Type: Tab. Manufacturer/Distributor: Aristopharma Generic Name: Pizotifen 0.5mg/tablet
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Indications
As prophylactic treatment of migraine.
In appetite loss of somatic or psychogenic origin in underweight patients.
As an adjuvant to treatment of the underlying condition, such as infectious or parasitic diseases (including during convalescence), chronic diarrhea, anorexia nervosa.
Depressive states in the elderly and mood disturbances in the elderly.
Pharmacology
Pizotifen works by blocking serotonin and histamine's peripheral activities in raising cranial vascular membrane permeability and plasma kinin transudation, as well as changing pain thresholds in migraines. Pizotifen inhibits serotonin signaling that causes cranial vasoconstriction, as well as serotonin-enhanced platelet activity and aggregation, by inhibiting 5-HT receptors. There is evidence that it also suppresses bradykinin's peripheral activities. Pizotifen alters tonicity and reduces passive distension of extracranial arteries by inhibiting serotonin reuptake by blood platelets. Pizotifen's hunger-stimulating effects could be attributable to the drug's metabolic effects rather than direct stimulation of the appetite center.
Dosage and Administration
For migraine: 1.5mg at night or 0.5 mg three times daily, adjusted according to response within the usual range 0.5-3 mg daily, maximum single dose 3 mg, maximum daily dose 4.5 mg.
Appetite loss:
Children: Low starting doses, gradually increasing to a mean maintenance dosage of 0.025mg/kg/day in 2-3 divided doses, or as directed by the physician.
Adults: Starting dose of 0.5 mg/day, gradually increasing to 0.5 mg three times daily.
Mood disturbances in the elderly: A starting of 0.5 mg/day is recommended increasing-preferably in steps of 0.5 mg daily until the optimum level is reached. Doses up to 12 mg/day are well tolerated.
Interaction
Pizotifen may augment the central effects of sedatives, hypnotics, antihistamines (including several common cold remedies), and alcohol. The hypotensive impact of adrenergic neuron blockers is counteracted by pizotifen.
Contraindications
Hypersensitivity to Pizotifen and children under 2 years of age. Pizotifen should not be administered in the presence of narrow-angle glaucoma or prostate hypertrophy.
Side Effects
Antimuscarinic effects- drowsiness, increased appetite, weight gain. Occasionally nausea, dizziness, CNS stimulation, may occur in children.
Pregnancy & Lactation
Use in pregnancy: Information about using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus.
Use in lactation: The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breastfeeding.
Precautions & Warnings
Urinary retention, renal impairment, pregnancy, and breastfeeding should be taken into consideration. Drowsiness may affect the performance of the skilled tasks (e.g. driving), the effect of alcohol is enhanced.
Storage Conditions
Keep in a dry place away from light and heat. Keep out of the reach of children.
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