KRINTAFEL Film‑coated tablet Ref.[10201] Active ingredients: Tafenoquine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

KRINTAFEL contains tafenoquine succinate, an antimalarial agent for oral administration. The chemical name of tafenoquine succinate is (±) 8-[(4-amino-1-methylbutyl)amino]-2,6-dimethoxy-4‑methyl-5-[3-(trifluoromethyl)phenoxy]quinoline succinate. The molecular formula of tafenoquine succinate is C24H28 F3N3O3 • C4H6O4, and its molecular mass is 581.6 as the succinate salt (463.5 as free base). The structural formula is shown below.

Each KRINTAFEL tablet contains 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate). Inactive ingredients include magnesium stearate, mannitol, and microcrystalline cellulose. The tablet film-coating inactive ingredients include hydroxypropylmethylcellulose, polyethylene glycol, red iron oxide, and titanium dioxide.

Dosage Forms and Strengths

KRINTAFEL tablets are pink, film‑coated, capsule-shaped tablets debossed with ‘GS J11’ on one side and contain 150 mg of tafenoquine.

How Supplied

KRINTAFEL tablets contain 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate) and are pink, film‑coated, capsule-shaped, and debossed with ‘GS J11’ on one side. KRINTAFEL is supplied as follows:

  • Unit Dose Pack of 2 tablets in a bottle with child-resistant closure (NDC 0173-0889-39). Bottles contain a desiccant.

Drugs

Drug Countries
KRINTAFEL United States

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