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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 4 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 12 months 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 6 months 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  co

Product summary:

 Montelukast sodium chewable tablets, 4 mg, are pink colored, oval biconvex shaped, uncoated tablets, debossed with '1079' on one side and '4 MG' on other side. They are supplied as follows: Bottles of 21                               NDC 43063-381-21 Bottles of 30                               NDC 43063-381-30 Storage Store montelukast sodium 4-mg chewable tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 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

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
PD-Rx Pharmaceuticals, Inc.
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Medication Guide
Montelukast Sodium (MON-te-LOO-kast SO-dee-um) Tablets USP and
Montelukast Sodium (MON-te-LOO-kast SO-dee-um) Chewable Tablets USP
Montelukast Sodium (MON-te-LOO-kast SO-dee-um) Oral Granules USP
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
•
reslessness
•
sleep walking
•
stuttering
•
suicidal thoughts and acions (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 12 months
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,

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
PD-RX PHARMACEUTICALS, 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 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
CAREFIVERS (
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 OUT 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 12 months 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 6 months 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 indications):
Asthma: Once daily in the evening for patients 12