Amoxicillindrug info
amoxicillin 250 MG / clavulanate 125 MG Oral Tablet
What it is used for
Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis.
Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta‑lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 9, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Amoxicillin and clavulanate potassium tablets, 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 Tablets, USP: 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium, USP). 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium, USP). 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium, USP). Inactive Ingredients: colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, talc and titanium dioxide. Each tablet of amoxicillin and clavulanate potassium tablets contains 0.63 mEq potassium. amoxi-stra.jpg amoxi-strb.jpg
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 9, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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