INDICATIONS AND USAGE

Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older.

DOSAGE

Lopinavir and ritonavir tablets can be given in once daily or twice daily dosing regimen. Lopinavir and ritonavir tablets once daily dosing regimen is not recommended in:

• 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.

• In combination with carbamazepine, phenobarbital, or phenytoin.

• In combination with efavirenz, nevirapine, or nelfinavir.

• In pediatric patients younger than 18 years of age.

• In pregnant women.

200 mg/50 mg Tablets: 800 mg/200 mg (4 tablets) once daily

200 mg/50 mg Tablets: 400 mg/100 mg (2 tablets) twice daily

Dosage Recommendations in Pediatric Patients

Lopinavir and ritonavir tablets are not recommended for once daily dosing in pediatric patients younger than 18 years of age. Lopinavir and ritonavir 100/25 mg tablets should be considered only in children who have reliably demonstrated the ability to swallow the intact tablet.

Lopinavir and ritonavir oral solution is not recommended in neonates before a postmenstrual age (first day of the mother’s last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been attained.

Lopinavir and ritonavir oral solution contains alcohol and propylene glycol. Total amounts of alcohol and propylene glycol from all medicines that are to be given to pediatric patients 14 days to 6 months of age should be taken into account in order to avoid toxicity from these excipients.

Dosage Recommendations in Pregnancy

Administer 400/100 mg of lopinavir and ritonavir tablets twice daily in pregnant patients with no documented lopinavir-associated resistance substitutions.

• Once daily lopinavir and ritonavir tablets dosing is not recommended in pregnancy.

• There are insufficient data to recommend dosing in pregnant women with any documented lopinavir-associated resistance substitutions.

• No dosage adjustment of lopinavir and ritonavir is required for patients during the postpartum period.

• Avoid use of lopinavir and ritonavir oral solution in pregnant women.

ADVERSE REACTIONS

QT Interval Prolongation, PR Interval Prolongation

Drug Interactions

Pancreatitis

Hepatotoxicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/4e5005b8-f00c-4671-be09-bb927190760f/spl-doc?hl=Lopinavir%20and%20Ritonavir

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