SPL Set ID: db25500a-90ee-429f-991f-da511cec7882

1 drug(s) with this SPL Set ID

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Amoxicillin and Clavulanate potassium AMOXICILLIN AND CLAVULANATE POTASSIUM
CIPLA USA INC. FDA Rx Only

Amoxicillin and Clavulanate Potassium for Oral Suspension 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 419.46. 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 of 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: 250 mg/62.5 mg: Following constitution, each 5 mL of oral suspension contains 250 mg of amoxicillin as the trihydrate, and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Colloidal silicon dioxide, hypromellose, mannitol, orange flavor, silicon dioxide, saccharin sodium and xanthan gum [see Warnings and Precautions ( 5.8 )] . Each 5 mL of reconstituted 250 mg/62.5 mg oral suspension of amoxicillin and clavulnate contains 0.31 mEq potassium. image description image description

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