MONTELUKAST SODIUM tablet, 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:

Dr.Reddy's Laboratories Limited

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. 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 decades with

Product summary:

Montelukast sodium tablets USP, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10).  Bottles of 30                                       NDC 55111-725-30 Bottles of 90                                       NDC 55111-725-90 Bottles of 100                                     NDC 55111-725-01 Bottles of 1000                                  NDC 55111-725-10 Unit Dosage Package of 100 (10x10) NDC 55111-725-78  Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                       NDC 55111-593-30 Bottles of 90                                       NDC 55111-593-90 Bottles of 500                                    NDC 55111-593-05 Unit Dosage Package of 100 (10x10) NDC 55111-593-78  Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                       NDC 55111-594-30 Bottles of 90                                       NDC 55111-594-90 Bottles of 500                                    NDC 55111-594-05 Unit Dosage Package of 100 (10x10) NDC 55111-594-78 Storage Store montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°C to 25°C (68°F to 77° 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, COATED
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
Dr.Reddy's Laboratories Limited
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Medication Guide
Montelukast Sodium (mon te loo' kast soe’ dee um)
Tablets USP, 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
• 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 sod

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, COATED
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
DR.REDDY'S LABORATORIES LIMITED
----------
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, 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).
INDICATIONS AND USAGE
Montelukast sodium tablets are 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
Administration (by indications):
Asthma :