Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
NIMODIPINE
BAYER INC
C08CA06
NIMODIPINE
30MG
CAPSULE
NIMODIPINE 30MG
ORAL
100 CAPSULES
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0116077001; AHFS:
CANCELLED POST MARKET
2009-08-06
PRODUCT MONOGRAPH PR NIMOTOP ® (Nimodipine Capsules) 30 mg For Oral Use Adjunct in the Management of Subarachnoid Hemorrhage Calcium Channel Blocking Agent Bayer Inc. 77 Belfield Road Toronto, Ontario M9W 1G6 Canada www.bayer.ca Date of Revision: July 3, 2008 Submission Control No.: 120965 © 2008 Bayer Inc. ® NIMOTOP is a registered trademark, use under licence by Bayer Inc. 2 PRODUCT MONOGRAPH PR NIMOTOP ® (30 MG NIMODIPINE CAPSULES) FOR ORAL USE THERAPEUTIC CLASSIFICATION ADJUNCT IN THE MANAGEMENT OF SUBARACHNOID HEMORRHAGE CALCIUM CHANNEL BLOCKING AGENT ACTIONS AND CLINICAL PHARMACOLOGY Delayed neurological deterioration secondary to cerebral ischemic deficits is believed to be a major determinant of outcome in patients who survive their initial subarachnoid hemorrhage (SAH). NIMOTOP (nimodipine) is a calcium channel blocker of the dihydropyridine group. It appears to have a more marked effect on the cerebral circulation than on the peripheral circulation. Since it acts on the vascular smooth muscle tone by modifying the contractile process which is dependent upon the movement of extracellular calcium into the cells during depolarization. it was tested in patients with SAH in an effort to improve the neurologic outcome in these patients. Clinical studies with nimodipine support its usefulness as an adjunct in the management of some patients with SAH from ruptured aneurysm by improving their neurologic outcome, particularly in Hunt and Hess grades 1 to 3 patients. The actual mechanism of the possible beneficial effect of nimodipine is, however, unknown. The original rationale for using nimodipine after SAH was to reduce cerebral arterial spasm, but available evidence indicates that nimodipine does not reduce the incidence or severity of cerebral spasm as seen on angiography. Nimodipine is rapidly and completely absorbed after oral administration of the capsule. Because of a strong first-pass metabolism in the liver, only about 10% of the unchanged drug enters the systemic circulation. The drug is detectable Perskaitykite visą dokumentą