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U.S. Department of Health and Human Services

For Consumers

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Important Dear Healthcare Provider letter about pediatric dosing

Abbott has sent out a Dear Healthcare Provider letter regarding KaIetra (lopinavir/ritonavir) oral solution and accidental overdose in children, highlighting important information about Kaletra dosing for children.

The Direct Healthcare Professional Communication indicated that Abbott was recently notified of an accidental overdose when an infant received a significantly large dose of Kaletra (lopinavir/ritonavir) Oral Solution. The infant subsequently died.

Abbott is reminding you that:

  • Kaletra Oral Solution is highly concentrated, containing 80 mg lopinavir and 20 mg ritonavir per mL (not per bottle).
  • Children dosages are calculated based on body weight. A child should receive less than 5 mL oral solution per dose unless they are also receiving certain concomitant antiretroviral medicines.

Further information on the safety concern:
The accidental overdose occurred in a 44-day-ld infant, born at 30 weeks gestation with HN, who was given approximately 6.5 mL of Katetra Oral Solution (this is about 10 times the calculated volume). The infant died nine days later of cardiogenic shock.

Special attention must be paid to accurate calculation of the dose, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors.

The FDA web site has a pediatric HIV drug page that provides additional information about pediatric dosing.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration