Flucloxa Injection 500/1000mg

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Flucloxacillin Sodium for Injection

Composition

Each vial contains:

Flucloxacillin Sodium BP

equivalent to Flucloxacillin………500 mg

Each vial contains:

Flucloxacillin Sodium BP

equivalent to Flucloxacillin………1000 mg

Pharmaceutical Form

Powder for solution for injection or infusion (Powder for injection or infusion)

Therapeutic Indication

Flucloxacillin is indicated for the treatment of infections due to penicillinase producing staphylococci and other gram-positive organisms susceptible to this anti-infective. Indications include: osteomyelitis and endocarditis. Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example, cardiothoracic and orthopaedic surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and Method of Administration

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

Method of administration

The usual routes of administration for Flucloxacillin 500mg and 1g Powder for Solution for Injection or Infusion are by low intravenous injection and intravenous infusion. Flucloxacillin 500mg Powder for Solution for Injection or Infusion may also be administered by intramuscular, intra-articular or intrapleural injection. The solutions must be prepared as follows:

Adults and the elderly

Intravenous: Dissolve 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%)

Intramuscular: Add 2mlof water for injections to500mg vial contents.

Intra-articular: Dissolve 500mg in up to 5ml of water for injections or 0.5% lignocaine hydrochloride solution for injection. The usual adult dosage (including the elderly) as

follows; By slow intravenous injection or by infusion: 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.

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 10m/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.

Contraindications

Hypersensitivity to the active substance. Flucloxacillin should not be given to patients with a history of hypersensitivity to ß-lactam antibiotics (e.g. penicillins, cephalosporins).

Flucloxacillin is contraindicated in patients with a previous history of flucloxacillin-associated jaundice / hepatic dysfunction.

Ocular or subconjunctival administrations contraindicated.

Shelf life

24 Months

The unreconstituted dry powder is stable for 24 Months. 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.