MONTELUKAST SODIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Montelukast sodium tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium 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 tablets are not indicated for the treatment of an acute asthma attack.

Product summary:

Montelukast sodium tablets, USP 10 mg are beige colored, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on other side. They are supplied as follows: NDC 43063-762-30 bottles of 30 Storage Store montelukast sodium tablets, USP 10 mg film-coated 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

PD-Rx Pharmaceuticals, Inc.
----------
DISPENSE WITH MEDICATION GUIDE AVAILABLE AT
WWW.ACCORDHEALTHCARE.US/MEDICATION-GUIDES
MEDICATION GUIDE
MONTELUKAST SODIUM TABLETS
(MON TE LOO′ KAST SOE′ DEE UM)
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 does 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 15 years
of age 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 15 years of age and older.
3.
Help control the symptoms of allergic rhinitis such as sneezing,
stuffy nose, runny nose, and
itching of the no

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM
TABLETS.
MONTELUKAST SODIUM 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 TABLETS ( 5.1).
DISCUSS BENEFITS AND RISKS OF MONTELUKAST SODIUM TABLETS WITH PATIENTS
AND
CAREGIVERS ( 5.1).
MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING MONTELUKAST
SODIUM
TABLETS ( 5.1).
DISCONTINUE MONTELUKAST SODIUM TABLETS IMMEDIATELY IF NEUROPSYCHIATRIC
SYMPTOMS
OCCUR ( 5.1).
BECAUSE THE BENEFITS OF MONTELUKAST SODIUM 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
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)
02/2021
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist
indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of
age and older ( 1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in
patients 15 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic
rhinitis (SAR) in patients 15 years of age
and older, and perennial allergic rhinitis (PAR) in patients 15 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 acute asthma attack ( 5.2).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma: Once dai