SINGULAIR ORAL GRANULES 4 mgsachet

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MONTELUKAST SODIUM 4.160MG EQV MONTELUKAST

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

R03DC03

Dosage:

4 mg/packet

Pharmaceutical form:

GRANULE

Composition:

MONTELUKAST SODIUM 4.160MG EQV MONTELUKAST 4 mg/packet

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Patheon Manufacturing Services LLC

Authorization status:

ACTIVE

Authorization date:

2003-11-07

Patient Information leaflet

SG-MK0476-MF-042014

PRODUCT CIRCULAR 

Tablets/Chewable Tablets/Oral Granules 
SINGULAIR® 
(montelukast sodium, MSD) 

I.  THERAPEUTIC CLASS 

SINGULAIR  (montelukast  sodium)  is  a  selective  and  orally  active  leukotriene  receptor  antagonist  that 
specifically inhibits the cysteinyl leukotriene CysLT
1
 receptor. 

II.  INDICATIONS 

SINGULAIR  is  indicated  in  adult  and  pediatric  patients  1  year  of  age  and  older  for  the  prophylaxis  and 
chronic  treatment  of  asthma,  including  the  prevention  of  day-  and  nighttime  symptoms,  the  treatment  of 
aspirin-sensitive asthmatic patients, and the prevention of
exercise-induced bronchoconstriction. 

SINGULAIR  is  indicated  for  the  relief  of  daytime  and  nighttime  symptoms  of  allergic  rhinitis  (seasonal 
allergic  rhinitis  in  adults  and  pediatric  patients  2  years  of  age  and  older,  and  perennial  allergic  rhinitis  in 
adults and pediatric patients 1 year of age and older). 

III.  DOSAGE AND ADMINISTRATION 

SINGULAIR should be taken once daily.  For asthma, the dose should be taken in the evening.  For allergic 
rhinitis, the time of administration may be individualized to suit
patient needs. 

Patients with both asthma and allergic rhinitis should take only one
tablet daily in the evening. 

Adults 15 Years of Age and Older with Asthma and/or Allergic
rhinitis 
The dosage for adults 15 years of age and older is one 10-mg tablet
daily. 

Pediatric Patients 6 to 14 Years of Age with Asthma and/or Allergic
rhinitis  
The dosage for pediatric patients 6 to 14 years of age is one 5-mg
chewable tablet daily. 

Pediatric Patients 2 to 5 Years of Age with Asthma and/or Allergic
rhinitis 
The dosage for pediatric patients 2 to 5 years of age is one 4-mg chewable ta

Summary of Product characteristics

SG-MK0476-MF-052019
PRODUCT CIRCULAR
Tablets/Chewable Tablets/Oral Granules
SINGULAIR®
(montelukast sodium)
I. THERAPEUTIC CLASS
SINGULAIR (montelukast sodium) is a selective and orally active
leukotriene receptor
antagonist that specifically inhibits the cysteinyl leukotriene CysLT
1
receptor.
II. INDICATIONS
SINGULAIR is indicated in adult and pediatric patients 1 year of age
and older for the
prophylaxis and chronic treatment of asthma, including the prevention
of day- and
nighttime
symptoms,
the
treatment
of
aspirin-sensitive
asthmatic
patients,
and
the
prevention of exercise-induced bronchoconstriction.
SINGULAIR is indicated for the relief of daytime and nighttime
symptoms of allergic rhinitis
(seasonal allergic rhinitis in adults and pediatric patients 2 years
of age and older, and
perennial allergic rhinitis in adults and pediatric patients 1 year of
age and older).
Because
the benefits of SINGULAIR may not outweigh the risk of
neuropsychiatric symptoms in
patients with allergic rhinitis, reserve use for patients who have an
inadequate response or
intolerance to alternative therapies.
III. DOSAGE AND ADMINISTRATION
SINGULAIR should be taken once daily. For asthma, the dose should be
taken in the
evening. For allergic rhinitis, the time of administration may be
individualized to suit
patient needs.
Patients with both asthma and allergic rhinitis should take only one
tablet daily in the
evening.
Adults 15 Years of Age and Older with Asthma and/or Allergic rhinitis
The dosage for adults 15 years of age and older is one 10-mg tablet
daily.
Pediatric Patients 6 to 14 Years of Age with Asthma and/or Allergic
rhinitis
The dosage for pediatric patients 6 to 14 years of age is one 5-mg
chewable tablet daily.
Pediatric Patients 2 to 5 Years of Age with Asthma and/or Allergic
rhinitis
The dosage for pediatric patients 2 to 5 years of age is one 4-mg
chewable tablet daily or
one packet of 4-mg oral granules daily.
Pediatric Patients 1 to 2 Years of Age with Asthma
The dosage for pediatric patients 1 to 2 years of ag