| Document Date: 2014-07-11 06:11:20
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Company Novartis Pharmaceuticals Corporation / / Continent Africa / / Country Thailand / / Event FDA Phase / / IndustryTerm prevention of malaria / food/drink / food / food consumption / administration site / chemical / / MedicalCondition acute / uncomplicated malaria infections / HIV / recrudescent P. falciparum infection / headache / symptomatic cardiac arrhythmias / bronchitis / Coartem Tablets System Organ Class Preferred Term General disorders / Uncomplicated P. falciparum Malaria / herpes / impetigo / Known hypersensitivity / hookworm infection / Vomiting Abdominal pain Diarrhea Nausea Infections / clinically relevant bradycardia / acute malaria present / acrodermatitis / Hypersensitivity / constipation / Infections / influenza / respiratory tract infection / asthma / long QT syndrome / nutrition disorders / ataxia / peptic ulcer / General disorders / pneumonia / hyperreflexia / Nervous system disorders / disease / arthralgia / severe cardiac disease / nasopharyngitis / gastroenteritis / malaria / dysphagia / hematuria / Carcinogenesis / infestations Insomnia Palpitations Hepatomegaly Splenomegaly Anemia Cough Pruritus Rash Vertigo Malaria Nasopharyngitis / Plasmodium vivax Infection / vomiting / P. vivax infection / urticaria / severe malaria / angioedema / P. falciparum malaria / infection / dizziness / cough / hypokalemia / Rash / abscess / disorders / acute malaria / / MedicalTreatment birth control / antibiotics / drug therapy / / Organization CYP2D6 Administration of Coartem Tablets / US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / / Person Antimalarials Halofantrine / Coartem Tablets / / / Position Term General / General / / Product Mefloquine / carbamazepine / Administration Instructions Coartem Tablets / The 6-dose Coartem Tablets / DOSAGE FORMS AND STRENGTHS Coartem Tablets / Coartem Tablets / rifampin / phenytoin / levonorgestrel / estradiol / CYP3A4 When Coartem Tablets / Ketoconazole / Plasmodium vivax Infection Coartem Tablets / Renal Impairment Coartem Tablets / Coartem / be used cautiously following Coartem Tablets / / ProvinceOrState Iowa / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Coartem Tablets safely and effectively. See full prescribing information for Coartem Tablets. Coartem (artemether/lu