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CONTRA-INDICAÇÕES COARTEM

Coartem treatment is contraindicated during the first trimester of pregnancy. During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus. Coartem is contraindicated in those with hypersensitivity to the active substances or any of the excipients, in cases of severe malaria, in the first trimester of pregnancy (see precautions), cardiac arrhythmia, bradycardia, severe cardiac diseases, QTc prolongation, family history of sudden death, disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia. Concomitant use of drugs that are known to be metabolised by cytochrome enzyme CYP2D6 or drugs that are known to prolong the QTc interval. Coartem is not indicated for prophylaxis, or for treating severe malaria, including cerebral malaria, or malaria with pulmonary oedema or renal failure. Coartem is not indicated for and has not been evaluated in, the treatment of malaria due to P. vivax, P. malariae or P. ovale. Coartem is active against the blood stages of P. vivax, but is not active against hypnozoites. Therefore, an 8- amino-quinoline derivative such as primaquine should be given sequentially after Coartem in cases of mixed infections of P. falciparum and P. vivax to achieve hypnozoites eradication.