Adult: For the treatment of candidaemia and other invasive Candida infections (intra-abdominal abscess and peritonitis): 200 mg as a single loading dose on Day 1, followed by 100 mg once daily. Doses are given via IV infusion at a rate not exceeding 1.1 mg/min. Treatment duration must be based on patient's clinical response. Continue treatment for at least 14 days after the last positive culture. Child: ≥1 month 3 mg/kg (Max: 200 mg) as a single loading dose on Day 1, followed by 1.5 mg/kg (Max: 100 mg) once daily. Doses are given via IV infusion at a rate not exceeding 1.1 mg/min. Treatment duration must be based on patient's clinical response. Continue treatment for at least 14 days after the last positive culture. Treatment recommendations may vary among individual products and between countries (refer to specific product or local guidelines).
Intravenous Oesophageal candidiasis
Adult: 100 mg as a single loading dose on Day 1, followed by 50 mg once daily. Doses are given via IV infusion at a rate not exceeding 1.1 mg/min. Treatment duration must be based on patient's clinical response. Continue treatment for at least 14 days and for at least 7 days after resolution of symptoms.
Hướng dẫn pha thuốc
Reconstitute vial labelled as 50 mg or 100 mg with 15 mL or 30 mL of sterile water for inj, respectively, to achieve a concentration of 3.33 mg/mL. Further dilute the reconstituted 50 mg or 100 mg vial with 50 mL or 100 mL, respectively, of only NaCl 0.9% or dextrose 5% in water to a final concentration of 0.77 mg/mL. In children, the required volume of infusion solution will vary depending on the patient's weight. Refer to specific product guidelines for further information.
Chống chỉ định
Hypersensitivity to anidulafungin or other echinocandin antifungals (e.g. caspofungin, micafungin).
Thận trọng
Children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Severe hypersensitivity reactions (including anaphylactic reactions and shock); infusion-related reactions (e.g. dyspnoea, hypotension, bronchospasm, flushing, pruritus, urticaria, rash); hepatic effects (including elevated LFTs, significant hepatic dysfunction, hepatitis, and hepatic failure). Blood and lymphatic system disorders: Thrombocythaemia, anaemia, leucocytosis, coagulopathy, thrombocytopenia. Cardiac disorders: Chest pain, atrial fibrillation, ventricular extrasystole, sinus arrhythmia, right bundle branch block. Eye disorders: Blurred vision, visual disturbance, eye pain. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, constipation, upper abdominal pain, oral candidiasis, Clostridium colitis. General disorders and administration site conditions: Fever, infusion site pain. Hepatobiliary disorders: Cholestasis. Infections and infestations: Bacteraemia. Investigations: Increased blood creatinine, increased blood urea; ECG abnormality (including prolonged QT interval). Metabolism and nutrition disorders: Hypokalaemia, hyperglycaemia, hyperkalaemia, hypomagnesaemia, hypercalcaemia, hypernatraemia, dehydration, peripheral oedema. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache, convulsion. Psychiatric disorders: Insomnia, depression, confusion. Renal and urinary disorders: UTI. Respiratory, thoracic and mediastinal disorders: Pleural effusion, cough, respiratory distress. Skin and subcutaneous tissue disorders: Decubitus ulcer. Vascular disorders: DVT, hypertension.
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to drug resistance risks. Monitor LFTs; signs and symptoms of anaphylaxis or infusion reactions (e.g. dyspnoea, hypotension, bronchospasm, flushing, pruritus, urticaria, rash).
Tác dụng
Description: Mechanism of Action: Anidulafungin is a semi-synthetic echinocandin antifungal agent. It selectively inhibits 1,3-β-D glucan synthase resulting in decreased formation of 1,3-β-D glucan, an essential component of the fungal cell wall. This action causes osmotic instability and cellular lysis. Pharmacokinetics: Distribution: Volume of distribution: 30-50 L. Plasma protein binding: >99%. Metabolism: Undergoes slow chemical hydrolysis to inactive peptide degradants. Excretion: Via faeces (approx 30%; <10% as unchanged drug); urine (<1%). Terminal elimination half-life: 40-50 hours.
Đặc tính
Anidulafungin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 166548, Anidulafungin. https://pubchem.ncbi.nlm.nih.gov/compound/Anidulafungin. Accessed Oct. 24, 2023.
Bảo quản
Intact vial: Store between 2-8°C. May be exposed to temperatures up to 25°C for 96 hours and the vial may be returned to refrigerated storage (2-8°C). Do not freeze. Reconstituted solution: May store at up to 25°C for up to 24 hours. Infusion solution: May store at up to 25°C for 48 hours. Do not freeze.
J02AX06 - anidulafungin ; Belongs to the class of other systemic antimycotics.
Tài liệu tham khảo
Anidulafungin 100 mg Powder for Concentrate for Solution for Infusion (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/10/2023.Anon. Anidulafungin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 23/08/2023.Anon. Anidulafungin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 16/10/2023.Buckingham R (ed). Anidulafungin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/10/2023.Eraxis 100 mg for Injection (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 23/08/2023.Eraxis 100 mg Lyophilized Powder for Injection (Pfizer, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 23/08/2023.Eraxis Injection, Powder, Lyophilized, for Solution (Roerig). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/08/2023.Joint Formulary Committee. Anidulafungin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/08/2023.
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