Amoxicillindrug info
12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet
What it is used for
Amoxicillin and Clavulanate Potassium Extended Release Tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/ mL. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release 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. In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablets is prescribed. Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S. pneumoniae plus a beta-lactamase-producing pathogen can be treated with another amoxicillin and clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium Extended Release Tablets is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for treatment of adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release 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 July 7, 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 Extended Release Tablets is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin sodium and amoxicillin trihydrate) 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 trihydrate molecular formula is C16H19N3O5S
3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate 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: The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino (4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid monosodium salt 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 C8H8KNO5, 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: Each tablet of Amoxicillin and Clavulanate Potassium Extended Release Tablets contains 1,000 mg of amoxicillin (437.5 mg of amoxicillin equivalent to 463.8 mg of amoxicillin sodium and 562.5 mg of amoxicillin in the form of amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of Amoxicillin and Clavulanate Potassium Extended Release Tablets contains approximately 13 mg of potassium and 30 mg of sodium. Amoxicillin Trihydrate Amoxicillin Sodium clavulanate potassium
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 7, 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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