Fusidic Acid

Pharmacologic Category

Antibiotic, Miscellaneous; Antibiotic, Topical

Dosing: Adult

Skin infections: Topical: Apply small amount to affected area 2 to 3 times daily for 7 to 14 days. If a gauze dressing is used, frequency of application may be reduced to once or twice daily.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Skin infections: Children and Adolescents: Topical: Refer to adult dosing.

Use: Labeled Indications

Note: Not approved in the US.

Skin infections: Treatment of primary (eg, impetigo contagiosa, erythrasma) and secondary (eg, infected wounds, infected burns) skin infections caused by susceptible Staphylococcus aureus, Streptococcus spp., Corynebacterium minutissimum

Administration: Topical

For topical use only; do not use near the eyes. Crust of impetigo contagiosa does not need to be removed prior to application of cream or ointment. When indicated, incision and drainage of infected lesions should precede application of the cream or ointment.

Administration: Pediatric

Topical: For topical use only; do not use near the eyes. Crust of impetigo contagiosa does not need to be removed prior to application of cream or ointment. When indicated, incision and drainage of infected lesions should precede application of the cream or ointment.

Storage/Stability

Cream, ointment: Store below 30°C (86°F). Use ointment within 3 months of first opening the tube.

Contraindications

Hypersensitivity to fusidic acid or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Skin reactions: Excipients in the topical cream and ointment may cause local skin reaction (eg, contact dermatitis); discontinue use if irritation or sensitization develops.

• Superinfection: Prolonged use may result in superinfection (including fungal infections). Discontinue use if superinfection occurs; evaluate and treat appropriately.

Other warnings/precautions:

• Appropriate use: Do not use topical cream or ointment near the eye; conjunctival irritation may occur. Supplemental systemic therapy may be necessary for severe or refractory lesions.

Pregnancy Considerations

Adverse effects were not observed in animal reproduction studies. Fusidic acid crosses the placenta following systemic administration. Systemic absorption following topical application is minimal.

Breast-Feeding Considerations

It is not known if fusidic acid is present in breast milk following topical application.

Fusidic acid is present in breast milk following systemic administration; however, systemic absorption following topical application is minimal. Topical fusidic acid has been evaluated for Staphylococcus aureus impetigo infection in breastfeeding patients with sore, cracked nipples; fusidic acid was not effective for systemic infection that may lead to mastitis (Livingstone 1999).

Adverse Reactions

Frequency not defined: Central nervous system: Pain (with treatment of deep leg ulcers)

Postmarketing and/or case reports: Anaphylaxis (Park 2013), angioedema, application site irritation, application site pain, conjunctivitis, dermatitis, erythema, hypersensitivity reaction, pruritus, skin blister, skin irritation, skin rash, urticaria

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Product Availability

Not available in the US

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Fucidin: 2% (5 g, 30 g)

Ointment, External:

Fucidin: 2% (5 g, 30 g)

Anatomic Therapeutic Chemical (ATC) Classification

• D06AX01
• D09AA02

Generic Available (US)

Yes

Mechanism of Action

Inhibits protein synthesis by blocking aminoacyl-tRNA transfer to protein in susceptible bacteria.

Pharmacodynamics/Kinetics

Absorption: ~2% (Fucidin H Canadian product labeling 2014)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Fusidate Sodium; Fusidic Acid Hemihydrate; Sodium Fusidate

References

Fucidin (fusidic acid) [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; July 2017.

Fucidin H (fusidic acid/hydrocortisone acetate) [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; August 2014.

Livingstone V, Stringer LJ. The treatment of Staphylococcus aureus infected sore nipples: a randomized comparative study [published correction appears in: J Hum Lact 2000;16(2):179.]. J Hum Lact. 1999;15(3):241-246. doi: 10.1177/089033449901500315.[PubMed 10578803]

Park MR, Kim DS, Kim J, Ahn K. Anaphylaxis to topically applied sodium fusidate [published online November 2, 2012]. Allergy Asthma Immunol Res. 2013;5(2):110-112.[PubMed 23450038]

Brand Names: International

Acdat (ID); Aceler (MX); Affusine (NL); Afucid (ID); Balad (AE, BH, QA); Defuzin (HK, MY); Difusin (TH); Disuf (HK); Facid (BD); Foban (ET, HK, ID, SG); Fucid (PH); Fucidin (AE, AR, AT, BB, BE, BH, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EE, EG, FI, FR, GB, GR, GT, HK, HN, HU, ID, IE, IL, IS, IT, JO, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NI, NL, NO, PA, PE, PH, PK, PL, PY, QA, RU, SA, SE, SI, SK, SV, TH, TR, TW, UY, VN, ZA); Fucidin Topical (AU, NZ); Fucidine (ES); Fucimycin (TW); Fucinex (PH); Fudion (ET); Fulosin (TW); Fusacid (HR, PL); Fusate (BD); Fusicutan (CH, DE); Fusid (LK, TH); Fusidane (PH); Fusidate (BD); Fusiderm (BH); Fusigra (ID); Fusitop (EC); Fuson (ID, PH); Fustadin (MY); Germacid (MY); Germidic (TH); Iretien (PY); Klinidox (CO); Niofen (PE); Nopetigo (LK); Phudicin (CN, HK); Stafoban (PH); Topidic (ET); Uniderm (CO, MX); Verof (BR); Verutex (BR); Woncare (PH); Zeta (AE, BH, JO, KW, LB, QA, SA)

Last Updated 8/28/20