MONTELUKAST 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:

Major Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric 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.   tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients  of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with   reserve use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium tablets are 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

Product summary:

Montelukast sodium tablets, USP 10 mg are beige, rounded square-shaped, film-coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows: Carton of 50 tablets (10 tablets each blister pack x 5), NDC 0904-6808-06 Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6808-61 Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Refer to package label for Distributor's NDC Number Storage Store 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-resistance container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MONTELUKAST- montelukast tablet, film coated
Major Pharmaceuticals
----------
MEDICATION GUIDE
Montelukast Sodium Tablets, USP
(mon" te loo' kast soe' dee um)
What is the most important information I should know about montelukast
sodium tablets?
Serious mental health problems have happened in people taking
montelukast sodium tablets 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 adolescents ages 15 years
and older.
Do not take montelukast sodium tablets 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 tablets are used to tre

Summary of Product characteristics

MONTELUKAST- MONTELUKAST TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
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 (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, Allergic Rhinitis (1.3) 04/2020
Dosage and Administration, Asthma (2.1),
Allergic Rhinitis (2.3), Asthma and Allergic Rhinitis (2.4) 04/2020
Warnings and Precautions, Neuropsychiatric Events (5.1) 04/2020
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).
DOSAGE AND ADMINISTRATION
Administration (by indications):
• Asthma (2.