Generic Medicine Info
Hypersensitivity to artesunate.
Special Precautions
Patient with cardiac and gastrointestinal disease. Hepatic and renal impairment. Children. Pregnancy and lactation. Monitoring Parameters Monitor for signs and symptoms of hypersensitivity and cardiotoxicity (high doses); Hb, reticulocyte count, haptoglobin, lactate dehydrogenase and total bilirubin once weekly for up to 4 weeks after treatment initiation. Monitor for evidence of haemolytic anaemia for 4 weeks after therapy. Consider performing direct antiglobulin test to determine if therapy for immune-mediated haemolysis is needed.
Adverse Reactions
Significant: Haemolysis, severe haemolytic anaemia, hypersensitivity (including anaphylaxis). Ear and labyrinth disorders: Tinnitus. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, taste alteration (metallic/bitter taste). General disorders and administration site conditions: Asthenia, pancreatitis, fever, fatigue, malaise, inj site pain. Hepatobiliary disorders: Jaundice. Musculoskeletal and connective tissue disorders: Muscle pain, arthralgia. Nervous system disorders: Ataxia, balance impairment, restlessness, tremor, dizziness, headache, paresis. Psychiatric disorders: Confusion. Renal and urinary disorders: Haemoglobinuria, acute renal failure. Respiratory, thoracic and mediastinal disorders: Cough, nasal symptoms. Skin and subcutaneous tissue disorders: Pruritus, rash.
Drug Interactions
May decrease dihydroartemisinin (DHA) plasma concentration thus reduce efficacy of artesunate with ritonavir, nevirapine or UDP-glucuronosyltransferase (UGT) inducers (e.g. rifampicin, carbamazepine, phenytoin). May increase DHA plasma concentration thereby increase the risk of side effects with UGT inhibitors (e.g. axitinib, vandetanib, imatinib, diclofenac).
CIMS Class
ATC Classification
P01BE03 - artesunate ; Belongs to the class of artemisinin and derivative antimalarials.
Disclaimer: This information is independently developed by CIMS based on artesunate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by
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