AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, multilayer, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), AMOXICILLIN SODIUM (UNII: 544Y3D6MYH) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Pieejams no:

Sandoz Inc

SNN (starptautisko nepatentēto nosaukumu):

AMOXICILLIN

Kompozīcija:

AMOXICILLIN ANHYDROUS 562.5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients with due to confirmed, or suspected β-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). Limitations of Use Amoxicillin and clavulanate potassium extended-release tablets is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL [see Clinical Studies (14)] . Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium extended-release tablets and other antibacterial drugs, amoxicillin and clavulanate potassium extended-releas

Produktu pārskats:

Amoxicillin and Clavulanate Potassium Extended-Release Tablets: Each white to cream tinged, oval film‑coated bilayer tablet, debossed SZ 137 on one side and scored on the reverse side, contains amoxicillin trihydrate and amoxicillin sodium equivalent to a total of 1,000 mg of amoxicillin and clavulanate potassium equivalent to 62.5 mg of clavulanic acid. NDC 0781-1943-82 Bottles of 28 (7 day Extended Release Tablets pack) NDC 0781-1943-39 Bottles of 40 (10 day Extended Release Tablets pack) Storage Store tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container. KEEP OUT OF THE REACH OF CHILDREN.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM
EXTENDED-
RELEASE TABLETS.
AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED-RELEASE TABLETS, FOR
ORAL USE.
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium extended-release tablets is a
combination of amoxicillin, a penicillin-
class antibacterial and clavulanate potassium, a β-lactamase
inhibitor, indicated for treatment of adults
and pediatric patients with
•
•
Limitations of Use
Amoxicillin and clavulanate potassium extended-release tablets is not
indicated for the treatment of
infections due to _S. pneumoniae_ with penicillin MICs greater than or
equal to 4 mcg/mL. Data are limited
with regard to infections due to _S. pneumoniae_ with penicillin MICs
greater than or equal to 4 mcg/mL. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium extended-release tablets and other antibacterial
drugs, amoxicillin and clavulanate
potassium extended-release tablets should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
•
INDICATION
DOSE
DURATION
Acute bacterial sinusitis
2 tablets every 12 hours
10 days
Community-acquired pneumonia
2 tablets every 12 hours
7 to 10 days
DOSAGE FORMS AND STRENGTHS
Extended-release Tablets: 1,000 mg/62.5 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
Warnings and Precautions (5) 11/2022
community-acquired pneumonia or
acute bacterial sinusitis
due to confirmed, or suspected β-lactamase-producing pathogens (i.e.,
_H. influenzae, M. catarrhalis,_
_H.