Thông tin thuốc của Micafungin

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Thông tin thuốc gốc

Chỉ định và Liều dùng

Intravenous
Oesophageal candidiasis

Adult: ≤40 kg: 3 mg/kg once daily; >40 kg: 150 mg once daily. Treatment should be given for at least 1 week after resolution of symptoms. All doses are given via IV infusion over approx 1 hour. Treatment and dosing recommendations may vary among individual products and between countries (refer to local treatment guidelines).
Child: ≥4 months ≤30 kg: 3 mg/kg once daily; >30 kg: 2.5 mg/kg once daily (Max: 150 mg daily). All doses are given via IV infusion over approx 1 hour. Treatment and dosing recommendations may vary among individual products and between countries (refer to local treatment guidelines).

Intravenous
Prophylaxis of candidiasis

Adult: In patients undergoing haematopoietic stem cell transplantation or those who are expected to have neutropenia for 10 days or more: ≤40 kg: 1 mg/kg once daily; >40 kg 50 mg once daily. Treatment should be given for at least 1 week after recovery of neutrophil. All doses are given via IV infusion over approx 1 hour. Treatment and dosing recommendations may vary among individual products and between countries (refer to local treatment guidelines).
Child: In patients undergoing haematopoietic stem cell transplantation or those who are expected to have neutropenia for 10 days or more: <4 months 2 mg/kg once daily; ≥4 months Same as adult dose. Treatment should be given for at least 1 week after recovery of neutrophil. All doses are given via IV infusion over approx 1 hour. Treatment and dosing recommendations may vary among individual products and between countries (refer to local treatment guidelines).

Intravenous
Invasive candidiasis

Adult: For the treatment of candidemia and other Candida infections: ≤40 kg: 2 mg/kg once daily for at least 14 days, may increase to 4 mg/kg once daily if response is inadequate; >40 kg: 100 mg once daily for at least 14 days, may increase to 200 mg once daily if response is inadequate. Continue treatment for at least 1 week after obtaining 2 sequential negative blood cultures and after resolution of symptoms. All doses are given via IV infusion over approx 1 hour. Treatment and dosing recommendations may vary among individual products and between countries (refer to local treatment guidelines).
Child: <4 months 4 mg/kg once daily; may increase up to 10 mg/kg once daily if CNS infection is suspected; ≥4 months Same as adult dose. Continue treatment for at least 1 week after obtaining 2 sequential negative blood cultures and after resolution of symptoms. All doses are given via IV infusion over approx 1 hour. Treatment and dosing recommendations may vary among individual products and between countries (refer to local treatment guidelines).

Hướng dẫn pha thuốc

Adults: Reconstitute vial labelled as 50 mg or 100 mg with 5 mL of NaCl 0.9% or dextrose 5% in water, respectively. Gently swirl to dissolve. Do not shake. Further dilute the reconstituted solution in 100 mL NaCl 0.9% or dextrose 5% in water to a final concentration of 0.5-2 mg/mL. Instructions for reconstitution may vary among individual products and between countries (refer to specific product guidelines).

Chống chỉ định

Hypersensitivity to micafungin or other echinocandin antifungals.

Thận trọng

Patient with pre-existing risk of malignancy caused by severe liver impairment or chronic liver disease (e.g. advanced liver fibrosis, cirrhosis, viral hepatitis, congenital enzyme defects). Severe hepatic impairment. Neonates and children. Pregnancy and lactation.

Tác dụng không mong muốn

Significant: New-onset or worsening hepatic impairment (including hepatitis and hepatic failure); increased BUN, increased serum creatinine, renal dysfunction, acute renal failure; severe anaphylactic reactions (including shock), infusion reactions (e.g. rash, pruritus, facial swelling, vasodilation), exfoliative cutaneous reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis), inj site reactions (e.g. phlebitis, thrombophlebitis). Rarely, haemolysis (including acute intravascular haemolysis or haemolytic anaemia).
Blood and lymphatic system disorders: Leucopenia, neutropenia.
Gastrointestinal disorders: Nausea, abdominal pain, vomiting, diarrhoea.
General disorders and administration site conditions: Fever.
Investigations: Increased AST or ALT, increased blood bilirubin, increased blood alkaline phosphatase.
Metabolism and nutrition disorders: Hypokalaemia, hypomagnesaemia, hypocalcaemia.
Nervous system disorders: Headache.

Phân loại thai kỳ (US FDA)

IV/Parenteral: C

Chỉ số theo dõi

Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to drug resistance risks. Monitor liver function periodically; serum creatinine, BUN, CBC. Assess for signs of infusion reactions (e.g. rash, pruritus, facial swelling, vasodilation).

Tương tác

Increased risk of hepatic abnormalities with hepatotoxic and/or genotoxic drugs. May increase the exposure of conventional amphotericin B, itraconazole, nifedipine and sirolimus.

Tác dụng

Description:
Mechanism of Action: Micafungin is a semisynthetic echinocandin antifungal which non-competitively inhibits 1,3-β-D-glucan synthase, thus decreasing 1,3-β-D-glucan formation (an essential component of the fungal cell wall that is absent in mammalian cells). The reduced glucan content causes osmotic instability and cellular lysis.
Pharmacokinetics:
Distribution: Rapidly distributed into tissues. Volume of distribution: 0.39 ± 0.11 L/kg. Plasma protein binding: >99%, mainly to albumin.
Metabolism: Metabolised in the liver by arylsulfatase into its catechol form (M1) and further metabolised by COMT into its methoxy form (M2). Additionally, undergoes hydroxylation by CYP3A4 isoenzymes into M5.
Excretion: Mainly via faeces (71%); urine (<1%). Elimination half-life: 11-21 hours.

Đặc tính

Chemical Structure Image — **Micafungin**

Bảo quản

Intact vial: Store between 20-25°C. Reconstituted solution and diluted solution: Store at 25°C for up to 24 hours. Protect from light. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Phân loại MIMS

Thuốc kháng nấm

Phân loại ATC

J02AX05 - micafungin ; Belongs to the class of other systemic antimycotics.

Tài liệu tham khảo

Anon. Micafungin (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/02/2024.

Anon. Micafungin Sodium. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 11/08/2023.

Anon. Micafungin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/02/2024.

Buckingham R (ed). Micafungin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/08/2023.

Joint Formulary Committee. Micafungin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/08/2023.

Micafungin 100 mg Powder for Concentrate for Solution for Infusion (Flynn Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 05/12/2024.

Micafungin Injection, Powder, Lyophilized, for Solution (Apotex Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/08/2023.

Micafungin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 24/08/2023.

Mycamine 50 mg/vial Powder for Solution for Infusion (Astellas Pharma Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/08/2023.

Paediatric Formulary Committee. Micafungin. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 07/02/2024.

Seqirus (NZ) Ltd. Mycamine 50 mg and 100 mg Powder for Injection data sheet 22 May 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 11/08/2023.

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