raltegravir 600 MG Oral Tablet Isentress
1 INDICATIONS AND USAGE Adult Patients: ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ( 1 ). Pediatric Patients: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg ( 1 ). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg ( 1 ). Adult Patients: ISENTRESS ® and ISENTRESS ® HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. Pediatric Patients: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg. ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg.
Merck Sharp & Dohme Corp.
OVAL YELLOW logo 242
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16 HOW SUPPLIED/STORAGE AND HANDLING ISENTRESS tablets 400 mg are pink, oval-shaped, film-coated tablets with "227" on one side. They are supplied as follows: NDC 0006-0227-61 unit-of-use bottles of 60. ISENTRESS HD tablets 600 mg are yellow, oval-shaped, film-coated tablets with corporate logo and "242" on one side and plain on the other side. They are supplied as follows: NDC 0006-3080-01 unit-of-use bottles of 60. ISENTRESS tablets 100 mg are pale orange, oval-shaped, orange-banana flavored, chewable tablets scored on both sides and imprinted on one face with the corporate logo and "477" on opposite sides of the score. They are supplied as follows: NDC 0006-0477-61 unit-of-use bottles of 60. ISENTRESS tablets 25 mg are pale yellow, round, orange-banana flavored, chewable tablets with the corporate logo on one side and "473" on the other side. They are supplied as follows: NDC 0006-0473-61 unit-of-use bottles of 60. ISENTRESS for oral suspension 100 mg is a white to off-white granular powder that may contain yellow or beige to tan particles, in child resistant single-use foil packets, packaged as A kit with two 1 mL syringes, two 3 mL syringes, two 10 mL syringes and two mixing cups. It is supplied as follows: NDC 0006-3603-61 unit of use carton with 60 packets. NDC 0006-3603-01 individual packet. Storage and Handling 400 mg film-coated Tablets, 600 mg film-coated Tablets, Chewable Tablets and For Oral Suspension Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature. 400 mg film-coated Tablets, 600 mg film-coated Tablets and Chewable Tablets Store in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture. For Oral Suspension Store in the original container. Do not open foil packet until ready for use.
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