Amoxicillin-clavulanate potassium description
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]
Description
AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).
Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
- Inactive Ingredients:
- Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium.
- Powder for Oral Suspension- Colloidal silicon dioxide, flavorings, xanthan gum, and one or more of the following: hypromellose, mannitol, silica gel, silicon dioxide, succinic acid,sodium saccharin, and aspartame. [see Warnings and Precautions (5.6]
- Chewable Tablets- Colloidal silicon dioxide, flavorings, magnesium stearate, mannitol, and one or more of the following: D&C Yellow No. 10, FD&C Red No. 40, glycine, sodium saccharin, and aspartame. [see Warnings and Precautions (5.6)
- Each 125-mg chewable tablet and each 5 mL of reconstituted 125/5 mL oral suspension of AUGMENTIN contains 0.16 mEq potassium
- Each 250-mg chewable tablet and each 5 mL of reconstituted 250/5 mL oral suspension of AUGMENTIN contains 0.32 mEq potassium
- Each 200-mg chewable tablet and each 5 mL of reconstituted 200/5 mL oral suspension of AUGMENTIN contains 0.14 mEq potassium
- Each 400-mg chewable tablet and each 5 mL of reconstituted 400/5 mL oral suspension of AUGMENTIN contains 0.29 mEq potassium[1]
References
Adapted from the FDA Package Insert.