CEFUROXIME AXETIL tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Cefuroxime axetil (UNII: Z49QDT0J8Z) (Cefuroxime - UNII:O1R9FJ93ED)

Dostępny od:

Proficient Rx LP

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Cefuroxime axetiltablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes . Limitations of Use Cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes . Cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β -lactamase–producing strains only). Limitations of Use The effectiveness of Cefuroxime axetil for sinus infections caused by β-lactamase–producing Ha

Podsumowanie produktu:

Cefuroxime Axetil Tablets, USP: Cefuroxime axetil tablets, 250 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with “204” debossed on one side and plain on the other side as follows: 20 Tablets/Bottle                      NDC 63187-991-20 60 Tablets/Bottle                      NDC 63187-991-60 Store at 20° to 25°C (68° to 77°F).  [See USP controlled room temperature]. Replace cap securely after each Use.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFUROXIME AXETIL
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CEFUROXIME
AXETIL TABLETS, USP.
CEFUROXIME AXETIL TABLETS, USP FOR ORAL USE
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
Dosage and Administration, Dosage for cefuroxime axetil tablets:
Secondary Bacterial Infections of Acute
Bronchitis (2.2)Removed
INDICATIONS AND USAGE
Cefuroxime axetil tablet is a cephalosporin antibacterial drug
indicated for the treatment of the following
infections due to susceptible bacteria:
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefuroxime axetil
and other antibacterial drugs, cefuroxime axetil should be used only
to treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DOSAGE AND ADMINISTRATION
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ADULT PATIENTS AND PEDIATRIC PATIENTS DOSAGE GUIDELINES FOR CEFUROXIME
AXETIL TABLETS
INFECTION
DOSAGE
DURATION (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 moderate)
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 every 12 hours
10
Uncomplicated urinary tract
infections
250 mg
every 12 hours
7 to 10
Uncomplicated gonorrhea
1,000 mg
single dose
Early Lyme disease
500 mg
every 12 hours
20
PEDIATRIC PATIENTS YOUNGER THAN 13 YEARS (WHO CAN SWALLOW TABLETS
WHOLE)
Acute bacterial otitis media
250 mg
every 12 hours
10
Acute bacterial maxillar