| FDA Approves Kaletra for Once Daily Dosing in Adults FDA has approved a new dosing regimen for Kaletra (lopinavir/ritonavir) tablets and oral solution. Kaletra can be administered once daily (800/200 mg) in patients with less than three lopinavir resistance associated substitutions. Once daily administration of Katetra is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V. Also, once daily administration of Kaletra is not recommended in pediatric patients.
The complete revised label is available at the FDA Web site:
http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA |