HIGHLIGHTS OF PRESCRIBING INFORMATION

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Method Pharmaceuticals, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 6 years of age and older. Montelukast sodium tablets 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 15 years of age and older. Because the benefits of montelukast sodium tablets 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 tablets are not indicated for the treatment of an acute asthma attack. Montelukast sodium tablets are contraindicated in patients with hypersensitivity to any of its components. Ri

Produkt oppsummering:

Montelukast Sodium Tablets USP, 10 mg are yellow round tablets, with "225" debossed on one side and plain on the other side. NDC 58657-717-30 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 58657-717-90 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant Storage Store 10 mg film-coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Method Pharmaceuticals, LLC
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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
•
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 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 does 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 age 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 treat the
following in people who have

Preparatomtale

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET
METHOD PHARMACEUTICALS, LLC
----------
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 TABLETS ( 5.1).
DISCUSS BENEFITS AND RISKS OF MONTELUKAST SODIUM TABLETS WITH PATIENTS
AND
CAREGIVERS ( 5.1).
MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING MONTELUKAST
SODIUM
TABLETS ( 5.1).
DISCONTINUE MONTELUKAST SODIUM TABLETS IMMEDIATELY IF NEUROPSYCHIATRIC
SYMPTOMS
OCCUR ( 5.1).
BECAUSE THE BENEFITS OF MONTELUKAST SODIUM TABLETS 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, 2.2, 2.3, 2.4) 02/2021
Warnings and Precautions ( 5.1) 02/2021
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 6 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).
Limitations of Use:
Not indicated to treat an acute asthma attack ( 5.2).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma: On