• 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.
• 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.

It is important to understand that the use of quinine sulfate involves potentially significant risks. As noted in the FDA-approved Qualaquin™ (quinine sulfate capsules, 324 mg) labeling, quinine sulfate may, among other risks, cause unpredictable serious and life-threatening hypersensitivity reactions, QT prolongation, serious or potentially fatal cardiac arrhythmias including torsades de pointes, and other serious adverseevents requiring medical intervention and hospitalization. Multiple drug interactions have been reported with quinine sulfate, eg, rifampin, phenytoin, erythromycin, cisapride, and others.

Quinine sulfate is CONTRAINDICATED in patients with:

• Prolonged QT interval
• Previous hypersensitivity to mefloquine, quinine, and quinidine
• Glucose-6-phosphate dehydrogenase deficiency
• Myasthenia gravis
• Optic neuritis.

WARNINGS against the use of Quinine sulfate:

• For treatment or prevention of nocturnal leg cramps
• In patients with known QT prolongation, elderly patients, and in patients with conditions known to prolong the QT interval; with other drugs known to cause QT prolongation; and with drugs that are CYP3A4 substrates known to cause QT prolongation
• Concomitant use of mefloquine or halofantrine
• Concomitant use of macrolide antibiotics such as erythryomycin
• Concomitant use of rifampin
• Concomitant use of neuromuscular blocking agents.

PRECAUTIONS regarding the use of Quinine sulfate include:

• Serious hypersensitivity reactions which may include anaphylaxis, urticaria or rash, serious skin reactions, angioedema, bronchospasm, thrombotic thrombocytopenic purpura- hemolytic uremic syndrome, thrombocytopenia, blackwater fever, and other reactions
• Use with caution in patients with atrial fibrillation or flutter
• Hypoglycemia.

1 Quinine sulfate [package insert]. Philadelphia, PA: Mutual Pharmaceutical Company; 2006. Available at: http://thomsonweb.esourcegroup.com/files/PI_0.pdf [0].