MONTELUKAST tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Macleods Pharmaceuticals Limited

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older. Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets 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 10 mg are beige colour, rounded square shaped, biconvex, film-coated tablet debossed with 'CL 26' on one side and plain on the other side. They are supplied as follows: Storage Store montelukast sodium 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.   Storage for Bulk Bottles Store bottles of 500 montelukast sodium 10-mg filmcoated 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 container. When product container is subdivided, repackage into a well-closed, light-resistant container. Preserve in tight containers, protected from light. Store at controlled room temperature.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MONTELUKAST - MONTELUKAST TABLET
Macleods Pharmaceuticals Limited
----------
MEDICATION GUIDE
Medication Guide
Montelukast sodium (MON-te-LOO-kast SOE-dee-um)Tablets
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 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 tablets?
•Montelukast sodium 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 tablets do not contain a
steroid.
Montelukast sodium tablets are used to:
1. Prevent asthma attacks and for the long-term treatment of asthma in
adults and children ages 15 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 15 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 people

Summary of Product characteristics

MONTELUKAST - MONTELUKAST TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM
TABLETS.
MONTELUKAST SODIUM 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 TABLETS. (5.1).
• DISCUSS BENEFITS AND RISKS OF MONTELUKAST SODIUM TABLETS WITH
PATIENTS AND
CAREGIVERS (5.1).
• MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING
MONTELUKAST SODIUM
TABLETS (5.1).
• DISCONTINUE MONTELUKAST SODIUM TABLETS IMMEDIATELY IF
NEUROPSYCHIATRIC SYMPTOMS
OCCUR (5.1).
• BECAUSE THE BENEFITS OF MONTELUKAST SODIUM TABLETS 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 tablets are a leukotriene receptor antagonist
indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of
age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in
patients 15 years of age and older
(1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic
rhinitis (SAR) in patients 15 years of age
and older, and perennial allergic rhinitis (PAR) in patients 15 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
Administration (by indications):
Ast