Amoxicillin Trihydrate BP and Clavulanic Acid BP


An antibacterial combination consisting of the antibiotic Amoxicillin and the b-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by b-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of b-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in combination of Amoxicillin and Clavulanic acid protects Amoxicillin from degradation by b-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms. 

Onclav 500 Tablet: Each film coated tablet contains Amoxicillin 500 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 125 mg as diluted PotassiumClavulanate BP. Onclav Powder for Suspension: Dry powder in a glass bottle for preparation of 100 ml suspension. After reconstitution each 5 ml contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 125 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.
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, lobar and 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-abdominal sepsis, etc.
Tablets: Adults and children over 12 years: The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Onclav 1 g Tablet every 12 hours or one Onclav 625 mg Tablet every 8 hours. Powder for Suspensions:
Neonate: 0.25 ml/kg 3 times daily. 1 month–1 year: 0.25 ml/kg 3 times daily, dose doubled in severe infection. 1–6 years: 5 ml 3 times daily or 0.25 ml/kg 3 times daily, dose doubled
History of Penicillin hypersensitivity. Attention should be paid to possible cross sensitivity with other beta-lactam antibiotics e.g., cephalosporins. Also contraindicated for patients with previous history of Onclav or penicillin associated cholestatic jaundice.
Onclav 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 beadjusted. During the administration of high dose of Onclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported. If gastrointestinal side effects occur with oral therapy, that may be reduced by taking Onclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but 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-lactam antibiotics angioedema and anaphylaxis have been reported.
Prolongation of bleeding time and prothrombin time has been reported in some patients receiving Onclav. In common with other broad-spectrum antibiotics, Onclav may reduce the efficacy of oral contraceptives and patient should be warned accordingly. Concomitant use of allopurinol during treatment with Amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Onclav with allopurinol.
Use in Pregnancy and Lactation Amoxicillin and Clavulanic acid has been used orally in human pregnancy in a limited number of cases with no untoward effect; however use of Onclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk. Problem of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxoclav may be removed from the circulation by haemodialysis.
Onclav 500 Tablet: Each box contains 5 blister of 4 tablets. Onclav Powder for suspension: Each bottle contains 100 ml of Suspension.