Amoxicillin And Clavulanic Acid Potassium Tablets 500MG + 125MG BP

AMO-CLAV 625 mg Tablets

COMPOSITION:

Amoxicillin Trihydrate equivalent to amoxicillin       500MG

Potassium clavulanate equivalent to clavulanic acid    125MG

PHARMACOLOGICAL ACTION:
Amo-clav is a combination of amoxicillin and potassium clavulanate. The amoxicillin component of the formulation exerts a bactericidal action against many strains of Gram positive and Gram-negative organisms. The clavulanic acid component has little or no antimicrobial action. It does, however, by inactivation of susceptible beta-lactamase protect amoxicillin from degradation by beta-lactamase enzymes produced by penicillin resistant strains of organisms.

INDICATIONS:

Amo-clav is indicated for the treatment of infections caused by amoxicillin resistant organisms producing beta-lactamases sensitive to clavulanic acid:
Upper respiratory tract infections: otitis media, tonsillitis, sinusitis.
Lower respiratory tract infections: bronchitis (caused by amoxicillin resistant beta-lactamases producing E. coli, H. influenzae and Haemophilus parainfluenzae), pneumonia.
Urinary tract infections: cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections.
Amo-clav formulations will also be effective in the treatment of infections caused by amoxicillin sensitive organisms at the appropriate amoxicillin dosage since in this situation the clavulanic acid component does not contribute to the therapeutic effect.

CONTRA-INDICATIONS:

Allergy to penicillins and cephalosporins. Safety in pregnancy has not been established. Amo-clav is contra-indicated in patients with a previous history of amoxicillin and potassium clavulanate associated jaundice/hepatic dysfunction. Amoc-lav is also contraindicated in infectious mononucleosis. Patients with lymphatic leukemia and patients with hyperuricaemia having been treated with allopurinol may also be at an increased risk of developing skin rashes.

WARNINGS:

Transient hepatitis and cholestatic jaundice has been reported, hence, Amo-clav should be used with caution in patients with evidence of hepatic dysfunction.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on 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.

DOSAGE AND DIRECTIONS FOR USE:

Tablets should be taken immediately before a meal.
General information:
For infections caused by amoxicillin sensitive organisms, the dosage is that approved for amoxicillin as the clavulanic acid component does not contribute to the therapeutic effect.
Adults (oral): 1 Amo-clav 625mg Tablet 8 hourly for more severe infections and infections of the respiratory tract.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria. The hypersensitivity reactions reported are erythematous maculopapular rashes, urticaria, fever and joint pains. Anaphylactic shock may occur.

Allergic reactions may occur, usually manifesting as pruritic skin rash, an erythematous skin reaction, urticaria, angiodema, anaphylaxis or eosinophilia –Coomb’s test may become positive. In this event, withdrawal of Amo-clav and the administration of antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, Amo-clav should be discontinued and the patient treated with the usual agents: adrenalin, corticosteroids and antihistamines.

STORAGE INSTRUCTIONS:

Store below 25°C, protected from light and moisture.
KEEP OUT OF REACH OF CHILDREN.