CEFPROZIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

CEFPROZIL

Composition:

CEFPROZIL ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefprozil 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: 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 ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observe

Product summary:

Each white film-coated, oval tablet debossed with ‘LUPIN’ on one side and ‘500’ on the other side, contains the equivalent of 500 mg anhydrous cefprozil. Bottles of 20 Tablets                         NDC 54868-5756-0 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFPROZIL - CEFPROZIL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
CEFPROZIL TABLETS USP 250 MG AND 500 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefprozil tablets
and other antibacterial drugs, cefprozil tablets 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 407.45.
Cefprozil tablets are intended for oral administration.
Cefprozil tablets contain cefprozil equivalent to 250 mg or 500 mg of
anhydrous cefprozil. In addition,
each tablet contains the following inactive ingredients: magnesium
stearate, methylcellulose,
microcrystalline cellulose, sodium starch glycolate and titanium
dioxide. The 250 mg tablet also
contains FD & C Yellow No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
The pharmacokinetic data were derived from the capsule formulation;
however, bioequivalence has
been demonstrated for the oral solution, capsule, tablet, and
suspension formulations under fasting
conditions.
Following oral administration of cefprozil to fasting subjects,
approximately 95% of the dose was
absorbed. The average plasma half-life in normal subjects was 1.3
hours, while the steady-state volume
of distribution was estimated to be 0.23 L/kg. The total body
clearance and renal clearance rates were
approximately 3 mL/min/kg and 2.3 mL/min/kg, respectively.
Average peak plasma concentrations after administration of 250 mg, 500
mg, or 1 g doses of cefprozil
to fasting subjects were approximately 6.1, 10.5, and 18.3 mcg/mL,
respectively, an