Product Description.:
AR 102, AR 102
capsule , clear , oblong oblong
Black ink2 black bandsContains white powder
QUALAQUIN? (quinine sulfate) Capsules USP, 324 mg WARNING Qualaquin use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematological reactions, including thrombocytopenia and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with Qualaquin use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit 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. Qualaquin is 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. INDICATIONS Treatment of Malaria Qualaquin is 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). Qualaquin oral capsules are not approved for patients with severe or complicated P. falciparum malaria. Qualaquin oral capsules are not approved for prevention of malaria. Qualaquin oral capsules are not approved for the treatment or prevention of nocturnal leg cramps. SIDE EFFECTS Quinine can adversely affect almost every body system. The most common adverse events associated with quinine use are a cluster of symptoms called ?cinchonism?, which occurs to some degree in almost all patients taking quinine. Symptoms of mild cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception. More severe symptoms of cinchonism are vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. Most symptoms of cinchonism are reversible and resolve with discontinuation of quinine.
