Composition
375 mg tablet: Each film coated tablet contains Amoxycillin 250 mg with Clavulanic acid 125 mg.
625 mg Tablet: Each film coated tablet contains Amoxycillin 500 mg with Clavulanic acid 125 mg.
1 gm Tablet: Each film coated tablet contains Amoxycillin 875 mg with Clavulanic acid 125 mg.
Suspension: Each 5 ml reconstituted suspension contains Amoxycillin 125 mg and Clavulanic acid 31.25 mg.
Forte/bid/DS Suspension: Each 5 ml reconstituted suspension contains Amoxycillin 400 mg and Clavulanic acid 57.50 mg
0.6 gm injection: Sterile powder in vials providing Amoxycillin 500 mg and Clavulanic Acid 100 mg.
1.2 gm injection: Sterile powder in vials providing Amoxycillin 1000 mg and Clavulanic Acid 200 mg.
Indications
Amoxycillin & Clavulanic Acid is indicated for short-term treatment of bacterial infections at the following sites:
Upper respiratory tract infections (including ENT); e.g., tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections; e.g., acute and chronic bronchitis, lobar and bronchopneumonia.
Genito-urinary tract infections; e.g., cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections.
Bone and joint infections; e.g., osteomyelitis.
Other infections; e.g., septic abortion, puerperal sepsis, intra-abdominal sepsis, etc.
Therapeutic Class
Broad spectrum penicillins
Pharmacology
Amoxycillin & Clavulanic Acidis an antibacterial combination consisting of the antibiotic Amoxicillin and the beta-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 beta-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 beta-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 beta-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.
Dosage & Administration
Oral:
Adults and children over 12 years: One 375 mg tablet 3 times a day. In severe infection one 625 mg tablet 3 times a day or one 1 gm tablet two times a day.
Children of 6-12 years: 2 teaspoonful Powder for Suspension every 8 hours.
Children of 1 -6 years: 1 teaspoonful Powder for Suspension every 8 hours.
Children below 1 year: 25 mg/kg/day in divided doses every 8 hours.
IV Injection:
Adults and children over 12 years: 1.2 g every 6-8 hours
Children up to 3 months: 30 mg/kg every 8 hours (every 12 hours in the perinatal period and in premature infants)
Child 3 months to 12 years: 30 mg/kg every 6-8 hours.
Interaction
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Coamoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patient should be warned accordingly. Concomitant use of allopurinol during treatment with amoxycillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
Contraindications
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 Amoxycillin & Clavulanic Acid or penicillin associated cholestatic jaundice.
Side Effects
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 Amoxycillin & Clavulanic Acid 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.
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