MONTELUKAST SODIUM tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)

Available from:

Slate Run Pharmaceuticals, LLC.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 2 to 14 years of age. Montelukast sodium chewable tablets indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 to 14 years of age. Montelukast sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 to 14 years of age and perennial allergic rhinitis in patients 2 to 14 years of age . Because the benefits of Montelukast sodium chewable tablet 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 tablets are not indicated for the treatment of an acute asthma attack. - Montelukast Sodium Chewable Tablets are contraindicated in patients with hypersensitivity to any of its components. Risk Summary Available data from pu

Product summary:

Montelukast Sodium 4 mg Chewable Tablets are pink, square-shaped tablets, debossed with “4” on one side and plain on the other. They are supplied as follows: Bottles of 90: NDC 70436-090-06 Montelukast Sodium 5 mg Chewable Tablets are pink, capsule-shaped tablets, debossed with “5” on one side and plain on the other. They are supplied as follows: Bottles of 90: NDC 70436-091-06 Storage Store montelukast sodium 4 mg chewable tablets and 5 mg chewable tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Slate Run Pharmaceuticals, LLC.
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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 are Montelukast Sodium Chewable Tablets?
Montelukast Sodium Chewable Tablets are 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 Tablets does not
contain a steroid.
Montelukast sodium chewable tablets are used to:
1.
Prevent asthma attacks and for the long-term treatment of asthma in
children ages 2 to 14 years.
Do not take montelukast sodium chewables tablets 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 to 14 years of age.
3.
Help control the symptoms of allergic rhinitis such as sneezing,
stuffy nose, runny nose, itching
of the nose. Montelukast sodium chewable ta

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
SLATE RUN PHARMACEUTICALS, LLC.
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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 tablets are leukotriene receptor
antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 to 14 years
of age( 1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in
patients 6 to 14 years of age( 1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic
rhinitis (SAR) in patients 2 to 14 years of
age, and perennial allergic rhinitis (PAR) in patients2 to 14 years of
age. 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 indications):
Asthma : Once daily in the evening f