MONTELUKAST 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:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.   tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients  of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with   reserve use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium tablets are 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. • Hypersensitivity to any component of this product. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) based on AUCs [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. Data Human Data Published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. Animal Data In embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the AUC in humans at the MRHDOD, respectively). Risk Summary A published clinical lactation study reports the presence of montelukast in human milk. Data available on the effects of the drug on infants, either directly [see Use in Specific Populations (8.4)]  or through breast milk, do not suggest a significant risk of adverse events from exposure to montelukast sodium. The effects of the drug on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for montelukast sodium and any potential adverse effects on the breastfed infant from montelukast sodium or from the underlying maternal condition. The safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. Of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults. The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required. No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency [see Clinical Pharmacology ( 12.3)]. No dosage adjustment is recommended in patients with renal insufficiency [see Clinical Pharmacology (12.3)].

Product summary:

Montelukast sodium tablets, USP 10 mg are beige, rounded square-shaped, film-coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-8075-0 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- MONTELUKAST TABLET, FILM COATED
Cardinal Health 107, LLC
----------
MEDICATION GUIDE
Montelukast Sodium Tablets, USP
(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 do 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 adolescents ages 15
years 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 nose. Montelukast sodium tablets are used to

Summary of Product characteristics

MONTELUKAST- MONTELUKAST TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
----------
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 (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 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).
DOSAGE AND ADMINISTRATION
Administration (by indications):
• Asthma