Brands of Flucloxacillin in Kenya
Dawaflox, Dawa Limited
Elyflox , Elys Chemical Industries Ltd
Floxapen, GSK
Floxazed , Zawadi Healthcare Ltd
Flucillin, Theon Pharmaceuticals Ltd
Flucloxacillin, Crown Healthcare
Flucloxin , Eskayef Bangladesh Ltd.
Flupene , Crown Healthcare
Flux , Opsonin Pharma Limited
Kloxy-f , Laboratory & Allied Ltd
Phylopen , Square Pharmaceuticals Ltd.
Rivaflux , Riva Pharma S.A.E
MODE OF ACTION
Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of antibiotics which exerts a bactericidal effect upon many Gram-positive organisms including
β-lactamase-producing staphylococci and streptococci.
INDICATIONS
Flucloxacillin is indicated for the treatment of infections due to sensitive Gram-positive organisms, including β-lactamase producing staphylococci and streptococci.
Typical indications include:
Skin and soft tissue infections:
Boils, cellulitis, infected burns, abscesses, infected skin conditions (e.g. ulcer, eczema, and acne), protection for skin grafts, carbuncles, furunculosis, infected wounds and impetigo
Respiratory tract infections:
Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media and externa, tonsillitis and quinsy
Other infections caused by flucloxacillin-sensitive organisms:
Osteomyelitis, urinary tract infection, enteritis, meningitis, endocarditis and septicaemia
Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery.
Parenteral usage is indicated where oral dosage is inappropriate.
Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents.
Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.
DOSAGE AND ADMINISTRATION
The dosage depends on the age, weight and renal function of the patient, as well as on the severity of the infection.
Usual adult dosage (Including elderly patients)
Oral – 250mg four times a day
In serious infections, the dosage may be doubled.
Osteomyelitis, endocarditis – Up to 8g daily, in divided doses six to eight hourly
Surgical prophylaxis – 1 to 2g IV at induction of anaesthesia followed by 500mg six hourly IV, IM or orally for up to 72 hours
Paediatric population
2-10 years: 125mg four times daily
Under 2 years: 62.5mg four times daily
Premature infants, neonates, sucklings and infants
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
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 dosages need to be administered either during, or at the end of the dialysis period.The maximum recommended dose in adults is 1 g every 8 to 12 hours.
Hepatic impairment:
Dose reduction in patients with reduced hepatic function is not necessary.
Administration:
Oral: This medicine should be taken on an empty stomach. This means an hour before food or two hours after food.
IM, IV, intrapleural, intraarticular
CONTRAINDICATIONS
Flucloxacillin should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins) or excipients.
Flucloxacillin is contra-indicated in patients with a previous history of flucloxacillin associated jaundice/hepatic dysfunction.
DRUG INTERACTION
Probenecid and sulfinpyrazone slow down the excretion of flucloxacillin by decreasing tubular secretion.
Other drugs, such as piperacillin, which are excreted via renal tubular secretion, may interfere with flucloxacillin elimination.
Oral typhoid vaccine may be inactivated by flucloxacillin.
Flucloxacillin reduces the excretion of methotrexate which can cause methotrexate toxicity.
Flucloxacillin may reduce the response to sugammadex.
There are cases of altered international normalised ratio (INR) in patients taking warfarin and prescribed a course of flucloxacillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored during addition or withdrawal of flucloxacillin.
Bacteriostatic drugs may interfere with the bactericidal action of flucloxacillin.
Caution should be taken when flucloxacillin is used concomitantly with paracetamol as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors.
ADVERSE EFFECTS
Blood and lymphatic system disorders
Very rare: Neutropenia (including agranulocytosis) and thrombocytopenia. These are reversible when treatment is discontinued. Eosinophilia, Haemolytic anaemia.
Immune system disorders
Very rare: Anaphylactic shock (exceptional with oral administration) , angioneurotic oedema.
If any hypersensitivity reaction occurs, the treatment should be discontinued.
Gastrointestinal disorders
Common: Minor gastrointestinal disturbances.
Very rare: Pseudomembranous colitis.
If pseudomembranous colitis develops, flucloxacillin treatment should be discontinued and appropriate therapy, e.g. oral vancomycin should be initiated.
Hepato-biliary disorders
Very rare: Hepatitis and cholestatic jaundice.Changes in liver function laboratory test results (reversible when treatment is discontinued).These reactions are related neither to the dose nor to the route of administration.
Hepatitis and cholestatic jaundice may be delayed for up to two months post-treatment; in several cases the course of the reactions has been protracted and lasted for some months.
Skin and subcutaneous tissue disorders
Uncommon: Rash, urticaria and purpura.
Very rare: Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Frequency not known: AGEP – acute generalized exanthematous pustulosis
Musculoskeletal and connective tissue disorders
Very rare: Arthralgia and myalgia sometimes develop more than 48 hours after the start of the treatment.
Renal and urinary disorders
Very rare: Interstitial nephritis.
This is reversible when treatment is discontinued.
General disorders and administration site conditions
Very rare: Fever sometimes develops more than 48 hours after the start of the treatment.
Metabolism and nutrition disorders
Post marketing experience: very rare case of high anion gap metabolic acidosis, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:
flucloxacillin in Kenya
flucloxacillin in Kenya
flucloxacillin in Kenya
flucloxacillin in Kenya
flucloxacillin in Kenya
flucloxacillin in Kenya
flucloxacillin in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: B
Routes of Administration: Oral, IM, IV, intrapleural, intraarticular
Bioavailability: 50–70%
Protein Binding: Not Available
Metabolosim: Hepatic
Onset of Action: N/A
Elimination Half life: 0.75–1 hour
Excretion: Renal
Legal Status | Dosage forms & Strengths
Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
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Drug Images
References/ Citation:
- PPB Drugs Retention Register
- Sutherland, R., E. A. P. Croydon, and G. N. Rolinson. “Flucloxacillin, a new isoxazolyl penicillin, compared with oxacillin, cloxacillin, and dicloxacillin.” Br Med J 4.5733 (1970): 455-460.
- Weaver, L. T., et al. “Prognosis in cystic fibrosis treated with continuous flucloxacillin from the neonatal period.” Archives of disease in childhood 70.2 (1994): 84-89.
- Leder, Karin, et al. “The clinical efficacy of continuous-infusion flucloxacillin in serious staphylococcal sepsis.” Journal of Antimicrobial Chemotherapy 43.1 (1999): 113-118.