KALETRA- lopinavir and ritonavir tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

DOH CENTRAL PHARMACY

INN (الاسم الدولي):

LOPINAVIR

تركيب:

LOPINAVIR 200 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 primary protease inhibitor mutations affects the virologic response to KALETRA [see Clinical Pharmacology (12.4)] . - Once daily administration of KALETRA is not recommended for therapy-experienced adult patients or any pediatric patients. ● KALETRA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. ●  Co-administration of KALETRA is contraindicated with drugs t

ملخص المنتج:

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. 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. 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. They are supplied by State of Florida DOH Central Pharmacy as follows:

الوضع إذن:

New Drug Application

نشرة المعلومات

KALETRA - LOPINAVIR AND RITONAVIR TABLET, FILM COATED
DOH CENTRAL PHARMACY
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MEDICATION GUIDE
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 effectiv

خصائص المنتج

KALETRA - LOPINAVIR AND RITONAVIR TABLET, FILM COATED
DOH CENTRAL PHARMACY
----------
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) TABLETS, FILM COATED FOR ORAL USE
KALETRA (LOPINAVIR/RITONAVIR) SOLUTION FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Contraindications, Table 3 (4) 6/2008
Dosage and Administration, Pediatric Patients (2.2) 6/2008
Warnings and Precautions, PR Interval Prolongation (5.5) 4/2009
Warnings and Precautions, QT Interval Prolongation (5.6) 4/2009
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:
● Therapy-experienced patients (2.1)
● Combination with efavirenz, nevirapine, (fos)amprenavir, or
nelfinavir (2.1)
● 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 Therapy-Naïve (2.1)
● 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.
ADULT PATIENTS Therapy-Experienced (2.1)
● 400/100 mg (two 200/50 mg tablets or 5 mL oral solution) twice
daily
PEDIATRIC PATIENTS (ages 14 days and older) (2.2)
● Twice daily dose is based on body weight.
Concomitant Therapy in Adults and Pediatric Patients (2.1,2.2)
● Dose adjustments of KALETRA may be needed when co-administering
with efavirenz, nevirapine, (fos)amprenavir, or
ne lfinavir.
DOSAGE FORMS AND STRENGTHS
● Film-coated tablets: 200 mg lopinavir and 50 mg ritonavir (3)
● Film-coated tablets: 100 mg lopinavir and 25 mg ritonavir (3)
● Oral solution: 80 mg lopinavir and 20 mg ritonavir per milliliter
(3)
CONTRAINDICATIONS
Hypersensitivity