Sodium Fusidate tablet is indicated for the treatment of localized and generalized staphylococcal infections, including: Abscesses, Furunculosis, Wound infections, Pneumonia, Peritonitis, Osteomyelitis, Septicaemia, Enteritis, Otorhinolaryngeal infections. In severe or deep-seated infections, infections caused by methicillin-resistant Staphylococci, or when prolonged therapy is required, Sodium Fusidate should be used in combination with other anti-staphylococcal antibiotics.

Sodium Fusidate is the sodium salt form of fusidic acid. Fusidic acid is an antibiotic derived from the fungus Fusidium coccineum. It acts by inhibiting bacterial protein synthesis through blocking translocation on the ribosome. After oral or parenteral administration, bactericidal concentrations against Staphylococci are achieved in various body tissues and fluids, including pus, exudate, soft tissues, bone, synovial fluid, aqueous and vitreous humours, burn eschar, intracranial abscess, sputum, and serum.

For staphylococcal skin infections:

• Adults and children from 12 years: 250 mg 2 times a day for 5–10 days.

For penicillin-resistant staphylococcal infections such as osteomyelitis, pneumonia, septicemia, wound infections, endocarditis, superinfected cystic fibrosis:

• Adults and children from 12 years: 500 mg 3 times a day. Dose can be increased to 1 gram 3 times a day for severe infections.

Oral suspension

• Children 1–11 months: 15 mg/kg 3 times a day
• Children 1–4 years: 250 mg 3 times a day
• Children 5–11 years: 500 mg 3 times a day
• Children 12–17 years: 750 mg 3 times a day
• Adults: 750 mg 3 times a day

Elderly: No dosage adjustment is necessary in the elderly.

Renal impairment patients: Since Sodium Fusidate is excreted in the bile, no dosage modifications are needed in renal impairment. No dosage adjustment is required in patients undergoing haemodialysis as it is not significantly dialysed.

Statin therapy should be discontinued during the entire course of Sodium Fusidate treatment. Concomitant systemic use of Sodium Fusidate and ciclosporin has been reported to increase plasma concentrations of ciclosporin.

This medicine is contraindicated in patients with hypersensitivity to any component of the formulation. It should not be used in patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

The most common adverse effects are dose-related gastrointestinal disturbances such as diarrhea, vomiting, abdominal pain, dyspepsia, and nausea. Skin reactions, reversible jaundice, blood disorders, and generalized hypersensitivity reactions have also been reported. Rarely, leukopenia, thrombocytopenia, anemia, anorexia, drowsiness, dizziness, headache, cholestasis, urticaria, pruritus, rash, and rhabdomyolysis may occur.

Pregnancy Category C. Animal studies show normal fertility and no fetal abnormalities. However, as a precaution, systemic Sodium Fusidate should be avoided during pregnancy.

It can cross the placenta and is detected in human milk; therefore, caution is advised during breastfeeding.

Sodium Fusidate must not be used with statins due to risk of serious muscle damage including rhabdomyolysis, which may be fatal. Statins should be stopped during treatment. Patients should seek immediate medical attention if muscle pain, weakness, or tenderness occurs. Statin therapy may be restarted 7 days after the last dose of Sodium Fusidate.

Other antibiotic

Keep away from light and moisture. Keep out of reach of children.