NARDIL phenelzine 15mg (as sulfate) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenelzine sulfate, Quantity: 25.83 mg (Equivalent: phenelzine, Qty 15 mg)

Available from:

Neon Healthcare Pty Limited

INN (International Name):

Phenelzine sulfate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; maize starch; mannitol; titanium dioxide; hypromellose; hyprolose; sunset yellow FCF; purified talc; erythrosine; stearic acid; polyvinyl acetate phthalate

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of major depression. Phenelzine sulfate should rarely be the first antidepressant drug used. Rather it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.

Product summary:

Visual Identification: ; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2003-03-26

Patient Information leaflet

NARDIL
®
_Phenelzine _
_ _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet
carefully before you take
Nardil.
This leaflet answers some
common questions about
Nardil. It does not contain all
the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking Nardil against the
benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT NARDIL IS USED
FOR
The name of your medicine is
Nardil. It contains the active
ingredient phenelzine.
Nardil is used to treat major
depression. There are many
different types of medicines
used to treat depression.
Nardil belongs to a group of
medicines called Monoamine
Oxidase Inhibitors (MAOIs).
Depression is longer lasting
and/or more severe than the
"low moods" everyone has
from time to time due to the
stress of everyday life. It is
thought to be caused by a
chemical imbalance in parts of
the brain. This imbalance
affects your whole body and
can cause emotional and
physical symptoms such as
feeling low in spirit, loss of
interest in activities, being
unable to enjoy life, poor
appetite or overeating,
disturbed sleep, often waking
up early, loss of sex drive, lack
of energy and feeling guilty
over nothing.
Antidepressants are thought to
work by acting on brain
chemicals called amines,
which are involved in
controlling mood.
Your doctor, however, may
prescribe Nardil for another
purpose. ASK YOUR DOCTOR IF
YOU HAVE ANY QUESTIONS
ABOUT WHY NARDIL HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE NARDIL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NARDIL IF:
•
You have an allergy to
phenelzine, or any of the
ingredients listed at the end
of this leaflet.
Allergic symptoms may
include difficulty breathing,
closing of your throat,
swelling of

Summary of Product characteristics

1
PRODUCT INFORMATION
NARDIL
phenelzine sulfate
NAME OF THE MEDICINE
phenelzine sulfate
Molecular Weight - 234.27
Chemical formula - C
8
H
12
N
2
.H
2
SO
4
.
CAS NUMBER: 156-51-4
DESCRIPTION
Phenelzine sulfate is a potent inhibitor of monoamine oxidase (MAO).
Phenelzine
sulfate is a hydrazine derivative.
Each film coated phenelzine sulfate tablet contains phenelzine sulfate
equivalent to
15 mg phenelzine base. Inactive ingredients include mannitol,
povidone, starch-maize,
magnesium stearate, and Opadry 20A25096 Red.
PHARMACOLOGY
MAO
is
a
complex
flavin-containing
enzyme
system
that
is
widely
distributed
throughout the body. MAO inhibitors exert their effects mainly on
organ systems
influenced by sympathomimetic amines and 5-hydroxytryptamine and
inhibit not only
MAO but also other enzymes as well, interfering with the hepatic
metabolism of many
drugs. It is unknown whether all the clinical effects produced by this
class of drug result
from
MAO
inhibition,
other
pharmacological
actions,
or
an
interaction
of
both.
Therefore the physician should become familiar with all the effects
produced by drugs
of this class.
Phenelzine sulfate is oxidised by MAO to form reactive intermediates
which then
irreversibly inactivate the flavin prosthetic group of MAO. In the
clinical setting, maximal
inhibition of MAO is usually achieved within a few days (5 to 10 days
in biopsy
samples), although the antidepressant effect may be delayed for 2 to 3
weeks.
Evaluation of MAO activity in human subjects indicates that favourable
clinical
responses are likely to occur when platelet MAO is inhibited by 85%.
2
Up to 2 weeks may be required to restore amine metabolism to normal
following
withdrawal of MAO inhibitors, presumably because of the necessity for
the re-synthesis
of MAO. This is the reason why a period of 10 to 14 days is necessary
after
discontinuing MAO therapy before commencing a normal diet (see
PRECAUTIONS).
PHARMACOKINETICS
There is little information available on the pharmacokinetics of
phenelzine sulfate.
Orally administer