MONTELUKAST SODIUM tablet, chewable MONTELUKAST SODIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

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 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

Product summary:

Montelukast Sodium Tablets USP: Montelukast Sodium Tablets USP, 10 mg are beige, rounded square shaped, film-coated tablets debossed with ‘X’ on one side and ‘54’ on other side.         Bottles of 30                                                        NDC 65862-574-30         Bottles of 90                                                        NDC 65862-574-90         Bottles of 10,000                                                 NDC 65862-574-19         Cartons of 100 (10 x 10) Unit-dose Tablets         NDC 65862-574-10 Montelukast Sodium Chewable Tablets USP: Montelukast Sodium Chewable Tablets USP, 4 mg are pink colored, oval, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘52’ on other side. The tablets may be mottled.         Bottles of 30                                                       NDC 65862-567-30         Bottles of 90                                                       NDC 65862-567-90         Bottles of 500                                                     NDC 65862-567-05 Montelukast Sodium Chewable Tablets USP, 5 mg are pink colored, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘53’ on other side. The tablets may be mottled.         Bottles of 30                                                       NDC 65862-568-30         Bottles of 90                                                       NDC 65862-568-90         Bottles of 500                                                     NDC 65862-568-05 Storage Store montelukast 4 mg chewable tablets, 5 mg chewable tablets and montelukast 10 mg film-coated tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 10,000 montelukast 10 mg film-coated tablets and 500 montelukast 4 mg, 5 mg chewable tablets at 20° to 25°C (68° to 77°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, FILM COATED
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Montelukast Sodium Tablets USP
and
Montelukast Sodium Chewable Tablets USP
(mon te loo' kast soe' 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 following
in

Summary of Product characteristics

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
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 ADMINISTRATION