MONTELUKAST SODIUM tablet, chewable MONTELUKAST SODIUM tablet MONTELUKAST SODIUM granule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent Pharmaceuticals 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 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  cohort  studies  over

Product summary:

 Montelukast sodium oral granules USP 4 mg are white to off white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: NDC 13668-531-11unit packet NDC 13668-531-94 carton with 30 packets. For Montelukast sodium film-coated tablets 10 mg The tablets are available as follow:  Montelukast sodium tablets USP, 10 mg, are light brown colored, round, biconvex film coated tablets debossed with "1081" on one side and "10 MG" on other side. They are supplied as follows: Bottles of 30                               NDC 13668-081-30 Bottles of 90                               NDC 13668-081-90 Bottles of 500                             NDC 13668-081-05 Bottles of 3,200                           NDC 13668-081-32 For Montelukast sodium chewable tablets 4 mg and 5 mg The tablets are available as follow:  Montelukast sodium chewable tablets USP, 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 30                               NDC 13668-079-30 Bottles of 90                               NDC 13668-079-90 Bottles of 500                             NDC 13668-079-05 Montelukast sodium chewable tablets USP, 5 mg, are pink colored, round shaped, uncoated tablets, debossed with '1080' on one side and '5 MG' on other side. They are supplied as follows: Bottles of 30                               NDC 13668-080-30 Bottles of 90                               NDC 13668-080-90 Bottles of 500                             NDC 13668-080-05 Storage Store montelukast sodium 4-mg oral granules, montelukast sodium 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated 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
MONTELUKAST SODIUM- MONTELUKAST SODIUM GRANULE
Torrent Pharmaceuticals Limited
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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
• 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 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 allergi

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET
MONTELUKAST SODIUM- MONTELUKAST SODIUM GRANULE
TORRENT PHARMACEUTICALS LIMITED
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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 AND MONTELUKAST
SODIUM ORAL
GRANULES
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 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: