Version May 2024
Corticosteroid-responsive dermatoses with secondary infection: Topical: Apply twice daily to affected area. Treatment should generally not exceed 14 days.
No dosage adjustment necessary.
No dosage adjustment necessary.
Refer to adult dosing.
Corticosteroid-responsive dermatoses with secondary infection: Children ≥6 years and Adolescents: Refer to adult dosing; avoid large amounts, occlusion, or long-term use
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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
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
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.
Not available in the US
Yes
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]
Topical: For topical use only; apply a thin layer to affected area; do not use near the eyes. Do not wrap or bandage treated area. Wash hands after use.
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.
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
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Betamethasone (Topical). Risk C: Monitor therapy
Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Topical). Risk C: Monitor therapy
Adverse events have been observed with corticosteroids in animal reproduction studies. See individual agents.
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.
Adrenal suppression with extensive/prolonged use; response to treatment; ocular changes
See individual agents.
See individual agents.
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