Augment Tablet 1gm

• 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).

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.

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.

Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.

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.