AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension AMOXICI

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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Enterobacter species. Limitations of Use When susceptibility te

Product summary:

Amoxicillin and clavulanate potassium tablets, USP are supplied as follows: 500 mg/125 mg: White, oblong–shaped, biconvex, film–coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20 tablets (NDC 0093–2274–34). 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 20 tablets (NDC 0093–2275–34). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Amoxicillin and clavulanate potassium for oral suspension, USP is supplied as follows: 200 mg/28.5 mg per 5 mL: White to off–white powder – Each 5 mL of reconstituted orange–raspberry–flavored suspension contains 200 mg amoxicillin, USP and 28.5 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 0093–2277–73). 400 mg/57 mg per 5 mL: White to off–white powder – Each 5 mL of reconstituted orange–raspberry–flavored suspension contains 400 mg amoxicillin, USP and 57 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 0093–2279–73). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Amoxicillin and clavulanate potassium tablets, USP (chewable) are supplied as follows: 200 mg/28.5 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other. They are available in bottles of 20 tablets (NDC 0093–2270–34). 400 mg/57 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other. They are available in bottles of 20 tablets (NDC 0093–2272–34). Store at 20º to 25ºC (68º to 77ºF) [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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, CHEWABLE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM TABLETS, AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR ORAL
SUSPENSION, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS
(CHEWABLE) SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND
CLAVULANATE
POTASSIUM TABLETS, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL
SUSPENSION,
AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS (CHEWABLE).
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, AMOXICILLIN AND
CLAVULANATE
POTASSIUM FOR ORAL SUSPENSION, AND AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLETS
(CHEWABLE) 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