ISENTRESS- raltegravir tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

RALTEGRAVIR POTASSIUM (UNII: 43Y000U234) (RALTEGRAVIR - UNII:22VKV8053U)

Sẵn có từ:

State of Florida DOH Central Pharmacy

INN (Tên quốc tế):

RALTEGRAVIR POTASSIUM

Thành phần:

RALTEGRAVIR 400 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

ISENTRESS1 is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14)] . The safety and efficacy of ISENTRESS have not been established in pediatric patients. Registered trademark of MERCK & CO., Inc. COPYRIGHT © 2007, 2009 MERCK & CO., Inc. All rights reserved None Pregnancy Category C ISENTRESS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. In addi

Tóm tắt sản phẩm:

ISENTRESS tablets 400 mg are pink, oval-shaped, film-coated tablets with “227” on one side. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage and Handling Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

ISENTRESS - RALTEGRAVIR TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ISENTRESS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ISENTRESS.
ISENTRESS (RALTEGRAVIR) TABLETS
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Indications And Usage (1) 07/2009
Dosage And Administration (2) 01/2009
Warnings And Precautions (5.2) - removal 07/2009
INDICATIONS AND USAGE
ISENTRESS® is a human immunodeficiency virus integrase strand
transfer inhibitor (HIV-1 INSTI) indicated:
In combination with other antiretroviral agents for the treatment of
HIV-1 infection in adult patients (1).
The safety and efficacy of ISENTRESS have not been established in
pediatric patients (1).
DOSAGE AND ADMINISTRATION
400 mg administered orally, twice daily with or without food (2).
During coadministration with rifampin, 800 mg twice daily (2).
DOSAGE FORMS AND STRENGTHS
TABLETS: 400 mg (3).
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Monitor for Immune Reconstitution Syndrome (5.1).
ADVERSE REACTIONS
The most common adverse reactions of moderate to severe intensity
(≥2%) which occurred at a higher rate than the
comparator are insomnia, headache, nausea, asthenia and fatigue (6.1).
Creatine kinase elevations were observed in subjects who received
ISENTRESS. Myopathy and rhabdomyolysis have
been reported; however, the relationship of ISENTRESS to these events
is not known. Use with caution in patients at
increased risk of myopathy or rhabdomyolysis, such as patients
receiving concomitant medications known to cause
these conditions (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MERCK & CO., INC. AT
1-877-888-4231 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Coadministration of ISENTRESS with drugs that are strong inducers of
UGT1A1 may result in reduced plasma
concentrations of raltegravir (7.2).
USE IN SPECIFIC POPULATIONS
Pre gnancy:
ISENTRESS should be used during pre