MONTELUKAST SODIUM tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MONTELUKAST (UNII: MHM278SD3E) (MONTELUKAST - UNII:MHM278SD3E)

Available from:

Macleods Pharmaceuticals Limited

INN (International Name):

MONTELUKAST

Composition:

MONTELUKAST 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium chewable tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. Montelukast sodium chewable tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium chewable tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium chewable tablet is not indicated for the treatment of an acute asthma attack. Montelukast Sodium Chewable Tablets is contraindicated in patients with hypersensitivity to any of its components. Risk Su

Product summary:

Montelukast sodium chewable tablets USP, 4 mg, are pink colour, oval, biconvex-shaped uncoated chewable mottled tablet, debossed with CL55 on one side and plain on the other side. They are supplied as follows: Bottle of 30: NDC 33342-110-07 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 90: NDC 33342-110-10 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 500: NDC 33342-110-15 unit dose of high-density polyethylene (HDPE) bottles of 500 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Bottle of 1000: NDC 33342-110-44 unit dose of high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Unit dose Blister packs of 100: NDC 33342-110-12 Unit dose Blister packs of 90: NDC 33342-110-39. Montelukast sodium chewable tablets USP, 5 mg, are pink colour, mottled, round, biconvex-shaped uncoated chewable mottle tablet, debossed with CL 56 on one side and plain on the other side. They are supplied as follows: Bottle of 30: NDC 33342-111-07 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 90: NDC 33342-111-10 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 500: NDC 33342-111-15 unit dose of high-density polyethylene (HDPE) bottles of 500 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Bottle of 1000: NDC 33342-111-44 unit dose of high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Unit dose Blister packs of 100: NDC 33342-111-12 Unit dose Blister packs of 90: NDC 3342-111-39.   Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in tight containers, protected from light. Store at controlled room temperature. Store in original package.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Macleods Pharmaceuticals Limited
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MEDICATION GUIDE
Dispense the Medication Guide available at www.macleodspharma.com/usa
Medication Guide
Montelukast Sodium (mon te loo′ kast soe′ dee um)
Chewable Tablets
What is the most important information I should know about montelukast
sodium chewable tablets?
Serious mental health problems have happened in people taking
montelukast sodium chewable tablets or
even after treatment has stopped.
This can happen in people with or without a history of mental health
problems. Stop taking montelukast
sodium chewable tablets and tell your healthcare provider right away
if you or your child have any
unusual changes in behavior or thinking, including any of these
symptoms:
•
agitation, including aggressive behavior or hostility
•
attention problems
•
bad or vivid dreams
•
depression
•
disorientation (confusion)
•
feeling anxious
•
irritability
•
hallucinations (seeing or hearing things that are not really there)
•
memory problems
•
obsessive-compulsive symptoms
•
restlessness
•
sleep walking
•
stuttering
•
suicidal thoughts and actions (including suicide)
•
tremor
•
trouble sleeping
•
uncontrolled muscle movements
What is montelukast sodium chewable tablets?
Montelukast sodium is a prescription medicine that blocks substances
in the body called leukotrienes.
This may help to improve symptoms of asthma and inflammation of the
lining of the nose (allergic
rhinitis). Montelukast sodium chewable tablet does not contain a
steroid.
Montelukast sodium chewable tablet is used to:
1.
Prevent asthma attacks and for the long-term treatment of asthma in
adults and children ages 2
years and older.
Do not take montelukast sodium chewable tablet if you need relief
right away for a sudden asthma
attack. If you have
an asthma attack, you should follow the instructions your healthcare
provider gave you for treating
asthma attacks.
2.
Prevent exercise-induced asthma in people 6 years of age and older.
3.
Help control the symptoms of allergic rhinitis such

Summary of Product characteristics

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
MACLEODS PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM
CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MONTELUKAST SODIUM CHEWABLE TABLETS.
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL 1998
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
_SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING
MONTELUKAST_
_SODIUM (5.1)._
_DISCUSS BENEFITS AND RISKS OF MONTELUKAST SODIUM WITH PATIENTS AND
CAREGIVERS (5.1)._
_MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING MONTELUKAST
SODIUM (5.1)._
_DISCONTINUE MONTELUKAST SODIUM IMMEDIATELY IF NEUROPSYCHIATRIC
SYMPTOMS OCCUR_
_(5.1)._
_BECAUSE THE BENEFITS OF MONTELUKAST SODIUM MAY NOT OUTWEIGH THE
POTENTIAL RISK OF_
_NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS WITH ALLERGIC RHINITIS, RESERVE
USE FOR PATIENTS_
_WHO HAVE AN INADEQUATE RESPONSE OR INTOLERANCE TO ALTERNATIVE
THERAPIES(1.3, 5.1)._
RECENT MAJOR CHANGES
Boxed Warning 04/2020
Indications and Usage (1.3, 1.4) 02/2021
Dosage and Administration (2.1,2.2, 2.3, 2.4) 02/2021
Warnings and Precautions (5.1, 5.6) 02/2021
INDICATIONS AND USAGE
Montelukast sodium chewable tablet is a leukotriene receptor
antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age
and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in
patients 6 years of age and older
(1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic
rhinitis (SAR) in patients 2 years of age and
older, and perennial allergic rhinitis (PAR) in patients 2 years of
age and older. Reserve use for patients
who have an inadequate response or intolerance to alternative
therapies (1.3).
Limitations of Use:
Not indicated to treat an acute asthma attack (5.2).
DOSAGE AND ADMINISTRATION
Administration (by indicati