AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Northstar RxLLC

INN (Kansainvälinen yleisnimi):

AMOXICILLIN

Koostumus:

AMOXICILLIN ANHYDROUS 250 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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: Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. 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 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. Amoxicillin and clavulanate potassium is con

Tuoteyhteenveto:

Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 16714-476-01 bottle of 30 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 16714-477-01 bottle of 20 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 16714-014-01 bottle of 20 film coated tablets NDC 16714-014-02 bottle of 100 film coated tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
NORTHSTAR RXLLC
REFERENCE LABEL SET ID: 8F8259CA-F356-4E55-8770-15FB7B345F90
REFERENCE LABEL SET ID: 7CD5A359-4EBC-4B2A-81D7-3B253069E346
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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
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium tablet 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 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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
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•
WARNINGS AND PRECAUTIONS
•
Warnings and Precautions (5) 8/2022
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/day every 8 hours, up to the adult dose. (2.3)
Neonates and infants less than 12 weeks of