Montelukast 10 mg Tablets — Generic For Singulair — Unichem

These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM.

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.

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 (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:

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 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 daily in the evening for patients 2 years and older (2.1).

Acute prevention of EIB : One tablet at least 2 hours before exercise for patients 6 years of age and older (2.2).

Seasonal allergic rhinitis: Once daily for patients 2 years and older (2.3).

Perennial allergic rhinitis: Once daily for patients 2 years and older (2.3).

Dosage (by age):

15 years and older: one 10-mg tablet (2).

6 to 14 years: one 5-mg chewable tablet (2).

2 to 5 years: one 4-mg chewable tablet (2).

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (2.4).

Dosage Forms And Strengths

Montelukast sodium tablets USP, 10 mg (3)

Montelukast sodium chewable tablets USP, 5 mg and 4 mg (3)

Contraindications

Hypersensitivity to any component of montelukast sodium (4).

Warnings And Precautions

• (5.1, 5.6) 02/2021 INDICATIONS AND USAGE Montelukast sodium is 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 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 daily in the evening for patients 2 years and older (2.1).
• Acute prevention of EIB : One tablet at least 2 hours before exercise for patients 6 years of age and older (2.2).
• Seasonal allergic rhinitis: Once daily for patients 2 years and older (2.3).

• (5.1, 5.6) 02/2021 INDICATIONS AND USAGE Montelukast sodium is 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 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 daily in the evening for patients 2 years and older (2.1).
• Acute prevention of EIB : One tablet at least 2 hours before exercise for patients 6 years of age and older (2.2).
• Seasonal allergic rhinitis: Once daily for patients 2 years and older (2.3).

Do not prescribe montelukast sodium to treat an acute asthma attack (5.2).

Advise patients to have appropriate rescue medication available (5.2).

Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute montelukast sodium for inhaled or oral corticosteroids (5.3).

Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium (5.4).

Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events have been sometimes associated with the reduction of oral corticosteroid therapy (5.5 and 6.2).

Inform patients with phenylketonuria that the 4-mg and 5-mg chewable tablets contain phenylalanine (5.6).

Adverse Reactions

Most common adverse reactions (incidence ≥5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA), Inc., at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 6/2023