MONTELUKAST SODIUM granule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Aurobindo Pharma Limited

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Montelukast sodium oral granules are indicated for the prophylaxis and chronic treatment of asthma in 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 established a drug-

Termék összefoglaló:

Montelukast Sodium Oral Granules USP, 4 mg are white to off white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: Unit of use carton with 30 packets                     NDC 59651-329-30 Storage Store montelukast sodium  4 mg oral granules USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Montelukast Sodium Oral Granules, USP
(mon te loo' kast soe' dee um)
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
•
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
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 does not contain a
steroid.
Montelukast
sodium
oral
granules
are
used
to:
1. Prevent asthma attacks and for the long-term treatment of asthma in
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.
3. 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 taken other medicines

Termékjellemzők

MONTELUKAST SODIUM - MONTELUKAST SODIUM GRANULE
AUROBINDO PHARMA LIMITED
----------
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
Boxed Warning 04/2020
Indications and Usage (1.3, 1.4) 02/2021
Dosage and Administration (2.1, 2.3, 2.4) 02/2021
Warnings and Precautions (5.1) 02/2021
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 alle