FUCIDIN® IV FUCIDIN® IV: BUFFER SCHEDULING STATUS: FUCIDIN® IV S4 FUCIDIN® IV: BUFFER S1 PROPRIETARY NAME: (and dosage form) FUCIDIN® IV Intravenous Infusion FUCIDIN® IV: BUFFER Intravenous Infusion COMPOSITION: A pack of two vials: FUCIDIN® IV contains sodium fusidate 500 mg (equivalent to fusidic acid 488 mg) as a dry powder. FUCIDIN® IV: BUFFER contains 10 mL sterile phosphate-citrate buffer solution (pH 7,3 - 7,7). PHARMACOLOGICAL CLASSIFICATION: FUCIDIN® IV: A 20.1: Antibiotics and Antibiotic combinations FUCIDIN® IV: BUFFER: A 34: Other PHARMACOLOGICAL ACTION: FUCIDIN® and its salts are anti-staphylococcal agents with ability to penetrate tissue, including bone. A single intravenous infusion of 500 mg FUCIDIN® administered over a two hour period produces serum levels of 30 - 45 micrograms/mL within one to two hours. FUCIDIN® is excreted mainly in the bile, little or none being excreted in the urine. INDICATIONS: FUCIDIN® should be administered intravenously only when oral therapy is inappropriate. FUCIDIN® is indicated in conjunction with other anti-staphylococcal agents in the treatment of severe staphylococcal infections. CONTRA-INDICATIONS: Hypersensitivity to the active ingredient. Impaired liver function. Safety in pregnancy has not been established. WARNINGS: When given as a single active ingredient, microbial resistance, as indicated by in vitro and in vivo studies, frequently develops. Hepatotoxicity is a common phenomenon especially with parenterally administered FUCIDIN®. DOSAGE AND DIRECTIONS FOR USE: Adults weighing more than 50 kg: 500 mg sodium fusidate three times daily. Children and adults weighing less than 50 kg: 18 to 21 mg per kilogram body mass per day, in three divided doses. Recommended Procedure: Dissolve the contents of one vial containing 500 mg sodium fusidate powder (equivalent to 488 mg of fusidic acid) in the 10 mL buffer provided. Immediately after reconstituting, add the fusidate/buffer solution to 250 - 500 mL of infusion fluid and infuse slowly over a period of not less than two to four hours. Infusions should be made into a wide bore vein with a good blood flow. Since FUCIDIN® is excreted in the bile, no dosage modifications are needed in renal impairment. The dosage in patients undergoing haemodialysis needs no adjustment as FUCIDIN® is not significantly dialysed. Oral treatment should be instituted as soon as possible. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Jaundice may occur most frequently in patients receiving intravenous FUCIDIN® in high dosage, or where the drug has been infused too rapidly or at too high a concentration in the infusion fluid. If the jaundice persists FUCIDIN® should be withdrawn. Due to local tissue injury, FUCIDIN® must not be administered intramuscularly or subcutaneously. Periodic liver function tests should be carried out when high doses are used or when the drug is given for prolonged periods. FUCIDIN® displaces bilirubin from its albumin binding site in vitro. Caution should be exercised with other antibiotics which may have similar biliary excretion pathways, e.g. lincomycin and rifampicin. Both oral and intravenous FUCIDIN® have been given in combination with other anti-staphylococcal antibiotics e.g. cloxacillin, and erythromycin. In most cases Sodium Chloride infusion is used as an infusion fluid. FUCIDIN®IV has also been given with the following intravenous fluids: -   Sodium Chloride 0,9%   Dextrose 5%   Compound Sodium Lactate BP   Sodium Lactate BP   Sodium Chloride 0,18% and Dextrose 4%   Potassium Chloride 0,3% and Sodium Chloride 0,9%   Potassium Chloride 0,3% and Dextrose 5% FUCIDIN® IV is incompatible with:-   Dextrose 40%   Dextrose 50%   Do not infuse with whole blood or aminosol infusions.   Opalescence may occur with more acidic samples of dextrose in which case the solution should be discarded.   Thrombophlebitis may occur at the site of injection. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See side effects. Treatment is supportive and symptomatic. IDENTIFICATION: FUCIDIN® IV:                White to off-white powder in a colourless glass vial. FUCIDIN® IV: BUFFER: Clear, colourless solution in a colourless glass vial. PRESENTATION: FUCIDIN® IV:                Colourless glass vial fitted with rubber stopper, which is secured with an aluminium ring with a removable centre part, containing a powder. FUCIDIN®IV: BUFFER: Colourless glass vial fitted with rubber stopper which is secured with an aluminium ring with a removable centre part, containing a solution. Both vials are packed together with a package insert in a single outer carton. STORAGE INSTRUCTIONS: Store below 30°C. Protect from light. Use within 24 hours once reconstituted with the buffer solution and mixed with the infusion fluid. Keep out of reach of children. REGISTRATION NUMBER: FUCIDIN® IV:                27/20.1/0065 FUCIDIN®IV: BUFFER: 27/34/0066 NAME AND BUSINESS ADDRESS OF THE APPLICANT: Adcock Ingram Limited Adcock Ingram Park 17 Harrison Avenue Bryanston Ext. 77 Private Bag X69 Bryanston 2021 DATE OF PUBLICATION OF THIS PACKAGE INSERT: August 1993 Under licence from: LEO PHARMACEUTICAL PRODUCTS