Amoxicillindrug info

amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension

What it is used for

Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms: Lower Respiratory Tract Infections Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Acute Bacterial Sinusitis Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Acute Bacterial Otitis Media Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Skin and Skin Structure Infections Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Urinary Tract Infections Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Limitations of Use Therapy may be initiated before bacteriological results are available when beta-lactamase-producing pathogens are suspected. When results show susceptibility to amoxicillin alone, amoxicillin and clavulanate potassium for oral suspension should not be used. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

1.1 Lower Respiratory

Tract Infections Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of lower respiratory tract infection due to confirmed or suspected beta-lactamase producing Haemophilus influenzae and Moraxella catarrhalis as follows: Amoxicillin and Clavulanate Pot assi um for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets

1.3 Acute Bacterial

Sinusitis Amoxicillin and clavulanate potassium for oral suspension are indicated for the treatment of acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis as follows: Amoxicillin and Clavulanate Po tassi um for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets

1.4 Acute Bacterial

Otitis Media Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of acute bacterial otitis media due to confirmed or suspected beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis as follows: Amoxicillin and Clavulanate Pot assi um for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets

1.6 Skin and

Skin Structure Infections Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of skin and skin structure infections due to confirmed or suspected beta-lactamase-producing S. aureus, Escherichia coli, and Klebsiella species as follows: Amoxicillin and Clav ulana te Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets

1.7 Urinary

Tract Infections Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of urinary tract infections due to confirmed or suspected beta-lactamase-producing E. coli, Klebsiella species, and Enterobacter species as follows: Amoxicillin and Clavulanate P otassi um for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets

1.8 Limitations of

Use Therapy may be initiated before bacteriological results are available when beta-lactamase-producing pathogens are suspected. When results show susceptibility to amoxicillin alone, amoxicillin and clavulanate po tassiu m for oral suspension should not be used.

1.9 Usage to

Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 13, 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 for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate. Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Amoxicillin trihydrate has a molecular formula of C 16 H 19 N 3 O 5 S

3H 2 O, and a molecular weight of 419.46. Chemically, it 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 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. Clavulanate potassium has a molecular formula of C 8 H 8 KNO 5 and a molecular weight of 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: 125 mg/31.25 mg: Following constitution, each 5 mL of oral suspension contains 125 mg of amoxicillin (equivalent to 143 mg of amoxicillin trihydrate) and 31.25 mg of clavulanic acid (equivalent to 37.23 mg of clavulanate potassium). 250 mg/62.5 mg: Following constitution, each 5 mL of oral suspension contains 250 mg of amoxicillin (equivalent to 287 mg of amoxicillin trihydrate) and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Amoxicillin and clavulanate potassium for oral suspension, USP is white to off-white granular powder and becomes white to pale yellow with orange flavored suspension after reconstitution. Each 5 mL of reconstituted 125 mg/31.25 mg oral suspension of amoxicillin and clavulanate contains 7 mg potassium. Each 5 mL of reconstituted 250 mg/62.5 mg oral suspension of amoxicillin and clavulanate contains 13 mg potassium. Inactive Ingredients: Aspartame, colloidal silicon dioxide, hypromellose, orange flavor, silicon dioxide, succinic acid, and xanthan gum. The orange flavor contains corn syrup, gum arabic and natural & artificial flavor. Chemical Structure 1 Chemical Structure2

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 13, 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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