Indications

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. ... Read more 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.

Composition

• 375 mg tablet: Each film coated tablet contains Amoxicillin 250 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP.
• 625 mg tablet: Each film coated tablet contains Amoxicillin 500 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP.
• 1 gm tablet: Each film coated tablet contains Amoxicillin 875 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 125 mg Diluted Potassium Clavulanate BP.
• Powder for Suspension: Each 5 ml reconstituted suspension contains Amoxicillin 125 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 31.25 mg as Diluted Potassium Clavulanate BP.
• Powder for Suspension (Forte): Each 5 ml reconstituted suspension contains Amoxicillin 400 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 57.5 mg as Diluted Potassium Clavulanate BP.
• 1.2 gm Injection: Each vial contains sterile mixture of Amoxicillin Sodium BP (equivalent to Amoxicillin 1 gm) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 200 mg).
• 0.6 gm injection: Each vial contains sterile mixture of Amoxicillin Sodium BP (equivalent to Amoxicillin 500) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 100 mg).

Pharmacology

Pharmacodynamic properties : This is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-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 (3-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 this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms. Pharmacokinetic properties : The pharmacokinetics of the two components of this combination is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.

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.

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.

Pregnancy & Lactation

Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.

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.

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.