Rx Item-Crixivan 400Mg Cap 180 By Merck

CRIXIVAN- indinavir sulfate capsule
Merck Sharp & Dohme Corp.

DESCRIPTION

CRIXIVAN� (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease. CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral administration in strengths of 200 and 400 mg of indinavir (corresponding to 250 and 500 mg indinavir sulfate, respectively). Each capsule also contains the inactive ingredients anhydrous lactose and magnesium stearate. The capsule shell has the following inactive ingredients and dyes: gelatin and titanium dioxide.



The chemical name for indinavir sulfate is [1(1S ,2R),5(S)]-2,3,5-trideoxy-N -(2,3-dihydro-2-hydroxy-1H -inden-1-yl)-5-[2-[[(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinylmethyl)-1-piperazinyl]-2-(phenylmethyl)-D-erythro -pentonamide sulfate (1:1) salt. Indinavir sulfate has the following structural formula:

image of indinavir sulfate chemical structure
(click image for full-size original)
Indinavir sulfate is a white to off-white, hygroscopic, crystalline powder with the molecular formula C36 H47 N5 O4 � H2 SO4 and a molecular weight of 711.88. It is very soluble in water and in methanol.

MICROBIOLOGY

Mechanism of Action:
HIV-1 protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors into the individual functional proteins found in infectious HIV-1. Indinavir binds to the protease active site and inhibits the activity of the enzyme. This inhibition prevents cleavage of the viral polyproteins resulting in the formation of immature non-infectious viral particles.

Antiretroviral Activity In Vitro:
The in vitro activity of indinavir was assessed in cell lines of lymphoblastic and monocytic origin and in peripheral blood lymphocytes. HIV-1 variants used to infect the different cell types include laboratory-adapted variants, primary clinical isolates and clinical isolates resistant to nucleoside analogue and nonnucleoside inhibitors of the HIV-1 reverse transcriptase. The IC95 (95% inhibitory concentration) of indinavir in these test systems was in the range of 25 to 100 nM. In drug combination studies with the nucleoside analogues zidovudine and didanosine, indinavir showed synergistic activity in cell culture. The relationship between in vitro susceptibility of HIV-1 to indinavir and inhibition of HIV-1 replication in humans has not been established.

RX ITEM-Crixivan 400Mg Cap 180 By Merck
NDC 00006-0573-62 UPC/GTIN No.3-00060-57362-3 Mfg.Part No.57362

Crixivan 400Mg Cap 180 By Merck
BRAND: CRIXIVAN NDC: 00006-0573-62,6057362 UPC: 3-00060-57362-3,300060573623 Merck & Co.

INDINAVIR SULFATE ORAL CA
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