SINGULAIR

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

MONTELUKAST SODIUM

Available from:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (International Name):

MONTELUKAST SODIUM

Dosage:

4.16 MG

Pharmaceutical form:

TABLET KUNYAH

Units in package:

DUS, 4 BLISTER @ 7 TABLET KUNYAH

Manufactured by:

MERCK SHARP & DOHME LTD. - United Kingdom

Authorization date:

2021-07-17

Summary of Product characteristics

SINGULAIR
TM
(MONTELUKAST SODIUM)
4-MG CHEWABLE TABLET
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 chewable tablet is indicated in pediatric 2-5 years of age
for the prophylaxis and chronic
treatment of asthma, including the prevention of exercise-induced
bronchoconstriction.
III. DOSAGE AND ADMINISTRATION
ASTHMA
Singulair should be taken once daily in the evening (one-4 mg chewable
tablet)
EXERCISE-INDUCED BRONCHOCONTRICTION (EIB)
For prevention of EIB, a single dose (one-4mg chewable tablet) of
SINGULAIR should be taken at least 2
hours before exercise.
An additional dose of SINGULAIR should not be taken within 24 hours of
previous dose. Patients already
taking SINGULAIR daily for another indication (including chronic
asthma) should not take an additional
dose to prevent EIB. All patients should have available for rescue a
short-acting β-agonist.
IV. CONTRAINDICATIONS

Hypersensitivity to any component of this product
V. PRECAUTIONS
The efficacy of oral SINGULAIR for the treatment of acute asthma
attacks has not been established.
Therefore, oral SINGULAIR should not be used to treat acute asthma
attacks. Patients should be advised
to have appropriate rescue medication available.
While
the
dose
of
concomitant
inhaled
corticosteroid
may
be
reduced
gradually
under
medical
supervision, SINGULAIR should not be abruptly substituted for inhaled
or oral corticosteroids.
DISETUJUI OLEH BPOM : 08/12/2021
ID : EREG100373VR12100389
Neuropsychiatric events have been reported in patients taking
SINGULAIR (see SIDE EFFECTS). Since other
factors may have contributed to these events, it is not known if they
are related to SINGULAIR. Physicians
should discuss these adverse experiences with their patients and/or
caregivers. Patients and/or caregivers
should be instructed to notify their physician if these changes occur.
In rare cases patients receiving anti-a