NOVO-CEFACLOR CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFACLOR

Available from:

TEVA CANADA LIMITED

ATC code:

J01DC04

INN (International Name):

CEFACLOR

Dosage:

250MG

Pharmaceutical form:

CAPSULE

Composition:

CEFACLOR 250MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

SECOND GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0113428003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-04-30

Summary of Product characteristics

PRODUCT MONOGRAPH
NOVO-CEFACLOR
(cefaclor)
250 mg and 500 mg Capsules
USP
Antibiotic
Teva Canada Limited
Date of Revision: May 7, 2014
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control # 173960
PRODUCT MONOGRAPH
NOVO-CEFACLOR
(cefaclor)
250 mg and 500 mg Capsules
USP
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
-lactam antibiotics, cefaclor owes its antibacterial activity to its
ability to bind to
and inhibit the action of certain bacterial cell wall synthetic
enzymes, the penicillin-binding
proteins.
CLINICAL PHARMACOLOGY
Cefaclor is well absorbed after oral administration to fed and fasted
subjects. Following doses
of 250 mg, 500 mg and 1 g to fasted subjects, average peak serum
levels of approximately 7, 13
and 23 mg/L respectively were obtained within 0.5 to 1.0 hour. Total
absorption is the same
whether the drug is given before or after meals. However, when it is
taken after food, the peak
concentration achieved is 50% to 75% of that observed when the drug is
administered to fasted
subjects and is delayed by 0.8 to 1 hour. Approximately 25% of
cefaclor is bound to human
plasma.
Within 8 hours 60% to 85% of the drug is excreted unchanged in the
urine, the greater portion
being excreted within the first 2 hours. During this 8-hour period,
peak urine concentrations
following the 250 mg, 500 mg and 1 g doses were approximately 600, 900
and 1,900 mg/L
respectively.
The serum half-life in normal subjects is 0.6 to 0.9 hours. In
patients with reduced renal
function, the serum half-life of cefaclor is slightly prolonged. In
those with complete absence of
renal function, the plasma half-life of the intact molecule is 2.3 to
2.8 hours. Excretion
pathways in patients with markedly impaired renal function have not
been determined.
Hemodialysis shortens the half-life by 25% to 30%.
Probenecid administered with a 500 mg dose of cefaclor
increased the peak serum concentration
only slightly, from 12.4 to 13.9 mg/L, and urine levels were
predictably diminished. The mean
half-life among five fasted volunteers with normal re