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.

Broad spectrum penicillins

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.

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.

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.

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, 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.

Amoxicillin and Clavulanic acid has been used orally in human pregnancy in a limited number of cases with no untoward effect; however use of Amoxycillin & Clavulanic Acid in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.

Amoxycillin & Clavulanic Acid 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 Amoxycillin & Clavulanic Acid adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.

Dosage in renal impairment: The dose should be adjusted in case of patients with renal impairment.

Adults or Children:

• Mild impairment (CrCl > 30 ml/min): No change in dose.
• Moderate impairment (CrCl 10- 30 ml/min): 625 mg tablet 12 hourly.
• Severe impairment (CrCl < 10 ml/min): Not more than one tablet 12 hourly; 625 mg tablet is not recommended.

Dosage in hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.This may be taken without regard to meals; however, absorption of Clavulanate potassium is enhanced when Amoxicillin/Clavulanic acid is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin/Clavulanic acid should be taken at the start of the meal.

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.

Should be stored at a temperature not exceeding 25° C or below. Protect from light and moisture. Once reconstituted suspension should be kept in refrigerator (but not frozen) and should be used by 7 days.