Lopinavir/ritonavir oral solution (Kaletra, Abbott Laboratories) should be avoided in premature or full-term infants for the first 14 days after their due dates because of possible cardiac, renal, or respiratory problems, the US Food and Drug Administration (FDA) announced today in a safety alert announcing a label change.
The solution contains alcohol and propylene glycol; premature infants and newborns are less capable of eliminating propylene glycol than older infants.
"Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning," the advisory states.
It is recommended that clinicians avoid the use of Kaletra oral solution in premature babies until 14 days after their due date, or in full-term infants in the first 2 weeks of life, unless it is determined that the benefits outweigh the possible risk.
If the solution is administered to at-risk infants, clinicians are strongly advised to monitor for increases in serum osmolality, serum creatinine, and other signs of toxicity.
More information on the warning can be seen on the FDA Web site.
Adverse events related to Kaletra oral solution should be communicated to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/MedWatch/report.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20857.
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