SINGULAIR- montelukast sodium granule SINGULAIR- montelukast sodium tablet, chewable SINGULAIR- montelukast sodium tablet, fil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

montelukast sodium

Composition:

montelukast 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. SINGULAIR 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 6 months of age and older. Because the benefits of SINGULAIR 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. SINGULAIR is not indicated for the treatment of an acute asthma attack. SINGULAIR is 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 estab

Product summary:

SINGULAIR 4 mg Oral Granules: white granules with 500 mg net weight, packed in a child-resistant foil packet. NDC 0006-3841-30 unit of use carton with 30 packets. SINGULAIR 4 mg Tablets: pink, oval, bi-convex-shaped chewable tablets, with code MSD 711 on one side and SINGULAIR on the other. NDC 0006-1711-31 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. SINGULAIR 5 mg Tablets: pink, round, bi-convex-shaped chewable tablets, with code MSD 275 on one side and SINGULAIR on the other. NDC 0006-9275-31 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. SINGULAIR 10 mg Tablets: beige, rounded square-shaped, film-coated tablets, with code MSD 117 on one side and SINGULAIR on the other. NDC 0006-9117-31 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 0006-9117-54 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 SINGULAIR 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°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Authorization status:

New Drug Application

Patient Information leaflet

SINGULAIR- MONTELUKAST SODIUM TABLET, CHEWABLE
SINGULAIR- MONTELUKAST SODIUM TABLET, FILM COATED
Merck Sharp & Dohme Corp.
----------
MEDICATION GUIDE
SINGULAIR® (SING-U-LAIR)
(MONTELUKAST SODIUM) TABLETS
CHEWABLE TABLETS
ORAL GRANULES
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 SINGULAIR?
Serious mental health problems have happened in people taking
SINGULAIR or even after treatment
has stopped. This can happen in people with or without a history of
mental health problems. Stop
taking SINGULAIR 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 SINGULAIR?
SINGULAIR 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). SINGULAIR does not contain a steroid. SINGULAIR 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 SINGULAIR 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. SINGUL

Summary of Product characteristics

SINGULAIR- MONTELUKAST SODIUM GRANULE
SINGULAIR- MONTELUKAST SODIUM TABLET, CHEWABLE
SINGULAIR- MONTELUKAST SODIUM TABLET, FILM COATED
MERCK SHARP & DOHME CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SINGULAIR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SINGULAIR.
SINGULAIR (MONTELUKAST SODIUM) TABLETS, FOR ORAL USE
SINGULAIR (MONTELUKAST SODIUM) CHEWABLE TABLETS, FOR ORAL USE
SINGULAIR (MONTELUKAST SODIUM) ORAL GRANULES
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
SINGULAIR
(5.1).
DISCUSS BENEFITS AND RISKS OF SINGULAIR WITH PATIENTS AND CAREGIVERS
(5.1).
MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING SINGULAIR
(5.1).
DISCONTINUE SINGULAIR IMMEDIATELY IF NEUROPSYCHIATRIC SYMPTOMS OCCUR
(5.1).
BECAUSE THE BENEFITS OF SINGULAIR 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
SINGULAIR 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).
Limitations of Use:
Not indicated to treat an acute asthma attack (5.2).
DOSAGE