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Infant Dies of Kaletra Overdose, Prompts Warning

August 13, 2007

An HIV-positive infant has died after an accidental Kaletra (lopinavir plus ritonavir) overdose, prompting Abbott Laboratories to issue a letter reminding healthcare professionals about the correct dose for children.

The overdose occurred in a 44-day-old baby born with HIV, who was given approximately 6.5 milliliters (mL) of the drug’s liquid formulation—approximately 10 times the necessary dose. The infant died nine days later from heart failure.

Abbott says that liquid Kaletra is highly concentrated and that children’s dosages are calculated based on body weight. The maximum dose, for children weighing more than 40 kilograms (88 pounds), should be no higher than 5.0 mL twice daily.

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