Fluclox^®

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Fluclox ® is indicated for the treatment of infections due to Gram positive organisms, including infections caused by beta-lactamase producing Staphylococci.
Typical indications include:

Skin and soft tissue infections: Boils, abscesses, carbuncles, infected skin conditions, for example, ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, protection for skin grafts, otitis media and external impetigo.

Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.

Other infections caused by Fluclox ® -sensitive organisms: Osteomyelitis, enteritis, endocarditis, urinary tract infections, meningitis, septicaemia.

Fluclox ® is also indicated for use as a prophylactic agent during major surgical procedures, where appropriate; for example, cardiothoracic and orthopaedic surgery.

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Adults (including elderly patients):

Fluclox ® may be administered by other routes in conjunction with systemic therapy.

Children:
2-10 years: ½ of the adult dose.
Under 2 years: ¼ of the adult dose.
Children have been given doses of 12.5 to 25 mg per kg body weight four times daily.


Abnormal renal function: In common with other penicillins, Fluclox ® usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance <10ml/min) a reduction in dose or an extension of dosage interval should be considered.
Fluclox ® is not significantly removed by dialysis and hence no supplementary dosages need to be administered either during or at the end of the dialysis period.

Administration:
Intramuscular: Add 1.5ml Water for Injection BP to 250mg vial contents or 2ml Water for Injection BP to 500mg vial contents.
Intravenous: Dissolve 250-500mg in 5-10ml water for Injection BP. Administer by slow intravenous injection (three to four minutes). Fluclox ® 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 250mg in 5-10ml Water for Injection BP.
Intra-articular: Dissolve 250-500mg in up to 5ml Water for Injection BP or 0.5% Lignocaine hydrochloride solution.
Nebuliser solution: Dissolve 125-250mg of the vial contents in 3ml sterile water.

Use in pregnancy and lactation: Animal studies with Flucloxacillin have shown no teratogenic effect. The use of Flucloxacillin in pregnancy should be reserved for cases considered essential by the clinician. During lactation, trace quantities of penicillins can be detected in breast milk.

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Side effects, as with other penicillins, are uncommon and mainly of a mild and transitory nature, gastrointestinal upsets (e.g. nausea, diarrhea) and skin rashes have been reported. If a skin rash occurs, treatment should be discontinued. Hepatitis and cholestatic jaundice have been reported rarely. Pseudomembranous colitis has been reported rarely and has usually been associated with use of Flucloxacillin in combination with other antibiotics.

Penicillin hypersensitivity; ocular administration.

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Problems of over dosage with Flucloxacillin are unlikely to occur; if encountered they may be treated symptomatically.

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Store in a cool, dry place, protected from light. Fluclox ® DS, Powder for Suspension should be freshly prepared. Prepared suspension is to be consumed within 7 days of preparation if kept in room temperature or within 14 days if kept in a refrigerator.
Solutions for IM or direct IV injection should normally be administered within 30 minutes of preparation. However, aqueous solutions of Fluclox ® , injections retain their activity for up to 24 hours at room temperature (25 0 C) and up to 72 hours in a refrigerator (5 0 C). Fluclox ® 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%); Intravenous solutions of Fluclox ® for infusion, stored up to 25 0 C, should be used within 24 hours of preparation. Reconstitution of Fluclox ® Injections and preparation of Fluclox ® infusion solutions must be carried out under appropriate conditions if the extended storage periods are required.
Fluclox ® should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions. If Fluclox ® is prescribed concurrently with an aminoglycoside, the two antibiotics should not be mixed in the syringe, intravenous fluid container or giving set; precipitation may occur.