CEFPROZIL tablet, film coated CEFPROZIL tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Wockhardt Limited

INN (nume internaţional):

CEFPROZIL

Compoziție:

CEFPROZIL ANHYDROUS 250 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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: 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. 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. Otitis Media 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 eradicatio

Rezumat produs:

Cefprozil Tablets USP Each white film-coated, capsule shaped tablet, debossed with "W712" on one side and plain on other side, contains the equivalent of 250 mg anhydrous cefprozil. Bottles of 50 Tablets                                 NDC 64679-712-01 Bottles of 1000 Tablets                      NDC 64679-712-02 Bottles of 100 Tablets                                 NDC 64679-712-03 Bottles of 500 Tablets                                 NDC 64679-712-04 Each white film-coated, capsule shaped tablet, debossed with "W713" on one side and plain on other side, contains the equivalent of 500 mg anhydrous cefprozil. Bottles of 50 Tablets                                 NDC 64679-713-01 Bottles of 500 Tablets                                 NDC 64679-713-02 Bottles of 100 Tablets                                 NDC 64679-713-03 Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CEFPROZIL - CEFPROZIL TABLET, FILM COATED
WOCKHARDT LIMITED
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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:
microcrystalline cellulose, methylcellulose,
sodium starch glycolate, low substituted hydroxypropyl cellulose,
magnesium stearate, polyethylene
glycol, hypromellose, and titanium dioxide.
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.