Facid

 2% Cream
Eskayef Pharmaceuticals Ltd.

15 gm tube: ৳ 90.00

Indications
  • Approved Indications:
    • Skin and soft tissue infections caused by Staphylococcus aureus, including:
      • Impetigo
      • Infected eczema
      • Folliculitis
      • Minor wound infections
    • Osteomyelitis, particularly due to S. aureus, including methicillin-resistant strains (MRSA)
    • Septic arthritis of staphylococcal origin
    • Staphylococcal bacteremia and endocarditis (adjunct therapy)
    • Pneumonia caused by S. aureus (adjunct therapy)
    • Ophthalmic infections such as conjunctivitis and blepharitis (topical use)
  • Clinically Accepted Off-label Uses:
    • Nasal carriage eradication of Staphylococcus aureus
    • Prophylaxis of surgical site infections in high-risk patients
    • Treatment of acne vulgaris in combination regimens
Dosage & Administration
  • Route: Oral, topical (cream/ointment), ophthalmic (eye drops/ointment), intravenous (in some regions)
  • Oral:
    • Adults: 500 mg every 8 hours (total 1.5 g/day), duration 7–14 days based on infection severity
    • Children:
      • 1–5 years: 250 mg every 8 hours
      • 6–12 years: 500 mg every 8 hours
      • Under 1 year: 20 mg/kg/day divided into three doses
  • Topical:
    • Apply to affected area 2–3 times daily for 7–10 days
  • Ophthalmic:
    • 1 drop into affected eye(s) twice daily for 7 days
  • Intravenous:
    • 500 mg every 8–12 hours (where available), often combined with other antibiotics for serious infections
  • Special Populations:
    • Elderly: No specific dose adjustment; monitor liver function
    • Renal impairment: No dose adjustment generally necessary
    • Hepatic impairment: Use cautiously; monitor liver function tests; dose reduction may be required
Mechanism of Action (MOA)

Sodium fusidate inhibits bacterial protein synthesis by binding to elongation factor G (EF-G) on the ribosome. This prevents translocation during translation, effectively halting peptide chain elongation. It is primarily bacteriostatic but may exhibit bactericidal activity against Staphylococcus aureus, including methicillin-resistant strains, by disrupting bacterial growth and replication.

Pharmacokinetics
  • Absorption: Well absorbed orally with approximately 91% bioavailability
  • Distribution: Widely distributed; penetrates bone, soft tissues, and bodily fluids effectively; plasma protein binding ~95%
  • Metabolism: Primarily hepatic via hydroxylation and acetylation
  • Half-life: 5–6 hours; may be prolonged in hepatic impairment
  • Excretion: Mainly biliary and fecal; minimal renal elimination
  • Onset: Therapeutic plasma levels reached within 1–2 hours post-dose
Pregnancy Category & Lactation
  • Pregnancy: No assigned FDA category. Animal studies do not demonstrate teratogenicity, but human data are limited. Use only if clearly needed.
  • Lactation: Excreted in small amounts in breast milk. Use with caution; benefits should outweigh risks. Monitor infants for adverse effects.
Therapeutic Class
  • Primary Class: Antibiotic
  • Subclass: Fusidane steroid antibiotic
Contraindications
  • Hypersensitivity to sodium fusidate or any formulation components
  • Severe hepatic dysfunction
  • Neonates at risk of kernicterus
  • Concurrent use with statins (e.g., simvastatin, atorvastatin) due to risk of severe muscle toxicity
Warnings & Precautions
  • Monitor liver function during treatment, especially in hepatic impairment
  • Avoid co-administration with statins due to increased risk of rhabdomyolysis
  • Prolonged or repeated use may promote resistance
  • Use topical and ophthalmic preparations only as directed to avoid irritation or secondary infections
  • Discontinue therapy if severe allergic reactions occur
Side Effects
  • Common: Nausea, vomiting, abdominal discomfort, diarrhea; local irritation with topical or ophthalmic use
  • Serious (rare): Hepatotoxicity, elevated liver enzymes, hypersensitivity reactions, rhabdomyolysis (with statins), Stevens-Johnson syndrome (very rare)
  • Timing: Usually onset within days of therapy initiation; severity may increase with prolonged use
Drug Interactions
  • Statins: Contraindicated; increased risk of rhabdomyolysis
  • Oral anticoagulants: Enhanced anticoagulant effect; monitor INR
  • CYP3A4 substrates: Sodium fusidate inhibits CYP3A4, increasing plasma levels of drugs metabolized by this enzyme
  • Hepatotoxic drugs: Co-administration may increase liver toxicity risk
Recent Updates or Guidelines
  • Recommendations emphasize cautious use to prevent resistance, particularly limiting topical use duration
  • Continued monitoring of S. aureus resistance patterns supports reserved use for confirmed infections or combination therapy
  • Guidelines advise against concurrent use with statins and recommend liver function monitoring
Storage Conditions
  • Store oral tablets and suspensions at 20°C to 25°C (68°F to 77°F), protected from moisture and light
  • Topical creams/ointments: store below 25°C, avoid freezing
  • Ophthalmic preparations: refrigerate at 2°C to 8°C; discard after 28 days of opening
  • Keep all forms out of reach of children and do not use past expiration date
Available Brand Names