CEFUROXIME AXETIL tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

H.J. Harkins Company, Inc.

INN (International Nazwa):

CEFUROXIME AXETIL

Skład:

CEFUROXIME 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

  - Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.   NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefuroxime axetil tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.   - Acute Bacterial Otitis Media caused by Streptococcus pneumoniae , Haemophilus influenzae (including beta-lactamase–producing strains), Moraxella catarrhalis (including beta-lactamase–producing strains), or Streptococcu

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CEFUROXIME AXETIL - CEFUROXIME AXETIL TABLET
H.J. HARKINS COMPANY, INC.
----------
CEFUROXIME AXETIL TABLETS, USP
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.
DESCRIPTION
Cefuroxime axetil tablets contain cefuroxime as cefuroxime axetil.
Cefuroxime axetil is a
semisynthetic, broad-spectrum cephalosporin antibiotic for oral
administration.
Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of
cefuroxime, is (_RS _)-1-hydroxyethyl
(6_R_,7_R_)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-
2-carboxylate, 7 -(_Z_)-(_O_-methyl-oxime), 1-acetate 3-carbamate. Its
molecular formula is
C
H N O S, and it has a molecular weight of 510.48.
Cefuroxime axetil is in the amorphous form and has the following
structural formula:
Cefuroxime axetil tablets are uncoated and contain the equivalent of
125, 250 or 500 mg of cefuroxime
as cefuroxime axetil. Cefuroxime axetil tablets contain the inactive
ingredients colloidal silicon
dioxide, croscarmellose sodium, hydrogenated vegetable oil,
microcrystalline cellulose and sodium
lauryl sulfate.
CLINICAL PHARMACOLOGY
ABSORPTION AND METABOLISM
After oral administration, cefuroxime axetil is absorbed from the
gastrointestinal tract and rapidly
hydrolyzed by nonspecific esterases in the intestinal mucosa and blood
to cefuroxime. Cefuroxime is
subsequently distributed throughout the extracellular fluids. The
axetil moiety is metabolized to
acetaldehyde and acetic acid.
2
20
22
4
10
PHARMACOKINETICS
Approximately 50% of serum cefuroxime is bound to protein. Serum
pharmacokinetic parameters for
cefuroxime axetil tablets are shown in Table 1.
TABLE 1. POSTPRANDIAL PHARMACOKINETICS OF CEFUROXIME ADMINISTERED AS
CEFUROXIME AXETIL
TABLETS TO ADULTS*
*Mean values of 12 healthy adult volunteers.
Drug administered immediately af