SPL Set ID: 22cd4e96-2288-470c-9264-8058cd7db9b0

Amoxicillin and clavulanate potassium tablets, USP and for oral suspension, USP are 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 )( 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 Tablets, USP: • 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, USP: • 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). • 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 • Amoxicillin and Clavulanate Potassium Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. ∘ Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium. • Amoxicillin and Clavulanate Potassium for Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel) [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