CEFUROXIME AXETIL tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

MedVantx, Inc.

INN (Nama Internasional):

CEFUROXIME AXETIL

Komposisi:

CEFUROXIME 500 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs, cefuroxime axetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY) Cefuroxime axetil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:  1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual dr

Ringkasan produk:

Cefuroxime axetil tablets, USP 250 mg: Light blue colored film coated, capsule shaped tablets having “250” on one side and “P125” on the other side. Tablets are supplied as follows: Bottle of 20 Tablets    NDC 16714-232-01                                                      Bottle of 60 Tablets     NDC 16714-232-02 Cefuroxime axetil tablets, USP 500 mg: Dark blue colored film coated, capsule shaped tablets having “500” on one side and “P126” on the other side. Tablets are supplied as follows: Bottle of 20 Tablets      NDC 16714-233-01                                                      Bottle of 60 Tablets      NDC 16714-233-02                Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Replace cap securely after each opening.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED
MEDVANTX, INC.
----------
CEFUROXIME AXETIL TABLETS, USP
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CEFUROXIME AXETIL TABLETS AND OTHER ANTIBACTERIAL DRUGS, CEFUROXIME
AXETIL TABLETS 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_,7R)-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 mg or 500 mg of
cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets contain the
inactive ingredients
pregelatinized starch, croscarmellose sodium, sodium lauryl sulphate,
microcrystalline cellulose,
colloidal silicon dioxide, hydrogenated vegetable oil and opadry blue.
Components of Opadry Blue (250 mg Tablets) are Hypromellose, Titanium
dioxide, Propylene glycol,
FD&C Blue # 1 / Brilliant Blue FCF Aluminum Lake, FD&C Blue #2 /
Indigo Carmine Aluminum Lake;
Opadry Blue (500 mg Tablets) are Hypromellose, Titanium dioxide,
Propylene glycol, FD&C Blue # 1
/ Brilliant Blue FCF Aluminum Lake, D&C Red #27 / Phloxine Aluminum
Lake.
CLINICAL PHARMACOLOGY
2
20
22
4
10
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