Adult: As conventional amphotericin B: Test dose 1 mg infused over 20-30 minutes. Then, initially, 0.25 mg/kg daily, gradually increase to 1 mg/kg daily, according to response and tolerance. In seriously ill patients, gradually increase dose up to a total of 1.5 mg/kg daily or on alternate days. Doses are given via slow infusion over 2-6 hours. Max total daily dose: 1.5 mg/kg. If treatment is interrupted for more than 7 days, restart at 0.25 mg/kg daily and increase slowly. As liposomal amphotericin B: Test dose 1 mg infused over 10 minutes, then 3 mg/kg once daily given via infusion over 30-60 minutes. Max: 5 mg/kg daily. As amphotericin B lipid complex: In patients not responding to conventional amphotericin B or to other antifungal drugs: Test dose 1 mg infused over 15 minutes, then 5 mg/kg once daily via infusion at a rate of 2.5 mg/kg/hour. Duration of treatment: At least 14 days.
Intravenous Visceral leishmaniasis
Adult: As liposomal amphotericin B: A total dose of 21-30 mg/kg via infusion given over 10-21 days.
Intravenous Fungal infection
Adult: As empiric treatment of presumed infection in febrile neutropenic patients: As liposomal amphotericin B: Test dose 1 mg infused over 10 minutes, then 3 mg/kg once daily given via infusion over 30-60 minutes. Max: 5 mg/kg daily.
Oral Oral candidiasis
Adult: As lozenge: Dissolve 1 lozenge in the mouth 4 times daily for 7-14 days.
Reconstitution
Conventional amphotericin B lyophilised powder for IV infusion: Reconstitute a 50 mg vial with 10 mL sterile water for inj (without preservatives) to a concentration of 5 mg/mL; for the infusion, further dilute the reconstituted solution with dextrose 5% in water (pH >4.2) to a final concentration of up to 0.1 mg/mL. Amphotericin B lipid complex suspension for IV infusion: Shake the vial until there is no yellow sediment at the bottom. Withdraw the required dose from the vial, attach the supplied 5-micron filter needle and inject into a correct volume of dextrose 5% in water to a final concentration of 1 mg/mL, or 2 mg/mL for children and patients with CV disease. Liposomal amphotericin B lyophilised powder for IV infusion: Reconstitute a 50 mg vial with 12 mL sterile water for inj (without preservatives) to a 4 mg/mL concentration; vigorously shake the vial for 30 seconds. For the infusion, withdraw the required dose from the vial, attach the supplied 5-micron filter then further inject into a correct volume of dextrose 5% in water to a final concentration of 1-2 mg/mL. To provide sufficient volume for infusion, a lower final concentration (0.2-0.5 mg/mL) may be appropriate for infants and small children. Recommendations for reconstitution, dilution and concentration may vary among individual products and countries (refer to detailed product guidelines).
Incompatibility
Incompatible with NaCl 0.9% or electrolyte solutions as precipitation may occur.
Contraindications
Hypersensitivity.
Special Precautions
Patient receiving leucocyte transfusion. Lipid-based (lipid complex, liposomal) amphotericin B and conventional amphotericin B (Na deoxycholate) formulations should not be used interchangeably since the dosing recommendations and pharmacokinetic and pharmacodynamic properties are not equivalent; verify the product and dosage before administration. Renal impairment. Neonates. Pregnancy and Lactation.
Monitor renal function frequently during therapy; BUN and serum creatinine every other day while tapering doses and weekly thereafter; electrolytes, primarily K, Mg; LFT, CBC, prothrombin time and partial thromboplastin time (PT/PTT), temperature, input and output. Monitor for signs of hypokalaemia.
Overdosage
Symptoms: Potentially fatal cardiac or cardiopulmonary arrest. Management: Symptomatic and supportive treatment.
Drug Interactions
May potentiate nephrotoxicity with nephrotoxic drugs (e.g. ciclosporin). Increased risk of hypotension, bronchospasm, and nephrotoxicity with antineoplastics. Increased risk of hypokalaemia with corticosteroids, corticotropin, loop and thiazide diuretics. May increase the toxicity of flucytosine and digitalis. May enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine).
Lab Interference
Liposomal amphotericin B: May cause falsely elevated serum phosphate result using PHOSm assay.
Action
Description: Mechanism of Action: Amphotericin B is a polyene antifungal antibiotic which interferes with cell membrane permeability by binding to ergosterol, thereby causing intracellular content leakage and eventually cell death. Pharmacokinetics: Absorption: Little to no absorption from the gastrointestinal tract. Time to peak plasma concentration: Within 1 hour after a 4- to 6-hour dose (conventional). Distribution: Crosses the placenta. Distributed in the aqueous humour, bile, pericardial fluid, pleural fluid, and synovial fluid (conventional); high concentration in the liver, spleen, and lung (lipid complex). Volume of distribution: 0.1-0.16 L/kg (liposomal); 4 L/kg (conventional); 131 L/kg (lipid complex). Plasma protein binding: 90% (conventional). Excretion: Via urine (2-5% as biologically active form [conventional]; 0.9% [lipid complex]). Elimination half-life: 15 days (conventional); 7-10 hours (liposomal); 173 hours (lipid complex).
Chemical Structure
Amphotericin B Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5280965, Amphotericin B. https://pubchem.ncbi.nlm.nih.gov/compound/Amphotericin-B. Accessed Aug. 22, 2023.
Storage
Lozenge: Store below 25°C. Intact vial (conventional amphotericin B, amphotericin B lipid complex): Store between 2-8°C. Protect from light. Do not freeze. Reconstituted conventional amphotericin B solution: Stable for not more than 8 hours when stored at room temperature or for 24 hours when stored between 2-8°C. Protect from light. Diluted amphotericin B lipid complex solution: Stable for 48 hours when stored between 2-8°C and for an additional 6 hours at room temperature. Do not freeze. Intact vial (liposomal amphotericin B): Store below 25°C. Reconstituted liposomal amphotericin B solution: Stable for 24 hours when stored between 2-8°C. Do not freeze. Storage and stability recommendations may vary between individual products or countries (refer to detailed product guidelines).
J02AA01 - amphotericin B ; Belongs to the class of antibiotics. Used in the systemic treatment of mycotic infections. A01AB04 - amphotericin B ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
References
Hope WW, Castagnola E, Groll AH et al. ESCMID* Guideline for the Diagnosis and Management of Candida Diseases 2012: Prevention and Management of Invasive Infections in Neonates and Children Caused by Candida spp. Clinical Microbiology and Infection. 2012;18(Suppl. 7):38-52. doi: 10.1111/1469-0691.12040. Accessed 01/08/2023Pappas PG, Kauffman CA, Andes DR et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases. 2016 Feb;62(4):e1-50. doi: 10.1093/cid/civ933. Accessed 01/08/2023Abelcet 100 mg (Leadiant Biosciences, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/08/2023.Abelcet Lipid Complex 5 mg/mL Concentrate for Dispersion for Infusion (Teva Pharma B.V.). MHRA. https://products.mhra.gov.uk. Accessed 01/08/2023.AmBisome Injection, Powder, Lyophilized, for Solution (Astellas Pharma US, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/08/2023.AmBisome Liposomal 50 mg Powder for Dispersion for Infusion (Gilead Sciences International Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/08/2023.Amphostal 50 mg Powder for Sterile Concentrate (Stallion Laboratories PVT. LTD.). MIMS Philippines. http://www.mims.com/philippines. Accessed 07/09/2020.Amphotericin B Injection, Powder, Lyophilized, for Solution (XGen Pharmaceuticals DJB, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/08/2023.Amphotericin B Lipid Complex (ABLC). Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 08/05/2023.Amphotericin B Liposomal (LAmB). Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 08/05/2023.Amphotericin B. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 08/05/2023.Anon. Amphotericin B (Conventional). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/09/2020.Anon. Amphotericin B (Lipid Complex) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2023.Anon. Amphotericin B (Lipid Complex). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/09/2020.Anon. Amphotericin B (Liposomal) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2023.Anon. Amphotericin B (Liposomal). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/09/2020.Anon. Amphotericin B Deoxycholate (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2023.Anon. Amphotericin B. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/05/2023.Buckingham R (ed). Amphotericin B. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/08/2023.Fungizone 50 mg Powder for Sterile Concentrate (CHEPLAPHARM Arzneimittel GmbH). MHRA. https://products.mhra.gov.uk. Accessed 04/09/2020.Joint Formulary Committee. Amphotericin B. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/09/2020.Paediatric Formulary Committee. Amphotericin B. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 01/08/2023.
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