This combination 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.
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This combination 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.

Dosage & Administration

Adults and children over 12 years:

Tablet:

• 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 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.

Suspension:

• Children 6-12 years: 2 teaspoonful every 8 hours.
• Children 1-6years: 1 teaspoonful every 8 hours.
• Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.

Forte suspension:

• The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
• For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).

Children of 2 to 12 years:
Mild to moderate infections:

• 25/3.6 mg/kg/day (Suspension)
• 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
• 7-12years (22-40kg) 5 ml suspension b.i.d

Serious infections:

• 45/6.4 mg/kg/day (Forte Suspension)
• 2-6 years (13-21 kg) 5 ml suspension b.i.d
• 7-12 years (22-40 kg) 10 ml suspension b.i.d

IV Injection

Adults-

• Usually, 1.2 gm every 8 hours
• Increased in more serious infections to 1.2 gm every 6 hours
• For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.

Children-

• 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
• 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.

Interaction

Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients 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 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 a previous history of Co-amoxiclav 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 Co-amoxiclav 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.

Precautions & Warnings

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

Overdose Effects

Problems 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-amoxiclav may be removed from the circulation by haemodialysis.

Therapeutic Class

Broad spectrum penicillins

Storage Conditions

This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.