Quinine

General Quinine sulphate is not approved for: • Treatment of severe or complicated P. falciparum malaria. • Prevention of malaria. • Treatment or prevention of nocturnal leg cramps. Use of Quinine-ODAN for Treatment or Prevention of Nocturnal Leg Cramps Quinine-ODAN may cause unpredictable serious and life-threatening hematologic reactions including thrombocytopenia and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP) in addition to hypersensitivity reactions, QT prolongation, serious cardiac arrhythmias including torsades de pointes, and other serious adverse events requiring medical intervention and hospitalization.

Chronic renal impairment associated with the development of TTP, and fatalities have also been reported. The risk associated with the use of Quinine-ODAN in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps, outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition [see Contraindications].