Source: FDA, National Drug Code (US) Revision Year: 2022
SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells.
SELZENTRY film-coated tablets for oral administration contain 25, 75, 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide.
SELZENTRY oral solution contains 20 mg per mL of maraviroc and the following inactive ingredients: citric acid (anhydrous), purified water, sodium benzoate, sodium citrate dihydrate, strawberry flavoring (501440T), and sucralose.
Maraviroc is chemically described as 4,4-difluoro-N-{(1S)3[exo3(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide.
The molecular formula is C29H41F2N5O and the structural formula is:
Maraviroc is a white to pale-colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5).
Dosage Forms and Strengths |
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Tablets:
Oral Solution:
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How Supplied |
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SELZENTRY film-coated tablets are available as follows: 25-mg, 75-mg, 150-mg, and 300-mg tablets are blue, biconvex, oval, film-coated tablets debossed with “MVC 25”, “MVC 75”, “MVC 150”, or “MVC 300”, respectively, on one side and plain on the other. 25-mg tablets: Bottle of 120 tablets (NDC 49702-233-08). 75-mg tablets: Bottle of 120 tablets (NDC 49702-235-08). 150-mg tablets: Bottle of 60 tablets (NDC 49702-223-18). 300-mg tablets: Bottle of 60 tablets (NDC 49702-224-18). Manufactured for: ViiV Healthcare, Durham, NC 27701 |
Drug | Countries | |
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SELZENTRY | Mexico, United States |
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