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Pizotifen Malate BP
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" Pizotifen BP (as Malate) is a tri-cyclic compound possessing structural similarities to cyproheptadine and tri-cyclic antidepressants. It is given orally for the prophylaxis of migraine and for the prevention of headache attacks during cluster periods. It is not effective in acute attacks of migraine. The prophylactic effect of Antigrain (Pizotifen) is associated with its ability to modify the humoral mechanisms of headache. It inhibits the permeability increasing effect of serotonin and histamine on the affected cranial vessels, thereby checking the transudation of plasmakinin so that the pain threshold of the receptor is maintained at ‘normal’ levels. In the sequence of events leading to migraine attack, depletion of plasma serotonin contributes to loss of tone of extracranial vessels. Pizotifen inhibits serotonin re-uptake by the platelets, thus maintaining plasma serotonin and preventing the loss of tone and passive diffusion of the extracranial arteries."
"Antigrain Tablet: Each film-coated tablet contains Pizotifen Malate BP 0.725 mg equivalent to Pizotifen 0.50 mg Antigrain TS Tablet: Each film-coated Tablet contains Pizotifen Malate BP 2.175 mg equivalent to Pizotifen 1.50 mg "
Indications And Uses
Antigrain is indicated in the Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache.
Dosage And Administration
Adults: Usually 1.5 mg daily at night as a single dose or in three divided doses. Dosage should be adjusted to individual patients requirements up to a maximum of 4.5 mg daily. Maximum single daily dose at night 3 mg. Children: Up to 1.5 mg daily, usually as a divided dose. Use of 1.5 mg at a time is not recommended, but up to 1 mg has been given as a single daily dose at night.
"The most commonly occurring side effects are drowsiness, Increased appetite, weight gain. Occasionally nausea, dizziness. CNS stimulationc may occur in children. "
Urinary retention, renal impairment, pregnancy, breast feeding should be taken in considration. Drowsiness may affect the performance of skilled (e.g. driving), effect of alcohol is enhanced.
Use In Pregnancy Lactation
"As clinical data with Pizotifen in pregnancy is very limited, it should only be administered during pregnancy under compelling circumstances. It’s use in nursing mother is not recommended"
Tolerance to alcohol may be lowered. Pizotifen may increase and prolong the drowsiness that occurs as an adverse effect of concurrently use of tranquilizers, hypnotics and anti-depressants. Pizotifen should not be used in patients receiving monoamine oxide (MAO) inhibitiors.
Keep in a cool and dry place, protected from light. Keep out of the reach of children.
Hypersensitivity to Pizotifen. Altough its anticholinergic activity is relatively weak, Pizotifen should not be administered in the presence of narrow-angle glaucoma or prostate hypertrophy. Antigrain should not be given to children under 2 years of age.
"Antigrain Tablet: Box containing (3x10’s tablets in blister strip. Antigrain TS Tablet: Box containing (2x10’s). (3x10’s), (5x10’s) tablets in blister strip. "