HEALTH 2000 INC. EXPANDING PARTNERSHIPS IN HEALTH CARE............

Amoxicillin 500mg + Clavulanate 125mg

(i) ROUTE OF ADMINISTRATION

Oral

DOSAGE AND ADMINISTRATION

Oral
Adults and children over 12 years
Mild to moderate infections: One tablet 8 hourly.
Treatment with Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets should not be extended beyond 14 days without review.
Renal Impairment

Mild impairment (Creatinine clearance > 30ml/min)	Moderate impairment (Creatinine clearance 10-30ml/min)	Severe impairment (Creatinine clearance < 10ml/min)
No change in dosage	1-2 tablets of 375 mg 12 hourly	1 tablet of 375 mg 12 hourly.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Upper respiratory tract infections e.g. Tonsillitis, sinusitis, otitis media. Lower respiratory tract infections e.g. Acute and chronic bronchitis, lobar and bronchopneumonia. Genitourinary tract infections e.g. Cystitis, urethritis, pyelo nephritis, septic abortion, puerperal sepsis.
Skin and soft tissue infections e.g. Boils/abscesses, cellulitis, wound infections. Bone and joint infections e.g. Osteomyelitis. Other infections e.g. Intra-abdominal sepsis.

(iii) DESCRIPTION OF DOSAGE FORM

Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets is a formulation of amoxicillin, a bactericidal broad-spectrum penicillin, and Potassium Clavulanate, a progressive and irreversible inhibitor of beta-lactamase enzymes. The presence of potassium Clavulanate protects amoxicillin from destruction and subsequent loss of antibacterial activity by the beta-lactamase enzymes produced by many Gram-negative and Gram-positive bacteria. The spectrum of amoxicillin is thus widened to include organisms normally resistant by virtue of their ability to produce beta-lactamase.
Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets will not only eliminate primary pathogens but will also not be inactivated by non-pathogenic beta-lactamase producing organisms at the site of infection. The combination is also active against anaerobes.

(v) CONTRAINDICATIONS

History of allergic reaction to any of the penicillins.

WARNING AND PRECAUTIONS

DRUG INTERACTIONS:
Probenecid: Probenecid slows the rate of renal tubular secretion of amoxicillin and produces higher and prolonged serum concentration of amoxicillin.
Allopurinol: A significant increase in skin rashes is observed when allopurinol
and amoxicillin are given concurrently.
Disulfiram: This combination should not be used in patients receiving disulfiram.
Anti-coagulation therapy: This combination should be used with care in patients on anti-coagulation therapy.

PREGNANCY:
Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets has been used in human pregnancy in a limited number of cases, with no untoward effect. However use of Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets in pregnancy is not recommended unless considered essential by physician’s. As with all drugs, therapy with Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets during pregnancy should be avoided if at all possible, especially during the first trimester.

NURSING MOTHERS:
Ampicillin class of antibiotics are excreted in milk, therefore caution should be exercised when Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets is administered to nursing woman.
IN IMPAIRED RENAL FUNCTION: See dosage and administration.

HEPATIC DYSFUNCTION:
Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets should be used with care in patients with severe hepatic dysfunction as changes in liver function tests have been observed.

BLEEDING TIME AND PROTHROMBIN TIME:
These have been found to be increased in some patients receiving the combination.

(vi) SIDE EFFECTS

Side effects as with amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhea, pseudomembranous colitis, indigestion, nausea, vomiting, and candidiasis have been reported. Nausea, although uncommon, is more often associated with higher oral dosages. If gastro-intestinal side effects occur with oral therapy they may be reduced by taking Health 2000 Amoxicillin 500mg + Clavulanate 125mg tablets at start of the meals. Urticarial and erythematous rashes sometimes occur but their incidence has been particularly low. An articarial rash suggests penicillin hypersensitivity and treatment should be discontinued. Erythematous rashes are frequently mild and transient but may be severe when associated with infectious mononucleosis,in which case treatment should be discontinued. Rare cases of erythema multiforme, Stevens-Johnson syndrome and an occasional case of exfoliative dermatitis have been reported. Serious and fatal hypersensitivity (anaphylactic reaction and angio-neurotic oedema have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parental therapy, it has occurred in patients taking oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

Transient leucopenia and thrombocytopenia have been reported during treatment with penicillins. Hepatitis and Cholestatic jaundice have been reported.

(vii) TOXIC EFFECTS

MUTAGENICITY
Studies have not been performed to date to evaluate the mutagenic potential of amoxicillin and clavulanate potassium.

CARCINOGENICITY
Not expected to produce cancer in humans under occupational exposure conditions. No components are listed as carcinogens by US.

TERATOGENICITY
Not expected to be genotoxic under occupational exposure conditions. Assessment based upon effects of structurally similar substances. Not expected to produce adverse effects on fertility or development under occupational exposure conditions. No adverse effects have been reported following extensive use or exposure in humans.