KALETRA lopinavir and ritonavir tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

LOPINAVIR (UNII: 2494G1JF75) (LOPINAVIR - UNII:2494G1JF75)

Tilgjengelig fra:

Cardinal Health

INN (International Name):

LOPINAVIR

Sammensetning:

LOPINAVIR 200 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

KALETRA- LOPINAVIR AND RITONAVIR TABLET, FILM COATED
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KALETRA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR KALETRA.
KALETRA (LOPINAVIR/RITONAVIR) TABLET, FILM COATED FOR ORAL USE
KALETRA (LOPINAVIR/RITONAVIR) SOLUTION FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Immune Reconstitution 02/2012
Syndrome. (5.8)
Indications and Usage. (1) 01/2013
INDICATIONS AND USAGE
KALETRA is an HIV-1 protease inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-
1 infection in adults and pediatric patients (14 days and older). (1)
DOSAGE AND ADMINISTRATION
Tablets: May be taken with or without food, swallowed whole and not
chewed, broken, or crushed. (2)
Oral solution: must be taken with food. (2)
Do not use once daily administration of KALETRA in:
HIV-1 infected 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. (2.1)
Combination with efavirenz, nevirapine, nelfinavir, carbamazepine,
phenobarbital, or phenytoin. (2.1, 7.3)
Pediatric patients. (2.2)
Adult Patients:
400/100 mg (two 200/50 mg tablets or 5 mL oral solution) twice daily.
or
800/200 mg (four 200/50 mg tablets or 10 mL oral solution) once daily
in patients with less than three lopinavir
resistance-associated substitutions. (2.1)
Pediatric Patients (14 days and older):
Twice daily dose is based on body weight or body surface area. (2.2)
Concomitant Therapy in Adults and Pediatric Patients:
Dose adjustments of KALETRA may be needed when co-administering with
efavirenz, nevirapine, or nelfinavir. (2.1,
2.2, 7.3)
KALETRA oral solution should not be administered to 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