CEFZIL POWDER FOR ORAL SUSPENSION-250 MG/ 5 ML POWDER FOR SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFPROZIL

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

J01DC10

INN (International Name):

CEFPROZIL

Dosage:

250MG

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

CEFPROZIL 250MG

Administration route:

ORAL

Units in package:

75/100ML

Prescription type:

Prescription

Therapeutic area:

SECOND GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0127613004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-09-14

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
CEFZIL
*
(CEFPROZIL)
TABLETS, 250 AND 500 MG
POWDER FOR ORAL SUSPENSION, 125 MG/5ML AND 250 MG/5ML, WHEN
RECONSTITUTED
ANTIBIOTIC
Bristol-Myers Squibb Canada
Date of Preparation:
Montreal, Canada
March 29, 1995
Date of Revision:
14 August 2012
*
Trade Mark Authorized User Bristol-Myers Squibb Canada Inc.
Control Number:
156520
2
PRODUCT MONOGRAPH
NAME OF DRUG
CEFZIL*
(cefprozil)
Tablets, 250 and 500 mg
Powder for oral suspension, 125 mg/5mL and 250 mg/5mL
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTIONS AND CLINICAL PHARMACOLOGY
CEFZIL (cefprozil) is a semi synthetic broad spectrum cephalosporin
antibiotic intended for oral
administration. It has
_in vitro_
activity against a broad range of gram positive and gram negative
bacteria.
The bactericidal action of cefprozil results from inhibition of
cell-wall synthesis.
Pharmacokinetics
Cefprozil is well absorbed following oral administration in both
fasting and non-fasting subjects. The
oral bioavailability of cefprozil is about 90%. The pharmacokinetics
of cefprozil are not altered when
administered with meals, or when co-administered with antacid. Average
plasma concentrations after
administration of cefprozil to fasting subjects are shown in the
following table. Urinary recovery
accounts for 60% of the administered dose.
3
DOSAGE
MEAN PLASMA CEFPROZIL*
CONCENTRATIONS (ΜG/ML)
8-HOUR URINARY
EXCRETION
Peak
∼
1.5 hr
4 hr
8hr
250 mg
500 mg
1 g
6.1
10.5
18.3
1.7
3.2
8.4
0.2
0.4
1.0
60%
62%
54%
*
Data represent mean values from 12 healthy, young male volunteers.
During the first four-hour period after drug administration, the
average urine concentrations following the
250 mg, 500 mg, and 1 g doses were approximately 170 μg/mL, 450
μg/mL and 600 μg/mL, respectively.
The average plasma half-life in normal subjects is 1.3 hours. Plasma
protein binding is approximately
36% and is independent of concentration in the range of 2 μg/mL to 20
μg/mL. There is no evidence of
accumulation of cefprozil in the plasma in individuals with normal
renal function