CEFTIN cefuroxime axetil powder for suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
15-05-2018

Aktivna sestavina:

CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)

Dostopno od:

GlaxoSmithKline LLC

INN (mednarodno ime):

CEFUROXIME AXETIL

Sestava:

CEFUROXIME 125 mg in 5 mL

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

New Drug Application

Lastnosti izdelka

                                CEFTIN- CEFUROXIME AXETIL POWDER, FOR SUSPENSION
CEFTIN- CEFUROXIME AXETIL TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFTIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CEFTIN.
CEFTIN (CEFUROXIME AXETIL) TABLETS, FOR ORAL USE
CEFTIN (CEFUROXIME AXETIL) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Indications and Usage, Acute Bacterial Exacerbations of Chronic
Bronchitis and Secondary Bacterial
Infections of Acute Bronchitis: Secondary Bacterial Infections of
Acute Bronchitis (1.4)-Removed
11/2016
Dosage and Administration, Dosage for CEFTIN Tablets: Secondary
Bacterial Infections of Acute
Bronchitis (2.2)-Removed
11/2016
Dosage and Administration, Preparation and Administration of CEFTIN
for Oral Suspension (2.4)
10/2017
INDICATIONS AND USAGE
CEFTIN is a cephalosporin antibacterial drug indicated for the
treatment of the following infections due to susceptible
bacteria: (1)
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of CEFTIN and other antibacterial
drugs, CEFTIN should be used only to treat or prevent infections that
are proven or strongly suspected to be caused by
bacte ria.
DOSAGE AND ADMINISTRATION
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ADULT PATIENTS AND PEDIATRIC PATIENTS DOSAGE GUIDELINES FOR CEFTIN
TABLETS (2.2)
INFE C TIO N
DO SAG E
DURATIO N
(DAYS)
ADULTS AND ADOLESCENTS (13 YEARS AND OLDER)
Pharyngitis/tonsillitis (mild to moderate)
250 mg
every 12 hours
10
Acute bacterial maxillary sinusitis (mild to
mode rate )
250 mg
every 12 hours
10
Acute bacterial exacerbations of chronic
bronchitis (mild to moderate)
250 or 500 mg
every 12 hours
10
Uncomplicated skin and skin-structure infections
250 or 500 mg
10
Pharyngitis/tonsillitis (adults and pediatric patients) (1.1)
Acute bacterial otitis media (pediatric patients) (1.2)
Acute bacterial maxillary sinusitis (adults and pediatric patients)
(1.3)
Acu
                                
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