MYLAN-SELEGILINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SELEGILINE HYDROCHLORIDE

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

N04BD01

INN (International Name):

SELEGILINE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

SELEGILINE HYDROCHLORIDE 5MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

MONOAMINE OXIDASE B INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0131374001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-08-02

Summary of Product characteristics

1
PRODUCT MONOGRAPH
MYLAN-SELEGILINE
(SELEGILINE HYDROCHLORIDE)
5 MG TABLETS
ANTIPARKINSONIAN AGENT
Mylan Pharmaceuticals ULC
Date of Preparation:
85 Advance Road
July 15, 2009
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
Control#: 131229
2
PRODUCT MONOGRAPH
MYLAN-SELEGILINE
(SELEGILINE HYDROCHLORIDE)
TABLETS - 5 MG
THERAPEUTIC CLASSIFICATION
ANTIPARKINSONIAN AGENT
CLINICAL PHARMACOLOGY
Selegiline hydrochloride, previously known as l-deprenyl
hydrochloride, a synthetic selective
inhibitor of the MAO-B enzyme when administered at the recommended
doses, has been found to be
of value as an adjunct to the management of some patients with
Parkinson's Disease when
administered as add-on therapy to levodopa/carbidopa. The mechanism of
action of selegiline
hydrochloride responsible for its action as an adjunct in the
symptomatic management of selected
Parkinsonian patients is not well understood. Inhibitors of type MAO-B
enzyme may be useful by
blocking the metabolism of dopamine and by increasing the net amount
of dopamine available. It
may increase dopaminergic activity by blocking dopamine uptake at the
synapses. Two principal
metabolites of selegiline hydrochloride, l-amphetamine and
l-metamphetamine (which with l-
desmethylselegiline account for 44% of dose administered, as excreted
metabolites) could also play
a
role.
They
interfere
with
neuronal
uptake.
By
inhibiting
MAO-B
enzyme,
selegiline
hydrochloride may prevent the generation of free radicals and hydrogen
peroxide resulting from
oxidation of dopamine. It may also prevent the conversion of MPTP to
MPP. Non-selective
3
inhibitors of MAOs which inhibit MAO-A enzymes are not used in the
management of Parkinson
patients because of side effects, such as hypertension, increase in
involuntary movements and toxic
delirium. Toxic delirium has also been reported with selegiline
hydrochloride when used as
adjunctive therapy to levodopa treatment.
HYPERTENSIVE CRISIS ("CHEESE REACTION").
The MAOs are currently subclassified into two types, A and B, which
differ in their