NIMOTOP - CAP 30MG CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

NIMODIPINE

Tilgjengelig fra:

BAYER INC

ATC-kode:

C08CA06

INN (International Name):

NIMODIPINE

Dosering :

30MG

Legemiddelform:

CAPSULE

Sammensetning:

NIMODIPINE 30MG

Administreringsrute:

ORAL

Enheter i pakken:

100 CAPSULES

Resept typen:

Prescription

Terapeutisk område:

DIHYDROPYRIDINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0116077001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2009-08-06

Preparatomtale

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