FLUCLOXACILLIN Powder for solution for injection / infusion Ref.[8149] Active ingredients: Floxacillin

The dosage depends on the severity and nature of the infection.

Method of administration

The usual routes of administration are by intramuscular injection, slow intravenous injection and intravenous infusion. Flucloxacillin may also be administered by intra-articular or intrapleural injection or inhaled by nebuliser. The solutions must be prepared as follows:

Adults and the elderly

Intramuscular: Add 1.5ml of water for injections to 250mg vial contents or 2ml of water for injections to 500mg vial contents.

Intravenous: Dissolve 250 to 500mg in 5 to 10ml of water for injections or 1g in 15 to 20ml of water for injections. Administer by slow intravenous injection (over three to four minutes). Flucloxacillin may also be added to infusion fluids or injected (suitably diluted) into the drip tube over three to four minutes. Flucloxacillin may be added to most intravenous fluids (eg water for injections, sodium chloride 0.9%, glucose 5%, sodium chloride 0.18% with glucose 4%).

Intrapleural: Dissolve 250mg in 5 to 10ml of water for injections.

Intra-articular: Dissolve 250 to 500mg in up to 5ml of water for injections or 0.5% lignocaine hydrochloride solution for injection.

Nebuliser Solution: Dissolve 125mg to 250mg of the vial contents in 3ml of water for injections.

The usual adult dosage (including the elderly) is as follows:

By intramuscular injection: 250mg every six hours.

By slow intravenous injection or by infusion: 250mg to 1g every six hours.

These doses may be doubled in severe infections. Doses of up to 8g daily have been suggested for endocarditis or osteomyelitis.

During surgical prophylaxis, doses of 1 to 2g should be given intravenously at induction of anaesthesia followed by 500mg six hourly intravenously or intramuscularly.

By intrapleural injection: 250mg once daily.

By intra-articular injection: 250mg to 500mg once daily.

By nebuliser: 125mg to 250mg every six hours.

Paediatric population

Any route of administration may be used. For children under two years old, a quarter of the adult dose should be administered. For children two to ten years old, half of the adult dose should be administered.

Renal impairment

Dosage reduction is not usually required. In severe renal failure, however, (creatinine clearance less than 10ml/min) a reduction in dose or extension of dose interval should be considered.

No supplementary dosages need be administered during or at the end of the dialysis period, as flucloxacillin is not significantly removed by dialysis.

Symptoms

With high parenteral doses of penicillins, neurotoxicity (e.g. convulsions, encephalopathy), blood disorders (e.g. neutropenia, haemolytic anaemia, prolongation of bleeding time, defective platelet function) or electrolyte disturbances may occur.

Treatment

Treatment is symptomatic. Flucloxacillin is not removed from the circulation by haemodialysis.

3 years.

The unreconstituted dry powder is stable for 3 years. For the reconstituted solution, chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C. From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Do not store above 25°C.

Flucloxacillin for Injection is supplied in Type II clear glass vials containing 250mg of flucloxacillin equivalent. The vials are closed with a Type I chlorobutyl rubber stopper, sealed with an aluminium ring. The vials are packed in cartons of 10 vials.

None.