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U.S. Department of Health and Human Services

For Consumers

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A new half-strength Kaletra formulation approved

On November 9, 2007, FDA approved a new half-strength Kaletra tablet formulation. Each film-coated tablet contains 100 mg lopinavir and 25 mg ritonavir. The major changes to the label include clear instructions regarding accurate calculation of the dose of Kaletra to minimize the risk for medication errors, overdose, or under dose, and the addition of tablet dosing to section 2.2, Pediatric Patients. Labeling for Kaletra is availble on the FDA web site at Drugs@FDA.

Kaletra is a combination protease inhibitor product containing lopinavir and ritonavir, manufactured by Abbott Laboratories. The original formulation was approved on September 15, 2000.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration