KALETRA- lopinavir and ritonavir tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lopinavir (UNII: 2494G1JF75) (Lopinavir - UNII:2494G1JF75), Ritonavir (UNII: O3J8G9O825) (Ritonavir - UNII:O3J8G9O825)

Available from:

HHS/Program Support Center/Supply Service Center

INN (International Name):

Lopinavir

Composition:

Lopinavir 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The following points should be considered when initiating therapy with KALETRA: - The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Clinical Pharmacology (12.4) and Clinical Studies (14)] . - Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Clinical Pharmacology (12.4)] . The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Clinical Pharmacology (12.4)] . - Once daily administration of KALETRA is not recommended for any pediatric patients. - KALETRA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. - Co-administration of KALETRA is contraindicated with drugs th

Product summary:

KALETRA® (lopinavir/ritonavir) Film-Coated tablets are available in the following strengths and package sizes: KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir Yellow film-coated ovaloid tablets debossed with the corporate Abbott "A" logo and the Abbo-Code KA: Bottles of 20 tablets ….…………… (NDC 11819-342-20) Recommended Storage Store KALETRA film-coated tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59° to 86°F)[see USP controlled room temperature]. Dispense in original container or USP equivalent tight container (250 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (250 mL or less) for longer than 2 weeks is not recommended.

Authorization status:

New Drug Application

Patient Information leaflet

KALETRA- LOPINAVIR AND RITONAVIR TABLET, FILM COATED
HHS/Program Support Center/Supply Service Center
----------
MEDICATION GUIDE
KALETRA® (kuh-LEE-tra)
(lopinavir/ritonavir)
Tablets
KALETRA® (kuh-LEE-tra)
(lopinavir/ritonavir)
Oral Solution
Read the Medication Guide that comes with KALETRA before you start
taking it and each time you get a
refill. There may be new information. This information does not take
the place of talking with your doctor
about your medical condition or treatment. You and your doctor should
talk about your treatment with
KALETRA before you start taking it and at regular check-ups. You
should stay under your doctor's care
when taking KALETRA.
What is the most important information I should know about KALETRA?
KALETRA may cause serious side effects, including:
•
Interactions with other medicines. It is important to know the
medicines that should not be taken
with KALETRA. Read the section "What should I tell my doctor before
taking KALETRA?"
•
Changes in your heart rhythm and the electrical activity of your
heart. These changes may be seen
on an EKG (electrocardiogram) and can lead to serious heart problems.
Your risk for these
problems may be higher if you:
•
already have a history of abnormal heart rhythm or other types of
heart disease.
•
take other medicines that can affect your heart rhythm while you take
KALETRA.
Tell your doctor right away if you have any of these symptoms while
taking KALETRA:
•
dizziness
•
lightheadedness
•
fainting
•
sensation of abnormal heartbeats
See the section below "What are the possible side effects of KALETRA?"
for more information about
serious side effects.
What is KALETRA?
KALETRA is a prescription anti-HIV medicine that contains two
medicines: lopinavir and ritonavir.
KALETRA is called a protease inhibitor that is used with other
anti-HIV-1 medicines to treat people with
human immunodeficiency virus (HIV-1) infection. HIV-1 is the virus
that causes AIDS (Acquired
Immune Deficiency Syndrome).
It is not known if KALETRA is safe and effec

Summary of Product characteristics

KALETRA- LOPINAVIR AND RITONAVIR TABLET, FILM COATED
HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER
----------
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 AND RITONAVIR) TABLET, FILM COATED FOR ORAL USE
KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Dosage and Administration, Pediatric Patients (2.2) 2/2011
Dosage and Administration, Adult Patients (2.1) 4/2010
Contraindications, Table 3 (4) 4/2010
Warnings and Precautions (5.2) 2/2011
Warnings and Precautions (5.1) 6/2010
Warnings and Precautions (5.4) 4/2010
INDICATIONS AND USAGE
KALETRA is an HIV-1 protease inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-
1 infection. (1)
DOSAGE AND ADMINISTRATION
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, amprenavir, nelfinavir,
carbamazepine, phenobarbital, or phenytoin (2.1, 7.3)
Pediatric patients (2.2)
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)
ADULT PATIENTS (2)
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.
PEDIATRIC PATIENTS (ages 14 days and older) (2.2)
Twice daily dose is based on body weight or body surface area.
Concomitant Therapy in Adults and Pediatric Patients (2.1, 2.2)
Dose adjustments of KALETRA may be needed when co-administering with
efavirenz, nevirapine, amprenavir, or
ne lfinavir.
KALETRA oral solution should not be administered to