MONTELUKAST SODIUM tablet, film coated 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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 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. - Hypersensitivity to any component of this product. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data] . In animal r

Product summary:

Montelukast Sodium Tablets USP are available as: 10 mg (montelukast) – beige, standard convex round, unscored, film-coated tablets, debossed with “TV” on one side of the tablet and “7426” on the other side, in bottles of 30 (NDC 0093-7426-56), 90 (NDC 0093-7426-98), and 1000 (NDC 0093-7426-10). Montelukast Sodium Chewable Tablets USP are available as: 4 mg (montelukast) – mottled pink, arc triangle-shaped, unscored tablets, debossed with “TV” on one side of the tablet and “7424”on the other side, in bottles of 30 (NDC 0093-7424-56) and 90 (NDC 0093-7424-98). 5 mg (montelukast) – mottled pink, square-shaped, unscored tablets, debossed with “TV” on one side of the tablet and “7425” on the other side, in bottles of 30 (NDC 0093-7425-56) and 90 (NDC 0093-7425-98). Storage Store 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 When product container is subdivided, repackage into a well-closed, light-resistant container. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Montelukast Sodium (mon” te loo’ kast soe’ dee um)
Tablets and Chewable 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 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
•
hallucinations (seeing or hearing things that are not really there)
•
irritability
•
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 n

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS AND
MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS.
MONTELUKAST SODIUM TABLETS AND 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, 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 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 inadequa