FLOXAPEN Powder for solution for injection / infusion Ref.[49870] Active ingredients: Floxacillin

Posology

The dosage depends on age, weight and renal function of the patient, as well as the severity and nature of the infection.

For instructions on the preparation of solution see section 6.6. For incompatibilities see section 6.2.

Intramuscular or intravenous

Adults and adolescents over 14 years of age

Total daily dosage of 1 g to 3 g, administered in three to four divided doses, by i.v. or i.m. injection.

In cases of severe infections: Up to 8 g per day administered in four infusions (over 20 to 30 min).

No single bolus injection or infusion should exceed 2 g.

The maximum dose of 12 g per day should not be exceeded.

In surgical prophylaxis: 2 g i.v. (bolus or infusion) upon induction of anaesthesia, to be repeated every 6 h for 24 h in cases of vascular and orthopaedic surgery, and for 48 h in cases of cardiac or coronary surgery.

Paediatric population

Children under 14 years of age

25 to 50 mg/kg/24 hours administered in three to four equally divided doses by i.m. or i.v. injection.

Children aged 10 to 14 years usually receive a daily dose of 1.5 g to 2 g and children aged 6 to 10 years 0.75 g to 1.5 g, divided into three to four equal doses.

In cases of severe infections: Up to 100 mg/kg/24 hours in three to four divided doses.

No single bolus injection or infusion should exceed 33 mg/kg.

Premature infants, neonates, sucklings and infants

Because of the possible induction of kernicterus, flucloxacillin should be used in premature infants and neonates only after a rigorous benefit-risk assessment (see section 4.4).

Premature infants and neonates as well as sucklings and infants are generally treated with 40 to 50 mg/kg/24 hours, divided into three equal doses. The daily dose may be increased to a maximum of 100 mg/kg.

Abnormal renal function

In common with other penicillins, Floxapen usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance <10 ml/min) a reduction in dose or an extension of dose interval should be considered. In high dose regimens the maximum recommended dose is 1 g every 8 to 12 hours (in anuric patients, the maximum dosage is 1 g every 12 h).

Floxapen is not significantly removed by dialysis and hence no supplementary dosages need be administered either during, or at the end of the dialysis period.

An intravenous injection/infusion should be performed slowly.

Intrapleural and intra-articular

The usual maximum dose is 500 mg once daily.

Inhalation route

The usual maximum daily dose is 125 mg to 250 mg three times daily.

Method of administration

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, as in the case of severe diarrhoea or vomiting, and particularly for the urgent treatment of severe infection.

Route of administration: Intramuscular, intravenous, intrapleural, intra-articular and aerosol.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Flucloxacillin is not removed from the circulation by haemodialysis.

As packaged for sale: 3 years.

From a microbiological point of view, the product should be administered within 30 minutes of preparation. However chemical and physical in-use stability of aqueous solutions of Floxapen has been demonstrated for 24 hours at 2-8°C. Reconstitution of the injection and preparation of the infusion solutions must be carried out under the appropriate aseptic conditions if these extended storage periods are required.

Unopened product: Do not store above 25°C.

Aqueous solutions of Floxapen may be stored for 24 hours at 2-8°C if prepared under the appropriate aseptic conditions (refer to section 6.3).

Clear type III glass vials with butyl rubber plug, aluminium seal and green flip off cap.

Boxes of 10.

Floxapen may be added to most intravenous fluids (e.g. Water for Injections, sodium chloride 0.9%, glucose 5%, sodium chloride 0.18% with glucose 4%).

Intramuscular: Add 1.5 ml Water for Injections BP to 250 mg vial contents.

Intravenous: Dissolve 250-500 mg in 5-10 ml Water for Injections BP. Administer by slow intravenous injection (three to four minutes). Floxapen may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes.

Intrapleural: Dissolve 250 mg in 5-10 ml Water for Injections BP.

Intra-articular: Dissolve 250-500 mg in up to 5 ml Water for Injections BP or 0.5% lignocaine hydrochloride solution.

Nebuliser solution: Dissolve 125-250 mg of the vial contents in 3 ml sterile water.

Appearance of the solution:

Clear, colourless or pale yellow, particle-free solution.

Any unused product or waste should be disposed of in accordance with local requirements.