PMS-CARBAMAZEPINE-CR TABLET (EXTENDED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CARBAMAZEPINE

Dostępny od:

PHARMASCIENCE INC

Kod ATC:

N03AF01

INN (International Nazwa):

CARBAMAZEPINE

Dawkowanie:

400MG

Forma farmaceutyczna:

TABLET (EXTENDED-RELEASE)

Skład:

CARBAMAZEPINE 400MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTICONVULSANTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108674004; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

1997-07-02

Charakterystyka produktu

PRODUCT MONOGRAPH
Pr
PMS-CARBAMAZEPINE
(carbamazepine)
200 mg Tablets, Manufacturer’s Standard
100 mg & 200 mg Chewable Tablets, Manufacturer’s Standard
Pr
PMS-CARBAMAZEPINE-CR
(carbamazepine)
200 mg & 400 mg
Controlled Release Tablets, Manufacturer’s Standard
ANTICONVULSANT
FOR SYMPTOMATIC RELIEF OF TRIGEMINAL NEURALGIA
ANTIMANIC
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
April 8, 2014
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Submission Control No: 172786
_pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph _
_Page 2 of 51_
PRODUCT MONOGRAPH
Pr
PMS-CARBAMAZEPINE
(Carbamazepine)
200 mg Tablets, Manufacturer’s Standard
100 mg & 200 mg Chewable Tablets, Manufacturer’s Standard
Pr
PMS-CARBAMAZEPINE-CR
(Carbamazepine)
200 mg & 400 mg Controlled Release Tablets, Manufacturer’s Standard
THERAPEUTIC CLASSIFICATION
Anticonvulsant
For Symptomatic Relief of Trigeminal Neuralgia
Antimanic
ACTIONS AND CLINICAL PHARMACOLOGY
pms-CARBAMAZEPINE
and
pms-CARBAMAZEPINE-CR
(carbamazepine)
has
anticonvulsant properties which have been found useful in the
treatment of partial seizures
(simple or complex) with and without secondary generalization, and
generalized tonic-clonic
seizures. A mild psychotropic effect has been observed in some
patients, which seems related to
the effect of carbamazepine in localization-related epilepsies and
syndromes.
CLINICAL TRIALS
Evidence supporting the efficacy of carbamazepine as an anticonvulsant
was derived from active
drug-controlled studies that enrolled patients with the following
seizure types:
1.
Partial seizures with simple or complex symptomatology.
2.
Generalized tonic-clonic seizures.
3.
Mixed seizure patterns which include the above, or other partial or
generalized seizures.
_pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph _
_Page 3 of 51_
Carbamazepine relieves or diminishes the pain associated with
trigeminal neuralgia often within
24 to 48 hours.
Carbamazepine given as a monotherapy or in combination with lithium or
neu