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

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Sandoz Inc

INN（国际名称）:

CEFPROZIL

组成:

CEFPROZIL ANHYDROUS 250 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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 0781-5043-01 in bottles of 100 tablets Cefprozil 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 0781-5044-50 in bottles of 50 tablets NDC 0781-5044-01 in bottles of 100 tablets Store at 20° to 25°C (68° to 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 0781-6202-91 50 mL bottle NDC 0781-6202-57 75 mL bottle NDC 0781-6202-46 100 mL bottle Cefprozil for Oral Suspension, USP, 250 mg/5 mL is supplied as follows: NDC 0781-6203-91 50 mL bottle NDC 0781-6203-57 75 mL bottle NDC 0781-6203-46 100 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.

授权状态:

Abbreviated New Drug Application

产品特点

CEFPROZIL- CEFPROZIL TABLET, FILM COATED
CEFPROZIL- CEFPROZIL POWDER, FOR SUSPENSION
SANDOZ INC
REFERENCE LABEL SET ID: A0AF02F7-8FDA-46C4-90DE-3741F0AA38D0
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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.
Cefprozil Tablets and Cefprozil for Oral Suspension are intended for
oral administration.
Each cefprozil tablet 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 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 were derived from the c