SELEGILINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SELEGILINE HYDROCHLORIDE

Available from:

AA PHARMA INC

ATC code:

N04BD01

INN (International Name):

SELEGILINE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

SELEGILINE HYDROCHLORIDE 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

MONOAMINE OXIDASE B INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

1997-02-13

Summary of Product characteristics

Page 1 of 29
PRODUCT MONOGRAPH
PR
SELEGILINE
SELEGILINE HYDROCHLORIDE TABLETS USP
(L-DEPRENYL HYDROCHLORIDE TABLETS USP)
5 MG
ANTIPARKINSONIAN AGENT
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT 1
VAUGHAN, ONTARIO
L4K 4N7
DATE OF REVISION:
MARCH 19, 2021
SUBMISSION CONTROL NO: 249480
Page 2 of 29
PRODUCT MONOGRAPH
Pr
SELEGILINE
Selegiline Hydrochloride Tablets USP
(I-Deprenyl Hydrochloride Tablets USP)
5 mg
THERAPEUTIC CLASSIFICATION
Antiparkinsonian Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Selegiline hydrochloride is an irreversible inhibitor of the enzyme
monoamine oxidase (MAO).
Because selegiline has greater affinity for type B than type A MAO, it
can serve as a selective
inhibitor of MAO-B if it is administered at the recommended dose.
Selegiline may have pharmacological effects unrelated to MAO-B
inhibition. There is some
evidence that it may increase dopaminergic activity by interfering
with dopamine re-uptake at the
synapse. Effects resulting from selegiline administration may also be
mediated through its
metabolites. Two of its three principle metabolites, amphetamine and
methamphetamine, have
pharmacological actions of their own, they interfere with neuronal
re-uptake and enhance the
release of several neurotransmitters (e.g., norepinephrine, dopamine,
serotonin). The extent to
which these neurotransmitters contribute to selegiline’s effects are
unknown.
Rationale for the use of selective MAO-B inhibitors in Parkinson’s
Disease
Many of the prominent symptoms of Parkinson’s Disease are due to a
deficiency of striatal
dopamine that is the consequence of a progressive degeneration and
loss of a population of
dopaminergic neurons which originate in the substantia nigra and
project to the striatum. Early in
the course of the disease, the deficit in the capacity of these
neurons to synthesize dopamine can
Page 3 of 29
be overcome by the administration of exogenous levodopa. After several
years of levodopa
therapy, the response to a given dose of levodopa is often accompanied
by side effects
(dyskinesia, on-