Fusidic Acid + Betamethasone

Pharmacologic Category

Antibiotic, Topical; Corticosteroid, Topical

Dosing: Adult

Corticosteroid-responsive dermatoses with secondary infection: Topical: Apply twice daily to affected area. Treatment should generally not exceed 14 days.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Pediatric

Corticosteroid-responsive dermatoses with secondary infection: Children ≥6 years and Adolescents: Refer to adult dosing; avoid large amounts, occlusion, or long-term use

Use: Labeled Indications

Corticosteroid-responsive dermatoses with secondary infection: Treatment of corticosteroid-responsive inflammatory dermatoses with suspected or confirmed secondary bacterial infection caused by Staphylococcus aureus, including atopic eczema, discoid eczema, stasis eczema, and seborrheic eczema

Administration: Topical

For topical use only; do not use near the eyes.

Administration: Pediatric

Topical: For external use only. Apply sparingly to affected areas. Not for use on broken skin or in areas of infection. Wash hands after use. Do not use near the eyes.

Storage/Stability

Store at or below 25°C (77°F); discard 3 months after opening.

Medication Safety Issues

​Pediatric patients: High-risk medication:

Contraindications

Hypersensitivity to fusidic acid, betamethasone, or any component of the formulation; primary bacterial, viral, or fungal skin infections; systemic fungal infections; skin manifestations in relation to tuberculosis or syphilis; perioral dermatitis; acne rosacea; eruption after vaccinations

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses, use over prolonged periods, or use with an occlusive dressing, including diapers.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or activate latent infection.

• Ocular effects: Topical corticosteroids, including betamethasone, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular symptoms. Avoid contact with eyes.

• Skin reactions: Local skin reactions may occur (eg, skin atrophy, contact dermatitis, dermatitis acneiform, perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis, depigmentation, and ecchymosis); may be more likely to occur with prolonged use.

• Superinfection/antibiotic resistance: Prolonged use may result in superinfection (including fungal infections) or antibiotic resistance. Discontinue use if superinfection occurs; evaluate and treat appropriately. Limiting use to ≤14 days at a time may minimize risk of developing resistance.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, application to large surface areas, or use on the face, scalp, axillae, and scrotum.

Special populations:

• Pediatrics: Avoid long-term use, large amounts, and occlusion in infants and children; children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression and Cushing syndrome have been reported in children receiving topical corticosteroids. Use lowest dose possible for shortest period of time to avoid systemic effects.

Dosage form specific issues:

• Cream: May contain methyl and propyl parahydroxybenzoate (E218 and E216), cetostearyl alcohol, and potassium sorbate, which may cause local skin reactions (eg, contact dermatitis) or allergic skin reactions.

Other warnings/precautions:

• Appropriate use: Do not use near the eye; increased intra-ocular pressure, cataract, or glaucoma may occur. Long-term continuous use should be avoided in particular on the face, on flexures, and intertriginous areas, and in infants and children.

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. See individual agents.

Breast-Feeding Considerations

Fusidic acid and betamethasone are present in breast milk. The manufacturer recommends that use should only be considered if the potential benefit to the mother outweigh the risk to the infant. Do not apply to breast. See individual agents.

Briggs' Drugs in Pregnancy & Lactation

• Betamethasone

Adverse Reactions

Also see individual agents.

<1%, postmarketing, and/or case reports: Application site edema, application site irritation, application site pain, application site vesicles, burning sensation of skin, contact dermatitis, erythematous rash, exacerbation of eczema, hypersensitivity reaction, pruritus, skin rash, urticaria, xeroderma

Allergy and Idiosyncratic Reactions

• Corticosteroid Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Test Interactions

May suppress the wheal and flare reactions to skin test antigens

Monitoring Parameters

Adrenal suppression with extensive/prolonged use; response to treatment; ocular changes

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:

Fucibet: Fusidic acid 2% and betamethasone valerate 0.1% (15 g, 30 g) [contains cetostearyl alcohol, methylparaben, propyl parahydroxybenzoate]

Anatomic Therapeutic Chemical (ATC) Classification

• D07CC01

Generic Available (US)

Yes

Mechanism of Action

See individual agents.

Pharmacodynamics/Kinetics

See individual agents.

Related Information

• Betamethasone (Topical)
• Fusidic Acid (Topical)

Index Terms

Betamethasone and Fusidic Acid; Betamethasone Valerate and Fusidic Acid; Fusidic Acid and Betamethasone Valerate

References

Fucibet (fusidic acid and betamethasone valerate) [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; April 2018.

Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191.[PubMed 32265601]

Brand Names: International

Aceler-Co (CR, DO, GT, HN, MX, NI, PA, SV); Acifusion B (AR); Defuzin-B (HK, MY); Dermorutex B (BR); Disuf-B (HK); Drum B (AR); Ezaderm (BH); Fisibact (QA); Fucibet (DK, ES, IE, IN); Fucibet Lipid Cream (GB); Fucicort (AE, AR, BE, BG, CH, CL, CO, CY, CZ, DE, DK, EC, EE, EG, FI, HK, HU, ID, IL, IT, JO, KW, LB, LU, MT, MX, MY, NZ, PH, PT, QA, RU, SA, SG, SK, TH, TR, UY); Fucitopic (SA); Fusibact B (AE, KW); Fusidasol (MY); Fusiderm-B (IN); Fusigal (BD); Fusimed B (AR, PY, UY); Fusimed-B (CL); Futasone (AE, LB); Germacort (MY); Inferuderm B (BR); Mexiderm-F (BD); Topizone (AE, LB); Veruderm B (BR); Verutex B (BR); Xzema (BD); Zeta-Cort (AE, KW, LB)

Last Updated 9/29/20