Sodium Fusidate (Oral)
Indications
Sodium Fusidate tablet is indicated for the treatment of localized, as well as generalized staphylococcal infections (e.g. abscesses, furunculosis, wound infections, pneumonia, peritonitis, osteomyelitis, septicaemia, enteritis and otorhinoiaryngeai infections). In severe infections, deep-seated infections, infections due to methicillin-resistant Staphylococci or when prolonged therapy may be required, Sodium Fusidate must be given concurrently with other anti-staphylococcal antibiotic therapy.
Pharmacology
Sodium Fusidate is a Sodium salt form of Fusidic Acid. Fusidic acid is an antibiotic derived from the fungus Fusidium coccineum. The mode of action is by inhibition of protein synthesis by the prevention of translocation on the ribosome. Concentrations adequate for bactericidal activity against Staphylococci after oral or parenteral administration have been demonstrated in the following: pus, exudate, soft tissue, bone tissue, synovial fluid, aqueous humour, vitreous body, burn crusts, intracranial abscess, sputum and serum.
Dosage & Administration
For staphylococcal skin infections:
Renal impairment patient: 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.
- Adults and children from 12 years: 250 mg 2 times a day for 5-10 days.
- 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.
- 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
Renal impairment patient: 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.
Interaction
Statin treatment should be discontinued throughout the duration of the Sodium Fusidate treatment. Co-administration of Sodium Fusidate systemically and Ciclosporin has been reported to cause increased plasma concentration of Ciclosporin.
Contraindications
Hypersensitivity to any of the ingredients of this formulation. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Side Effects
The most frequently reported undesirable effects to Sodium Fusidate are dose dependent gastrointestinal disorders like diarrhoea, vomiting, abdominal pain, dyspepsia, nausea. Various skin reactions, reversible jaundice, haematological disorders and generalised hypersensitivity reactions have been reported. Leukopenia, thrombocytopenia, anemia, anorexia, drowsiness, dizziness, headache, cholestasis, urticaria, pruritus, rash,
rhabdomyolysis may rarely occur.
rhabdomyolysis may rarely occur.
Pregnancy & Lactation
Pregnancy Category C. In reproduction studies, mating frequency and fertility were normal and the offspring showed no morbid changes.As a precautionary measure, it is preferable to avoid the use of systemic Sodium Fusidate during pregnancy.
Lactation: Safety in lactation has not been established. There is evidence that the drug can penetrate the placental barrier and is detectable in human milk. Caution is therefore required when it is used in mothers who wish to breast feed.
Lactation: Safety in lactation has not been established. There is evidence that the drug can penetrate the placental barrier and is detectable in human milk. Caution is therefore required when it is used in mothers who wish to breast feed.
Precautions & Warnings
Sodium Fusidate must not be co-administered with statins. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. In patients where the use of systemic Sodium Fusidate is considered essential, statin treatment should be discontinued throughout the duration of treatment. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of Sodium Fusidate.
Therapeutic Class
Other antibiotic
Storage Conditions
Keep away from light and wet place. Keep out of reach of children.
