Description
Indications
Co-amoxiclav 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: Co-amoxiclav 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 Co-amoxiclav 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
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)ред
- 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.






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