| DESCRIPTION
Augmentin is an oral antibacterial combination consisting of
the semisynthetic antibiotic amoxicillin and the b-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.
Clavulanic acid is produced by the fermentation of Streptomyces
clavuligerus. It is a b-lactam structurally related to the penicillins
and possesses the ability to inactivate a wide variety of b-lactamases
by blocking the active sites of these enzymes. Clavulanic acid
is particularly active against the clinically important plasmid
mediated b-lactamases frequently responsible for transferred
drug resistance to penicillins and cephalosporins. 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.
Each Augmentin tablet contains 0.63 mEq potassium.
Each 125 mg chewable tablet and each 5 ml of reconstituted
Augmentin 125 mg/5 ml oral suspension contains 0.16 mEq potassium.
Each 250 mg chewable tablet and each 5 ml of reconstituted Augmentin
250 mg/5 ml oral suspension contains 0.32 mEq potassium. Each
200 mg chewable tablet and each 5 ml of reconstituted Augmentin
200 mg/5 ml oral suspension contains 0.14 mEq potassium. Each
400 mg chewable tablet and each 5 ml of reconstituted Augmentin
400 mg/5 ml oral suspension contains 0.29 mEq of potassium.
Inactive Ingredients
Powder for Oral Suspension: Colloidal silicon dioxide, flavorings
(see HOW SUPPLIED), succinic acid, xanthan gum, and one or more
of the following: aspartame, hydroxypropyl methylcellulose,
mannitol, silica gel, silicon dioxide and sodium saccharin.
Chewable Tablets: Colloidal silicon dioxide, flavorings (see
HOW SUPPLIED), magnesium stearate, mannitol and one or more
of the following: aspartame, D&C yellow no. 10, FD&C
red no. 40, glycine, sodium saccharin and succinic acid.
(For additional information concerning aspartame see PRECAUTIONS,
Information for the Patient.)
Tablets: Colloidal silicon dioxide, hydroxypropyl methylcellulose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol, sodium starch glycolate and titanium dioxide.
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