AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
04-02-2023
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Active ingredient:
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANIC ACID (UNII: 23521W1S24) (CLAVULANIC ACID - UNII:23521W1S24)
Available from:
A-S Medication Solutions
INN (International Name):
AMOXICILLIN
Composition:
AMOXICILLIN ANHYDROUS 400 mg in 5 mL
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Amoxicillin and Clavulanate Potassium for Oral Suspension 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 Clavulan
Product summary:
Product: 50090-0831 NDC: 50090-0831-0 100 mL in a BOTTLE Product: 50090-0832 NDC: 50090-0832-0 100 mL in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN
AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL
SUSPENSION.
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1984
RX ONLY
RECENT MAJOR CHANGES
Warnings and Precautions (5) 8/2022
INDICATIONS AND USAGE
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 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 for Oral Suspension should not
be used. (1)
Usage
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 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 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 divided
every 12 hours, based on the
amoxicillin component. Use of the 125 mg/5 mL oral
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