AUGMENTIN ES-600- amoxicillin and clavulanate potassium for suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

USAntibiotics, LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

AUGMENTIN ES-600 is indicated for the treatment of pediatric patients with - Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors:      - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance [s ee Microbiology (12.4) ]. Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. AUGMENTIN ES-600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the

Dettagli prodotto:

How Supplied AUGMENTIN ES-600® amoxicillin and clavulanate potassium for oral suspension, USP 600 mg/42.9 mg per 5 mL: Strawberry cream-flavored powder for oral suspension. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt (equivalent to 51.1 mg of clavulanate potassium). Storage Store dry powder for oral suspension at or below 25°C (77°F). Dispense in original container. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

AUGMENTIN ES-600 - AMOXICILLIN AND CLAVULANATE POTASSIUM FOR
SUSPENSION
USANTIBIOTICS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AUGMENTIN ES-600 ,
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AUGMENTIN
ES-600 .
AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR ORAL
SUSPENSION
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5)
6/2022
INDICATIONS AND USAGE
AUGMENTIN ES-600 is a combination of amoxicillin, a penicillin-class
antibacterial and clavulanate
potassium, a beta-lactamase inhibitor, indicated for the treatment of
pediatric patients with
Recurrent or persistent acute otitis media due to _S. pneumoniae_
(penicillin MICs less than 2 mcg/mL),
_H. influenzae_ (including β-lactamase-producing strains), or _M.
catarrhalis_ (including β-lactamase-
producing strains) characterized by the following risk factors (1):
- Antibacterial drug exposure for acute otitis media within the
preceding 3 months, and either of the
following: 1) age 2 years, or younger or 2) daycare attendance.
Limitations of Use
Acute otitis media due to _S. pneumoniae_ alone can be treated with
amoxicillin. AUGMENTIN ES-600 is not
indicated for the treatment of acute otitis media due to _S.
pneumoniae_ with penicillin MIC greater than or
equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the
results from bacteriological studies
when there is reason to believe the infection may involve both _S.
pneumoniae_ (penicillin MIC less than or
equal to 2 mcg/mL) and the β-lactamase-producing organisms listed
above. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AUGMENTIN ES-
600 and other antibacterial drugs, AUGMENTIN ES-600 should be used
only to treat or prevent infections
that are proven or strongly suspected to be caused by bacteria.(1)
DOSAGE AND ADMINISTRATION
Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12
hours, administered for 10 day