KALETRA- lopinavir and ritonavir tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

LOPINAVIR (UNII: 2494G1JF75) (LOPINAVIR - UNII:2494G1JF75), RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825)

Boleh didapati daripada:

Dispensing Solutions, Inc.

INN (Nama Antarabangsa):

LOPINAVIR

Komposisi:

LOPINAVIR 200 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 tha

Ringkasan produk:

KALETRA® (lopinavir/ritonavir) Film-Coated tablets and Oral Solution are available in the following strengths and package sizes: Yellow film-coated ovaloid tablets debossed with the corporate Abbott “A” logo and the Abbo-Code KA: Bottles of 120 tablets ….…………… (NDC 0074-6799-22) 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. Pale yellow film-coated ovaloid tablets debossed with the corporate Abbott “A” logo and the Abbo-Code KC: Bottles of 60 tablets ….…………… (NDC 0074-0522-60) 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 (100 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (100 mL or less) for longer than 2 weeks is not recommended. KALETRA (lopinavir/ritonavir) oral solution is a light yellow to orange colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir/100 mg ritonavir per 5 mL (80 mg lopinavir/20 mg ritonavir per mL) packaged with a marked dosing cup in the following size: 160 mL bottle……………………………….(NDC 0074-3956-46) Recommended Storage Store KALETRA oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use, refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.

Status kebenaran:

New Drug Application

Risalah maklumat

KALETRA- LOPINAVIR AND RITONAVIR TABLET, FILM COATED
Dispensing Solutions, Inc.
----------
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-human immunodeficiency virus (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 HIV-1 infection. HIV-1 is the
virus that causes AIDS (Acquired
Immune Deficiency Syndrome).
It is not known if KALETRA is safe and effective in child

Ciri produk

KALETRA- LOPINAVIR AND RITONAVIR TABLET, FILM COATED
DISPENSING SOLUTIONS, INC.
----------
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
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
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, amprenavir, 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.
(2.1)
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, amprenavir, 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 of at least 14 days has been
attained (2.2, 5.2)