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Flucopen (Flucloxacillin)

Pharmacology:

FLUCOPEN (Flucloxacillin) is an isoxazolyl penicillin which combines the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase producing Staphylococci.

PRESENTATION:

FLUCOPEN 250 Capsule : Each Capsule contains Flucloxacillin BP 250 mg as Flucloxacillin Sodium.
FLUCOPEN 500 Capsule : Each Capsule contains Flucloxacillin BP 500 mg as Flucloxacillin Sodium.
FLUCOPEN Syrup : When reconstituted each 5 ml Syrup contains Flucloxacillin BP 125 mg as Flucloxacillin Sodium.

INDICATION:

FLUCOPEN (Flucloxacillin) is indicated for the treatment of infections due to Gram positive organisms, including infections caused by $-lactamase producing Staphylococci.
Typical indications include :
Skin & soft tissue infections:
Boils, abscesses, cellulitis, carbuncles, furunculosis, infected wounds, infected burns, infected skin conditions, e.g. ulcer, eczema and acne, protection of skin grafts, impetigo, otitis media and externa.
Respiratory tract & ENT infections:
Pneumonia, Sinusitis, tonsillitis, pharyngitis, Lung abscess, empyema and quinsy.
Other infections:
Osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis and septicaemia.
Also used as a prophylactic agent during major surgical procedures where appropriate; for example, cardiothoracic and orthopaedic surgery.

DOSAGE AND ADMINISTRATION:

Usual adult dosage (including elderly patients)
250 mg orally four times a day. Oral doses should be administered half to one hour before meals.Osteomyelitis, endocarditis : Up to 8 g daily, in divided doses six to eight hourly.
Usual children dosage :
2-10 years : Half of the adult dose.
Under 2 years : Quarter of the adult dose.
Infants upto 6 months of age : Oral, 6.25 mg per kg of body weight every six hours. Children have been given doses of 12.5 mg to 25 mg per kg body weight four times daily.
Abnormal renal function : In common with other penicillins, flucloxacillin 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 dose interval should be considered.
Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosage need to be administered either during, or at the end of the dialysis period.

CONTRAINDICATION:

It is contraindicated in penicillin hypersensitive patients.

PREGNANCY:

Animal studies with flucloxacillin have shown to have teratogenic effects. The limited number of reported cases of use in human pregnancy have shown no evidence of untoward effects. During lactation trace quantities of flucloxacillin can be detected in breast milk.

SIDE EFFECTS:

Side effects as with other penicillins are uncommon and mainly of a mild and transitory nature. Gastrointestinal upsets e.g. nausea & diarrhoea and skin rashes have been reported. If skin rash occurs, treatment should be discontinued.

PRECAUTION:

FLUCOPEN (Flucloxacillin) should not be used in patients with penicillin or cephalosporin allergy as cross allergy between penicillin and cephalosporin may exist. Hepatitis and cholestatic jaundice may occur up to several weeks after treatment with flucloxacillin; in that situation it is advised to stop the drug. Administration for more than 2 weeks and increasing age are risk factors.

DRUG INTERACTION:

The administration of probenecid with flucloxacillin results in higher serum peak concentrations and prolongs the time that therapeutic concentration of flucloxacillin are achieved in serum. Physical incompatibility or loss of activity of flucloxacillin in solution has been reported when given with Gentamycin sulphate, Streptomycin sulphate, Vitamin mixture. Physical incompatibility or loss of acitivity of flucloxacillin, up to 72 hours at 15 degree C or 30 degree C, was reported with atropine sulphate, benzylpenicillin, chlorpromazine, diazepam, hyoscine butyl bromide, isosorbide dinitrate, metoclopromide, tetracycline HCI, prochlorperazine, promethazine etc.
Flucloxacillin should not be added to intravenous lipids, blood products and protein hydrolysates or other proteinaceous fluids.

INFORMATION TO THE PATIENT:

Capsule : Patients should be cautioned that Flucloxacillin capsule should not be opened, chewed or crushed and should be swallowed whole.
Syrup : The reconstituted Syrup must be used within 7 days if kept at room temperature and within 10 days when stored in a refrigerator. The preparation should be kept in a cool, dry place and away from children.
Medicaments should be kept in a cool, dry place, away from fight and out of reach of children.

PACKAGING:

FLUCOPEN 250 Capsule : Each box contain 7x4 capsules in alu-alu blister pack.
FLUCOPEN 500 Capsule : Each box contain 5x4 capsules in alu-alu blister pack.
FLUCOPEN Syrup : Bottle containing powder to produce 100 ml Syrup when reconstituted with water.

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