Montelukast Sodium — Membership Pricing

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What Montelukast Sodium is approved for (FDA label)

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 ).

Source: Read the full FDA label on DailyMed. Label effective date: July 28, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Montelukast Sodium (FDA label)

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood [see Warnings and Precautions ( 5.1 )]. Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage ( 1.3 )]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium. Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately [see Warnings and Precautions ( 5.1 )]. WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS See full prescribing information for complete boxed warning.

Source: FDA prescribing information (DailyMed). Set ID: 1eeb3123-9e93-4681-8096-800a7c7acf8a. SPL document ID: 92c7019c-7aba-4a08-ab99-2acb438d7a44. Label effective date: July 28, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Montelukast Sodium (FDA label)

• Montelukast sodium tablets USP, 10 mg are pale yellow coloured, round shaped, film coated tablets, 'U' debossed on one side and '220' on other side. • Montelukast sodium chewable tablets USP, 5 mg are light yellow coloured, round shaped biconvex tablets, debossed with '222' on one side and 'U' on other side. • Montelukast sodium chewable tablets USP, 4 mg are light yellow coloured, round shaped biconvex tablets, debossed with '221' on one side and 'U' on other side. • Montelukast sodium tablets USP, 10 mg ( 3 ) • Montelukast sodium chewable tablets USP, 5 mg and 4 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 1eeb3123-9e93-4681-8096-800a7c7acf8a. SPL document ID: 92c7019c-7aba-4a08-ab99-2acb438d7a44. Label effective date: July 28, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Montelukast Sodium (FDA label)

The following clinically significant adverse reactions are described elsewhere in the labeling: • Neuropsychiatric Events [see Warnings and Precautions ( 5.1 )] 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 ).

Source: FDA prescribing information (DailyMed). Set ID: 1eeb3123-9e93-4681-8096-800a7c7acf8a. SPL document ID: 92c7019c-7aba-4a08-ab99-2acb438d7a44. Label effective date: July 28, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Montelukast Sodium (FDA label)

Montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. • Hypersensitivity to any component of montelukast sodium ( 4 ).

Source: FDA prescribing information (DailyMed). Set ID: 1eeb3123-9e93-4681-8096-800a7c7acf8a. SPL document ID: 92c7019c-7aba-4a08-ab99-2acb438d7a44. Label effective date: July 28, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Montelukast Sodium (FDA label)

• 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 ). 5.1 Neuropsychiatric Events Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium.

Source: FDA prescribing information (DailyMed). Set ID: 1eeb3123-9e93-4681-8096-800a7c7acf8a. SPL document ID: 92c7019c-7aba-4a08-ab99-2acb438d7a44. Label effective date: July 28, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Montelukast Sodium (FDA label)

No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology ( 12.3 )].

Source: FDA prescribing information (DailyMed). Set ID: 1eeb3123-9e93-4681-8096-800a7c7acf8a. SPL document ID: 92c7019c-7aba-4a08-ab99-2acb438d7a44. Label effective date: July 28, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.