Adult: As sodium fusidate: Patients weighing <50 kg: 6-7 mg/kg tid; ≥50 kg: 500 mg tid. Doses are given via infusion through central line over 2 hours or through a superficial vein over at least 6 hours. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines). Child: Same as adult dose. Dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Ophthalmic Bacterial ophthalmic infections
Adult: In cases caused by susceptible organisms, including bacterial conjunctivitis, blepharitis, stye, and keratitis: As 1% eye drops: Instil 1 drop into the conjunctival sac of the eye bid. Continue treatment for at least 48 hours after the eye returns to normal. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines). Child: Same as adult dose. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Oral Skin and soft tissue infections
Adult: As sodium fusidate tab: 250 mg bid. In severe cases, dose may be doubled or suitable combined therapy may be used. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Adult: As sodium fusidate tab: 500 mg tid. In severe cases, dose may be doubled or suitable combined therapy may be used. As 250 mg/5 mL fusidic acid suspension: 750 mg (15 mL) tid. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines). Child: As 250 mg/5 mL fusidic acid suspension: <1 year 50 mg (1 mL)/kg daily divided into 3 equal doses; 1-5 years 250 mg (5 mL) tid; >5-12 years 500 mg (10 mL) tid; >12 years Same as adult dose. As sodium fusidate tab: >12 years Same as adult dose. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Topical/Cutaneous Skin infections
Adult: For the treatment of primary (e.g. erythrasma, impetigo contagiosa, sycosis barbae, paronychia, folliculitis) and secondary (e.g. infected wounds) skin infections caused by susceptible organisms: As 2% fusidic acid cream or 2% sodium fusidate ointment: Apply to the affected area 2-3 times daily, usually for 7 days. Alternatively, apply to the affected area 3-4 times daily. Frequency of applications may be reduced if gauze dressing is used. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines). Child: Frequency of application or treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Administration
Should be taken on an empty stomach. Food may reduce fusidic acid's absorption. Oral susp: Shake well before use.
Reconstitution
IV infusion: Reconstitute vial labelled as 500 mg sodium fusidate with 10 mL of the provided diluent. Further dilute with 500 mL of NaCl 0.9% or other suitable IV solution (e.g. dextrose 5% in water).
Incompatibility
IV: Incompatible with solutions containing dextrose 20% or more, lipid infusions, and peritoneal dialysis fluids. Infusion solutions with a pH of <7.4 may cause precipitation of fusidic acid. Not for concomitant infusion with amino acid solutions or in whole blood.
Contraindications
Hypersensitivity to fusidic acid or its salts. Concomitant use with HMG-CoA reductase inhibitors.
Special Precautions
Patient with impaired transport or metabolism of bilirubin, biliary disease, biliary tract obstruction. Oral tab and oral suspension are not bioequivalent; refer to specific product guidelines prior to administration. Patient taking drugs with similar biliary excretion pathway (e.g. clindamycin, rifampicin). Hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hepatobiliary disorders (e.g. elevated liver enzymes, jaundice, hyperbilirubinaemia); contact sensitisation (prolonged or recurrent topical use). Blood and lymphatic system disorders: Pancytopenia, leucopenia, thrombocytopenia, anaemia. Eye disorders: Transient blurred vision, burning or stinging sensation of the eye, eyelid oedema, increased lacrimation (ophthalmic). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain or discomfort, dyspepsia. General disorders and administration site conditions: Asthenia, fatigue, lethargy; malaise (IV); application site pruritus or discomfort (ophthalmic); application site pain or irritation (ophthalmic/topical). Immune system disorders: Anaphylactic reaction or shock. Nervous system disorders: Headache, somnolence; dizziness (IV). Renal and urinary disorders: Renal failure. Skin and subcutaneous tissue disorders: Urticaria, rash, acute generalised exanthematous pustulosis, angioedema, erythema, pruritus. Vascular disorders: Venous spasm, thrombophlebitis (IV). Potentially Fatal: Drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), rhabdomyolysis.
Patient Counseling Information
Ophthalmic: Contact lenses must not be worn during treatment with fusidic acid.
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Regularly monitor LFTs with prolonged use or when high doses are used; in patients with abnormal liver function or biliary tract obstruction; and in patients concomitantly receiving hepatotoxic agents or agents with hepatobiliary excretion. Assess for signs and symptoms of cutaneous reactions (e.g. DRESS, TEN, SJS).
Overdosage
Symptoms: Gastrointestinal disturbances and possible effects on liver function. Management: Symptomatic and supportive treatment.
Drug Interactions
Concurrent administration of HIV protease inhibitors (e.g. ritonavir, saquinavir) and systemic fusidic acid may cause increased plasma concentrations of both drugs, which may lead to hepatotoxicity. May increase the plasma concentration and potentiate the therapeutic effect of oral anticoagulants (e.g. warfarin or other coumarin derivatives). Potentially Fatal: Increased risk of rhabdomyolysis with HMG-CoA reductase inhibitors.
Food Interaction
Food reduces the rate and extent of absorption of fusidic acid.
Action
Description: Mechanism of Action: Fusidic acid, including its salts, is an antibiotic that possesses antibacterial activity against a wide range of gram-positive organisms, particularly Staphylococcus aureus. It prevents protein synthesis by inhibiting the transfer of aminoacyl-transfer RNA (tRNA) to protein in susceptible bacteria. Pharmacokinetics: Absorption: Well absorbed in the gastrointestinal tract. Reduced rate and extent of absorption with food. Bioavailability: Tab: Approx 90%. Oral susp: Approx 70% compared to tab. Time to peak plasma concentration: 2-4 hours (tab). Distribution: Widely distributed into the tissues and body fluids, including bone, synovial fluids, and pus; penetrates cerebral abscesses, but penetrates poorly to CSF; penetrates intact skin and well into the aqueous humour. Crosses the placenta and enters breast milk. Plasma protein binding: 91-98%. Metabolism: Extensively metabolised in the liver. Excretion: Mainly via bile (as metabolites); faeces (2% as unchanged drug); urine (small amounts or negligible). Elimination half-life: Approx 9-29 hours; may be dose-dependent.
Chemical Structure
Fusidic acid Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3000226, Fusidic Acid. https://pubchem.ncbi.nlm.nih.gov/compound/Fusidic-Acid. Accessed Apr. 28, 2024.
Storage
Tab/Oral susp/Cream/Ointment: Store below 30°C. Intact IV vials: Store between 2-8°C. Diluted solutions for infusion are stable for at least 24 hours at room temperature. Ophthalmic drops: Store between 2-25°C. Storage recommendations may vary between products (refer to specific product guidelines).
S01AA13 - fusidic acid ; Belongs to the class of antibiotics. Used in the treatment of eye infections. D06AX01 - fusidic acid ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases. J01XC01 - fusidic acid ; Belongs to the class of steroid antibacterials. Used in the systemic treatment of infections.
References
AFT Pharmaceuticals Ltd. Foban 2% Cream & Foban 2% Ointment data sheet February 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 03/04/2023.AFT Pharmaceuticals Ltd. Fucithalmic 1% w/w Viscous Eye Drops data sheet December 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 03/04/2023.Anon. Fusidic Acid (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/02/2024.Anon. Fusidic Acid (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/02/2024.Anon. Fusidic Acid (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/02/2024.Buckingham R (ed). Fusidic Acid. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2023.Foban Cream and Ointment (HOE Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/02/2024.Fucidin 2% Topical Ointment (Getz Bros. Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 03/04/2023.Fucidin 250 mg Film-coated Tablet (Getz Bros. Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 03/04/2023.Fucidin 250 mg Tablets (Leo Laboratories Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/04/2023.Fucidin 250 mg/5 mL Oral Suspension (Leo Laboratories Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/04/2023.Fucidin 50 mg/mL (Getz Bros. Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 03/04/2023.Fucithalmic Viscous Eye Drops (DKSH Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/02/2024.Fuderm 2% w/w Cream (Winwa Medical Sdn. Bhd.). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 03/04/2023.Fusate 250 mg Tablet (Noripharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/02/2024.Fusidic Acid 20 mg/g Cream (Focus Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 03/04/2023.Fusithalmic 1% w/w Viscous Eye Drops (Amdipharm UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 19/02/2024.Joint Formulary Committee. Fusidic Acid. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2023.Leo Pharma Ltd. Fucidin 250 mg Tablets data sheet 27 April 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 03/04/2023.Sodium Fusidate 500 mg for Intravenous Infusion (Essential Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/04/2023.Vaxcel Sodium Fusidate 500 mg Injection (Kotra Pharma [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/02/2024.
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