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Perpen®
Composition
Perpen® 250: Each capsule contains Flucloxacillin 250 mg as Flucloxacillin Sodium BP.
Perpen® 500: Each capsule contains Flucloxacillin 500 mg as Flucloxacillin Sodium BP.
Perpen® Granules for Suspension: When reconstituted, each 5 ml contains Flucloxacillin BP
125mg/5ml as Flucloxacillin Sodium BP.
Description
Perpen® is an isoxazolyl penicillin of the beta-lactam group of antibiotics, which exerts a
bactericidal effect upon many Gram-positive organisms including streptococci, clostridia and
neisseria and beta-lactamase producing staphylococci. It is not inactivated by hydrolysis due to
penicillinase enzyme and is stable to gastric acid. Flucloxacillin kills bacteria by interfering the
synthesis of the bacterial cell wall. Flucloxacillin binds to penicillin-binding proteins (PBPs) on
the bacterial cell wall, thus interfering the synthesis of Peptidoglycan, a building block material
of Bacterial cell wall. Due to this interference, the cell wall becomes weakened and then
ruptured. The penicillinase resistant activity is probably related with the steric hindrance induced
by the acyl side chain which prevents the opening of the ß-lactam ring.
Indication
Perpen® is indicated for the treatment of infections due to Gram-positive organisms, including
infections caused by ß-lactamase producing staphylococci.
Typical indications include: Skin and Soft Tissue Infections: Boils, abscesses, carbuncles,
furunculosis, cellulitis, infected wounds, infected burns, protection of skin grafts, and impetigo.
Infected Skin Conditions: Ulcer, eczema and acne etc.
Respiratory Tract Infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis,
tonsillitis, quinsy, otitis media and externa.
Other infections caused by Flucloxacillin-sensitive organisms such as osteomyelitis, enteritis,
endocarditis, urinary tract infections, meningitis, and septicaemia.
Dosage and Administration
Adult: The usual adult dose is 250mg 6 hourly. In severe infections, the dose may be doubled to
500mg 6 hourly.
Children 2-10 years: Half of the adult dose.
Children Under 2 Years: Quarter of the adult dose.
Osteomyelitis, endocarditis: Up to 8 gm daily, in divided doses six to eight hourly.
Doses should be administered half to one hour before meals.
Abnormal renal function: In common with other penicillins, Flucloxacillin usage in patients
with renal impairment does not usually require dosage reduction. However in presence of severe
renal failure (Creatinine clearance <10ml/min), a reduction in dose or an extension of doseinterval should be considered.
Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosages need
to be administered either during or at the end of the dialysis.
Contraindication
Flucloxacillin is a penicillin and should not be given to patients with a history of hypersensitivity
to beta-lactam antibiotics (eg. penicillins, cephalosporins) or excipients. Flucloxacillin is
contraindicated in patients with a previous history of Flucloxacillin-associated jaundice/hepatic
dysfunction.
Warning and Precaution
Before initiating therapy with Flucloxacillin, careful inquiry should be made concerning previous
hypersensitivity reactions to beta-lactams. Cross-sensitivity between penicillins and
cephalosporins is well documented.
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction.
Special caution is essential in the newborn because of the risk of hyperbilirubinemia. During
prolonged treatments (e.g. osteomyelitis, endocarditis), regular monitoring of hepatic and renal
functions is recommended. Prolonged use of an anti-infective agent may occasionally result in
overgrowth of non-susceptible organisms.
Dosage should be adjusted in renal impairment.
Pregnancy
Animal studies with Flucloxacillin have shown no teratogenic effects. Limited information is
available concerning the results of the use of Flucloxacillin in human pregnancy. Therefore the
use of Flucloxacillin in pregnancy should be reserved for cases considered essential by
physicians.
Lactation
Trace quantities of Flucloxacillin are excreted in breast milk. Flucloxacillin may be administered
during the period of lactation. With the exception of the risk of sensitization, there are no
detrimental effects for the breastfed infant.
Side effect
Side effects are usually uncommon and mild and transitory in nature. Minor gastrointestinal
disturbances, such as nausea, diarrhoea, may occur during treatment. If hypersensitivity reactions
e.g. skin rash & urticaria occur, treatment should be discontinued. Hepatic and cholestatic
jaundice have been reported rarely. Changes in Liver Function Test results may occur, but are
reversible when treatment is discontinued. Pseudomembranous colitis is very uncommon and
usually has been associated with the use of Flucloxacillin in combination with other antibiotics.
Overdose
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.
Drug Interaction
Bacteriostatic agents may interfere with the bactericidal action of Flucloxacillin. Probenecid
decreases the renal tubular secretion of Flucloxacillin. Concurrent administration of probenecid
delays the renal excretion of Flucloxacillin.
Storage Condition
Perpen® Capsule: Store at room temperature (25°- 30° C).
Perpen® Granules for Suspension: Prior to reconstitution-Store at room temperature (25°- 30°
C). After reconstitution-The product may be stored for 7 days at room temperature or for 14 days
in a refrigerator (2°- 8°C).
Packaging Quantity
Perpen® 250 Capsule: Each box contains 10 x 4's capsules in Alu-Alu blister pack.
Perpen® 500 Capsule: Each box contains 7 x 4's capsules in Alu-Alu blister pack.
Perpen® Granules for Suspension: Each bottle contains granules to produce 100 ml of
suspension when reconstituted.