9628415
Patient Information
SIN G U LA IR
(SIN G-u-lair)Tablets, Chew ableTablets, and Oral Granules
Generic name: m ontelukast (m on-te-LOO-kast) sodium
Read this inform ation before you start taking
S IN G U LA IR . A lso , read the leaflet you get each tim e
you refill SIN GULAIR, 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 w ith your doctor
about your m edical condition and/or your treatm ent.
W hat is S IN G U LA IR *?
•
S IN G U LA IR is a m edicine called a leukotriene
receptor antagonist. It w o rks by blocking
su b stances in the body called leukotrienes.
Blocking leukotrienes im proves asthm a and allergic
rhinitis. SIN G U LA IR is not a steroid. Studies have
show n that S IN G U LA IR does not affect the growth
rate of children. (See the end of this leaflet for m ore
inform ation about asthm a and allergic rhinitis.)
S IN G U LA IR is prescribed for the treatm ent of asthm a,
the prevention of exercise-induced asthm a, and
allerg ic rhinitis:
1. A sthm a.
S IN 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 SIN 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.
S IN G U LA IR is used for the prevention of exercise-
induced asthm a in patients 15 years of age and older.
3. A llerg ic R h in itis.
S IN G U LA IR is used to help control the sym ptom s
of allergic rhinitis (sneezing, stu ffy nose, runny
nose, itching of the nose). SIN G U LA IR is used to
treat seasonal allergic rhinitis (outdoor allerg ies
that happen part of the year) in adults and children
ages
2
yea rsa n d older, and perennial allergic
rhinitis (indoor allerg ies that happen all year) in
adults and children ages
6
m onths and older.
W ho should not take SIN G U LA IR ?
Do not take SIN G U LA IR if you are allergic to SIN G U LAIR
or any of its ingredients.
The active ingredient in S IN G U LA IR is m ontelukast
sodium .
See the end of this leaflet for a list of all the ingredients
in S IN G U LA IR .
W hat should I tell m y doctor before I sta rt taking
SIN G U LA IR ?
Tell your doctor about:
•
Pregnancy: If you are pregnant or plan to becom e
pregnant, S IN G U LA IR m ay not be right for you.
•
Breast-feeding: If you are breast-feeding,
S IN G U LA IR m ay be passed in your m ilk to your
baby. You should consult your doctor before
taking S IN G U LA IR if you are breast-feeding or
intend to breast-feed.
•
M edical Problem s or A llerg ies: Talk about any
m edical problem s or allerg ies you have now or
had in the past.
•
O ther M edicines: 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
S IN G U LA IR w orks, or S IN G U LA IR m ay affect
how your other m edicines w ork.
How should I take SIN 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 LA IR once a day in the evening.
•
Take S IN 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 SIN G U LAIR with food or without food.
•
If your asthm a sym ptom s get w o rse, or if you
need to increase the use of your inhaled rescue
m edicine for asthm a attacks, call your doctor
right aw ay.
•
Do not take SIN 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 low er the dose of your other
asthm a m edicines unless your doctor tells you to.
For p atien ts 15 years of age and older for the
prevention of exercise-induced asthm a:
•
Take S IN G U LA IR at least 2 hours before exercise.
•
A lw ays have your inhaled rescue m edicine for
asthm a attacks w ith you.
•
If you are taking S IN G U LA IR d aily fo rchro nic
asthm a or allerg ic 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
treatm ent of exercise-induced asthm a.
•
Do not take an additional dose of SIN G U LA IR
w ithin 24 hours of a p revious dose.
For ad ults and children 2 years of age and older
w ith seaso nal allerg ic rh in itis, or for ad ults and
children
6
m onths of age and older w ith perennial
allerg ic rh in itis:
•
Take S IN G U LA IR once a day, at about the sam e
tim e each day.
•
Take S IN G U LA IR every day for as long as your
doctor prescrib es it.
•
You m ay take SIN G U LAIR with food or without food.
How should I give SIN G U LAIR oral granules to m y child?
Do not open the packet until ready to use.
S IN G U LA IR 4-mg oral granules can be given:
•
d irectly in the m outh;
•
dissolved in 1 teaspoonful (5 m L) of cold or room
tem perature baby form ula or breast m ilk;
•
m ixed w ith a spoonful of one of the follow ing soft
foods at cold or room tem perature: applesauce,
m ashed carro ts, rice, or ice cream .
Be sure that the entire dose is m ixed w ith the food,
baby form ula, or breast milk and that the child is
given the entire spoonful of the food, baby form ula, or
breast m ilk m ixture right aw ay (w ithin 15 m inutes).
IM PO RTAN T: N ever store any oral granules m ixed
w ith food, baby fo rm ula, or b reast m ilk for use at a
later tim e. Thro w aw ay any unused portion.
Do not put SIN G U LA IR oral granules in any
liquid drink other than baby form ula or breast
m ilk. How ever, your child m ay drink liquids after
sw allow ing the S IN G U LA IR oral granules.
W hat is the dose of SIN G U LA IR ?
For asth m a—Take once daily in the evening:
•
One 10-mg tablet for adults and adolescents
15 years of age and older,
•
One 5-mg chew able tablet for children
6
to
14 years of age.
•
One 4-mg chew able 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 m onths of age.
For exercise-induced a sth m a -T a k e at least 2 hours
before exercise, but not m ore than once daily:
•
One 10-mg tablet for adults and adolescents
15 years of age and older
•
joint pain, m uscle aches and m uscle cram ps
•
sw elling
B eh avio r and m ood-related ch an g es have been
reported: agitation including ag gressive behavior or
hostility, bad/vivid dream s, depression, feeling anxious,
hallucinations (seeing things that are not there), irritability,
restlessn ess, sleep w alking, suicidal thoughts and
actions (including suicide), trem or, trouble sleeping.
Tell your doctor if you exp erience behavior or mood-
related changes w hile taking S IN G U LA IR .
Rarely, asthm atic patients taking S IN 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
w ere taking steroid pills by mouth for asthm a and
those steroids w ere being slo w ly low ered or stopped.
Although S IN 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 SIN G U LA IR.
For m ore inform ation ask your doctor or pharm acist.
Talk to your doctor if you think you have side effects
from taking S IN 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 S IN G U LA IR for a condition for w hich it
w as not prescribed. Do not give S IN 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 S IN G U LA IR and all
m ed icin eso u t of the reach of children.
Store SIN G U LA IR at 25‘C (77’ F). Protect from m oisture
and light. Store in original package.
T h is leaflet sum m arizes inform ation about
S IN G U LA IR . If you w ould like m ore inform ation, talk
to your doctor. You can ask your pharm acist or doctor
for inform ation about S IN G U LA IR that is w ritten for
health pro fessionals.
W hat are the ingred ients in SIN G U LA IR ?
For allerg ic rh in itis—Take once d aily at about the
sam e tim e each day:
•
One 10-mg tablet for adults and adolescents
15 years of age and older,
•
One 5-mg 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-mg 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 w ith
perennial allergic rhinitis.
W hat should I avoid w h ile taking SIN G U LA IR ?
If you have asthm a and if your asthm a is m ade
w o rse by asp irin, continue to avoid aspirin or other
m edicines called non-steroidal anti-inflam m atory
drugs w hile taking S IN G U LA IR .
W hat are the po ssible side effe cts of SIN G U LA IR ?
The side effects of S IN 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 w ith
SIN G U LA IR w ere sim ilar in type and frequency to side
effects in patients w ho w ere given a placebo (a pill
containing no m edicine).
The m ost com m on side effects w ith SIN G U LA IR
include:
•
stom ach pain
•
stom ach or intestinal upset
•
heartburn
•
tiredness
•
fever
•
stu ffy nose
•
cough
•
flu
•
upper resp irato ry infection
•
dizziness
•
headache
•
rash
Le ss com m on side effects that have happened with
S IN G U LA IR include:
•
increased bleeding tendency
•
allergic reactions (including swelling of the face, lips,
tongue, and/or throat (w hich m ay cause trouble
breathing or sw allow ing), h ives and itching)
•
d ro w sin ess, pins and needles/num bness,
seizu res (co nvulsio ns or fits)
•
palpitations
•
nose bleed
•
diarrhea, indigestion, inflam m ation of the
pancreas, nausea, vom iting
•
hepatitis
•
bruising
A ctive ingredient: m ontelukast sodium
S IN G U LA IR chew ab le tab lets contain asp artam e,
a source of phenylalanine.
Phenylketonurics: SIN G U LA IR 4-mg and 5-mg
chew able tablets contain 0.674 and 0.842 mg
phenylalanine, respectively.
Inactive ingredients:
•
4-m g oral g ranules: m annitol, hydroxypropyl
cellulo se, and m agnesium stearate.
•
4-m fl and.5-m g chew able tab lets: m annitol,
m icro crystalline cellulose, hydroxypropyl
cellulo se, red ferric oxide, croscarm ellose
sodium , cherry flavor, aspartam e, and
m agnesium stearate.
•
10
-mg tab let: m icro crystalline cellulo se, lactose
monohydrate, croscarmellose sodium, hydroxypropyl
cellulo se, m agnesium stearate, hydroxypropyl
m ethylcellulose, titanium dioxide, red ferric
oxide, yello w ferric oxide, and carnauba w ax.
W hat is asthm a?
A sthm a is a continuing (chronic) inflam m ation of the
bronchial p assag ew ays w hich are the tubes that carry
air from outside the body to the lungs.
Sym ptom s of asthm a include:
•
coughing
•
w heezing
•
chest tightness
•
sh o rtn ess of breath
W hat is exercise-induced asthm a?
Exercise-induced asthm a, m ore accurately called
exercise-induced bronchoconstriction occurs w hen
exercise triggers sym ptom s of asthm a.
W hat is allerg ic rhinitis?
•
Seasonal allerg ic rhinitis, also know n a s 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 allerg ens such as
dust m ites, anim al dander, and/or mold spores.
•
Sym p tom s of allergic rhinitis m ay include:
•
stu ffy, runny, and/or itchy nose
•
sneezing
Rx only
U S Patent No.: 5,565,473
Issued August 2009
Distributed by:
M ERCK & CO ., INC.
W hitehouse Station, N J 08889, U SA
21051270(2)(415)-SNG
