SINGULAIR

Χώρα: Ινδονησία

Γλώσσα: Ινδονησιακά

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

Δραστική ουσία:

MONTELUKAST SODIUM

Διαθέσιμο από:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Διεθνής Όνομα):

MONTELUKAST SODIUM

Δοσολογία:

10.4 MG

Φαρμακοτεχνική μορφή:

TABLET SALUT SELAPUT

Μονάδες σε πακέτο:

DRUM, MAKSIMUM @ 55 KG

Κατασκευάζεται από:

MERCK SHARP & DOHME LTD. - United Kingdom

Ημερομηνία της άδειας:

2021-08-05

Αρχείο Π.Χ.Π.

SINGULAIR
TM
(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 adults 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-10 mg tablet)
EXERCISE-INDUCED BRONCHOCONTRICTION (EIB)
For prevention of EIB, a single dose (one-10mg 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.
DISETUJUI OLEH BPOM : 29/11/2021
ID : EREG100373VR12100387
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.
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-asthma agents, including
leukotriene receptor antagonists,
have exper