Montelukast Sodium

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Administration (by indications):
• Asthma:
• Once daily in the evening for patients 15 years and older ( 2.1 ).
• Acute prevention of EIB:
• 10 mg tablet at least 2 hours before exercise for patients 15 years of age and older ( 2.2 ).
• Seasonal allergic rhinitis: Once daily for patients 15 years and older ( 2.3 ).
• Perennial allergic rhinitis : Once daily for patients 15 years and older ( 2.3 ).
• Dosage (by age): 15 years and older: one 10-mg tablet ( 2 ).
• Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ( 2.4 ).
• 2.1 Asthma For asthma, administer montelukast sodium tablets 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 Adult and adolescent patients 15 years of age and older one 10 mg tablet Patients who miss a dose should take the next dose at their regular time and should not
• take 2 doses at the same time.
• 2.2 Exercise-Induced Bronchoconstriction (EIB) For prevention of EIB, administer a single dose of montelukast sodium tablets orally at least 2 hours, before exercise.
• The following doses are recommended:
• Table 2:
• Recommended Dosage in Exercise-Induced Bronchoconstriction (EIB) Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet An additional dose of montelukast sodium tablets should not be taken within 24 hours of a previous dose.
• Patients already taking montelukast sodium tablets daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB.
• All patients should have available for rescue a short-acting β-agonist.
• Daily administration of montelukast sodium tablets for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
• 2.3 Allergic Rhinitis For allergic rhinitis, administer montelukast sodium tablets orally once daily without regard to time of food ingestion.
• Time of administration in patients with allergic rhinitis can be individualized to suit patient needs.
• The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:
• Table 3:
• Recommended Dosage in Seasonal Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
• Table 4:
• Recommended Dosage in Perennial Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Patients who miss a dose should take the next dose at their regular time and should not
• take 2 doses at the same time.
• 2.4 Asthma and Allergic Rhinitis For patients with both asthma and allergic rhinitis, administer only one montelukast sodium tablets dose orally once daily in the evening.
• Patients who miss a dose should take the next dose at their regular time and should not
• take 2 doses at the same time.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 Accord Healthcare Inc, at 1-866-941-7875 or www.accordhealthcare.us 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 respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.
• Adults and Adolescents 15 Years of Age and Older with Asthma Montelukast sodium has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials.
• In placebo-controlled clinical trials, the following adverse reactions reported with montelukast sodium occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo:
• Table 5:
• Adverse Reactions Occurring in ≥ 1% of Patients with an Incidence Greater than that in Patients Treated with Placebo Montelukast 10 mg/day (%) (n=1955) Placebo (%) (n=1180) Body As A Whole Pain, abdominal Asthenia/fatigue Fever Trauma 2.9 1.8 1.5 1.0 2.5 1.2 0.9
• 0.8 Digestive System Disorders Dyspepsia Pain, dental Gastroenteritis, infectious 2.1 1.7 1.5 1.1 1.0
• 0.5 Nervous System/Psychiatric Headache Dizziness 18.4 1.9 18.1
• 1.4 Respiratory System Disorders Influenza Cough Congestion, nasal 4.2 2.7 1.6 3.9 2.4
• 1.3 Skin/Skin Appendages Disorder Rash 1.6
• 1.2 Laboratory Adverse Reactions Number of patients tested (montelukast sodium and placebo, respectively):
• ALT and AST, 1935, 1170; pyuria, 1924, 1159.
• ALT increased AST increased Pyuria 2.1 1.6 1.0 2.0 1.2
• 0.9 The frequency of less common adverse reactions was comparable between montelukast sodium and placebo.
• The safety profile of montelukast sodium, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for montelukast sodium.
• Cumulatively, 569 patients were treated with montelukast sodium for at least 6 months, 480 for one year, and 49 for two years in clinical trials.
• With prolonged treatment, the adverse reaction profile did not significantly change.
• Adults and Adolescents 15 Years of Age and Older with Seasonal Allergic Rhinitis Montelukast sodium has been evaluated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials.
• Montelukast sodium administered once daily in the morning or in the evening had a safety profile similar to that of placebo.
• In placebo-controlled clinical trials, the following reaction was reported with montelukast sodium with a frequency ≥1% and at an incidence greater than placebo:
• upper respiratory infection, 1.9% of patients receiving montelukast sodium vs. 1.5% of patients receiving placebo.
• In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies.
• The incidence of somnolence was similar to that of placebo in all studies.
• Adults and Adolescents 15 Years of Age and Older with Perennial Allergic Rhinitis Montelukast sodium has been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received montelukast sodium in two, 6-week, clinical studies.
• Montelukast sodium administered once daily had a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo.
• In these two studies, the following reactions were reported with montelukast sodium with a frequency ≥1% and at an incidence greater than placebo:
• sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT.
• The incidence of somnolence was similar to that of placebo.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of montelukast sodium.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Blood and lymphatic system disorders increased bleeding tendency, thrombocytopenia.
• Immune system disorders hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
• Psychiatric disorders including, but not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tic, and tremor [see Boxed Warning , Warnings and Precautions (5.1) ] Nervous system disorders drowsiness, paraesthesia/hypoesthesia, seizures Cardiac disorders palpitations Respiratory, thoracic and mediastinal disorders epistaxis, pulmonary eosinophilia Gastrointestinal disorders diarrhea, dyspepsia, nausea, pancreatitis, vomiting Hepatobiliary disorders Cases of cholestatic hepatitis, hepatocellular liver-injury, and mixed-pattern liver injury have been reported in patients treated with montelukast sodium.
• Most of these occurred in combination with other confounding factors, such as use of other medications, or when montelukast sodium was administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis Skin and subcutaneous tissue disorders angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria Musculoskeletal and connective tissue disorders arthralgia, myalgia including muscle cramps Renal and urinary disorders enuresis in children General disorders and administration site conditions edema Patients with asthma on therapy with montelukast sodium may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
• These reactions have been sometimes associated with the reduction of oral corticosteroid therapy.
• Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients [see Warnings and Precautions (5.5) ] .

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).
• Advise patients about the potential risk for serious neuropsychiatric symptoms and behavioral changes with montelukast sodium tablets use [see Warnings and Precautions (5.1) ] .
• Discuss the benefits and risks of montelukast sodium tablets with patients when prescribing or continuing treatment with montelukast sodium tablets [see Warnings and Precautions (5.1) ] .
• Advise patients to monitor for changes in behavior or neuropsychiatric symptoms in patients taking montelukast sodium tablets [see Warnings and Precautions (5.1) ] .
• Instruct patients to discontinue montelukast sodium tablets and contact a healthcare provider immediately if changes in behavior or thinking that are not typical for the patient occur, or if the patient develops suicidal ideation or suicidal behavior [see Warnings and Precautions (5.1) ] .
• Advise patients to take montelukast sodium tablets daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physicians if their asthma is not well controlled.
• Advise patients that oral montelukast sodium tablets is not for the treatment of acute asthma attacks.
• They should have appropriate short-acting inhaled β-agonist medication available to treat asthma exacerbations.
• Patients who have exacerbations of asthma after exercise should be instructed to have available for rescue a short-acting inhaled β-agonist.
• Daily administration of montelukast sodium tablets for the chronic treatment of asthma has not been established to prevent acute episodes of EIB [see Warnings and Precautions (5.2) ] .
• Advise patients to seek medical attention if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hour period are needed.
• Instruct patients to continue other anti-asthma medications as prescribed unless instructed by a physician.
• Instruct patients with known aspirin sensitivity to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium tablets [see Warnings and Precautions (5.4) ] .
• Manufactured For :
• Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA.
• Manufactured By:
• Intas Pharmaceuticals Limited, Ahmedabad -380 054, India. 10 1653 7 6011991 Issued October 2021

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Montelukast sodium tablets, USP 10 mg are beige coloured, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on the other side. Tablets:
• 10 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Montelukast sodium tablets, USP 10 mg are beige colored, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on other side.
• They are supplied as follows:
• NDC 43063-762-30 bottles of 30 Storage Store montelukast sodium tablets, USP 10 mg film-coated at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Protect from moisture and light.
• Store in original package.

Quoted from the official label, section “How Supplied”.

What is in it

• Montelukast sodium, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor.
• Montelukast sodium is described chemically as [ R -( E )]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt.
• The empirical formula is C 35 H 35 ClNNaO 3 S, and its molecular weight is 608.18.
• The structural formula is:
• Montelukast sodium is a hygroscopic, optically active, white to off-white powder.
• Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.
• Each 10-mg film-coated montelukast sodium tablet, USP contains 10.4 mg montelukast sodium, USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients:
• microcelac 100, croscarmellose sodium, low substituted hydroxypropyl cellulose, and magnesium stearate.
• The film coating consists of hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide red and iron oxide yellow. image of chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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