Bula do remedy Sandomigran

the package insert of the medicine Sandomigran. Therapeutic class of Analgesic. Active principles Maleate Acid Pizotifeno. Sale under medical prescription.

what For?

the prophylactic Treatment of headaches, vascular diseases, such as:
migraines typical and atypical;
headaches vasomotoras;
headaches on saved syndrome (Horton).

Sandomigran is less effective in headaches, blood pressure, and in the ways in psychogenic and post-traumatic. Sandomigran is not acting in the crisis of migraine is already established.

Pharmacokinetics

How it works?

the absorption of The pizotifeno is rapid (half-life of absorption to 0.5-0.8 per hour) and nearly complete (80%). The substance is metabolized with a half-life of about 1 hour. The main metabolite (N-glicuronĂ­dio) is eliminated with a half-life of about 23 hours. The binding to proteins is of the order of 91% and the volume of distribution is 485 litres. Less than 1% of the administered dose is excreted unchanged in the urine, whereas 55% is excreted in form of metabolites. Thus, patients with renal insufficiency may require an adjustment in dosage.

Contraindications

When should I not use?

Hypersensitivity to the drug.

Dosage

How to use?

Adults
The dose should be increased gradually, starting with 0.5 mg per day. The average dose of maintenance is 1.5 mg daily in divided doses or as a single dose in the evening. In refractory cases, the doctor may increase gradually the dose up to 3-4,5 mg a day, administered in three doses fractionated.

Children above 12 years:
The initial daily dosage should be 0.5 mg and can be increased up to 1.5 mg in divided doses, or 1 mg as a single dose in the evening.

Side Effects

What are the evils that can cause me?

The most common side effect is sedation; rarely dizziness, dry mouth, nausea and constipation. In children can occur stimulation of the SNC.

it Was reported elevation of mood (antidepressant effect).

Warnings and Precautions

what should I know before using?

you Should warn patients of the possible sedative effects of the pizotifeno can slow down your reactions when driving vehicles, handling machinery, etc..

Due to the discrete effect of anticholinergic of pizotifeno, it is recommended caution in patients with angle-closure glaucoma (except in the cases treated surgically with success) or with risk of urinary retention (for example: prostate hypertrophy). Up to now, there is no reported undesirable reactions in these patients, even in the elderly, with the recommended dose.

As the data on the clinical use of pizotifeno in pregnancy are very limited, Sandomigran should only be administered in pregnancy if there is an absolute need to.

Although the concentrations of pizotifeno detected in breast milk pose little likelihood of affecting the infant, the use of Sandomigran during lactation is not recommended.

In patients with atony of the bowel, it is recommended alternative treatment.

Overdose

what to do if someone use a larger amount than is recommended?

Symptoms: drowsiness, nausea, hypotension, dizziness, excitation (in children), respiratory depression, convulsion (particularly in children), coma.

Treatment: gastric lavage followed by the administration of activated charcoal. if necessary, symptomatic treatment including monitoring of systems cardiovascular and respiratory; in cases of convulsions or excitation: benzodiazepines.