SANDOMIGRAN Tablet Ref.[27801] Active ingredients:

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 1 to 6 mg/day. Up to 3mg may be given as a single dose. The average maintenance dose is 1.5 mg/day.

Geriatrics (>65 years of age)

The safety and efficacy of Sandomigran (pizotifen) in patients 65 years of age or older have not been established. Caution should be exercised with the use of Sandomigran in the elderly, recognizing the more frequent hepatic, renal, central nervous system and cardiovascular dysfunctions, and more frequent use of concomitant medications in this population.

Pediatrics (<12 years of age)

Sandomigran is contraindicated in children under the age of 12.

Adolescents (12-17 years of age)

Sandomigran may be prescribed in adolescents over the age of 12 years. Oral treatment should be initiated with a dose of 0.5 mg at bedtime. A maximum single dose of 1mg can be given at night. Daily doses up to a maximum of 1.5 mg may be given in divided doses.

Dosing Considerations

Since migraine is a paroxysmal but basically chronic disorder, treatment must extend over an adequate period of time in order to obtain maximal benefit. While some patients have responded rather quickly, a 4-week trial period should be instituted to determine the true efficacy of Sandomigran in specific cases. The periodic nature of the disorder will have to be considered in determining when and for how long therapy should be maintained.

Since some investigators have observed a change in headache pattern after several months of therapy, a drug-free interval is advisable to reassess the necessity of continuing treatment. The dosage should be reduced gradually during the last 2 weeks of each treatment course to avoid a “headache rebound”.

As with other antiserotonin agents, the benefits of Sandomigran decrease after a period of time in a certain number of patients.

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, confusion, tachycardia, ataxia, nausea, vomiting, dyspnea, cyanosis, convulsions, coma, respiratory paralysis and CNS depression. Drowsiness precedes excitement, convulsions and postictal depression.

Children

Antihistamine poisoning in children exhibits excitation, hallucinations, ataxia, incoordination, convulsions, fixed dilated pupils, flushed faces, and fever (pyrexia), leading to coma and cardiorespiratory collapse.

Treatment

Administration of activated charcoal is recommended. In case of very recent uptake, if vomiting has not occurred spontaneously, induce emesis or perform gastric lavage and diuresis. Supportive measures should be instituted to maintain respiration and vital signs should be monitored; severe hypotension must be corrected (caveat: adrenaline (epinephrine) may produce paradoxical effects).

Because Sandomigran can cause tachycardia, an ECG should be performed and attention directed at the QRS and QT intervals. Patients with abnormal ECGs or signs of evolving toxicity should undergo ECG monitoring.

Short-acting barbiturates or benzodiazepines (diazepam or lorazepam) may be used for the treatment of excitatory states or convulsions. Analeptics (i.e., stimulating the central nervous system, the respiratory system or the cardiovascular system) should be avoided.

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.