CECLOR POWDER FOR SUSPENSION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CEFACLOR

Dostopno od:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Koda artikla:

J01DC04

INN (mednarodno ime):

CEFACLOR

Odmerek:

375MG

Farmacevtska oblika:

POWDER FOR SUSPENSION

Sestava:

CEFACLOR 375MG

Pot uporabe:

ORAL

Enote v paketu:

70ML/100ML

Tip zastaranja:

Prescription

Terapevtsko območje:

SECOND GENERATION CEPHALOSPORINS

Povzetek izdelek:

Active ingredient group (AIG) number: 0113428002; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2016-10-25

Lastnosti izdelka

1
PRODUCT MONOGRAPH
PR
CECLOR
®
Cefaclor Capsules USP
250 mg and 500 mg
Cefaclor for Oral Suspension USP
125 mg/5 mL, 250 mg/5 mL and 375 mg/5 mL
ANTIBIOTIC
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount, Suite 100
Montreal, Quebec
H4P 2T4
DATE OF PREPARATION:
February 20, 2012
CONTROL # 153365
®
Registered trademark of Pharmascience Inc.
2
PRODUCT MONOGRAPH
PR
CECLOR
®
(Cefaclor Capsules USP and Oral Suspensions USP)
250 mg, 500 mg, 125 mg/5 mL, 250 mg/5 mL and 375 mg/5 mL
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
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.
CLINICAL PHARMACOLOGY
CECLOR
®
(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
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. Hemodial