COMPOSITION:
Each 10ml Syrup 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) divided into three doses، or 1mg daily as a single dose at night (20ml Syrup ).
Adults: 1.5mg daily (30ml Syrup ). It can be taken as a single dose at night or in three divided doses، each of 0.5 mg (10ml Syrup). Dosage should be adjusted to the requirement of individual patients، up to a maximum of 4.5mg daily (90ml Syrup ). Or up to 3 mg (60ml Syrup) 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 (10ml Syrup)، to be gradually increased to 1.5mg daily (30ml Syrup).
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.