MONTELUKAST SODIUM tablet MONTELUKAST SODIUM tablet, chewable

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Hikma Pharmaceuticals USA Inc.

INN (Международно Name):

MONTELUKAST SODIUM

Композиция:

MONTELUKAST 10 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Montelukast sodium tablets and 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 tablets and montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium tablets and 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 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 and montelukast sodium chewable tablets are not indicated for the treatment of an acute asthma attack. Ris

Каталог на резюме:

Montelukast Sodium Tablets, USP The 10 mg (base) tablets are supplied as light tan, round, biconvex film-coated tablets; with product identification “54” over “157” on one side and plain on the other side. NDC 0054-0259-13: Bottle of 30 Tablets NDC 0054-0259-22: Bottle of 90 Tablets Montelukast Sodium Chewable Tablets, USP The 4 mg (base) tablets are supplied as pink, speckled, oval, biconvex tablets with product identification “54” over “144” on one side and plain on the other side. NDC 0054-0288-13: Bottle of 30 Tablets The 5 mg (base) tablets are supplied as pink, speckled, round, biconvex tablets with product identification “54” over “741” on one side and plain on the other side. NDC 0054-0289-13: Bottle of 30 Tablets NDC 0054-0289-22: Bottle of 90 Tablets Storage Store Montelukast Sodium Tablets, USP and Montelukast Sodium Chewable Tablets, USP at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Store in original package.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Montelukast Sodium Tablets, USP
and
Montelukast Sodium Chewable Tablets, USP
(mon” te loo’ kast soe’ dee um)
Rx only
What is the most important information I should know about Montelukast
Sodium Tablets and
Montelukast Sodium Chewable Tablets?
Serious mental health problems have happened in people taking
Montelukast Sodium Tablets or
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 Tablets or
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 sleeping
•
uncontrolled muscle
movements
What is Montelukast Sodium Tablets and Montelukast Sodium Chewable
Tablets?
Montelukast Sodium Tablets and 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 Tablets and Montelukast
Sodium Chewable Tablets do not contain a steroid.
Montelukast Sodium Tablets and 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 Tablets or Montelukast
Sodium Chewable
Tablets if you need relief right aw

Данни за продукта

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM
TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM TABLETS AND MONTELUKAST
SODIUM CHEWABLE
TABLETS.
MONTELUKAST SODIUM TABLETS, FOR ORAL USE
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
RECENT MAJOR CHANGES
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 is a leukotriene receptor antagonist indicated for:
•
•
•
•
DOSAGE AND ADMINISTRATION
Administration (by indications):
•
•
•
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).
Boxed Warning
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