CEFPROZIL- cefprozil tablet, film coated CEFPROZIL- cefprozil powder, for suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CEFPROZIL (UNII: 4W0459ZA4V) (CEFPROZIL ANHYDROUS - UNII:1M698F4H4E)

Tilgjengelig fra:

DAVA Pharmaceuticals Inc

INN (International Name):

CEFPROZIL

Sammensetning:

CEFPROZIL ANHYDROUS 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Cefprozil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 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. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES .) NOTE: In the treatment of otitis media due to β-lactamase-producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a

Produkt oppsummering:

Cefprozil Tablets USP, 250 mg are oval-shaped, white to cream tinged, unscored, film-coated tablets, debossed 347 on one side and 250 on the reverse side and are supplied as follows: NDC 67253-231-10 in bottles of 100 tablets Ceprozil Tablets USP, 500 mg are oval-shaped, beige, unscored, film-coated tablets, debossed 348 on one side and 500 on the reverse side and are supplied as follows: NDC 67253-232-05 in bottles of 50 tablets Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Cefprozil for Oral Suspension, USP, 125 mg/5 mL is supplied as follows: NDC 67253-233-40 50 mL bottle NDC 67253-233-43 75 mL bottle NDC 67253-233-44 100 mL bottle Cefprozil for Oral Suspension, USP, 250 mg/5 mL is supplied as follows: NDC 67253-234-40 50 mL bottle NDC 67253-234-43 75 mL bottle NDC 67253-234-44 100 mL bottle All powder formulations for oral suspension contain cefprozil in a fruity flavored mixture. Cefprozil powder is slightly cream tinged to beige. After reconstitution the suspension is light orange and of a fruity odor and flavor.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CEFPROZIL- CEFPROZIL TABLET, FILM COATED
CEFPROZIL- CEFPROZIL POWDER, FOR SUSPENSION
DAVA PHARMACEUTICALS INC
REFERENCE LABEL SET ID: A0AF02F7-8FDA-46C4-90DE-3741F0AA38D0
----------
CEFPROZIL TABLETS, USP
250 MG AND 500 MG
CEFPROZIL FOR ORAL SUSPENSION, USP
125 MG/5 ML AND 250 MG/5 ML
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefprozil and
other antibacterial drugs, cefprozil should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic.
Cefprozil is a cis and trans isomeric mixture (≥ 90% cis). The
chemical name for the monohydrate is
(6R,
7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the
structural formula is:
Cefprozil is a white to yellowish powder with a molecular formula for
the monohydrate of
C
H N O S•H O and a molecular weight of 407.44.
Each cefprozil tablet intended for oral administration contains
cefprozil equivalent to 250 mg or 500 mg
of anhydrous cefprozil. In addition each tablet contains the following
inactive ingredients:
hypromellose, magnesium stearate, methylcellulose, microcrystalline
cellulose, polyethylene glycol
400, polysorbate 80, sodium starch glycolate and titanium dioxide. The
500 mg tablets also contain
ferric oxide.
Cefprozil for oral suspension is intended for oral administration.
Cefprozil for oral suspension contains
cefprozil equivalent to 125 mg or 250 mg anhydrous cefprozil per 5 mL
constituted suspension. In
addition, the oral suspension contains the following inactive
ingredients: aspartame,
carboxymethylcellulose sodium, citric acid anhydrous, colloidal
silicon dioxide, FD & C Yellow No.
6, glycine, microcrystalline cellulose and carboxymethylcellulose
sodium, polysorbate 80,
simethicone, sodium benzoate, sodium chloride, sucrose, and
Tutti-Frutti flavor.
CLINICAL PHARMACOLOGY
The pharmacokinetic data