SINGULAIR 4 mg TABLET

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

Organon South Africa (Pty) Ltd

Dosis:

See ingredients

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg

Estado de Autorización:

Registered

Fecha de autorización:

2005-01-04

Información para el usuario

SINGULAIR 4 MG
APPROVED PIL
_JT 20101130 _
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_Resp to CCR dated 05 October 2010 _
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FINAL TYPED PATIENT INFORMATION LEAFLET
INFORMATION FOR THE PATIENT
ABOUT SINGULAIR
® (MONTELUKAST, MSD)
_READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING _
SINGULAIR
_ _
•
_Keep this leaflet. You may need to read it again. _
•
_If you have further questions, please ask your doctor or your
pharmacist. _
•
_This medicine has been prescribed for you personally and you should
not share your _
_medicine with other people. It may harm them, even if their symptoms
are the same as_
_ _
_yours._
_ _
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
SINGULAIR
®
4 mg Chewable Tablets
(4 mg montelukast)
WHAT SINGULAIR CONTAINS
SINGULAIR (montelukast sodium, MSD) contains montelukast sodium as the
active ingredient.
It is available as:
•
a 4 mg chewable tablet for children 2 to 5 years old.
Each 4 mg chewable tablet contains 4 mg of montelukast.
In addition, SINGULAIR contains the following inactive ingredients:
SINGULAIR 4 mg contains: Artificial Cherry Flavour, Aspartame,
Croscarmellose Sodium,
Hydroxypropylcellulose, Magnesium Stearate, Mannitol, Microcrystalline
Cellulose, Red Ferric Oxide.
SINGULAIR 4 mg Chewable Tablet is sugar free.

Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ, USA.
COPYRIGHT

2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ, USA
. All rights
reserved
.
SINGULAIR 4 MG
APPROVED PIL
_JT 20101130 _
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_Resp to CCR dated 05 October 2010 _
_Page 2 of 7 _
WHAT SINGULAIR IS USED FOR
SINGULAIR is use for treatment of asthma
WHY HAS MY DOCTOR PRESCRIBED SINGULAIR?
Your doctor has prescribed SINGULAIR to treat:
- Your child’s asthma, including preventing asthma symptoms
HOW DOES SINGULAIR TREAT ASTHMA?
SINGULAIR blocks substances in your child’s lungs called
leukotrienes that cause narrowing and
inflammation of airways
WHY IS COMPLIANCE (GIVING YOUR CHI

Ficha técnica

SINGULAIR 4 MG
APPROVED PACKAGE INSERT
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
SINGULAIR
®
4 mg Chewable Tablets
COMPOSITION
SINGULAIR 4 mg: Each 4 mg chewable tablet contains montelukast sodium
equal to the molar equivalent
of 4,0 mg of free acid.
SINGULAIR 4 mg chewable tablet is sugar free
PHARMACOLOGICAL CLASSIFICATION
A.10.2.2 Other anti-asthmatics
Leukotriene receptor antagonist
PHARMACOLOGICAL ACTION
MECHANISM OF ACTION
The cysteinyl leukotrienes (LTC
4
, LTD
4
, LTE
4
), are potent inflammatory eicosanoids released from various
cells including mast cells and eosinophils. These important
pro-asthmatic mediators bind to cysteinyl
leukotriene receptors (CysLT) found in the human airway and cause a
number of airway actions, including
bronchoconstriction, mucous secretion, vascular permeability, and
eosinophil recruitment.
Montelukast binds with high affinity and selectivity to the CysLT
1
receptor (in preference to other
pharmacologically important airway receptors such as the prostanoid,
cholinergic, or beta-adrenergic
receptor). Montelukast inhibits physiological actions of LTC
4
, LTD
4
, and LTE
4
at the CysLT
1
receptor
without agonist activity.
®

Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ, USA.
COPYRIGHT

2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ, USA
. All rights
reserved
.
_JT 20101130 _
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_Resp to CCR dated 05 October 2010 _
_Page 1 of 8 _
SINGULAIR 4 MG
APPROVED PACKAGE INSERT
PHARMACOKINETICS
Absorption
Montelukast is absorbed following oral administration.
For the 4 mg chewable tablet, C
max
is achieved 2 hours after administration in paediatric patients 2 to
5 years of age in the fasted state.
Safety and efficacy were demonstrated in clinical studies where the 4
mg chewable tablet was
administered without regard to the timing of food ingestion.
Distribution
Montelukast is more than 99 % bound to plasma proteins. Studies in
rats