AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 200 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: 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. 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 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 contri

Product summary:

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 200 mg/28.5 mg per 5 mL: The dry powder is white to off white with fruity flavor. Each 5 mL of reconstituted creamy suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. NDC 68788-0047-1.................. 100 mL bottle Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 400 mg/57 mg per 5 mL: The dry powder is white to off white with fruity flavor. Each 5 ml of reconstituted creamy suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. 100 mL bottle - 68788-0598-1 Dispense in original container. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
----------
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)
•
•
•
•
•
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
•
•
•
DOSAGE FORMS AND STRENGTHS
Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
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