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 chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium chewable 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 2 years of age and older. Because the benefits of montelukast sodium chewable 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 chewable tablets are not indicated for the treatment of an acute asthma attack. Montelukast sodium chewable tablets are contraindicated in patient

Produkt oppsummering:

Montelukast Sodium Chewable Tablets USP, 4 mg are pink oval tablets, debossed with '227' on one side and plain on the other side. NDC 58657-715-30 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 58657-715-90 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 Montelukast Sodium Chewable Tablets USP, 5 mg pink round tablets, debossed with '226' on one side and plain on the other side. NDC 58657-716-30 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 58657-716-90 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 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
----------
MEDICATION GUIDE
Montelukast Sodium Chewable Tablets, USP
(mon te loo′kast soe′dee um)
What is the most important information I should know about montelukast
sodium chewable tablets?
Serious mental health problems have happened in people taking
montelukast sodium chewable 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 chewable 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 chewable tablets?
Montelukast sodium chewable 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 chewable tablets does not
contain a steroid. Montelukast sodium
chewable 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 chewable 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. Mo

Preparatomtale

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
METHOD PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM
CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MONTELUKAST SODIUM CHEWABLE TABLETS.
MONTELUKAST SODIUM CHEWABLE 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 CHEWABLE TABLETS ( 5.1).
DISCUSS BENEFITS AND RISKS OF MONTELUKAST SODIUM CHEWABLE TABLETS WITH
PATIENTS
AND CAREGIVERS ( 5.1).
MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING MONTELUKAST
SODIUM
CHEWABLE TABLETS ( 5.1).
DISCONTINUE MONTELUKAST SODIUM CHEWABLE TABLETS IMMEDIATELY IF
NEUROPSYCHIATRIC
SYMPTOMS OCCUR ( 5.1).
BECAUSE THE BENEFITS OF MONTELUKAST SODIUM CHEWABLE 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, 5.6) 02/2021
INDICATIONS AND USAGE
Montelukast sodium chewable tablets are a leukotriene receptor
antagonist indicated for:
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 response or intolerance to alternative
therapies ( 1.3).
Limitations of Use:
Not indicated to treat an ac