CEFUROXIME AXETIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

Cefuroxime axetil

Pharmaceutical form:

TABLET

Composition:

125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: 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 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

Product summary:

Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with “RX831, RX832 and RX833 ” on one side and plain on the other side, respectively. They are supplied as follows: The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831” NDC 63304-831-30 Bottles of 30 NDC 63304-831-04 Bottles of 250 NDC 63304-831-77 Blister unit-dose pack of 100 The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832” NDC 63304-832-20 Bottles of 20 NDC 63304-832-05 Bottles of 500 NDC 63304-832-77 Blister unit-dose pack of 100 The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833” NDC 63304-833-20 Bottles of 20 NDC 63304-833-60 Bottles of 60 NDC 63304-833-05 Bottles of 500 NDC 63304-833-77 Blister unit-dose pack of 100 Store at 20 - 25°C (68 - 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.

Summary of Product characteristics

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET
RANBAXY PHARMACEUTICALS INC.
----------
RX ONLY
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, USP contain Cefuroxime as cefuroxime
axetil, USP (amorphous).
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 are blue colored, uncoated caplets (capsule-shaped tablets)
and contain the equivalent of
125, 250, or 500 mg of cefuroxime as cefuroxime axetil (amorphous).
Cefuroxime axetil tablets contain
the inactive ingredients colloidal silicon dioxide, croscarmellose
sodium, FD&C Blue No. 1 aluminum
lake, microcrystalline cellulose, sodium lauryl sulfate, and stearic
acid.
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: POSTPRANDIALPHARMACOKINETICS OF CEFUROXIME ADMINISTERED AS
CEFUROXIMEAXETIL TABLETS TO ADULTS
D