SPL Set ID: 90d0aa94-5c32-4fb7-8561-8763810d2847

1 drug(s) with this SPL Set ID

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Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM
DEVATIS, INC. FDA Rx Only

Amoxicillin and clavulanate potassium for oral suspension, USP 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 C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.45. Chemically, amoxicillin is (2 S, 5 R, 6 R )-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 C 8 H 8 KNO 5 , 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: Amoxicillin and clavulanate potassium for Oral Suspension: • 400 mg/57 mg: Following constitution, each 5 mL of oral suspension contains 400 mg of amoxicillin as the Trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium). Inactive Ingredients: Carboxymethylcellulose Sodium, Sucralose, Sodium Citrate, Anhydrous Citric Acid, Silicon Dioxide, Colloidal Silicon Dioxide, Xanthan Gum, Vanilla Flavor, Tutti Frutti Flavor. • Each 5 mL of reconstituted 400 mg/57 mg oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq of potassium. amoxicillin structural formula clavulanic acid structural formula

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