Sodium Fusidate 500mg for Intravenous Infusion
Summary of Product Characteristics Updated 06-Jan-2012 | Leo Laboratories Limited

1. Name of the medicinal product2. Qualitative and quantitative composition3. Pharmaceutical form4. Clinical particulars4.1 Therapeutic indications4.2 Posology and method of administration4.3 Contraindications4.4 Special warnings and precautions for use4.5 Interaction with other medicinal products and other forms of interaction4.6 Pregnancy and lactation4.7 Effects on ability to drive and use machines4.8 Undesirable effects4.9 Overdose5. Pharmacological properties5.1 Pharmacodynamic properties5.2 Pharmacokinetic properties5.3 Preclinical safety data6. Pharmaceutical particulars6.1 List of excipients6.2 Incompatibilities6.3 Shelf life6.4 Special precautions for storage6.5 Nature and contents of container6.6 Special precautions for disposal and other handling7. Marketing authorisation holder8. Marketing authorisation number(s)9. Date of first authorisation/renewal of the authorisation10. Date of revision of the text
1. Name of the medicinal product
Sodium Fusidate 500mg for Intravenous Infusion
2. Qualitative and quantitative composition
Sodium Fusidate Ph.Eur. 500mg (equivalent to 480mg fusidic acid) contained in one vial. (The second vial contains buffer solution).

3. Pharmaceutical form
Powder for reconstitution and use as an intravenous infusion.

4. Clinical particulars
4.1 Therapeutic indications
This product is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis, cutaneous infections.

It should be administered intravenously whenever oral therapy is inappropriate, which includes cases where absorption from the gastro-intestinal tract is unpredictable.

4.2 Posology and method of administration
Adults weighing more than 50 kg: 500 mg sodium fusidate three times daily.

Children and adults weighing less than 50 kg: 6-7 mg sodium fusidate per kg bodyweight three times daily.

Recommended procedure: To reconstitute, dissolve the contents of one vial containing 500 mg sodium fusidate powder (equivalent to 480 mg of fusidic acid) in the 10 ml buffer provided.

For adults weighing more than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of infusion fluid.

For children and adults weighing less than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of infusion fluid. Each dose corresponds to 6-7 ml of the resulting solution per kg bodyweight.

The diluted fluid should be infused via a central venous line over 2 hours. If a superficial vein is employed a more prolonged period of at least 6 hours is advisable.

This product should be administered intravenously into a wide bore vein with a good blood flow. Excessive doses may cause venospasm, thrombophlebitis and haemolysis of erythrocytes. Both oral and intravenous presentations have been given concurrently with other antibiotics, e.g. cloxacillin, flucloxacillin, ampicillin, methicillin and erythromycin.

Since it is excreted in the bile, no dosage modifications are needed in renal impairment.

The dosage in patients undergoing haemodialysis needs no adjustment as this product is not significantly dialysed.

Dosage in the elderly: No dosage alterations are necessary in the elderl