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Amoxicillin + Clavulanic acid: Indications and contraindications


Therapeutic indications

Fleming is indicated for short-term treatment of bacterial infections at the following sites: Upper respiratory tract infections e.g. recurrent tonsillitis, sinusitis, and otitis media. Lower respiratory tract infections e.g. acute and chronic bronchitis, lobar and bronchopneumonia.  
Genital-urinary tract infections, e.g. cystitis, urethritis, pyelonephritis.  
Skin and soft tissue infections, e.g. bolis, abscesses, cellulitis, wound infections.  
Bone and joint infections, e.g. osteomyelitis.  
Dental infections, e.g. dentoalveolar abscess.


Fleming is bactericidal to a wide range of organisms including: Gram-positive and gram- negative bacteria.Fleming is bactericidal to a wide range of organisms including: Gram-positive and gram- negative bacteria. Some members of these species of bacteria produce β-lactamase, rendering them insensitive to amoxicillin alone. Infections caused by amoxicillin-susceptible organisms are amenable to Fleming treatment due to its amoxicillin content. Mixed infections caused by amoxicillin-susceptible organisms in conjunction with Fleming-susceptible β-lactamase producing organisms may therefore be treated with Fleming.


Dosage and administration: 

Consult your physician or pharmacist
Usual dosage for the treatment of infection: 
Adults and children over 12 years mild-moderate infections two tablets of 625mg = 562.5 mg a day.
Children: the usual recommended daily dosage is 25mg/kg/day in divided doses every eight hours
In more serious infections the dosage may be increased up to 50mg/kg/day in divided doses every eight hours.
Fleming 375 mg tablets are not recommended in children of 12 years and under.




Oral administration

To minimize potential gastrointestinal intolerance, administer at the start of a meal. The absorption of Fleming is optimized when taken at the start of a meal. Treatment should not extended beyond 14 days without review.

Contraindications


·        Penicillin hypersensitivity.
Attention should be paid to possible cross-sensitivity with other b-lactam antibiotics, e.g. cephalosporins. A previous Fleming or penicillin associated jaundice/ hepatic dysfuction.
Fleming should be avoided if glandular fever is suspected. Prolonged use may also occasionaly result in overgrowth of non-susceptible organisms.

Drug interactions

Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Fleming. Fleming should be used with care in patients on anti-coagulation therapy. Fleming may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin.

Pregnancy and lactation


Reproduction studies in animals (mice and rats) with orally and parenterally administered amoxicillin/clavulanate have shown no teratogenic effects. There is limited information on the use of Fleming in human pregnancy.
Fleming may be administered during the period of lactation. With the exception of the risk of sensitization, associated with the excretion of trace quantities in breast milk, there are no detrimental effects for the infant.

Effects on ability to drive and use machines: None known


Pharmacodynamic properties:


Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in Fleming anticipates this defense mechanism by blocking the β-lactamase enzymes, thus rendering the organisms sensitive to amoxicillin’s rapid bactericidal effect at concentrations readily attainable in the body.




Undesirable effects

·        Gastrointestinal reactions: diarrhea, indigestion, nausea and vomiting.
·        Hypersensitivity reactions: urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported.

Amoxicillin + Clavulanic acid: Indications and contraindications Amoxicillin + Clavulanic acid: Indications and contraindications Reviewed by gafacom on September 15, 2019 Rating: 5

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