COMPOSITION:
Each tablet contains 0.725mg pizotifen malate, equivalent to 0.5mg pizotifen base.
MECHANISM OF ACTION:
Pizofen has anti-serotonin and anti-tryptaminic properties, anti-histaminic effect and antagonistic activity against kinins. It also has a sedative and appetite stimulating properties. Pizofen has prophylactic effect in migraine.
INDICATIONS:
Prophylactic treatment of recurrent vascular headache, including common migraine, neural migraine. It should not be used during acute attack. It is also used as an appetite stimulating.
DOSAGE AND ADMINISTRATION:
• Prophylactic treatment of migraine:
Children: up to 1.5mg daily (30ml Syrup or 3 Tablets) divided into three doses, or 1mg daily as a single dose at night (20ml Syrup or 2 Tablets).
Adults: 1.5mg daily (3 Tablets). It can be taken as a single dose at night or in three divided doses, each of 0.5 mg (1 Tablet). Dosage should be adjusted to the requirement of individual patients, up to a maximum of 4.5mg daily (9 Tablets). Or up to 3 mg (6 Tablets) may be given as single dose daily.
• As an appetite stimulant: It should be taken before the meal.
Children: 0.025 mg/kg.
2 – 6 years: 5 – 10ml daily, 2 – 3 divided doses.
6 – 12 years: 10 – 20ml daily, 2 – 3 divided doses.
Adults: To start with 0.5mg daily (1 Tablet), to be gradually increased to 1.5mg daily (30ml Syrup or 3 Tablets).
CONTRAINDICATIONS:
Hypersensitivity to the drug.
SIDE EFFECTS:
Drowsiness is more common, rarely may occur: Dizziness, dry mouth, nausea, constipation, Pizofen affects normal reaction of the body, a central sedative effect, and increasing body weight and appetite.
DRUG INTERACTION:
It increases the effect of hypnotics, sedatives, and alcohol.
PRECAUTION:
Caution is required in the presence of closed angle glaucoma, in patients with a predisposition to urinary retention and when driving machinery or cars. Dosage adjustment may be necessary in patients with kidney insufficiency.
USE IN PREGNANCY OR LACTATION:
It is not recommended to use during pregnancy or lactation.