Flustar Capsule - Renata Limited

Flucloxacillin sodium BP
PRESENTATION
Flustar® 250 Capsule: Each capsule contains Flucloxacillin
sodium BP equivalent to 250mg Flucloxacillin.
Flustar® 500 Capsule: Each capsule contains Flucloxacillin
sodium BP equivalent to 500mg Flucloxacillin.
Flustar® Dry Powder for Suspension: After reconstitution,
each 5ml contains Flucloxacillin sodium BP equivalent to
125mg Flucloxacillin.
INDICATIONS
Flustar® 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 and acne.
Furunculosis, cellulitis, infected wounds, infected bums,
protection for skin grafts, otitis media and external impetigo.
Respiratory tract infections: Pneumonia, lung abscess,
empyema, sinusitis, pharyngitis, tonsillitis, quinsy.
Other infections caused by Flustar® sensitive organisms:
Osteomyelitis, enteritis, endocarditis, urinary tract infections,
meningitis, septicemia.
DOSAGE AND ADMINISTRATION
Should be administered half to one hour before meals.
Usual adult dosage (including elderly patients): 250mg four
times daily.
In severe infections: Dosage should be doubled.
In osteomyelitis, endocarditis: Upto 8g daily in divided doses 6
to 8 hourly.
In case of secondary bacterial infection in chicken pox: Flustar®
500mg 6 hourly.
Usual child dosage:
2-10 years: Half of the adult dosage.
Under 2 years: Quarter of the adult dosage.
Children have been given doses of 12.5 to 25mg per kg body
weight 4 times daily.
Dose adjustment in renal impairment:
In common with other penicillins, Flustar® 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.
Flustar® 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.
CONTRAINDICATIONS
Penicillin hypersensitivity, ocular administration.
USE IN PREGNANCY AND LACTATION
Animal studies with Flucloxacillin have shown no teratogenic
effects. 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.
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.
DRUG INTERACTIONS
The administration of probenecid with Flucloxacillin results in
higher serum peak concentrations and prolong the time that
therapeutic concentrations of Flucloxacillin are achieved in
serum. Physical incompatibility and/or loss of activity of
Flucloxacillin in solution has been reported when given with
gentamycin sulphate, streptomycin sulphate, vitamin
mixtures.
OVERDOSAGE
Problems of overdosage with Flucloxacillin are unlikely to
occur; if encountered they may be treated symptomatically.
PHARMACEUTICAL PRECAUTIONS
Store in a cool & dry place, protected from light.
Flustar® Dry 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.
PACKAGING
Flustar 250mg Capsule: Box containing 12X4 capsules in
alu-alu blisters.
Flustar 500mg Capsule: Box containing 7X4 capsules in alu-alu
blisters.
Flustar Dry Powder for Suspension: Dry powder in glass bottle
for reconstitution into 100ml of suspension.
Renata Limited
Rajendrapur, Gazipur
Bangladesh
® Trade Mark