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Isentress (Raltegravir) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ISENTRESS [

Registered trademark of MERCK & CO., Inc.
COPYRIGHT © 2007, 2009 MERCK & CO., Inc.
All rights reserved

] 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].

The safety and efficacy of ISENTRESS have not been established in pediatric patients.

DOSAGE AND ADMINISTRATION

For the treatment of patients with HIV-1 infection, the dosage of ISENTRESS is 400 mg administered orally, twice daily with or without food. During coadministration with rifampin, the recommended dosage of ISENTRESS is 800 mg twice daily with or without food.

DOSAGE FORMS AND STRENGTHS

400 mg pink, oval shaped, film-coated tablets with "227" on one side.

HOW SUPPLIED/STORAGE AND HANDLING

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:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0650-1 400 mg 30 Tablets in a Blister Pack pink 0006-0227

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.

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