SELZENTRY Film-coated tablet / Oral solution Ref.[50720] Active ingredients: Maraviroc

Source: FDA, National Drug Code (US)  Revision Year: 2022 

Product description

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

Tablets:

  • 25-mg blue, oval, film-coated tablets debossed with “MVC 25” on one side and plain on the other.
  • 75-mg blue, oval, film-coated tablets debossed with “MVC 75” on one side and plain on the other.
  • 150-mg blue, oval, film-coated tablets debossed with “MVC 150” on one side and plain on the other.
  • 300-mg blue, oval, film-coated tablets debossed with “MVC 300” on one side and plain on the other.

Oral Solution:

  • 20 mg per mL clear, colorless, strawberry-flavored oral solution.
How Supplied

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

Drugs

Drug Countries
SELZENTRY Mexico, United States

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