Country: Canada
Language: English
Source: Health Canada
PIZOTIFEN (PIZOTIFEN MALATE)
PALADIN LABS INC.
N02CX01
PIZOTIFEN
0.50MG
TABLET
PIZOTIFEN (PIZOTIFEN MALATE) 0.50MG
ORAL
100
Prescription
ANTIMIGRAINE AGENTS, MISCELLANEOUS
Active ingredient group (AIG) number: 0110877002; AHFS:
CANCELLED POST MARKET
2021-07-28
_ _ 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 Read the complete document