CEFUROXIME AXETIL tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

H.J. Harkins Company, Inc.

INN (Mezinárodní Name):

Cefuroxime axetil

Složení:

Cefuroxime 250 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CEFUROXIME AXETIL - CEFUROXIME AXETIL TABLET, FILM COATED
H.J. HARKINS COMPANY, INC.
----------
RX ONLY
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, USP 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 film-coated and contain the equivalent
of 250 or 500 mg of cefuroxime as
cefuroxime axetil. Cefuroxime axetil tablets contain the inactive
ingredients microcrystalline cellulose,
croscarmellose sodium, sodium lauryl sulfate, colloidal silicon
dioxide, calcium stearate, calcium
carbonate, crospovidone, hypromellose, titanium dioxide, propylene
glycol, FD &C blue no.1
Aluminium lake.
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.
PHARMACOKINETICS: Approximately 50% of serum cefuroxime is bound to
protein. Serum
pharmacokinetic parameters for cefuroxime axetil tablets are shown in
Table 1.
2
20
22
4
10
TABLE 1. POSTPRANDIAL PHARMACOKINETICS OF CEFUROXIME ADMINISTERED AS
CEFUROXIME AXETI