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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium oral granules are 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 oral granules 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 oral granules are not indicated for the treatment of an acute asthma attack. Montelukast sodium oral granules are contraindicated in patients with hypersensitivity to any of its components. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not establishe

Product summary:

Montelukast sodium oral granules USP, 4 mg (montelukast) are white to slightly yellow granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: 4 mg – unit of use carton with 30 packets (NDC 0093-7487-56). 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Montelukast (mon′′ te loo′ kast soe′ dee um) Sodium
Oral Granules
What is the most important information I should know about montelukast
sodium oral granules?
Serious mental health problems have happened in people taking
montelukast sodium oral granules or even after treatment has stopped.
This can happen in
people with or without a history of mental health problems. Stop
taking montelukast sodium oral granules 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
•
hallucinations (seeing or
hearing things that are
not really there)
•
suicidal thoughts and actions (including suicide)
•
attention problems
•
memory problems
•
tremor
•
bad or vivid dreams
•
obsessive-compulsive
symptoms
•
trouble sleeping
•
depression
•
restlessness
•
uncontrolled muscle movements
•
disorientation (confusion)
•
sleep walking
•
feeling anxious
•
stuttering
•
irritability
What are montelukast sodium oral granules?
Montelukast sodium oral granules 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 oral granules do not contain a steroid.
Montelukast sodium oral granules are 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 oral granules 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. Help control the symptoms of allergic rhinitis such as sneezing,
stuffy nose, runny nose, and itching of the nose. Montelukast sodium
oral granules are
used to treat the following in people who have already ta

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM GRANULE
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
ORAL GRANULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MONTELUKAST
SODIUM ORAL GRANULES.
MONTELUKAST SODIUM ORAL GRANULES, 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
Indications and Usage (1.3, 1.4)
2/2021
Dosage and Administration (2.1, 2.3, 2.4) 2/2021
Warnings and Precautions (5.1)
2/2021
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).
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:
Not indicated to treat an acute asthma attack (5.2).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma: Once daily in the evening for patients 12 months and older
(2.1).
Seasonal allergic rhinitis: Once daily for patients 2 years and older
(2.3).
Perennial allergic rhinitis: Once