U.S. Food and Drug Administration • Center for Drug Evaluation
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U.S. Food and Drug Administration • Center for Drug Evaluation
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Drug Information |
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Kaletra InformationFDA issued an accelerated approval for Kaletra, a protease inhibitor, for adults and children greater than 6 months of age with HIV. Kaletra is a combination of lopinavir and ritonavir, (a previously approved protease inhibitor). Lopinavir's antiviral properties are combined with a low dose of ritonavir that inhibits lopinavir's metabolism. This results in blood levels of lopinavir that enhance its effectiveness against HIV. The new drug is used in combination with other anti-HIV drugs. It should be taken with food to increase absorption into the blood stream. The usual dose for adults is three capsules or 5.0 mL twice a day. Dosing for children ages 6 months to 12 years, determined by the child's weight, is also given twice daily. FDA Talk Paper on Kaletra Approval (9/15/2000) Kaletra Approval Letter
9/18/00 Kaletra Label Kaletra Patient Package
Insert FDA/Center for Drug Evaluation and Research |
(9/18/2000)
