SANDOMIGRAN Tablet (2012)
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Περιεχόμενα
Name of the medicinal product
SANDOMIGRAN & SANDOMIGRAN DS Pizotifen hydrogen malate 0.5 mg and 1 mg Pizotifen Tablets.
Summary product information
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 ...
Indications and clinical use
Sandomigran (pizotifen as hydrogen malate) may be used for the prophylactic management of migraine. In various clinical trials, about ⅓ to ⅔ of patients with migraine experienced some benefit from Sandomigran ...
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 ...
Warnings and precautions
Renal impairment Caution is required in patients with renal impairment. Dosage adjustment may be necessary. Hepatic impairment Caution is required in patients with hepatic impairment. Dosage adjustment ...
Adverse reactions
Increased appetite, weight gain and drowsiness (including somnolence and fatigue) are the most common side effects. Physicians should be aware of the potential negative effects of Sandomigran (pizotifen ...
Drug interactions
Pizotifen is extensively metabolized in the liver, primarily by N-glucuronidation. Increased plasma concentration of pizotifen upon concomitant administration of drugs which exclusively undergo glucuronidation ...
Dosage and administration
Adults Oral treatment should be initiated with a dose of 0.5 mg at bedtime. This is increased gradually to a total dose of 1.5 mg administered at bedtime or in three divided doses. The dosage range is ...
Overdosage
For management of a suspected drug overdose, contact your regional Poison Control Centre. Adults The symptoms of overdosage in adults are sedation, drowsiness, dizziness, hypotension, dryness of the mouth, ...
Storage and stability
Store at room temperature (15-30°C) and protect from exposure to light and moisture. Keep in a safe place out of the sight and reach of children.
Dosage forms, composition and packaging
Sandomigran <u>Each ivory, sugar-coated tablet contains:</u> 0.5 mg of pizotifen (as hydrogen malate), lactose monohydrate, corn starch, povidone, magnesium stearate, propyl paraben, acacia, colloidal ...
Detailed pharmacology
Pizotifen is a white to yellowish crystalline powder, readily soluble in water and organic solvents, and is designated chemically as 4 -(9,10-Dihydro-4H-benzo[4,5] cycloheptal [1,2- b]thien-4-ylidene)-1-methylpiperidine ...
Toxicology
Acute Toxicity Acute toxicity studies were conducted in mice, rats and rabbits: LD<sub>50</sub> (mg/kg) Mouse Rat Rabbit <b>Oral</b> <b>I.V.</b> <b>Oral</b> <b>I.V.</b> <b>Oral</b> <b>I.V.</b> 880 ...
References
CLINICAL 1. Arthur, G.P.: The Treatment of Migraine with BC-105 (Sandomigran). A double-blind trial, New Zealand Medical Journal, 73:5-9, 1971. 2. Briars G.L., Travis S.E., Anand B., Kelly A.M.: Weight ...
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