CEFACLOR CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CEFACLOR

Saatavilla:

MM THERAPEUTICS INC

ATC-koodi:

J01DC04

INN (Kansainvälinen yleisnimi):

CEFACLOR

Annos:

250MG

Lääkemuoto:

CAPSULE

Koostumus:

CEFACLOR 250MG

Antoreitti:

ORAL

Kpl paketissa:

250

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SECOND GENERATION CEPHALOSPORINS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2009-12-18

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
CEFACLOR
(Cefaclor Capsules and Oral Suspensions)
250 mg, 500 mg, 125 mg/5 mL, 250 mg/5 mL and 375 mg/5 mL
ANTIBIOTIC
MM THERAPEUTICS INC.
Date of Preparation:
6111 Royalmount Avenue, Suite 100
OCTOBER 9, 2009
Montreal, Quebec
H4P 2T4
Control #
:133194
2
PRODUCT MONOGRAPH
PR
CEFACLOR
(Cefaclor Capsules and Oral Suspensions)
250 mg, 500 mg, 125 mg/5 mL, 250 mg/5 mL and 375 mg/5 mL
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
Like other
$
-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 (cefaclor capsules and oral suspensions): 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
3
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 CEFA