NAME OF THE MEDICINAL PRODUCT Artesunate Amodiaquine Winthrop® 25mg/67.5mg tablets Artesunate, amodiaquine Artesunate Amodiaquine Winthrop® 50mg/135mg tablets Artesunate, amodiaquine Artesunate Amodiaquine Winthrop® 100mg/270mg tablets Artesunate, amodiaquine Special warnings and precautions for use ARTESUNATE AMODIAQUINE WINTHROP should not be used in regions where amodiaquine resistance is widespread, as the treatment with the combination under such conditions may mean effectively a treatment with artesunate alone with an insufficient duration and decreased plasma concentrations as compared to artesunate alone (see section “Interaction with other medicinal products”). As a result, the risk of development of resistance of P.falciparum to artesunate increases significantly. Amodiaquine is effective against some chloroquine-resistant strains of P.falciparum, although there is cross-resistance. ARTESUNATE AMODIAQUINE WINTHROP has not been evaluated for the treatment of complicated malaria and is therefore not recommended. ARTESUNATE AMODIAQUINE WINTHROP has not been evaluated in the treatment of malaria due to Plasmodium vivax, Plasmodium malariae or Plasmodium ovale and is therefore not recommended. ARTESUNATE AMODIAQUINE WINTHROP has not been evaluated for malaria prophylaxis. The use of amodiaquine for prophylaxis results in an unacceptably high risk of agranulocytosis and liver toxicity and is contraindicated. Therefore, the combination of amodiaquine and artesunate is also contraindicated for malaria prophylaxis (see section “Contraindications”). It is not known, whether the toxicity of amodiaquine, observed with prophylactic use (i.e. agranulocytosis, hepatotoxicity), may also develop after repeated cycles of curative treatment. ARTESUNATE AMODIAQUINE WINTHROP has not been studied specifically in patients with thalassaemia, sickle cell anaemia or G6PD deficiency. In the absence of specific clinical studies, caution should be exercised in patients with renal or hepatic impairment. Symptoms suggestive of the following diseases should be carefully monitored: • Hepatitis, pre-icteric phase and especially when jaundice has developed, • Agranulocytosis (as suggested, for instance, by a clinical condition including fever and/or tonsillitis and/or mouth ulcers). When these symptoms develop or exacerbate during the course of therapy with ARTESUNATE AMODIAQUINE WINTHROP, laboratory tests for liver function and/or blood cell counts should be performed at once. Immediate discontinuation of treatment may be required. In such cases, continuation of treatment with amodiaquine increases the risk of death.
Posted on: Tue, 13 Jan 2015 04:23:50 +0000
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