AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE- amoxicillin and clavulanate potassium tablet, film coated, extended rele

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Dr. Reddy's Laboratories Inc

INN (nume internaţional):

AMOXICILLIN

Compoziție:

AMOXICILLIN ANHYDROUS 562.5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 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 Extended Release Tablets is indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis 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 penic

Rezumat produs:

Amoxicillin and Clavulanate Potassium Extended Release Tablets : Each white, oval film‑coated bilayer scored tablet, debossed with AUGMENTIN XR, 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 43598‑220‑28 Bottles of 28 (7 day Extended Release pack) NDC 43598‑220‑40 Bottles of 40 (10 day Extended Release pack) Storage Dispense in original container Store tablets at or below 25°C (77°F). Keep out of reach of children.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE- AMOXICILLIN
AND
CLAVULANATE POTASSIUM TABLET, FILM COATED, EXTENDED RELEASE
DR. REDDY'S LABORATORIES INC
----------
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
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
INFECTIONS THAT ARE PROVEN OR STRONGLY
SUSPECTED TO BE CAUSED BY SUSCEPTIBLE BACTERIA.(1)
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium Extended Release Tablets are a
combination of a penicillin-class antibacterial drug
and a beta-lactamase inhibitor indicated for treatment of
community-acquired pneumonia and acute bacterial sinusitis (1).
DOSAGE AND ADMINISTRATION
Adults and Pediatric Patients > 40 kg: The recommended dose of
Amoxicillin and Clavulanate Potassium Extended Release
Tablet is 4,000 mg/250 mg daily at the start of a meal according to
the following table (2):
Indication
Dose
Duration
Acute bacterial sinusitis
2 tablets q12h 10 days
Community acquired pneumonia 2 tablets q12h 7-10 days
DOSAGE FORMS AND STRENGTHS
Tablets: 1,000 mg of amoxicillin /62.5 mg of clavulanic acid. (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to Amoxicillin and
Clavulanate Potassium Extended Release Tablet or to other beta-lactams
(e.g., penicillins or cephalosporins) (4.1)
History of cholestatic jaundice/hepatic dysfunction associated with
Amoxicillin and Clavulanate Potassium Extended
Release Tablets. (4.2)
In patien