Dermabac

Fusidic acid combined with hydrocortisone is indicated for treating inflammatory skin conditions complicated by bacterial infection.

Approved Indications:

• Infected Eczema / Dermatitis: Moderate to severe eczema with secondary bacterial infection, particularly caused by Staphylococcus aureus.
• Psoriasis with Superimposed Infection: Plaque psoriasis with bacterial involvement.
• Other Superficial Skin Infections: Localized pyoderma or impetiginized dermatitis where inflammation is present.

Off-label / Clinically Accepted Uses:

• Contact dermatitis or allergic dermatitis complicated by bacterial infection.
• Inflammatory lesions resistant to monotherapy with either antibiotic or corticosteroid.

Topical Use (Cream/Ointment):

• Apply a thin layer to the affected area 2–3 times daily.
• Treatment duration: Usually 7–14 days, depending on clinical response.
• Avoid prolonged or widespread use to prevent corticosteroid-related adverse effects.

Special Populations:

• Pediatrics: Use minimal effective amount for the shortest duration. Avoid occlusive dressings unless prescribed.
• Elderly: Standard topical dosing; monitor for local adverse effects.
• Renal/Hepatic Impairment: No dose adjustment needed for topical use.

Administration Route: Topical only.

• Fusidic Acid: Inhibits bacterial protein synthesis by binding to elongation factor G (EF-G) on bacterial ribosomes, blocking translocation of tRNA and mRNA, thereby inhibiting bacterial growth.
• Hydrocortisone: A corticosteroid that binds to glucocorticoid receptors, modulating gene transcription to reduce inflammation, redness, and immune cell infiltration.
• The combination provides rapid relief of both bacterial infection and inflammatory symptoms, addressing the dual pathology of infected inflammatory skin conditions.

Topical Application:

• Absorption: Minimal systemic absorption; slightly increased on inflamed or damaged skin.
• Distribution: Mainly localized to the stratum corneum; negligible systemic distribution.
• Metabolism: Fusidic acid remains primarily in the skin; absorbed corticosteroid metabolized hepatically.
• Elimination: Minor systemic fusidic acid excreted via urine and bile; hydrocortisone metabolized by the liver and excreted in urine.
• Onset of Action: Anti-inflammatory effects evident within 24–48 hours; antibacterial effect may take several days.

• Pregnancy: Category C (corticosteroid component). Topical use in small amounts is generally considered low risk; avoid extensive application.
• Lactation: Topical use is usually safe; avoid application on or near breasts. Monitor infants if systemic absorption occurs.
• Use with caution in both pregnant and breastfeeding women; prolonged use may increase risk.

• Primary Class: Combination topical therapy
• Subclass: Antibiotic + Corticosteroid

• Known hypersensitivity to fusidic acid, hydrocortisone, or any excipients.
• Viral, fungal, or tuberculosis skin infections unless specifically indicated.
• Rosacea, acne vulgaris, or perioral dermatitis (due to corticosteroid component).

• High-risk Patients: Pediatric, elderly, pregnant, or breastfeeding individuals.
• Corticosteroid Risks: Skin atrophy, telangiectasia, or striae with prolonged use.
• Bacterial Resistance: Avoid unnecessary or prolonged use to reduce resistance risk.
• Monitoring: Watch for worsening infection, local irritation, or systemic corticosteroid effects.
• Severe Adverse Signs: Persistent redness, pustules, or allergic reactions require discontinuation.

Common:

• Burning, stinging, itching, or irritation at the application site
• Dryness or peeling

Serious / Rare:

• Secondary fungal infection
• Allergic dermatitis or rash
• Skin thinning or striae with prolonged use

Timing & Dose Dependence:

• Local reactions typically occur within days.
• Severity increases with prolonged use or application under occlusion.

• Minimal systemic interactions due to low absorption.
• Significant systemic corticosteroid absorption may interact with CYP3A4 substrates.
• Avoid simultaneous use of other potent topical corticosteroids on the same area.

• Recommended treatment duration: 1–2 weeks to limit corticosteroid-related adverse effects.
• Use only when bacterial infection and inflammation coexist; monotherapy with either component is less effective.
• Avoid prophylactic use to prevent bacterial resistance.

• Store at 20°C to 25°C, away from light and moisture.
• Keep container tightly closed.
• Do not freeze.
• Discard if expired or if formulation consistency changes.