SPL Set ID: 1b8a6312-ae47-45fb-ba5e-eedbc176afa0

Amoxicillin and Clavulanate Potassium 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 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 )(2 R ,5 R )-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 Tablets: • 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). • 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). • 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium for Oral Suspension: • 125 mg/31.25 mg : Following constitution, each 5 mL of oral suspension contains 125 mg of amoxicillin as the trihydrate, and 31.25 mg of clavulanic acid (equivalent to 37.23 mg of clavulanate potassium). • 200 mg/28.5 mg : Following constitution, each 5 mL of oral suspension contains 200 mg of amoxicillin as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium). • 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). • 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). Amoxicillin and Clavulanate Potassium Chewable Tablets: • 125 mg/31.25 mg: Each chewable tablet contains 125 mg of amoxicillin as the trihydrate, and 31.25 mg of clavulanic acid (equivalent to 37.23 mg of clavulanate potassium). • 200 mg/28.5 mg: Each chewable tablet contains 200 mg of amoxicillin as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium). • 250 mg/62.5 mg: Each chewable tablet contains 250 mg of amoxicillin as the trihydrate, and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). • 400 mg/57 mg: Each chewable tablet contains 400 mg of amoxicillin as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium). Inactive Ingredients: • Amoxicillin and Clavulanate Potassium Tablets - Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. • Each tablet of Amoxicillin and Clavulanate Potassium contains 0.63 mEq potassium. • Amoxicillin and Clavulanate Potassium for Oral Suspension, 125 mg/31.5 mg per 5mL and 250 mg/62.5 mg per 5mL - Colloidal silicon dioxide, flavorings, xanthan gum, mannitol, succinic acid, silica gel and sodium saccharin. • Each 5 mL of reconstituted 125 mg/31.5 mg oral suspension of Amoxicillin and Clavulanate Potassium contains 0.16 mEq potassium • Each 5 mL of reconstituted 250 mg/62.5 mg oral suspension of Amoxicillin and Clavulanate Potassium contains 0.32 mEq potassium • Amoxicillin and Clavulanate Potassium for Oral Suspension, 200 mg/28.5 mg per 5mL and 400 mg/57 mg per 5mL - Colloidal silicon dioxide, flavorings, xanthan gum, silica gel, hypromellose and aspartame [see Warnings and Precautions ( 5.8 )] • Each 5 mL of reconstituted 200 mg/28.5 mg oral suspension of Amoxicillin and Clavulanate Potassium contains 0.14 mEq potassium • Each 5 mL of reconstituted 400 mg/57 mg oral suspension of Amoxicillin and Clavulanate Potassium contains 0.29 mEq potassium • Amoxicillin and Clavulanate Potassium Chewable Tablets, 125 mg/31.25 mg and 250 mg/62.5 mg - Colloidal silicon dioxide, flavorings, magnesium stearate, mannitol, sodium saccharin, glycine, and D&C Yellow No.10. o Each 125 mg/31.25 mg chewable tablet of Amoxicillin and Clavulanate Potassium contains 0.16 mEq potassium o Each 250 mg/62.5 mg chewable tablet of Amoxicillin and Clavulanate Potassium contains 0.32 mEq potassium • Amoxicillin and Clavulanate Potassium Chewable Tablets, 200 mg/28.5 mg and 400 mg/57 mg - Colloidal silicon dioxide, flavorings, magnesium stearate, mannitol, FD&C Red No. 40 and aspartame [see Warnings and Precautions ( 5.8 )] o Each 200 mg/28.5 mg chewable tablet of Amoxicillin and Clavulanate Potassium contains 0.14 mEq potassium o Each 400 mg/57 mg chewable tablet of Amoxicillin and Clavulanate Potassium contains 0.29 mEq potassium structure-amoxicillin structure-clav-acid