Drugplain

SINGULAIR 4 mg/1

montelukast sodium · TABLET, CHEWABLE · Organon LLC

No Recall HistoryCurrently in Shortage
Plain English

SINGULAIR is a tablet, chewable containing montelukast sodium at 4 mg/1, taken oral. Manufactured by Organon LLC.

Key Facts

Brand Name
SINGULAIR
Generic Name
montelukast sodium
NDC Code (Product)
78206-170
Manufacturer
Organon LLC
Strength
4 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
NDA020830
Marketing Start
06/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

asthma14,723 reports
dyspnoea14,579 reports
drug ineffective9,023 reports
cough8,887 reports
fatigue8,563 reports
headache8,090 reports
wheezing7,546 reports
pneumonia6,836 reports
nausea6,699 reports
pain6,432 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months 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 ). 1.1 Asthma SINGULAIR ® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 Allergic Rhinitis SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Because th…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administration (by indications): Asthma: Once daily in the evening for patients 12 months 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 6 months 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 or one packet of 4-mg oral granules ( 2 ). 6 to 23 months: one packet of 4-mg oral granules ( 2 ). Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ( 2.4 ). For oral granules: Must administer within 15 minutes after opening the packet (with or without mixing with food) ( 2.5 ). 2.1 Asthma For asthma, administer SINGULAIR orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The following doses are recommended: Table 1: Recommended Dosage in Asthma Age Dose Adul…

Contraindications

4 CONTRAINDICATIONS SINGULAIR is contraindicated in patients with hypersensitivity to any of its components. Hypersensitivity to any component of SINGULAIR ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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) ].

Adverse Reactions

6 ADVERSE REACTIONS 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 ). To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., Inc., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence ≥5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper re…

Frequently Asked Questions

What is SINGULAIR used for?

SINGULAIR contains montelukast sodium. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is SINGULAIR a controlled substance?

SINGULAIR is not classified as a controlled substance by the DEA.

What is the generic name for SINGULAIR?

The generic name for SINGULAIR is montelukast sodium. There are 11 other brand versions of montelukast sodium.

What is the NDC code for SINGULAIR 4 mg/1?

The NDC (National Drug Code) for SINGULAIR 4 mg/1 is 78206-170, listed by Organon LLC.

Product NDC

78206-170

Package NDC

78206-170-01

Other SINGULAIR Dosages

Other Montelukast Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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