AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

PD-Rx Pharmaceuticals, Inc.

Designación común internacional (DCI):

AMOXICILLIN

Composición:

AMOXICILLIN ANHYDROUS 875 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are 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 En

Resumen del producto:

Amoxicillin and clavulanate potassium tablets, USP are supplied as follows: 875 mg/125 mg: White, capsule–shaped, biconvex, film–coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side. Each tablet contains 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of : NDC 43063-077-03 Bottles of 3 NDC 43063-077-04 Bottles of 4 NDC 43063-077-06 Bottles of 6 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light–resistant container as defined in the USP, with a child–resistant closure (as required). Keep this and all medications out of the reach of children.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM TABLETS, SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS.
AMOXICILLIN AND CLAVULANATE POTASSIUM 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 tablets, amoxicillin and
clavulanate potassium for oral suspension,
and amoxicillin and clavulanate potassium tablets (chewable) are
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 tablets, amoxicillin and
clavulanate potassium for oral suspension,
and amoxicillin and clavulanate potassium tablets (chewable) should
not be used. ( 1)
Usage
To reduce the development of drug–resistant bacteria and maintain
the effectiveness of amoxicillin and
clavulanate potassium tablets, amoxicillin and clavulanate potassium
for oral suspension, and amoxicillin
and clavulanate potassium tablets (chewable) and other antibacterial
drugs, amoxicillin and clavulanate
potassium tablets, amoxicillin and clavulanate potassium for oral
suspension, and amoxicillin and
clavulanate potassium tablets (chewable) 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 th