APO-CEFACLOR CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CEFACLOR

Disponible depuis:

APOTEX INC

Code ATC:

J01DC04

DCI (Dénomination commune internationale):

CEFACLOR

Dosage:

500MG

forme pharmaceutique:

CAPSULE

Composition:

CEFACLOR 500MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SECOND GENERATION CEPHALOSPORINS

Descriptif du produit:

Active ingredient group (AIG) number: 0113428004; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2019-12-02

Résumé des caractéristiques du produit

0
PRODUCT MONOGRAPH
APO-CEFACLOR
CEFACLOR CAPSULES USP
250 AND 500 MG
CEFACLOR FOR ORAL SUSPENSION USP
125, 250 AND 375 MG/5 ML
ANTIBIOTIC
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
November 21, 2018
_NC Control No: 214441_
_ _
1
PRODUCT MONOGRAPH
APO-CEFACLOR
Cefaclor Capsules USP
250 and 500 mg
Cefaclor for Oral Suspension USP
125, 250 and 375 mg/5 mL
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
Like other
β‐
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.
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 percent 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 1900 mg/L
respectively.
2
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 concentratio