MONTELUKAST tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Legacy Pharmaceutical Packaging, LLC

INN (Jina la Kimataifa):

MONTELUKAST SODIUM

Tungo:

MONTELUKAST 10 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent 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 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 the indicated population is unknow. 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 8 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)].

Bidhaa muhtasari:

Montelukast sodium (equivalent to 10 mg montelukast) tablets 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:          Unit of Use Bottles of 30                                   NDC 68645-560-54 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

MONTELUKAST- MONTELUKAST TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
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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
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 tablet is 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 ( 1.3). Reserve use for
patients
who have an inadequate response or intolerance to alternative
therapies (1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
• Asthma ( 2.1): Once daily in the evening for patients 15 years of
age and older.
• Acute prevention of EIB ( 2.2): One tablet at least 2 hours before
exercise for patients 15 years of age
and older.
• Seasonal allergic rhinitis ( 2.3): Once daily for patients 15
years of age and older.
• Perennial allergic rhinitis ( 2.3): Once daily for patients 15
years of age and older.
Dosage (by age) ( 2):
• 15 years and older: one 10 mg tablet.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening ( 2.4).
DOSAGE FORMS AND STRENGTHS
• Tablets: 10 mg (3) (3)
CONTRAINDICATIONS
•Hypersensitivity to any component of this product ( 4).
WARNINGS AND PRECAUTIONS
•Do not pres