CYCLOBENZAPRINE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CYCLOBENZAPRINE HYDROCHLORIDE

Saadav alates:

SORRES PHARMA INC

ATC kood:

M03BX08

INN (Rahvusvaheline Nimetus):

CYCLOBENZAPRINE

Annus:

10MG

Ravimvorm:

TABLET

Koostis:

CYCLOBENZAPRINE HYDROCHLORIDE 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

100/500

Retsepti tüüp:

Prescription

Terapeutiline ala:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0112363001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2014-06-20

Toote omadused

PRODUCT MONOGRAPH
PR
CYCLOBENZAPRINE
(Cyclobenzaprine Hydrochloride Tablets USP)
10 mg
SKELETAL MUSCLE RELAXANT
SORRES PHARMA INC.
Date of Preparation:
6111 Royalmount Ave.,
March 30, 2010
Montreal, Quebec
H4P 2T4
CONTROL #: 137552
2
PRODUCT MONOGRAPH
PR
CYCLOBENZAPRINE
(Cyclobenzaprine Hydrochloride Tablets USP)
10 mg
THERAPEUTIC CLASSIFICATION
Skeletal - Muscle Relaxant
ACTION AND CLINICAL PHARMACOLOGY
Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local
origin without interfering
with muscle function. It is ineffective in muscle spasm due to central
nervous system disease.
Controlled clinical studies show that cyclobenzaprine hydrochloride
improves the signs and the
symptoms of skeletal muscle spasm.
Cyclobenzaprine hydrochloride is well absorbed in man. After oral or
intravenous doses (10 mg)
of
14
C-labelled cyclobenzaprine hydrochloride to human subjects, plasma
levels of radioactivity
were comparable. In addition, the excretion of radioactivity was
similar after both routes (38 to 51
percent in the urine; 14 to 15 percent in the feces), suggesting that
oral absorption is almost
complete. The half-life varies from one to three days. No effect, on
plasma levels or bioavailability
was noted in 14 human subjects, when cyclobenzaprine hydrochloride and
multiple doses of
acetylsalicylic acid was coadministered.
Cyclobenzaprine hydrochloride is extensively metabolized in man. In
the study with
14
C-labelled
drug, about 4 percent of the dose was excreted in the urine as
unchanged cyclobenzaprine
hydrochloride.
The
metabolites
(probably
glucuronides)
were
excreted
as
water-soluble
conjugates. After oral or intravenous administration of 40 mg of
unlabelled cyclobenzaprine
hydrochloride to two subjects, only 0.2 to 1.5 percent of the dose was
excreted as unchanged drug
in the urine within 24 hours.
3
A single 20 mg (2 tablets) dose, comparative two-way cross-over
bioavailability study was
performed using normal human volunteers on Cyclobenzaprine 10mg
tablets versus FLEXRIL 10
mg tablets (Merck Fross