Amoxycillin Trihydrate USP & Potassium Clavulanate USP

To be submitted at the time of inclusion.

Tablet
Each tablet contains Amoxycillin Trihydrate USP equivalent to Amoxycillin 500 mg & Potassium Clavulanate equivalent to Clavulanic acid 125 mg.

Co-Amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
1. Upper respiratory tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media.
2. Lower respiratory tract infections e.g. acute and chronic bronchitis, lobarand bronchopneumonia.
3. Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.
4. Skin and soft tissue infections.
5. Bone and joint infections e.g. osteomyelitis.
6. Other infections e.g. septic abortion, puerperal sepsis, intra-abdominalsepsis, etc.

Adults and children over 12 years:
The usual adult dose is one Co-Amoxiclav 625 mg tablet every 12 hours or one Co-Amoxiclav 375 mg tablet every 8 hours.
For more severe infections and infections of the respiratory tract, the dose should be one Co-Amoxiclav 1gm tablet every 12 hours or one Co-Amoxiclav 625 mg tablet every 8 hours.

Side effects, as with Amoxicillin, are uncommon and mainly of a mild andtransitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported. If gastrointestinal side effectsoccur with oral therapy, that may be reduced by taking Co-amoxiclav at thestart of meals. Hepatitis and cholestatic jaundice have been reported rarelybut are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactamantibiotics angioedema and anaphylaxis have been reported.

Co-amoxiclav should be used with care in patients on anti-coagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of high dose of Co-Amoxiclav adequate fluid intake and urinaryoutput should be maintained to minimize the possibility of crystalluria.

Penicillin hypersensitivity. Attention should be paid to possible cross sensitivity with other beta-lactam antibiotics e.g. cephalosporins, previoushistory of Co-amoxiclav or penicillin associated cholestatic jaundice.

Prolongation of bleeding time and prothrombin time have been reported insome patients receiving Co-amoxiclav. In common with other broad-spectrumantibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives andpatient should be warned accordingly. Concomitant use of allopurinol during treatment with Amoxicillin can increasethe likelihood of allergic skin reactions. There are no data on the concomitantuse of Co-amoxiclav and allopurinol.

Animal studies with orally and parenterally administered Co-amoxiclav haveshown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however useof Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin canbe detected in breast milk.

Problems of overdose with Co-amoxiclav are unlikely to occur, if encounteredgastrointestinal symptoms and disturbance of the fluid and electrolytebalances may be evident. Co-amoxiclav may be removed from the circulationby haemodialysis.

• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.

Box containing 5 X 10 Capsules in blister pack.