Brands of Amoxicillin / Flucloxacillin in Kenya
Flamox , Cosmos Limited
Fluxate , Sphinx Pharmaceuticals Ltd
Kemoxyl Plus F , Laboratory & Allied Ltd
Megamox , Elys Chemical Industries Ltd
Moxaforte , Dawa Limited
Moxicor F, Twokay chemicals Ltd
Supramox , Biodeal Laboratories Ltd
Suprazed DS,Zawadi Healthcare Ltd
MODE OF ACTION
Flucloxacillin
Properties: Flucloxacillin is a narrow-spectrum antibiotic of the group of isoxazolyl penicillins; it is not inactivated by staphylococcal β-lactamases.
Activity: Flucloxacillin, by its action on the synthesis of the bacterial wall, exerts a bactericidal effect on streptococci except those of group D (Enterococcus faecalis) staphylococci. It is not active against methicillin-resistant staphylococci
Amoxicillin
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.
Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.
Synergism
This drug exhibits synergistic bacterial activity in vitro and in experimental animals in vivo against some ampicillin-resistant organisms
Additive Effects
The two components ( amoxicillin and Flucloxacillin) generally exhibit an additive effect against sensitive bacteria, and bacteria that are sensitive to amoxicillin or to flucloxacillin remain sensitive to the combination, showing that antagonism does not occur when the two components are combined
INDICATIONS
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/ amoxicillin sensitive organisms:
Osteomyelitis, urinary tract infection, enteritis, meningitis, endocarditis and septicaemia
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
For oral use.
Adults :
500mg (Flucloxacillin 250mg /Amoxicillin 250mg) four times a day or as directed by the physician.
Children 2-10 years :
5ml (flucloxacillin 125/ amoxicillin 125mg) four times a day or as directed by the physician.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the penicillins.
It should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins) or excipients.
It is is contra-indicated in patients with a previous history of flucloxacillin associated jaundice/hepatic dysfunction
DRUG INTERACTIONS
Drug interactions associated with Flucloxacillin
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
Drug interactions associated with Amoxicillin
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.
Allopurinol
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Tetracyclines
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.
Oral anticoagulants
Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary.
Methotrexate
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
ADVERSE EFFECTS
Adverse effects associated with Flucloxacillin
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.
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
Adverse effects associated with Amoxicillin
Infections and infestations
Very rare: Mucocutaneous candidiasis
Blood and lymphatic system disorders
Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and prothrombin
Immune system disorders
Very rare: Severe allergic reactions, including angioneurotic oedema, anaphylaxis, serum sickness and hypersensitivity vasculitis .
Not known: Jarisch-Herxheimer reaction
Nervous system disorders
Very rare: Hyperkinesia, dizziness and convulsions .
Gastrointestinal disorders
Clinical Trial Data
Common: Diarrhoea and nausea.
Uncommon: Vomiting.
Post-marketing Data
Very rare: Antibiotic associated colitis including pseudomembraneous colitis and haemorrhagic colitis.
Hepato-biliary disorders
Very rare: Hepatitis and cholestatic jaundice; a moderate rise in AST and/or ALT.
Skin and subcutaneous tissue disorders
Clinical Trial Data
Common: Skin rash
Uncommon: Urticaria and pruritus
Post-marketing Data
Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS).
Renal and urinary disorders
Very rare: Interstitial nephritis, crystalluria .
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:
Amoxicillin / Flucloxacillin in Kenya
Amoxicillin / Flucloxacillin in Kenya
Amoxicillin / Flucloxacillin in Kenya
Amoxicillin / Flucloxacillin in Kenya
Amoxicillin / Flucloxacillin in Kenya
Amoxicillin / Flucloxacillin in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category:
Routes of Administration: Oral
Bioavailability:
Protein Binding:
Metabolosim:
Onset of Action:
Elimination Half life: Not Available
Excretion: Not Available
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:
Drug Indentifiers:
Drug Images
References/ Citation:
- Adrianzén Vargas, Manuel R., et al. “Pharmacokinetics of intravenous flucloxacillin and amoxicillin in neonatal and infant cardiopulmonary bypass surgery.” European journal of cardio-thoracic surgery 25.2 (2004): 256-260.