Facid BT

 2%+0.1% Cream
Eskayef Pharmaceuticals Ltd.

10 gm tube: ৳ 170.00

Indications

Fusidic acid combined with betamethasone is used 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 exhibiting signs of bacterial infection and inflammation.
  • Other Superficial Skin Infections: Where inflammation and infection coexist, e.g., impetiginized dermatitis or localized pyoderma.

Off-label / Clinically Accepted Uses:

  • Certain allergic dermatitis or contact dermatitis with secondary infection.
  • Inflammatory skin lesions resistant to monotherapy with topical corticosteroids or antibiotics alone.
Dosage & Administration

Topical Use (Cream/Ointment):

  • Apply a thin layer to the affected area 2–3 times daily.
  • Duration: Usually 7–14 days, depending on severity and clinical response.
  • Avoid prolonged use to prevent steroid-related adverse effects.

Special Populations:

  • Pediatrics: Use the lowest effective dose for the shortest possible duration. Avoid occlusive dressings unless specifically advised.
  • Elderly: Standard topical dosing; monitor for skin thinning or local adverse effects.
  • Renal/Hepatic Impairment: No dose adjustment required for topical application.

Administration Route: Topical (cream or ointment only).

Mechanism of Action (MOA)
  • Fusidic Acid: Inhibits bacterial protein synthesis by binding to elongation factor G (EF-G) on the ribosome, preventing translocation of tRNA and mRNA, which halts bacterial growth. Primarily effective against Gram-positive organisms like Staphylococcus aureus.
  • Betamethasone: A potent corticosteroid that binds to glucocorticoid receptors, modulating gene expression to reduce inflammation, vasodilation, and immune cell recruitment. This combination provides simultaneous anti-inflammatory and antibacterial effects, rapidly alleviating both infection and inflammatory symptoms.
Pharmacokinetics

Topical Application:

  • Absorption: Minimal systemic absorption; higher absorption may occur on inflamed or broken skin.
  • Distribution: Primarily localized to skin; systemic distribution negligible.
  • Metabolism: Minimal systemic metabolism; corticosteroid absorbed is metabolized hepatically.
  • Elimination: Fusidic acid largely remains in the stratum corneum; minor absorbed fraction excreted in urine and bile. Betamethasone metabolized hepatically, excreted in urine.
  • Onset: Relief of inflammation often within 24–48 hours; antibacterial effects evident over several days.
Pregnancy Category & Lactation
  • Pregnancy: Category C (corticosteroid component). Topical use generally considered low risk if applied in small amounts for short durations. Avoid extensive or prolonged use.
  • Lactation: Topical use unlikely to cause adverse effects in nursing infants. Avoid application to the breast. Monitor infants if significant systemic absorption occurs.
Therapeutic Class
  • Primary Class: Combination topical therapy
  • Subclass: Antibiotic + Corticosteroid
Contraindications
  • Known hypersensitivity to fusidic acid, betamethasone, or excipients.
  • Viral, fungal, or tuberculosis skin infections unless specifically indicated.
  • Rosacea, perioral dermatitis, or acne vulgaris (due to corticosteroid component).
Warnings & Precautions
  • High-risk Groups: Pediatric patients, pregnant or breastfeeding women, elderly with thin skin.
  • Corticosteroid-related Risks: Skin atrophy, striae, telangiectasia with prolonged use.
  • Resistance Risk: Avoid prolonged or unnecessary use to prevent bacterial resistance.
  • Monitoring: Observe for local irritation, worsening infection, or systemic corticosteroid effects.
  • Early Signs of Severe Adverse Events: Persistent redness, pustules, or allergic reactions warrant discontinuation.
Side Effects

Common:

  • Skin irritation, burning, stinging, or itching at the application site
  • Dryness or peeling of skin

Serious / Rare:

  • Secondary fungal infections due to corticosteroid-induced immunosuppression
  • Allergic dermatitis or rash
  • Skin thinning, striae, telangiectasia with prolonged use

Timing & Dose Dependence:

  • Local side effects often appear within days.
  • Severity increases with prolonged use or application under occlusion.
Drug Interactions
  • Topical Therapy: Minimal systemic drug interactions.
  • Systemic Absorption: Rare interactions with CYP3A4 substrates if significant corticosteroid absorption occurs.
  • Other Topical Medications: Avoid concurrent use of other potent topical corticosteroids on the same area to prevent additive adverse effects.
Recent Updates or Guidelines
  • Current guidelines emphasize limiting duration to 1–2 weeks to prevent corticosteroid-related adverse effects and reduce fusidic acid resistance.
  • Recommended for inflammatory skin infections where monotherapy with either antibiotic or corticosteroid alone is insufficient.
  • Topical fusidic acid should not be used as prophylaxis to reduce the risk of antimicrobial resistance.
Storage Conditions
  • Store at 20°C to 25°C, protected from light and moisture.
  • Keep container tightly closed.
  • Do not freeze.
  • Discard if past expiry or if consistency changes.
Available Brand Names