Patient Information
SINGULAIR® (SING-u-lair) Tablets, ChewableTablets, and Oral Granules
Generic name: montelukast (mon-te-LOO-kast) sodium
9628414
Read
this information before you start taking
SINGULAIR®. Also, read the leaflet you get each time
you refill SINGULAIR, since there may be
new
information
in
the leaflet since the last time you saw
it. This leaflet
does not take the place of talking w
ith your doctor
about your medical condition and/or your treatment.
What is SINGULAIR*?
•
SINGULAIR is a medicine called a leukotriene
receptor antagonist. It works by blocking
substances in
the body called leukotrienes.
Blocking leukotrienes improves asthma and allergic
rhinitis. SINGULAIR is not a steroid. Studies have
shown that SINGULAIR does not affect the growth
rate of children. (See the end of this leaflet for more
information about asthma and allergic rhinitis.)
SINGULAIR is prescribed for the treatment of asthma,
the prevention of exercise-induced asthma, and
allergic rhinitis:
1
. Asthma.
SINGULAIR should be used for the long-term
management of asthma in
adults and
children
ages 12 months and older.
Do
not take SINGULAIR for the immediate relief
of an asthma attack. If you get an
asthma attack,
you should follow
the instructions your doctor
gave you for treating asthma attacks.
2
. Prevention of exercise-induced asthma.
SINGULAIR is used for the prevention of exercise-
induced asthma in
patients
15
years of age and
o
lder.
3
. Allergic Rhinitis.
SINGULAIR is used to
help control the symptoms
of allergic rhinitis (sneezing, stuffy nose, runny
nose, itching of the nose). SINGULAIR is used to
treat seasonal allergic rhinitis (outdoor allergies
that happen part of the year) in
adults and
children
ages 2 years and older, and perennial allergic
rhinitis (indoor allergies that happen all year) in
adults and children ages 6
months and older.
Who should not take SINGULAIR?
Do
not take SINGULAIR
if you are allergic to
SINGULAIR
or any of its ingredients.
The active ingredient in
SINGULAIR is montelukast
sodium
.
See the end of this leaflet for a list of all the ingredients
in
SINGULAIR.
What should I tell my doctor before I start taking
SINGULAIR?
Tell your doctor about:
•
Pregnancy: If you are pregnant or plan to
become
pregnant, SINGULAIR may not be right for you.
•
Breast-feeding: If you are breast-feeding,
SINGULAIR may be passed in
your m
ilk to
your
baby. You should consult your doctor before
taking SINGULAIR if you are breast-feeding or
intend to
breast-feed.
•
Medical Problems or Allergies: Talk about any
medical problems or allergies you have now
or
had
in
the past.
•
Other Medicines: Tell your doctor about all
the medicines you take, including prescription
and non-prescription medicines, and herbal
supplements. Some medicines may affect how
SINGULAIR works, or SINGULAIR may affect
how
your other medicines work.
How
should I take SINGULAIR?
For adults and children
12
months of age and older
w
ith asthma:
•
Take SINGULAIR once a day in
the evening.
•
Take SINGULAIR every day for as long as your
doctor prescribes it, even if you have no
asthma
symptoms.
•
You may take SINGULAIR
w
ith food
or w
ithout food.
•
If your asthma symptoms get worse, or if you
need to
increase the use of your inhaled rescue
medicine for asthma attacks, call your doctor
right away.
•
Do
not take SINGULAIR for the immediate relief
of an asthma attack. If you get an
asthma attack,
you should follow
the instructions your doctor
gave you for treating asthma attacks.
•
Always have your inhaled rescue medicine for
asthma attacks w
ith you.
•
Do
not stop taking or lower the dose of your other
asthma medicines unless your doctor tells you to.
For patients
15
years of age and older for the
prevention of exercise-induced asthma:
•
Take SINGULAIR at least
2
hours before exercise.
•
Always have your inhaled rescue medicine for
asthma attacks w
ith you.
•
If you are taking SINGULAIR daily for chronic
asthma or allergic rhinitis, do
not take an
additional dose to
prevent exercise-induced
asthma. Speak to
your doctor about your
*
Reg
istered
trademark of MERCK
&
CO
., Inc.
COPYRIGHT ©
1998-2007
MERCK
&
CO
., Inc.
A
ll rights reserved
treatment of exercise-induced asthma.
•
Do
not take an
additional dose of SINGULAIR
w
ithin
24
hours of a previous dose.
For adults and children
2
years of age and older
w
ith seasonal allergic rhinitis, or for adults and
children 6
months of age and older w
ith perennial
allergic rhinitis:
•
Take SINGULAIR once a day, at about the same
time each day.
•
Take SINGULAIR every day for as long as your
doctor prescribes it.
•
You
may take SINGULAIR
w
ith food
or w
ithout food.
How
should I give SINGULAIR
oral granules to my child?
Do
not open the packet until ready to
use.
SINGULAIR
4
-mg oral granules can be
given:
•
directly in
the mouth;
•
dissolved in
1
teaspoonful
(5
mL) of cold or room
temperature baby formula or breast m
ilk;
•
m
ixed w
ith a spoonful of one of the follow
ing soft
foods at cold or room
temperature: applesauce,
mashed carrots, rice, or ice cream
.
Be
sure that the entire dose is m
ixed w
ith the food,
baby formula, or breast m
ilk and
that the child is
given the entire spoonful of the food, baby formula, or
breast m
ilk m
ixture right away (w
ithin
15
m
inutes).
IMPORTANT: Never store any oral granules m
ixed
w
ith food, baby formula, or breast m
ilk for use at a
later time. Throw
away any unused portion.
Do
not put SINGULAIR oral granules in any
liquid drink other than baby formula or breast
m
ilk. However, your child may drink liquids after
swallow
ing the SINGULAIR oral granules.
What is the dose of SINGULAIR?
For asthma—
Take once daily in the evening:
•
One
10
-mg tablet for adults and
adolescents
15
years of age and older,
•
One
5
-mg chewable tablet for children 6
to
14
years of age,
•
One
4
-mg chewable tablet or one packet of
4
-mg
oral granules for children
2
to
5
years of age, or
•
One packet of
4
-mg oral granules for children
12
to
23
months of age.
For exercise-induced asthma—
Take at least
2
hours
before exercise, but not more than once daily:
•
One
10
-mg tablet for adults and
adolescents
15
years of age and older
For allergic rhinitis—
Take once daily at about the
same time each day:
•
One
10
-mg tablet for adults and
adolescents
15
years of age and older,
•
One
5
-mg chewable tablet for children 6
to
14
years of age,
•
One
4
-mg chewable tablet for children
2
to
5
years of age, or
•
One packet of
4
-mg oral granules for children
2
to
5
years of age w
ith seasonal allergic rhinitis,
or for children 6
months to
5
years of age w
ith
perennial allergic rhinitis.
What should I avoid while taking SINGULAIR?
If you have asthma and if your asthma is made
worse by aspirin, continue to
avoid aspirin or other
medicines called non-steroidal anti-inflammatory
drugs while taking SINGULAIR.
What are the possible side effects of SINGULAIR?
The side effects of SINGULAIR are usually m
ild, and
generally did not cause patients to
stop taking their
medicine. The side effects in
patients treated w
ith
SINGULAIR were sim
ilar in type and
frequency to
side
effects in
patients who
were given a placebo (a
pill
containing no
medicine).
The most common side effects w
ith SINGULAIR
include:
•
stomach pain
•
stomach or intestinal upset
•
heartburn
•
tiredness
•
fever
•
stuffy nose
•
cough
•
flu
•
upper respiratory infection
•
dizziness
•
headache
•
rash
Less common side effects that have happened w
ith
SINGULAIR include:
•
increased bleeding tendency
•
allergic reactions [including swelling of the
face, lips,
tongue, and/or throat (which may cause trouble
breathing or swallow
ing), hives and
itching]
•
behavior and
mood related changes [agitation
including aggressive behavior, bad/vivid dreams,
depression, feeling anxious, hallucinations
(seeing things that are not there), irritability,
restlessness, suicidal thoughts and actions
(including suicide), tremor, trouble sleeping]
•
drowsiness, pins and needles/numbness,
seizures (convulsions or fits)
•
palpitations
•
nose bleed
•
diarrhea, indigestion, inflammation of the
pancreas, nausea, vom
iting
•
hepatitis
•
bruising
•
joint pain, muscle aches and muscle cramps
•
swelling
Rarely, asthmatic patients taking SINGULAIR have
experienced a condition that includes certain
symptoms that do
not go
away or that get worse.
These occur usually, but not always, in
patients who
were taking steroid pills by mouth for asthma and
those steroids were being slow
ly lowered or stopped.
Although SINGULAIR has not been shown to
cause
this condition, you must tell your doctor right away if
you get one or more of these symptoms:
•
a feeling of pins and needles or numbness of
arms or legs
•
a flu-like illness
•
rash
•
severe inflammation (pain and swelling) of the
sinuses (sinusitis)
These are not all the
possible side effects of SINGULAIR.
For more information ask your doctor or pharmacist.
Talk to
your doctor if you think you have side effects
from
taking SINGULAIR.
General Information about the safe and effective use
of SINGULAIR
Medicines are sometimes prescribed for conditions
that are not mentioned in patient information leaflets.
Do
not use SINGULAIR for a condition for which it
was not prescribed. Do
not give SINGULAIR to
other
people even if they have the same symptoms you
have. It may harm
them
. Keep SINGULAIR and all
medicines out of the reach of children.
Store SINGULAIR at
25
°C (
77
°F). Protect from
moisture
and light. Store in original package.
This leaflet summarizes information about
SINGULAIR. If you would like more information, talk
to
your doctor. You can ask your pharmacist or doctor
for information about SINGULAIR that is written for
health professionals.
What are the ingredients in SINGULAIR?
Active ingredient: montelukast sodium
SINGULAIR chewable tablets contain aspartame,
a source of phenylalanine.
Phenylketonurics: SINGULAIR
4
-mg and
5
-mg
chewable tablets contain
0.674
and
0.842
mg
phenylalanine, respectively.
Inactive ingredients:
•
4
-mg oral granules: mannitol, hydroxypropyl
cellulose, and magnesium
stearate.
•
4
-mg and
5
-mg chewable tablets: mannitol,
m
icrocrystalline cellulose, hydroxypropyl
cellulose, red
ferric oxide, croscarmellose
sodium
, cherry flavor, aspartame, and
magnesium
stearate.
•
10-mg tablet: m
icrocrystalline cellulose, lactose
monohydrate, croscarmellose sodium
, hydroxypropyl
cellulose, magnesium
stearate, hydroxypropyl
methylcellulose, titanium
dioxide, red
ferric
oxide, yellow
ferric oxide, and carnauba wax.
What is asthma?
Asthma is a continuing (chronic) inflammation of the
bronchial passageways which are the tubes that carry
air from
outside the body to
the lungs.
Symptoms of asthma include:
•
coughing
•
wheezing
•
chest tightness
•
shortness of breath
What is exercise-induced asthma?
Exercise-induced asthma, more accurately called
exercise-induced bronchoconstriction occurs when
exercise triggers symptoms of asthma.
What is allergic rhinitis?
•
Seasonal allergic rhinitis, also known as hay fever,
is triggered by outdoor allergens such as pollens
from
trees, grasses, and weeds.
•
Perennial allergic rhinitis may occur year-round and
is generally triggered by indoor allergens such as
dust m
ites, animal dander, and/or mold spores.
•
Symptoms of allergic rhinitis may include:
•
stuffy, runny, and/or itchy nose
•
sneezing
Rx only
US Patent No.:
5
,
565,473
Issued July
2008
D
istributed by:
MERCK
&
CO
., INC.
Whitehouse Station, NJ
08889
, USA
20950137
(
1
)(
414
)-SNG-CON
