KEMOXYL+F® (Amoxicillin/Flucloxacillin)

KEMOXYL+F® (Amoxicillin/Flucloxacillin)

KEMOXYL+F®

Kemoxyl+F offers broad spectrum antibiotic therapy across a wide range of infections including; pelvic infections, respiratory tract infections, skin and soft tissue infections, upper respiratory tract infections, urinary tract infections.

Dosage and directions for use

Depends on the age and weight of the patient

Adults: one 500mg capsule three times a day

Children 2-12 years: 5ml of suspension three times a day

Children under 2 years: 2.5ml of suspension three times a day.

40mg/kg/day in divided doses for children may be needed.

In severe infections these dosages may safely be increased.

To ensure maximal absorption Kemoxyl+F should be given in the fasting state, i.e. approximately 1 hour before a meal.

Contraindications

Kemoxyl+F should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins) or to any of the excipients.

Kemoxyl+F is contraindicated in patients with a previous history of Flucloxacillin-associated jaundice/hepatic dysfunction and not indicated for ocular administration.

Precautions and warnings

Before initiating therapy with Kemoxyl+F careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactams. Cross-sensitivity between penicillins and cephalosporins is well documented. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. These reactions are more likely to occur in individuals with a history beta-lactam hypersensitivity. If an allergic reaction occurs, Kemoxyl+F should be discontinued and appropriate alternative therapy instituted.

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Kemoxyl+F should be avoided if infectious mononucleosis is suspected since the occurrence of a morbiliform rash has been associated with this condition following the use of Amoxicillin.

Kemoxyl+F contains Flucloxacillin which has been associated with hepatitis, predominantly of a cholestatic type. Very rarely, deaths have occurred, almost always in patients with serious underlying disease. Reports have been more frequent with increasing age or following prolonged treatment

Special caution is essential in the newborn because of the risk of hyperbilirubinaemia.

During prolonged treatments (e.g. osteomyelitis, endocarditis), regular monitoring of hepatic and renal functions is recommended. Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

The sodium content of the formulations should be considered in the daily allowance of patients on sodium-restricted diets.

The magnesium content of formulation should be considered for patients with impaired renal function (creatinine clearance of less than 30ml/min). Dosage should be adjusted in renal impairment. At high doses an adequate fluid intake and urinary output must be maintained.

Drug interactions

Bacteriostatic drugs may interfere with the bactericidal action of Flucloxacillin and Amoxicillin. In common with other oral antibiotics, Kemoxyl+F may reduce the efficacy of oral contraceptives and patients should be warned accordingly. The renal tubular excretion of Kemoxyl+F can be reduced by simultaneous administration with probenecid, which results in an increase in the plasma levels of both components. Concurrent administration of allopurinol during treatment with Amoxicillin can increase the likelihood of allergic skin reactions.

Kemoxyl+F contains Amoxicillin, it is recommended that glucose oxidase methods are used when testing for the presence of glucose in urine during Amoxicillin treatment.

Pregnancy and lactation

Penicillins are generally considered safe for use in pregnancy. Animal studies with Flucloxacillin or Amoxicillin have shown no teratogenic effects. Limited information is available concerning the results of the use of Kemoxyl+F in human pregnancy. Kemoxyl+F should only be used in pregnancy when the potential benefits outweigh the potential risks associated with the treatment. Kemoxyl+F may be administered during the lactation period.

Undesirable effects

There have been few reports of adverse effects with Kemoxyl+F. this include;

Hypersensitivity: If any hypersensitivity reaction occurs, the treatment should be discontinued. As with other antibiotics, severe allergic reactions including anaphylaxis, angioneuroticoedema, serum sickness and allergic vasculitis have been reported rarely. Rash, purpura, fever, esophilia, pruritus and urticarial have been reported. Rarely reactions such as erythema multiforme, Stevens-Johnson syndrome, bullous and exfoliative dermatitis have been reported.

Gastrointestinal reactions: Minor gastrointestinal disturbances may occur during treatment, including nausea, vomiting and diarrhea. As with other antibiotics, pseudomembranous colitis and intestinal candidiasis have been reported rarely.

Hepatic: As with other penicillins and cephalosporins, hepatitis and cholestatic jaundice have been reported. These may be delayed in onset for up to two months post-treatment. Changes in liver function test results may occur, but are reversible with treatment discontinued.

Renal effects:Interstitial nephritis may occur.

CNS effects: In patients suffering from renal failure, neurological disorders with convulsions are possible with the use of high intravenous doses.

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Haematological effects: As with other beta-lactams, haematological effects including reversible leicopenia, reversible thrombocytopenia and haemolyticanaemia have been reported rarely.

Pharmacodynamic properties

Kemoxyl+F is a broad spectrum formulation of Amoxicillin and penicillinase stable Flucloxacillin. It exhibits bactericidal activity against a wide range of Gram-positive and Gram-negative organisms, including beta-lactamase producing staphylococci.

These include

Gram-Positive: Clostridium species, Corynebactriumdiptheriae, Listeria monocytogenes, (including beta-lactamase producing strains), Streptococcus faecalis, Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus virifand, Bacillus anthracis

Gram negative: Bordetella pertussis, Brucellaspp, Escherichia coli., Neisseria spp, Hemophillus influenza, Proteus mirabilis, Salmonella spp, Pasteurelaseptica, Laptospiraspp, fusobacterium spp. However Kemoxyl+F is not active against Gram-negative beta-lactamase producing organisms, Pseudomonas or Bacteroides.

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