Generic Name and Formulations:
Quinine sulfate 324mg; caps.
Sun Pharmaceutical Industries
Indications for QUALAQUIN:
Treatment of uncomplicated P. falciparum malaria (including chloroquine-resistant strains).
Take with food. ≥16yrs: 648mg every 8hrs for 7 days. Severe renal impairment: 648mg once, after 12hrs start 324mg every 12hrs. Hepatic impairment (severe): not recommended; (mild and moderate): monitor closely.
<16yrs: not established.
Prolonged QT interval. G6PD deficiency. Myasthenia gravis. Mefloquine, quinidine or related allergy. History of thrombocytopenic purpura, hemolytic uremic syndrome, thrombocytopenia, blackwater fever associated with previous quinine use. Optic neuritis.
Not for treatment of severe or complicated P. falciparum malaria. Not for prevention of malaria. Not for treatment or prevention of nocturnal leg cramps; serious and life-threatening hematologic reactions may develop. Discontinue if any signs/symptoms of hypersensitivity occurs (eg, thrombocytopenic purpura, hemolytic uremic syndrome, thrombocytopenia, blackwater fever). Underlying structural heart disease. Preexisting conduction abormalities. Cardiac arrhythmias. Atrial fibrillation or atrial flutter. MI. Hypoglycemia. Hypokalemia. Bradycardia. Severe hepatic impairment: use alternative therapy. Elderly with sick sinus syndrome. Pregnancy (Cat.C). Nursing mothers.
Quinoline (cinchona alkaloids).
Avoid drugs that can prolong QT interval (eg, quinidine, procainamide, disopyramide, amiodarone, sotalol, dofetilide), other CYP3A4 substrates (eg, cisapride, terfenadine, pimozide, halofantrine, quinidine), erythromycin, troleandomycin. Avoid concomitant mefloquine, halofantrine (may cause seizures or ECG changes), rifampin, ritonavir, antacids. Potentiates warfarin, oral anticoagulants, neuromuscular blocking agents (avoid). Potentiated by urinary alkalizers. May potentiate atorvastatin (monitor). May antagonize anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), CYP2D6 substrates (eg, flecainide, metoprolol, paroxetine, dextromethorphan). Increases digoxin levels (monitor). Monitor cimetidine, ranitidine, ketoconazole, tetracycline, theophylline, aminophylline.
Headache, vasodilation, sweating, nausea, tinnitus, hearing impairment, vertigo, dizziness, blurred vision, disturbances in color perception, cardiac rhythm or conduction, vomiting, diarrhea, abdominal pain, deafness, blindness, lupus-like syndrome, blood dyscrasias; rashes (may be serious, eg, Stevens-Johnson), cardiovascular effects (eg, chest pain, AV block, torsades de pointes), hypoglycemia (esp. in pregnancy).
Caps—30, 100, 500, 1000