Montiget 4mg Chewable Tablet

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Montelukast (as Sodium)

Available from:

Getz Pharma (Phils.) Inc.; Distributor: Getz Bros. Philippines, Inc.

INN (International Name):

Montelukast (as Sodium)

Dosage:

4mg

Pharmaceutical form:

Chewable Tablet

Units in package:

Alu-Alu Pack of 7's (Box of 14's), Alu/Alu pack x 7's (box of 14's)

Manufactured by:

Getz Pharma Pvt. Ltd., Pakistan

Authorization date:

2021-10-22

Summary of Product characteristics

-
Inhaled Corticosteroids: Treatment with Montelukast sodium (Montiget
)
provides additional clinical benefit to patients treated with inhaled
corticosteroids. A reduction in the corticosteroid dose can be made as
tolerated. The dose should be reduced gradually with medical
supervision. In some patients, the dose of the inhaled corticosteroids
can be tapered off completely. Montelukast sodium (Montiget
) should
not be abruptly substituted for inhaled corticosteroids.
_ADMINISTRATION OF MONTELUKAST SODIUM (MONTIGET_
_) PEDIATRIC GRANULES_
Montelukast sodium (Montiget
) pediatric granules 4mg can be administered
either directly in the mouth, or mixed with a spoonful of cold or room
temperature soft foods. The sachet should not be opened until ready to
use. After opening the sachet, the full dose (with or without food)
must
be adminstered within 15 minutes. If mixed with food, Montelukast
sodium
(Montiget
) pediatric granules must not be stored for future use. Discard
any unused portion. MONTELUKAST SODIUM (Montiget
) PEDIATRI
C GRANULES
ARE NOT INTENDED TO BE DISSOLVED IN LIQUID FOR ADMINISTRATION.
However,
liquids may be taken subsequent to administration.
ADVERSE EFFECTS
Montelukast sodium is generally well tolerated. However, following are
the adverse effects reported which usually were mild and did not
require
discontinuation of therapy.
•
Hypersensitivity reactions (including anaphylaxis, angioedema, rash,
pruritus, urticaria and very rarely, hepatic eosinophillic
infiltration);
•
Dream abnormalities, hallucinations, palpitations, drowsiness,
irritability,
restlessness, insomnia, increased sweating, headache;
•
Nausea, vomiting, dyspepsia, diarrhea, abdominal pain;
•
Myalgia including muscle cramps;
•
Increased bleeding tendency, bruising edema;
•
Tremor, dry mouth, vertigo, arthralgia.
CONTRAINDICATIONS
Montelukast sodium is contraindicated in a patient who has shown
hypersensitivity to the drug or any of its components.
Montelukast sodium is not indicated for use in acute asthma attacks
including