FDAnews
www.fdanews.com/articles/97483-abbott-reminds-doctors-of-pediatric-kaletra-dosing-regimen

Abbott Reminds Doctors of Pediatric Kaletra Dosing Regimen

August 21, 2007

Abbott Laboratories sent out a “Dear Healthcare Professional” letter last week after an infant was accidentally given an overdose of the HIV drug Kaletra and died, according to a MedWatch safety alert.

Pediatric dosing of Kaletra (lopinavir/ritonavir) oral solution should be calculated based on body weight, and children weighing less than 40 kg should receive less than the adult dose of 5 mL twice a day, the company said.

The accidental overdose occurred in a 44-day-old infant born at 30 weeks gestation who was given approximately 6.5 mL of Kaletra oral solution and died nine days later of cardiogenic shock, Abbott said. The company estimates that the dose was roughly 10 times the calculated dose for this patient.

The company reminds physicians to pay close attention to the drug’s prescribing information, especially tables of recommended doses based on weight.