SANDOMIGRAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PIZOTIFEN (PIZOTIFEN MALATE)

Disponible depuis:

PALADIN LABS INC.

Code ATC:

N02CX01

DCI (Dénomination commune internationale):

PIZOTIFEN

Dosage:

0.50MG

forme pharmaceutique:

TABLET

Composition:

PIZOTIFEN (PIZOTIFEN MALATE) 0.50MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTIMIGRAINE AGENTS, MISCELLANEOUS

Descriptif du produit:

Active ingredient group (AIG) number: 0110877002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2021-07-28

Résumé des caractéristiques du produit

_ _
PRODUCT MONOGRAPH
PR
SANDOMIGRAN &
PR
SANDOMIGRAN DS
Pizotifen hydrogen malate
0.5 mg and 1 mg Pizotifen Tablets
THERAPEUTIC CLASSIFICATION
Serotonin and Tryptamine Antagonist
Migraine Prophylaxis
_ _
_ _
_ _
ATC code: N02CX
Paladin Labs Inc.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 102
OCTOBER 30, 2012
Montreal, Quebec
_ _
H4P 2T4
CONTROL NO.: 152247
- 2 -
_ _
NAME OF DRUG
PR
SANDOMIGRAN &
PR
SANDOMIGRAN DS
(pizotifen tablets as hydrogen malate)
THERAPEUTIC CLASSIFICATION
Serotonin and Tryptamine Antagonist
Migraine Prophylaxis
ACTION
Sandomigran (pizotifen as hydrogen malate) is a strong serotonin and
tryptamine antagonist,
with weak anticholinergic, anti-histaminic and anti-kinin effects. It
also possesses sedative and
appetite-stimulating properties.
The mode of action of Sandomigran in preventing migraine is not fully
understood but it is
known to inhibit the permeability increasing effect of serotonin and
histamine to control the
transudation of plasmakinin across cranial vessel membranes, an effect
which may alter pain
thresholds. Sandomigran also inhibits serotonin re-uptake by blood
platelets, impacting tonicity
and decreasing passive distension of extracranial arteries.
INDICATIONS AND CLINICAL USE
Sandomigran (pizotifen as hydrogen malate) may be used for the
prophylactic management of
migraine.
- 3 -
_ _
In various clinical trials, about 1/3 to 2/3 of patients with migraine
experienced some benefit
from Sandomigran and in most trials it was more effective than placebo
in reducing the
frequency or severity of attacks.
Sandomigran is not useful for the clinical treatment of acute
migrainous attack or for the
treatment of tension headaches.
CONTRAINDICATIONS
_ _
Sandomigran (pizotifen as hydrogen malate) is contraindicated for
patients:

taking monoamine oxidase (MAO) inhibitors,

with pyloroduodenal obstruction and stenosing pyloric ulcer,

who are hypersensitive to pizotifen or to any ingredient in the
formulation or component
of the container (for a complete listing, see the
DOSAGE