AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, coated AMOXICILLIN AND CLAVULANATE POTASSIUM for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Available from:

USAntibiotics, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin and Clavulanate Potassium is 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 shou

Product summary:

Amoxicillin and Clavulanate Potassium  Tablets, USP: 250 mg/125 mg Tablets : Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). 500 mg/125 mg Tablets : Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). 875 mg/125 mg Tablets : Each scored white capsule‑shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium for Oral Suspension, USP : 125 mg/31.25 mg per 5 mL : Banana-flavored powder for oral suspension, each 5 mL of reconstituted suspension contains 125 mg of amoxicillin as the trihydrate and 31.25 mg of clavulanic acid as the potassium salt (equivalent to 37.23 mg of clavulanate potassium). 200 mg/28.5 mg per 5 mL : Orange-flavored powder for oral suspension, each 5 mL of reconstituted suspension contains 200 mg of amoxicillin as the trihydrate and 28.5 mg of clavulanic acid as the potassium salt (equivalent to 34 mg of clavulanate potassium). 250 mg/62.5 mg per 5 mL : Orange-flavored powder for oral suspension, each 5 mL of reconstituted suspension contains 250 mg of amoxicillin as the trihydrate and 62.5 mg of clavulanic acid as the potassium salt (equivalent to 74.5 mg of clavulanate potassium). 400 mg/57 mg per 5 mL Orange-flavored powder for oral suspension, each 5 mL of reconstituted suspension contains 400 mg of amoxicillin as the trihydrate and 57 mg of clavulanic acid as the potassium salt (equivalent to 68 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium Chewable Tablets, USP : 125 mg/31.25 mg Chewable Tablets : Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 189, contains 125 mg of  amoxicillin as the trihydrate and 31.25 mg clavulanic acid as the potassium salt (equivalent to 37.23 mg of clavulanate potassium). 200 mg/28.5 mg Chewable Tablets : Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with AUGMENTIN 200, contains 200 mg of amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt (equivalent to 34 mg of clavulanate potassium). 250 mg/62.5 mg Chewable Tablets : Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190, contains 250 mg of  amoxicillin as the trihydrate and 62.5 mg clavulanic acid as the potassium salt (equivalent to 74.5 mg of clavulanate potassium). 400 mg/57 mg Chewable Tablets : Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with AUGMENTIN 400, contains 400 mg of amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt (equivalent to 68 mg of clavulanate potassium). Dispense in original container. Store tablets and dry powder at or below 25°C (77°F). Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, COATED
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM FOR SUSPENSION
USANTIBIOTICS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
AMOXICILLIN AND CLAVULANATE POTASSIUM.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, FOR ORAL USE
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
Warnings and Precautions (5)
8/2022
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium is 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: (1)
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 should not be used. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Amoxicillin and
Clavulanate Potassium and other antibacterial drugs, Amoxicillin and
Clavulanate Potassium should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every
12 hours or 250 or 500 mg every
8 hours, based on the amoxicillin component. (2.2, 2.3)
Pediatric patients aged 12 weeks (3 months) and older: 25 to 45
mg/kg/day every 12 hours or 20 to 40
mg/kg/day every 8 hours, up to the adult dose. (2.3)
Neonates and infants less than 12 weeks of age: 30 mg/kg/day divid