Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Pizotifen malate
Novartis Pharmaceuticals Australia Pty Ltd
Medicine Registered
SANDOMIGRAN ® _Pizotifen malate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sandomigran. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. Some more recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sandomigran against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SANDOMIGRAN IS USED FOR Sandomigran is used to prevent "vascular" headaches, including migraine, cluster headaches and vasomotor headaches. Vascular headaches are thought to be caused by temporary changes in the size of small blood vessels in the brain. These changes cause the pain and problems with vision that often happen during a severe headache. Sandomigran prevents an attack by stopping the blood vessels from changing in size. Sandomigran is only used to prevent severe headaches from happening. It will not stop an attack once it has started. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Sandomigran is only available with a doctor's prescription. It is not addictive. There is not enough information to recommend this medicine for children. BEFORE YOU TAKE SANDOMIGRAN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SANDOMIGRAN IF YOU HAVE AN ALLERGY TO PIZOTIFEN (THE ACTIVE INGREDIENT) OR TO Lesen Sie das vollständige Dokument
1 SANDOMIGRAN ® (PIZOTIFEN MALATE) DESCRIPTION Pizotifen is a cycloheptathiophene derivative structurally related to cyproheptadine and the tricyclic antidepressants. The malate salt is a white to yellow-tinged crystalline powder. MW = 429.54, pKa 6.95 in water. EXCIPIENTS: silica colloidal anhydrous, lactose, magnesium stearate, starch-maize, talc- purified, povidone, acacia, sucrose, titanium dioxide, cetyl palmitate. PHARMACOLOGY PHARMACODYNAMICS Sandomigran (pizotifen) is a competitive serotonin antagonist. It also possesses antihistamine, antibradykinin and weak anticholinergic properties. It is suitable for the prophylactic treatment of migraine, reducing the frequency of attacks, but is without effect in the migraine attack. The migraine attack is thought to consist of a prodromal phase of constriction followed by dilatation of the extracranial vessels. The mode of action of pizotifen in preventing migraine is not fully understood but it is known to inhibit the reuptake of serotonin by blood platelets, preventing loss of tone of extracranial vessels. It also possesses appetite-stimulating and antidepressant properties. PHARMACOKINETICS The absorption of pizotifen is rapid (absorption half-life 0.5 - 0.8 hours) and nearly complete (estimated 80%). Peak plasma levels are achieved 4 - 6 hours following a single oral dose. Metabolism is extensive and the drug is widely distributed. Volume of distribution is at least 7 litres/kg. Protein binding amounts to 91%. The main metabolite (N-glucuronide) is eliminated N S CH 3 Pizotifen COOH COOH CH CH 2 OH . MALATE 2 with a half-life of about 23 hours. Less than 1% of the drug is excreted in the urine unchanged although as much as 55% of a dose has been detected in the urine as metabolites. In patients with kidney insufficiency dosage adjustment may therefore be necessary. INDICATIONS Prophylactic (in Lesen Sie das vollständige Dokument