SPL Set ID: 26992a71-e4a0-4e41-aa3c-3219868c2226
1 drug(s) with this SPL Set ID
Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is an oral antibacterial combination consisting of the semisynthetic antibacterial 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, USP molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.4. Chemically, amoxicillin is (2 S ,5 R ,6 R )-6-[( R )-2-amino-2-(4-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 a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-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 237.3. Chemically, clavulanate potassium is potassium ( Z )-(2 R ,5 R )-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid and may be represented structurally as: Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin, USP as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, citric acid anhydrous, colloidal silicon dioxide, hypromellose, mannitol, orange flavour, trisodium citrate dihydrate, and xanthan gum [see Warnings and Precautions ( 5.8 )] . Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL contains 0.23 mEq potassium. amoxi-strua.jpg amoxi-strub.jpg