated in HIV-1 infected pediatric subjects age 15 days to less than 3 months.<br />
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The most frequently reported adverse events related to Nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both&nbsp;zidovudine&nbsp;and Nevirapine.<br />
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<strong>Geriatric Use</strong>: Clinical trials of Nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.<br />
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<strong>Renal Impairment</strong>: In subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. Nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. Nevirapine metabolites may accumulate in patients receiving&nbsp;dialysis; however, the clinical significance of this accumulation is not known. No adjustment in nevirapine dosing is required in patients with CrCL greater than or equal to 20 mL per min. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCl less than 20 mL per min. In patients undergoing chronic&nbsp;hemodialysis, an additional 200 mg dose following each dialysis treatment is indicated.<br />
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<strong>Hepatic Impairment</strong>: Because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer Nevirapine to patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment.</p>