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Drug
Uses
Remeron
Tablets
are
indicated
for the
treatment
of major
depressive
disorder.
Remeron
is used
to
relieve
symptoms
of
depression
such as
feelings
of
sadness,
worthlessness,
or
guilt;
loss of
interest
in daily
activities;
changes
in
appetite;
tiredness;
sleeping
too
much;
insomnia;
and
thoughts
of death
or
suicide.
How
Taken
Remeron
is
available
in a
regular
tablet
formulation
(Remeron)
that
should
be
swallowed
with
water.
The
recommended
starting
dose for
Remeron
Tablets
is 15
mg/day,
administered
in a
single
dose,
preferably
in the
evening
prior to
sleep.
Warnings/Precautions
Do not
take
Remeron
if you
are
currently
taking,
or have
taken
within
the last
14 days,
a
monoamine
oxidase
inhibitor.
Before
taking
Remeron,
tell
your
doctor
if you
have
liver
disease;
have
kidney
disease;
have a
manic-depressive
disorder;
have
blood
problems;
have
high or
low
blood
pressure
or heart
disease;
have had
a heart
attack
in the
last 6
weeks;
or have
epilepsy
or
seizures.
You may
not be
able to
take
Remeron,
or you
may
require
a dosage
adjustment
or
special
monitoring
during
treatment
if you
have any
of the
conditions
listed
above.
Remeron
is in
the FDA
pregnancy
category
C. This
means
that it
is not
known
whether
Remeron
will
harm an
unborn
baby. Do
not take
Remeron
without
first
talking
to your
doctor
if you
are
pregnant.
It is
not
known
whether
Remeron
passes
into
breast
milk. Do
not take
Remeron
without
first
talking
to your
doctor
if you
are
breast-feeding
a baby.
If you
are over
60 years
of age,
you may
be more
likely
to
experience
side
effects
such as
drowsiness,
dizziness,
unsteadiness,
feeling
uncoordinated
and low
blood
pressure.
You may
require
a lower
dose of
this
medication.
Missed
Dose
Take the
missed
dose as
soon as
you
remember.
However,
if it is
almost
time for
your
next
dose,
skip the
missed
dose and
take
only
your
next
regularly
scheduled
dose. Do
not take
a double
dose of
this
medication
unless
otherwise
directed
by your
doctor.
Possible
Side
Effects
If you
experience
any of
the
following
serious
side
effects,
stop
taking
Remeron
and call
your
doctor
immediately
or seek
emergency
medical
treatment:
an
allergic
reaction
(swelling
of the
lips,
face, or
tongue;
difficulty
breathing);
seizures;
a fast
or
irregular
heartbeat;
or
fever,
chills,
a sore
throat,
flu-like
symptoms,
or sores
in your
mouth or
nose.
Other,
less
serious
side
effects
may be
more
likely
to
occur.
Continue
to take
Remeron
If you
experience
any of
the
following
serious
side
effects,
stop
taking
Remeron
and call
your
doctor
immediately
or seek
emergency
medical
treatment:
drowsiness;
nausea;
increase
in
weight
or
appetite;
dizziness;
dry
mouth;
constipation;
or mild
tremor.
Side
effects
other
than
those
listed
here may
also
occur.
Talk to
your
doctor
about
any side
effect
that
seems
unusual
or that
is
especially
bothersome.
Storage
Store at
controlled
room
temperature
20°- 25°
C(68°-
77° F).
Dispense
in a
tight,
light
resistant
container.
Overdose
Signs
and
symptoms
reported
in
association
with
overdose
included
disorientation,
drowsiness,
impaired
memory,
and
tachycardia.
There
were no
reports
of ECG
abnormalities,
coma or
convulsions
following
overdose
with
Remeron
alone.
Seek
emergency
medical
attention.
More
Information
Use
caution
when
driving,
operating
machinery,
or
performing
other
hazardous
activities.
Remeron
may
cause
drowsiness
and
dizziness.
If you
experience
drowsiness
or
dizziness,
avoid
these
activities.
Dizziness
is
likely
to occur
when you
rise
from a
sitting
or lying
position.
Rise
slowly
to
prevent
dizziness
and a
possible
fall.
Avoid
the use
of
alcohol
while
taking
Remeron.
Alcohol
may
increase
drowsiness
and
dizziness.
REMERON® (mirtazapine) Tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated
1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine
and has the empirical formula of C17H19N3. Its molecular weight is 265.36.
Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water.
REMERON® is supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose, and other inactive ingredients.
