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AMOXICLAVE

CO-AMOXICLAV · by NOVARTIS

BETA-LACTAM ANTIBACTERIALS, PENICILLINS Beta-lactamase inhibitor/Broad-spectrum penicillin NOVARTIS

Composition

Susp 156.25 mg: Per 5 ml: Clavulanic acid 31 mg, amoxicillin 125 mg; powder for reconstitution. Susp 228.5 mg: Per 5 ml: Clavulanic acid 28.5 mg, amoxicillin 200 mg; powder for reconstitution

Indications & Dosage

Infections due to beta-lactamase-producing strains(where amoxicillin alone not appropriate), including respiratory tract infections, bone and joint infections, genito-urinary and abdominal infections, skin and soft tissue infection, cellulitis and animal bites: ORAL TAB: Adult &Children 12-17 yrs: 250/125 mg every 8 hours; increased to 500/125 mg every 8 hours, increased dose used for severe infection. BY IV INJ, OR BY IV INF: Adult: 1.2 g every 8 hours. Children 1-2 months: 30 mg/kg every 12 hours; 3 months-17 years: 30 mg/kg every 8 hours (max.per dose 1.2 g every 8 hours) ORAL SUSP 125/3: Children 1-11 months: 0.25 ml/kg 3 times a day, dose doubled in severe infection; 1-5 years: 0.25 ml/kg 3 times a day, alternatively 5 ml 3 times a day, dose doubled in severe infection ORAL SUSP 250/62: Children 6-11 years: 0.15 ml/kg 3 times a day, alternatively 5 ml 3 times a day, dose doubled in severe infection. ORAL SUSP 400/57: Children 2 months-1 year: 0.15 ml/kg twice daily, doubled in severe infection; 2-6 years (body-weight 13-21 kg): 2.5 ml twice daily, doubled in severe infection; 7-12 years (body-weight 22-40 kg): 5 ml twice daily, doubled in severe infection; 12-17 years (body-weight 41 kg and above): 10 ml twice daily; increased if necessary to 10 ml 3 times a day, increased frequency to be used in severe infection. Adult: 10 ml twice daily; increased if necessary to10 ml 3 times a day, increased frequency to be used in severe infection. Severe dental infection with spreading cellulitis, Dental infection not responding to first-line antibacterial: ORAL TAB: Adult &Children 12-17 years: 250/125 mg every 8 hours for 5 days. Surgical prophylaxis: BY IV INJ, OR BY IV INF: Adult: 1.2 g, to be administered up to 30 minutes before the procedure, then 1.2 g every 8 hours for up to2-3 further doses in high risk procedures.

Administration

By direct IV push over a period of 3-4 min used within 20 min of reconstitution, By IV intermittent infusion over 30-40 min and complete within 4 hours of reconstitution.

Contraindications

Penicillin hypersensitivity, history of coamoxiclav-associated or penicillin associated jaundice or hepatic dysfunction.

Precautions

Hepatic impairment (monitor hepatic function), risk of crystalluria with high doses, patient should be well hydrated. Do not dilute Syp below half- strength.

Interactions

Anticoagulants, allopurinol, probenecid, oral contraceptives, methotrexate.

Pregnancy

No evidence of risk

Lactation

Contraindicated

Side Effects

Dizziness, headache, hepatitis, cholestatic jaundice, convulsions (particularly with high doses or in renal impairment), superficial staining of teeth with suspension, phlebitis at injecction site, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis, exfoliative dermatitis, vasculitis, rarely prolongation of bleeding time