Quinine Sulfate Recall
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Side Effects & Adverse Reactions
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FDA Labeling Changes
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Quinine sulfate capsules, USP are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)].
Quinine sulfate oral capsules are not approved for:• Treatment of severe or complicated P. falciparum malaria. • Prevention of malaria. • Treatment or prevention of nocturnal leg cramps [ see Warnings and Precautions (5.1)].
There is currently no drug history available for this drug.
Quinine sulfate is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2•H2SO4•2H2O and a molecular weight of 782.96.
The structural formula of quinine sulfate is:
Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether.
Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.