AUGMENTIN ES 600 Description

December 2, 2018 | By More

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN ES-600 (amoxicillin/clavulanate potassium) and other antibacterial drugs,AUGMENTIN ES-600 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety ofβ-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula isC8H8KNO5 and the molecular weight is 237.25.

Inactive Ingredients: Powder for Oral Suspension—Colloidal silicon dioxide, strawberry cream flavor, xanthan gum, aspartame•, sodium carboxymethylcellulose, and silicon dioxide.• See PRECAUTIONS–Information for the Patient/Phenylketonurics.Each 5 mL of reconstituted 600 mg/5 mL oral suspension of AUGMENTIN ES-600 contains 0.23 mEq potassium.

CLINICAL PHARMACOLOGY

The pharmacokinetics of amoxicillin and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given AUGMENTIN ES-600 at an amoxicillin dose of 45 mg/kg q12h with a snack or meal.

The effect of food on the oral absorption of AUGMENTIN ES-600 has not been studied.Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mLof 250 mg/5 mL suspension of AUGMENTIN.Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.Neither component in AUGMENTIN ES-600 is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound.

Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.

Category: Augmentin ES

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