CEFPROZIL- cefprozil powder, for suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

OrchidPharma Inc

INN (Διεθνής Όνομα):

CEFPROZIL

Σύνθεση:

CEFPROZIL ANHYDROUS 125 mg in 5 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Cefprozil for oral suspension 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: UPPER RESPIRATORY TRACT 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 for oral suspension is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil for oral suspension 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

Περίληψη προϊόντος:

Cefprozil for Oral Suspension USP Each 5 mL of constituted suspension contains the equivalent of 125 mg anhydrous cefprozil. 50 mL Bottle NDC 42043-262-57 75 mL Bottle NDC 42043-262-77 100 mL Bottle NDC 42043-262-38 Each 5 mL of constituted suspension contains the equivalent of 250 mg anhydrous cefprozil. 50 mL Bottle NDC 42043-263-57 75 mL Bottle NDC 42043-263-77 100 mL Bottle NDC 42043-263-38 All powder formulations for oral suspension contain cefprozil in a tutti-frutti flavored mixture. Reconstitution Directions for Oral Suspension Prepare the suspension at the time of dispensing; for ease in preparation, add water in two portions and shake well after each aliquot. After mixing, store in a refrigerator and discard unused portion after 14 days. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CEFPROZIL- CEFPROZIL POWDER, FOR SUSPENSION
ORCHIDPHARMA INC
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CEFPROZIL FOR ORAL SUSPENSION, USP
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 USP is a semi-synthetic broad-spectrum cephalosporin
antibiotic.
Cefprozil USP 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 USP is a pale yellow to yellow crystalline powder with a
molecular formula for the
monohydrate of C
H N O S.H O and a molecular weight of 407.45.
Cefprozil for oral suspension USP is intended for oral administration.
Cefprozil for oral suspension USP contains cefprozil USP equivalent to
125 mg or 250 mg anhydrous
cefprozil per 5 mL constituted suspension. In addition, the oral
suspension contains the following
inactive ingredients: microcrystalline cellulose and
carboxymethylcellulose sodium, anhydrous citric
acid, anhydrous sodium citrate, sodium chloride, sodium benzoate,
colloidal silicon dioxide, aspartame,
glycine, tutti-frutti flavor and sucrose.
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 25