MONTELUKAST SODIUM- montelukast sodium tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MONTELUKAST (UNII: MHM278SD3E) (MONTELUKAST - UNII:MHM278SD3E)

Available from:

Camber Pharmaceuticals, Inc.

INN (International Name):

MONTELUKAST

Composition:

MONTELUKAST 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 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 , use for patients who have an inadequate response or intolerance to alternative therapies. 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 ben

Product summary:

Montelukast Sodium Chewable Tablets 4 mg are light pink to pink colored, speckled, oval, biconvex shaped, chewable tablets debossed with 'I' on one side and '112' on the other side.  They are supplied as follows: Bottles of 30 tablets                                                     NDC 31722-727-30 Bottles of 90 tablets                                                     NDC 31722-727-90  Bottles of 100 tablets                                                   NDC 31722-727-01 Bottles of 1000 tablets                                                 NDC 31722-727-10 Blister card of 10 Unit-dose tablets                              NDC 31722-727-31 Blister pack of 100 (10 x 10) Unit-dose tablets            NDC 31722-727-32 Montelukast Sodium Chewable Tablets 5 mg are light pink to pink colored, speckled, round, biconvex shaped, chewable tablets debossed with 'I' on one side and '113' on the other side. Bottles of 30 tablets                                                     NDC 31722-728-30 Bottles of 90 tablets                                                     NDC 31722-728-90 Bottles of 100 tablets                                                   NDC 31722-728-01 Bottles of 1000 tablets                                                 NDC 31722-728-10 Blister card of 10 Unit-dose tablets                              NDC 31722-728-31 Blister pack of 100 (10 x 10) Unit-dose tablets            NDC 31722-728-32 . Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light-resistance container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MONTELUKAST SODIUM - montelukast sodium tablet, chewable
Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
Montelukast Sodium Chewable Tablets
(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
• 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 muscle movements sleeping
• uncontrolled
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 do 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,

Summary of Product characteristics

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 ( 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).
RECENT MAJOR CHANGES
Boxed Warning 04/2020
Indications and Usage, Allergic Rhinitis ( 1.3) 04/2020
Dosage and Administration, Asthma ( 2.1),
Allergic Rhinitis (2.3), Asthma and Allergic Rhinitis ( 2.4) 04/2020
Warnings and Precautions, Neuropsychiatric Events ( 5.1) 04/2020
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 alt