SPL Set ID: 7cd5a359-4ebc-4b2a-81d7-3b253069e346

Amoxicillin and clavulanate potassium for oral suspension, USP and chewable tablets. USP are an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-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 ( 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 β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-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 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: Each chewable tablet and each teaspoon (5 mL) of reconstituted oral suspension contains 200 mg or 400 mg amoxicillin as the trihydrate and 28.5 or 57 mg clavulanic acid as the potassium salt. Each 200 mg/28.5 mg chewable tablet and each 5 mL of reconstituted amoxicillin and clavulanate potassium 200 mg/28.5 mg oral suspension contains 0.14 mEq potassium. Each 400 mg/57 mg chewable tablet and each 5 mL of reconstituted 400 mg/57 mg oral suspension contains 0.29 mEq of potassium. Inactive Ingredients Powder for Oral Suspension - Aspartame*, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (carmel). Chewable Tablets - Aspartame*, banana flavoring (See HOW SUPPLIED ), cherry flavoring (See HOW SUPPLIED ), colloidal silicon dioxide, FD&C Red No. 40, magnesium stearate, mannitol, and sodium starch glycolate. *See PRECAUTIONS-Information for Patients . Amoxicillin Chemical Structure Clavulanate Potassium Chemical Structure