FUSIBACT-B CREAM 30G

Indications

Approved Uses

Short-term treatment of infected inflammatory dermatoses (e.g., eczema/dermatitis) where infection with susceptible organisms (notably staphylococci) is present or suspected.

Dosage & Administration

Dosing by Condition

Infected inflammatory dermatoses: apply a thin layer to affected area 2-3 times daily for a short course (generally up to 2 weeks); reassess if not improving within ~7 days.

Initial Dose

Apply a thin layer to the affected area 3 times daily

Maintenance Dose

Apply a thin layer to the affected area 3 times daily for up to 2 weeks

Maximum Dose

A treatment course should not normally exceed 2 weeks; apply thinly 1-2 times daily to affected areas only and avoid large surface areas/occlusion unless directed.

Dose Adjustment Notes

No renal/hepatic dose adjustment is required for topical use; minimize duration and avoid large surface areas, occlusion, and use on thin skin/face, and use extra caution in children to reduce systemic corticosteroid absorption.

How to Take

For topical use: clean and dry the affected area, then apply a thin layer and rub in gently; wash hands before and after application (unless treating the hands); avoid eyes, mouth and other mucous membranes; do not use under occlusive/airtight dressings unless directed; use for the shortest duration needed.

Side Effects

Common Side Effects

Common: application-site burning/stinging, itching, irritation, dryness, and erythema; less common: contact dermatitis and folliculitis; with prolonged use: skin atrophy/striae/telangiectasia.

Side Effect Frequency

Common: application-site burning/stinging/irritation, pruritus, erythema, dryness. Uncommon: contact dermatitis, rash/eczema aggravation, folliculitis, acneiform eruption. Rare (usually with prolonged/extensive use, occlusion, or use on thin skin): skin atrophy, striae, telangiectasia, perioral dermatitis/rosacea-like dermatitis, and systemic corticosteroid effects (HPA-axis suppression/Cushingoid features).

Safety & Warnings

Contraindications

Contraindicated in hypersensitivity to fusidic acid, betamethasone valerate, or excipients; and in primary viral (e.g., herpes simplex, varicella), fungal, or mycobacterial skin infections; and in rosacea, acne vulgaris, and perioral dermatitis.

Warnings & Precautions

Avoid eyes and mucous membranes; do not use under occlusion unless directed; limit duration (generally ≤2 weeks) and avoid prolonged facial use; use extra caution in children and when treating large areas; discontinue if irritation/sensitization occurs; prolonged use may promote fusidic acid resistance; not for ophthalmic use.

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant drug interactions are expected with appropriate topical use; additive systemic corticosteroid effects are theoretically possible if used extensively/occluded with other corticosteroids.

Interaction Severity

No clinically significant drug-drug interactions are expected with normal topical use; theoretical additive systemic corticosteroid effects may occur only with extensive/prolonged use or occlusion alongside other corticosteroids.

Food Interaction

Not applicable (no food interactions expected with topical administration).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Elderly

Standard adult dosing; use with caution on fragile or atrophic skin common in elderly patients

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Missed Dose

Apply when remembered; if it is close to the next scheduled application, skip the missed dose and continue as usual; do not apply extra to make up for a missed dose.

Stopping the Medicine

Stop when the condition has cleared; if used for prolonged periods/large areas or on the face, taper (reduce frequency) rather than abrupt cessation to reduce rebound.

Overdose

Acute topical overdose is unlikely; prolonged/excessive use (large areas, occlusion, children) may cause systemic corticosteroid effects (HPA-axis suppression/Cushingoid features) and local skin atrophy-manage by stopping/reducing use and supportive care; ingestion warrants medical assessment.

Patient Counseling

Apply a thin layer to the affected area only, as prescribed (typically 2-3 times daily), and use for the shortest duration-generally not more than 1-2 weeks unless your prescriber advises. Avoid eyes, mouth, and mucous membranes; avoid use on the face, groin, or underarms unless specifically directed. Do not use on large areas, broken/infected skin beyond the prescribed site, or under occlusive dressings/tight bandages unless instructed (increases steroid absorption). Wash hands after application (unless treating hands). Stop and seek advice if worsening, no improvement within ~7 days, or signs of spreading infection/irritation; do not share as it is prescription-only (SFDA legal status: Prescription).

Monitoring Requirements

Short courses: monitor clinically for improvement and local irritation; prolonged/extensive/occlusive use or pediatric use: monitor for skin atrophy/striae/telangiectasia and rare systemic corticosteroid effects (e.g., HPA-axis suppression).

Pharmacology

Mechanism of Action

Fusidic acid inhibits bacterial protein synthesis by preventing EF-G-mediated translocation on the ribosome; betamethasone valerate activates glucocorticoid receptors to suppress inflammatory gene expression and mediator release, reducing erythema, pruritus, and swelling.

Onset of Action

Symptomatic anti-inflammatory improvement is often seen within 1-3 days; antibacterial response is typically evident within a few days-reassess if no improvement by ~7 days.

Duration of Effect

No single-dose duration is defined; clinical benefit is maintained with regular application during the treatment course and wanes after discontinuation.

Half-Life

Topical half-life is not well-defined; if systemically absorbed, fusidic acid has an elimination half-life around ~5-6 hours, and betamethasone has a longer systemic half-life (variable, often reported in the tens of hours).

Bioavailability

Systemic absorption is low from intact skin; absorption increases with inflamed/damaged skin, large surface area use, prolonged use, or occlusion.

Metabolism

Fusidic acid: hepatic metabolism with biliary excretion. Betamethasone valerate: hydrolyzed in skin to betamethasone; absorbed fraction undergoes hepatic metabolism (largely CYP3A-mediated pathways) to inactive metabolites.

Excretion

Fusidic acid: mainly excreted via bile/feces. Betamethasone (after systemic absorption): metabolites excreted primarily in urine.

Protein Binding

Fusidic acid: highly protein bound (>95%, commonly ~97%). Betamethasone: moderately protein bound (about ~64%).

Product Information

Available Dosage Forms

Cream (this product).

Composition per Dose

Each 1g of cream contains: 20mg Fusidic Acid and 1mg Betamethasone (as valerate).

Generic Availability

Yes

OTC Alternatives

No OTC equivalent for this antibiotic-potent steroid combination; if inflammation is mild and not infected, OTC hydrocortisone 1% may be an option, but suspected infection generally requires prescription therapy.

Skin Condition

Eczema, Bacterial

Steroid Potency

Moderate

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