| Document Date: 2013-04-16 14:57:20
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City Reference / / Company SUSPECTED ADVERSE REACTIONS / Mutual Pharmaceutical Company Inc. / / / Event FDA Phase / / Facility Laboratory Interactions QUALAQUIN / Laboratory Interactions Quinine / / IndustryTerm food / Prevention of malaria / Monitor for signs and symptoms / / MedicalCondition photophobia / hypoprothrombinemia / tremors / ventricular tachycardia / Torsades de Pointes / aphasia / serious cardiac arrhythmias / disseminated intravascular coagulation / myopathy / seizures / esophagitis / coma / Thrombotic thrombocytopenic purpura / Uncomplicated P. falciparum Malaria / toxic epidermal necrolysis / fatal ventricular arrhythmia / uncomplicated Plasmodium falciparum malaria / bullous dermatitis / bradycardia / diarrhea / ataxia / acute dystonic reaction / cardiac arrest / hepatitis / Hypoglycemia / night blindness / asthma / G6PD deficiency receiving quinine / neutropenia / granulomatous hepatitis / abdominal pain / granulomatous hepatitis / fatal cardiac arrhythmias / severe chronic renal impairment / malaria / aches / chills / Carcinogenesis / uncorrected hypokalemia / chronic / neutropenia / cutaneous vasculitis / sick sinus syndrome / hemoglobinuria / renal failure / fever / pancytopenia / aplastic anemia / Serious hypersensitivity / vomiting / hemoglobinuria / ventricular fibrillation / respiratory depression / P. falciparum malaria / Atrial fibrillation / dizziness / deficiency / thrombocytopenic purpura / Chronic renal impairment / acute renal failure / tinnitus / nocturnal leg cramps / allergic contact dermatitis / anaphylactic shock / chest pain / headache / leukopenia / unifocal premature ventricular contractions / gastric irritation / Fatal torsades de pointes / nausea / Thrombocytopenia / muscle weakness / Known hypersensitivity / Stevens-Johnson syndrome / syncope / falciparum malaria / atrioventricular block / deafness / erythema multiforme / tachycardia / hypersensitivity / myoglobinuria / restlessness / hemolytic uremic syndrome / dyspnea / pulmonary edema / lupus / pruritus / thrombocytopenia and hemolytic-uremic syndrome / hearing impairment / agranulocytosis / atrial flutter / blindness / Myasthenia gravis / hypotension / purpura / arrhythmia / hemolytic anemia / angioedema / facial edema / Nocturnal Leg Cramps QUALAQUIN / bronchospasm / petechiae / flushing / disease / Thrombocytopenia Quinine-induced thrombocytopenia / Optic neuritis / acute interstitial nephritis / vertigo / disorientation / apnea / exfoliative dermatitis / immune-mediated disorder / Rhabdomyolysis / asthenia / lupus-like syndrome / acral necrosis / thrombocytopenia and hemolytic uremic syndrome / fixed drug eruption / urticaria / postural hypotension / structural heart disease / acute uncomplicated malaria / uremic syndrome / diplopia / idiopathic thrombocytopenic purpura / active optic neuritis / myocardial ischemia / clinically significant hypoglycemia / acute malaria / / MedicalTreatment Oral contraceptives / antibiotics / / Organization DOSAGE AND ADMINISTRATION / FDA / Concomitant administration / / / Position General / / Product simvastatin / sodium bicarbonate / vitamin K / erythromycin / cimetidine / acetazolamide / phenytoin / FDA-Approved Medication / Theophylline / digoxin / ranitidine / mefloquine / carbamazepine / QUALAQUIN / Isoniazid / rifampin / CL / pancuronium / aminophylline / FDAApproved Medication / Ketoconazole / lovastatin / Cholestyramine / / Technology antibodies / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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• Avoid concomitant use with neuromuscular blocking agents. QUALAQUIN HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use QUALAQUIN® safely and effectively. See ful