CEFUROXIME AXETIL tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Direct_Rx

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

1.1 Pharyngitis/Tonsillitis Cefuroxime axetil tablets 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 The efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials. The efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials. 1.2 Acute Bacterial Otitis Media 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. 1.3 Acute Bacterial Maxillary Sinusitis Cefuroxime axetil tablets are indicated f

Ringkasan produk:

Cefuroxime axetil tablets,USP 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 60 Tablets/Bottle 100 Tablets/Bottle 30 Tablets (3x10 Unit-dose Tablets) Cefuroxime Axetil Tablets,USP 500 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with 203'' debossed on one side and plain on the other side as follows: 20 Tablets/Bottle 60 Tablets/Bottle 100 Tablets/Bottle 30 Tablets (3x10 Unit-dose Tablets) NDC 67877-216-84 Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Replace cap securely after each use.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED
DIRECT_RX
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CEFUROXIME AXETIL
1.1 Pharyngitis/Tonsillitis
Cefuroxime axetil tablets 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
The efficacy of cefuroxime axetil in the prevention of rheumatic fever
was not
established in clinical trials.
The efficacy of cefuroxime axetil in the treatment of
penicillin-resistant strains of
Streptococcus pyogenes has not been demonstrated in clinical trials.
1.2 Acute Bacterial Otitis Media
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.
1.3 Acute Bacterial Maxillary Sinusitis
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 Haemophilus influenzae or Moraxella
catarrhalis in patients with
acute bacterial maxillary sinusitis was not established due to
insufficient numbers of
these isolates in the clinical trials [see Clinical Studies (14.1)].
1.4 Acute Bacterial Exacerbations of Chronic Bronchitis
Cefuroxime axetil tablets are indicated for the treatment of adult
patients and pediatric
patients (aged 13 and older) with mild-to-moderate acute bacterial
exacerbations of
chronic bronchitis caused by susceptible strains of Streptococcus
pneumoniae,
Haemophilus influenzae (β-lacta