Fucimax(Sodium Fusidate )

Therapeutic Group: Antibiotic

Presentation

Fucimax Tablet: Each tablet contains Sodium Fusidate BP 250 mg.

Description

Sodium Fusidate is a potent anti-staphylococcal agent with unusual ability to penetrate tissue. Bactericidal levels have been assayed in bone and necrotic tissue. Concentrations of 0.03 – 0.12 micrograms/ml inhibit nearly all strains of Staphylococcus aureus. Fusidic acid is active against Staphylococcus epidermidis and methicillin-resistant staphylococci.

Indications

Sodium Fusidate is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: cutaneous infections, osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.

Dosage & Administration

For staphylococcal skin infections:
Tablet
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:
Tablet
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
*Oral suspension is not available for Fucimax.

Elderly:
No dosage adjustment is necessary in the elderly.

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.

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.

Precautions

Periodic liver function tests should be carried out when the product is given for prolonged periods and to patients with liver dysfunction.

Use in Pregnancy & Lactation

Pregnancy: Based on animal data does not cause fetal harm. Do not use unless the potential benefit justifies the potential risk.
Lactation: Caution should be exercised when administered to a nursing woman.

Drug 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.

Over Dose

Acute symptoms of overdose include gastrointestinal disturbances and possible effects liver function. Treatment should be restricted to symptomatic and supportive measures.

Storage

Do not store above 30 C. Keep out of the reach of children.

Commercial Pack

Fucimax Tablet: Each box contains 1 blister strip of 10 tablets.