Monday, May 21, 2012

New warning label of kaletra oral solution for severe and fatal risk when used in baby after birth both in premature or full term

Wednesday, March 9, 2011 13:39

Lopinavir/Ritonavir marketed as Kaletra oral solution from Abbott Laboratories is a drug for the treatment of HIV infection that available in capsules, tablets and oral solution.

As this drug when used in babies after birth could leading to the problems of cardiac, renal, and respiratory problems, therefore, the US Food and Drug Administration (FDA) announced yesterday to avoid use in babies after 2 weeks of full-term birth or 2 weeks after their due date of premature infants.

According to the agency, the root cause might be due to propylene glycol inside the drugs that hard to eliminated by the babies compared with older babies.

The FDA strongly recommended the clinicians to avoid use the Kaletra oral solution in such babies categories, unless they seen the benefits outweigh the risk, however, they should monitor the increasing of serum osmolality, serum creatinine, and other signs of toxicity.

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