SPL Set ID: 8ea86ac2-174b-4da0-963f-6a051dccbe36
1 drug(s) with this SPL Set ID
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, USP 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, USP 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 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, USP 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, USP: 200 mg/28.5 mg : Following constitution, each 5 mL of oral suspension contains 200 mg of amoxicillin, USP as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium, USP). 400 mg/57 mg: Following constitution, each 5 mL of oral suspension contains 400 mg of amoxicillin, USP as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium, USP). Inactive Ingredients: colloidal silicon dioxide, flavorings (golden caramel, orange flavor and raspberry flavor), xanthan gum, silicon dioxide, succinic acid, 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. The compositions of flavors are listed below: Orange flavor – Flavoring preparation, maltodextrin (maize), modified starch E1450 (waxy maize), nature identical flavoring substance and natural flavoring substance. Raspberry Flavor – Maltodextrin (waxy maize), modified starch E1450 (waxy maize), nature identical flavoring substance and propylene glycol. Golden Caramel Flavor – Acetic acid, artificial flavors, maltodextrin, natural flavors and triethyl citrate amoxiclavu-stra.jpg amoxiclavu-strb.jpg