HIGHLIGHTS OF PRESCRIBING INFORMATION

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

montelukast sodium (UNII: U1O3J18SFL) (montelukast - UNII:MHM278SD3E)

Dostępny od:

Prasco Laboratories

INN (International Nazwa):

montelukast sodium

Skład:

montelukast 4 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years 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 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

Podsumowanie produktu:

Montelukast Sodium Oral Granules, 4 mg, are white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: NDC 66993-416-30 unit of use carton with 30 packets. Storage Store Montelukast Sodium 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Status autoryzacji:

New Drug Application Authorized Generic

Ulotka dla pacjenta

Prasco Laboratories
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MEDICATION GUIDE
MONTELUKAST SODIUM TABLETS1 CHEWABLE TABLETS1 ORAL GRANULES
1 Tablets and Chewable Tablets marketed as SINGULAIR®
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 04/2020
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 12
months 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. Monteluk

Charakterystyka produktu

MONTELUKAST SODIUM- MONTELUKAST SODIUM GRANULE
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM.
MONTELUKAST SODIUM TABLETS, FOR ORAL USE
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
MONTELUKAST SODIUM ORAL GRANULES
TABLETS AND CHEWABLE TABLETS MARKETED AS SINGULAIR
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 12 months 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 6 months of age and
older. Reserve use for patients who have an inadequate
response or intolerance to alternative therapies (1.3)