MONTELUKAST SODIUM tablet, film coated 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:

Unichem Pharmaceuticals (USA), Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium  is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. Montelukast sodium  is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium  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 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 is not indicated for the treatment of an acute asthma attack.. Montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. Risk Summary Available data from published prospective and retrospective cohort studies over decades

Product summary:

Montelukast sodium tablets USP, 10 mg are pale yellow coloured, round shaped, film coated tablets with 'U' debossed on one side and '220' on other side. Bottles of 30 (NDC# 29300-220-13) Bottles of 90 (NDC# 29300-220-19) Bottles of 100 (NDC# 29300-220-01) Bottles of 1000 (NDC# 29300-220-10) Montelukast sodium chewable tablets USP, 5 mg are light yellow coloured, round shaped biconvex tablets, debossed with '222' on one side and 'U' on other side. Bottles of 30 (NDC# 29300-222-13) Bottles of 90 (NDC# 29300-222-19) Bottles of 1000 (NDC# 29300-222-10) Montelukast sodium chewable tablets USP, 4 mg are light yellow coloured, round shaped biconvex tablets, debossed with '221' on one side and 'U' on other side. Bottles of 30 (NDC# 29300-221-13) Bottles of 90 (NDC# 29300-221-19) Bottles of 1000 (NDC# 29300-221-10) Storage Store montelukast sodium chewable tablets and 10-mg film-coated tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1000 montelukast sodium chewable tablets and 10-mg film coated tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
Unichem Pharmaceuticals (USA), Inc.
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MEDICATION GUIDE
MONTELUKAST SODIUM TABLETS USP
MONTELUKAST SODIUM CHEWABLE TABLETS USP
(mon te loo' kas t s oe' dee um)
What is the most important information I should know about montelukast
sodium?
Serious mental health problems have happened in people taking
montelukast sodium or even after
treatment has stopped. This can happen in people with or without a
history of mental health
problems. Stop taking montelukast sodium 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?
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 does not contain a
steroid.
Montelukast sodium 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 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 as sneezing,
stuffy nose, runny nose,
and itching of the nose. Montelukast sodium is used to treat the
follow

Summary of Product characteristics

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, FILM COATED
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
UNICHEM PHARMACEUTICALS (USA), INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM.
MONTELUKAST SODIUM TABLETS, FOR ORAL USE
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 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 ADMINI