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Patient Inform ation
SINGULAIR
(SING-u-lair)Tablets, ChewableTablets, and Oral Granules
Generic name: m ontelukast (mon-te-LOO-kast) sodium
Read this inform ation before you start taking
SIN G U LA IR . A lso, read the leaflet you get each time
you refill SINGULAIR, since there may be new information
in the leaflet since the last tim e you saw it. T h is leaflet
does not take the place of talking with your doctor
about your m edical condition and/or your treatment.
W hat is SIN G U LA IR *?
•
SIN G U LA IR is a m edicine called a leukotriene
receptor antagonist. It w orks by blocking
substances in the body called leukotrienes.
Blocking leukotrienes im proves asthm a and allergic
rhinitis. S IN G U LA IR is not a steroid. Studies have
shown that SIN G U LA IR does not affect the growth
rate of children. (See the end of this leaflet for more
inform ation about asthm a and allergic rhinitis.)
SIN G U LA IR is prescribed for the treatment of asthm a,
the prevention of exercise-induced asthm a, and
allerg ic rhinitis:
1. A sthm a.
SIN G U LA IR should be used for the long-term
m anagem ent of asthm a in adults and children
ages 12 m onths and older.
Do not take S IN G U LA IR for the im m ediate relief
of an asthm a attack. If you get an asthm a attack,
you should follow the instructions your doctor
gave you for treating asthm a attacks.
2. Prevention of exercise-induced asthm a.
SIN G U LA IR is used for the prevention of exercise-
induced asthma in patients 15 years of age and older.
3. A llerg ic R hinitis.
SIN G U LA IR is used to help control the sym ptom s
of allergic rhinitis (sneezing, stuffy nose, runny
nose, itching of the nose). SIN G U LA IR 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 m onths and older.
W ho should not take S IN G U LA IR ?
Do not take SIN G U LA IR if you are allergic to SINGU LAIR
or any of its ingredients.
The active ingredient in SIN G U LA IR is montelukast
sodium .
See the end of this leaflet for a list of all the ingredients
in SIN G U LA IR .
W hat should I tell m y doctor before I start taking
S IN G U LA IR ?
Tell your doctor about:
•
Pregnancy: If you are pregnant or plan to become
pregnant, SIN G U LA IR m ay not be right for you.
•
B reast-feeding: If you are breast-feeding,
SIN G U LA IR m ay be passed in your m ilk to your
baby. You should consult your doctor before
taking SIN G U LA IR if you are breast-feeding or
intend to breast-feed.
•
M edical Problem s or A lle rg ie s: Talk about any
m edical problem s or allergies you have now or
had in the past.
•
O ther M edic in e s: Tell your doctor about all
the m edicines you take, including prescription
and non-prescription m edicines, and herbal
supplem ents. Som e m edicines m ay affect how
SIN G U LA IR works, or SIN G U LA IR m ay affect
how your other m edicines work.
How should I take S IN G U LA IR ?
For ad ults and children 12 m onths of age and older
w ith asthm a:
•
Take s in g u l a ir p.ac.e_a.d.ay in_ttie_ey.en.i.Qg.
•
Take SIN G U LA IR every day for as long as your
doctor prescrib es it, even if you have no asthm a
sym ptom s.
•
You m ay take SINGULAIR with food or without food.
•
If your asthm a sym ptom s get w orse, or if you
need to increase the use of your inhaled rescue
m edicine for asthm a attacks, call your doctor
right away.
•
Do not take S IN G U LA IR for the im m ediate relief
of an asthm a attack. If you get an asthm a attack,
you should follow the instructions your doctor
gave you for treating asthm a attacks.
•
A lw ays have your inhaled rescue m edicine for
asthm a attacks w ith you.
•
Do not stop taking or lower the dose of your other
asthm a m edicines unless your doctor tells you to.
For patients 15 years of age and older for the
prevention of exercise-induced asthm a:
•
Take SIN G U LA IR at least 2 hours before exercise.
•
A lw ays have your inhaled rescue m edicine for
asthm a attacks with you.
•
If you are taking SIN G U LA IR d aily for chronic
asthm a or allergic rhinitis, do not take an
additional dose to prevent exercise-induced
asthm a. Speak to your doctor about your
* Registered trademark of MERCK & CO., Inc.
COPYRIGHT© 1998-2009 MERCK & CO.
. Inc.
All rights reserved
treatment of exercise-induced asthm a.
•
Do not take an additional dose of SIN G U LA IR
w ithin 24 hours of a previous dose.
For ad ults and children 2 years of age and older
w ith seasonal alle rg ic rh in itis, or for ad ults and
children 6 m onths of age and older w ith perennial
allerg ic rhinitis:
•
Take SIN G U LA IR once a day, at about the sam e
tim e each day.
•
Take SIN G U LA IR every day for a s long as your
doctor prescribes it.
•
You m ay take SINGU LAIR with food or without food.
How should I give SINGU LAIR oral granules to m y child?
Do not open the packet until ready to use.
SIN G U LA IR 4-m g oral granules can be given:
•
d irectly in the mouth;
•
d issolved in 1 teaspoonful (5 mL) of cold or room
tem perature baby form ula or breast milk;
•
m ixed w ith a spoonful of one of the follow ing soft
foods at cold or room tem perature: applesauce,
m ashed carrots, rice, or ice cream .
Be sure that the entire dose is m ixed with the food,
baby form ula, or breast m ilk and that the child is
given the entire spoonful of the food, baby form ula, or
breast m ilk m ixture right aw ay (within 15 minutes).
IM PORTANT: Never store any oral granules m ixed
w ith food, baby form ula, or breast m ilk for use at a
later tim e. Throw aw ay any unused portion.
Do not put S IN G U LA IR oral granules in any
liq u id d rink other than baby form ula or breast
m ilk. However, your child m ay drink liq u id s after
sw allow ing the SIN G U LA IR oral granules.
W hat is the dose of S IN G U LA IR ?
For asth m a—Take once d aily in the evening:
•
One 10 -m g tablet for adults and adolescents
15 years of age and older,
•
One 5-m g chew able tablet for children 6 to
14 years of age,
•
One 4-m g chew able tablet or one packet of 4-m g
oral granules for children 2 to 5 years of age, or
•
One packet of 4-m g oral granules for children
12 to 23 m onths of age.
For exercise-induced asth m a—Take at least 2 hours
before exercise, but not m ore than once d aily:
•
One 10 -m g tablet for adults and adolescents
15 years of age and older
For allerg ic rh in itis—Take once d aily at about the
sam e tim e each day:
•
One 10 -m g tablet for adults and adolescents
15 years of age and older,
•
One 5-m g chew able tablet for children 6 to
14 years of age,
•
One 4-m g chew able tablet for children 2 to
5 years of age, or
•
One packet of 4-m g oral granules for children
2 to 5 years of age w ith seasonal allerg ic rhinitis,
or for children 6 m onths to 5 years of age with
perennial allerg ic rhinitis.
W hat should I avoid w hile taking S IN G U LA IR ?
If you have asthm a and if your asthm a is made
w orse by aspirin, continue to avoid aspirin or other
m edicines called non-steroidal anti-inflam m atory
drugs w hile taking SIN G U LA IR .
W hat are the possible side effects of S IN G U LA IR ?
The side effects of SIN G U LA IR are usually m ild, and
generally did not cause patients to stop taking their
m edicine. The side effects in patients treated with
SIN G U LA IR were sim ilar in type and frequency to side
effects in patients who were given a placebo (a pill
containing no m edicine).
The m ost com m on side effects with SIN G U LA IR
include:
•
stom ach pain
•
stom ach or intestinal upset
•
heartburn
•
tiredness
•
fever
•
stuffy nose
•
cough
•
flu
•
upper respiratory infection
•
dizziness
•
headache
•
rash
Less com m on side effects that have happened with
SIN G U LA IR include:
•
increased bleeding tendency
•
allergic reactions (including swelling of the face, lips,
tongue, and/or throat (which m ay cause trouble
breathing or sw allow ing), hives and itching]
•
drow siness, pins and needles/num bness,
seizures (convulsions or fits)
•
palpitations
•
nosebleed
•
diarrhea, indigestion, inflam m ation of the
pancreas, nausea, vom iting
•
hepatitis
•
bruising
•
joint pain, m uscle aches and m uscle cram ps
•
sw elling
B ehavio r and m ood-related ch an g es have been
reported: agitation including aggressive behavior or
hostility, bad/vivid dream s, depression, feeling anxious,
hallucinations (seeing things that are not there), irritability,
restlessness, sleep w alking, su icid al thoughts and
actions (including suicide), tremor, trouble sleeping.
Tell your doctor if you experience behavior or m ood-
related changes w hile taking SIN G U LA IR .
Rarely, asthm atic patients taking SIN G U LA IR have
experienced a condition that includes certain
sym ptom s that do not go aw ay or that get w orse.
These occur usually, but not alw ays, in patients who
were taking steroid pills by mouth for asthm a and
those steroids were being slo w ly lowered or stopped.
Although SIN G U LA IR has not been show n to cause
this condition, you m ust tell your doctor right aw ay if
you get one or m ore of these sym ptom s:
•
a feeling of pins and needles or num bness of
arm s or legs
•
a flu-like illness
•
rash
•
severe inflam m ation (pain and sw elling) of the
sin u ses (sinusitis)
These are not all the possible side effects of SINGULAIR.
For m ore inform ation ask your doctor or pharm acist.
Talk to your doctor if you think you have side effects
from taking SIN G U LA IR .
G eneral Inform ation about the safe and effective use
of SIN G U LA IR
M edicines are som etim es prescribed for conditions
that are not m entioned in patient inform ation leaflets.
Do not use SIN G U LA IR for a condition for w hich it
w as not prescribed. Do not give SIN G U LA IR to other
people even if they have the sam e sym ptom s you
have. It m ay harm them. Keep SIN G U LA IR and all
m edicines out of the reach of children.
Store SIN G U LA IR at 25eC (779F). Protect from m oisture
and light. Store in original package.
T h is leaflet sum m arizes inform ation about
SIN G U LA IR . If you w ould like more inform ation, talk
to your doctor. You can ask your pharm acist or doctor
for inform ation about SIN G U LA IR that is written for
health professionals.
W hat are the ingred ients in S IN G U LA IR ?
Active ingredient: m ontelukast sodium
SIN G U LA IR chew able tab lets contain aspartam e,
a source of phenylalanine.
Phenylketonurics: SIN G U LA IR 4-m g and 5-m g
chew able tablets contain 0.674 and 0.842 mg
phenylalanine, respectively.
Inactive ingredients:
•
4-m o oral g ranu les: m annitol, hydroxypropyl
cellulose, and m agnesium stearate.
•
4 -m g and 5 -m g chew able tab let?: m annitol,
m icro crystalline cellulose, hydroxypropyl
cellulose, red ferric oxide, croscarm ellose
sodium , cherry flavor, aspartam e, and
m agnesium stearate.
•
10-m g tablet: m icrocrystalline cellulose, lactose
monohydrate, croscarmellose sodium, hydroxypropyl
cellulose, m agnesium stearate, hydroxypropyl
m ethylcellulose, titanium dioxide, red ferric
oxide, yellow ferric oxide, and carnauba wax.
W hat is asthm a?
Asthm a is a continuing (chronic) inflam m ation of the
bronchial passagew ays w hich are the tubes that carry
air from outside the body to the lungs.
Sym ptom s of asthm a include:
•
coughing
•
wheezing
•
chest tightness
•
shortness of breath
W hat is exercise-induced asthm a?
Exercise-induced asthm a, m ore accurately called
exercise-induced bronchoconstriction occurs when
exercise triggers sym ptom s of asthm a.
W hat is alle rg ic rh in itis?
•
Seasonal allerg ic rhinitis, also known as hay fever,
is triggered by outdoor allergens such as pollens
from trees, g rasses, and w eeds.
•
Perennial allergic rhinitis m ay occur year-round and
is generally triggered by indoor allergens such as
dust m ites, anim al dander, and/or m old spores.
•
Sym ptom s of allerg ic rhinitis m ay include:
•
stuffy, runny, and/or itchy nose
•
sneezing
Rx only
US Patent No.: 5,565,473
Issued August 2009
Distributed by:
M ERCK & CO ., INC.
W hitehouse Station, N J 08889, USA
21051270 (2X 4 15)-SN G
