- 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).
- 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.
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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
Pregnancy & Lactation
Precautions & Warnings
Use in Special Populations
- Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
- Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
- Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
- A similar reduction in dosage should be made for children.
- Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.