Amoxicillin / Flucloxacillin

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

Probenecid

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) , ℞-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:




What was the patient being treated for