Tablet 250 mg: Each film-coated Tablet contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 250 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
Tablet 500 mg: Each film-coated Tablet contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 500 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
Tablet 875 mg: Each film-coated Tablet contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 875 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
Suspension: Each 5 ml contains Amoxicillin BP equivalent to Amoxicillin 125 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.
IV Injection: Each combipack contains a vial of for Injection BP consisting of Amoxicillin Sodium equivalent to Amoxicillin 1 g and Potassium Clavulanate BP equivalent to Clavulanic Acid 200 mg and 2 ampoules of Water for Injection USP 10 ml.
Augment® is a combined preparation of Amoxicillin and Clavulanic Acid. Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by β-lactamases, and therefore, the spectrum of activity does not include organisms which produce these enzymes. Clavulanic Acid is a β-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of β-lactamase enzymes commonly found in microorganisms resistant to Penicillins and Cephalosporins. In particular, it has good activity against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance. The formulation of Amoxicillin and Clavulanic acid protects Amoxicillin from degradation by β-lactamase enzymes and effectively extends the antibiotic spectrum of Amoxicillin to include many bacteria normally resistant to Amoxicillin and other β-lactam antibiotics. Thus, this combination possesses the distinctive properties of a broad-spectrum antibiotic and a β-lactamase inhibitor.
Neonates and infants aged < 12 weeks (< 3 months): Due to incompletely developed renal function affecting elimination of Amoxicillin in this age group, the recommended dose of this combination is 30 mg/kg/day divided every 12h, based on the Amoxicillin component. Clavulanate elimination is unaltered in this age group.
Patients aged 12 weeks (3 months) and older:
Pediatrics patients weighing 40 kg and more and the adult patients: The usual adult dose is one 500 mg tablet every 12 hours or one 250 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg tablet every 12 hours or one 500 mg tablet every 8 hours.
Dosage and Administration of Augment IV Injection:
Augment 1.2 IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection USP.
Augment 1.2 IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
Administration:
Note: Augment 1.2 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 vial must be used within 20 minutes and thereafter any unused material should be discarded.
Dosage Guideline:
Note: Each 30 mg of this combination contains 25 mg amoxicillin and 5 mg Clavulanate.
Pregnancy Category B: There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ampicillin-class antibiotics are excreted in the milk; therefore, caution should be exercised when this combination is administered to a nursing woman.
While this combination possesses the characteristic low toxicity of the Penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy. Severe and occasional hypersensitivity can be occurred with this combination. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including this combination, and has ranged in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
For Tablet: Do not store above 25°C temperature. Keep away from light and wet place. Keep out of reach of children.
For Suspension: Do not store above 25°C temperature. Keep away from light and wet place. Reconstituted suspension should be kept tightly closed and to be consumed within 7 days of preparation while stored in a refrigerator (2-8°C) temperature.
For IV Injection: Do not store dry powder above 25°C. Keep away from light and wet place. Reconstituted injection should be used within 20 minutes. Do not freeze the reconstituted solution.