MONTELUKAST SODIUM granule MONTELUKAST SODIUM tablet, chewable MONTELUKAST SODIUM- montelukast tablet, chewable MONTELUKAST S

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ajanta Pharma USA Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium tablets, chewable tablets and 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 tablets and chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium tablets, chewable tablets and 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 tablets, chewable tablets and oral granules 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, chewable tablets and oral granules are not indicated for the treatment of an acute asth

Product summary:

Montelukast Sodium Oral Granules, USP 4 mg: white granules with 500 mg net weight, packed in a child-resistant foil sachet. NDC 27241-015-31 unit of use carton with 30 sachets. Montelukast Sodium Chewable Tablets, USP 4 mg: pink colored, slightly mottled, circular, biconvex, uncoated tablets, with code 'MT1' engraved on one side and plain on the other side. NDC 27241-016-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-016-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. Montelukast Sodium Chewable Tablets, USP 5 mg: pink colored, slightly mottled, circular, biconvex, uncoated tablets, with code 'MT2' engraved on one side and plain on the other side. NDC 27241-017-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-017-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. Montelukast Sodium Tablets, USP 10 mg: beige colored, circular, biconvex, film-coated tablets with code 'MO1' engraved on one side and plain on the other side. NDC 27241-018-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-018-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-018-90 high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous threaded cap, an aluminum foil induction seal, and silica gel canister. 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°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:

Abbreviated New Drug Application

Patient Information leaflet

MONTELUKAST SODIUM - montelukast sodium tablet, chewable
MONTELUKAST SODIUM - montelukast sodium tablet, coated
Ajanta Pharma USA Inc.
----------
MEDICATION GUIDE
Montelukast Sodium (mon te loo' kast soe' dee um)
Tablets Chewable
Tablets Oral Granules
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. Montelukast sodiu

Summary of Product characteristics

MONTELUKAST SODIUM - MONTELUKAST SODIUM GRANULE
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, COATED
AJANTA PHARMA USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM
TABLETS, CHEWABLE TABLETS AND ORAL GRANULES SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM TABLETS, CHEWABLE
TABLETS AND ORAL
GRANULES.
MONTELUKAST SODIUM TABLETS, FOR ORAL USE
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
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
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 S 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 (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, chewable tablets, and oral granules are 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