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Artesun

Artesun Special Precautions

artesunate

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma
Full Prescribing Info
Special Precautions
Non-falciparum malaria: Artesunate has not been evaluated in the treatment of severe malaria due to Plasmodium vivax, Plasmodium malariae or Plasmodium ovale.
Resistance to antimalarials: Local inflammation on the prevalence of resistance to antimalarials should be considered in choosing the appropriate combination antimalarial regimen for use with Artesun (see Dosage & Administration).
Post-treatment haemolytic anaemia: Delayed haemolytic anemia following treatment with injectable artesunate has been observed in children in malaria endemic areas and in non-immune travelers presenting with severe falciparum malaria. The risk was most pronounced in patients with hyperparasitaemia and in younger children. Given the persistent uncertainties regarding the risk of delayed hemolysis, a minimum follow-up should be strictly observed until day 28 (see Adverse Reactions).
Hepatic/renal impairment: Data regarding artesunate pharmacokinetics in patients with hepatic and/or renal impairment are limited. Based on data from studies in patients with severe malaria, as well as the known metabolism of artesunate (see Pharmacology: Pharmacokinetics under Actions), dosage adjustment is not considered necessary in patients with hepatic or renal impairment.
Effects on ability to drive and use of machines: There is no information on the effect of artesunate on the ability to drive or use machines. The patient's clinical status should be considered when assessing ability to drive or operate machinery.
Use in Children: In clinical trials, the efficacy and safety of intravenous and intramuscular artesunate have been similar in adult and paediatric populations.
There is no clinical data available for infants weighing below 5 kg and adults weighing over 100 kg.
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