MONTELUKAST tablet, film coated MONTELUKAST tablet, chewable

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Sandoz Inc

INN (Nome Internazionale):

MONTELUKAST SODIUM

Composizione:

MONTELUKAST 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 w

Dettagli prodotto:

Montelukast sodium tablets, 10 mg are beige colored, round, biconvex, film coated tablets with "SZ 344" debossed on one side and plain on other side. They are available as follows: Montelukast sodium chewable tablets, 4 mg are pink colored, round, mottled, and debossed with “SZ 74” on one side and plain on the other side. They are available as follows: Montelukast sodium chewable tablets, 5 mg are pink colored, round, mottled, and debossed with “SZ 76” on one side and plain on other side. They are available as follows: Storage Store 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. Storage for Bulk Bottles Store 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. When product container is subdivided, repackage into a well-closed, light-resistant container.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

UKAST- MONTELUKAST TABLET, FILM COATED
MONTELUKAST- MONTELUKAST TABLET, CHEWABLE
Sandoz Inc
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MEDICATION GUIDE
Montelukast Sodium Tablets
(mon-tell-OO-kast)
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
•
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 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 do 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 children ages 2 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 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
sodium tablets are used to t

Scheda tecnica

MONTELUKAST- MONTELUKAST TABLET, FILM COATED
MONTELUKAST- MONTELUKAST TABLET, CHEWABLE
SANDOZ INC
----------
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 AND MONTELUKAST SODIUM CHEWABLE TABLETS,
FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
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, 5.6)
02/2021
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist
indicated for:
•
•
•
Limitations of Use
Not indicated to treat an acute asthma attack (5.2)
DOSAGE AND ADMINISTRATION
Administration (by indications):
•
•
•
•
Dosage (by age) (2):
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).
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