CEFUROXIME AXETIL FOR ORAL SUSPENSION- cefuroxime axetil suspension

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

Composition:

CEFUROXIME 125 mg in 5 mL

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 for oral suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of cefuroxime axetil for oral suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well-controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen. - 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 for oral suspensio

Product summary:

Cefuroxime Axetil For Oral Suspension USP: When reconstituted as directed, cefuroxime axetil for oral suspension USP provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. It is supplied as follows: The 125 mg/5 mL: is a white to cream colored granular powder forming white to cream colored suspension on constitution with water. The resulting suspension has a fruity flavor. NDC 63304-963-03 50 mL bottles NDC 63304-963-04 100 mL bottles The 250 mg/5 mL: is a white to cream colored granular powder forming white to cream colored suspension on constitution with water. The resulting suspension has a fruity flavor. NDC 63304-964-03 50 mL bottles NDC 63304-964-04 100 mL bottles Before reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature) After reconstitution, immediately store suspension between 2 - 8 ° C (36 - 46 ° F), in a refrigerator. DISCARD AFTER 10 DAYS.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFUROXIME AXETIL FOR ORAL SUSPENSION- CEFUROXIME AXETIL SUSPENSION
RANBAXY PHARMACEUTICALS INC
----------
CEFUROXIME AXETIL FOR ORAL SUSPENSION,USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefuroxime
axetil for oral suspension and other antibacterial drugs, cefuroxime
axetil for oral suspension should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Cefuroxime axetil for oral suspension, USP contains cefuroxime as
cefuroxime axetil. Cefuroxime
axetil USP 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)glyoxylamido]-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 crystalline form and has the following
structural formula:
Cefuroxime axetil for oral suspension USP, when reconstituted with
water, provides the equivalent of
125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of
suspension. Cefuroxime axetil
USP for oral suspension contains the following inactive ingredients:
aspartame, hypromellose phthalate,
mannitol, methacrylic acid copolymer, monosodium citrate, peppermint
flavor, silicon dioxide, sodium
benzoate, sodium chloride, sucrose, tutti frutti flavor, xanthan gum.
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
pharmacoki