Montelukast

Generic name: montelukast sodium · Brand names: Singulair

Quick facts

Drug class
Montelukast is a leukotriene receptor antagonist.
Section
Highlights, Indications and Usage
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Rx or otc
Rx (label includes a Medication Guide) - source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Controlled schedule
Not controlled (no schedule appears in the label text read)
Forms and strengths
  • Montelukast sodium, USP film-coated tablets, 10 mg. (3)
  • Amneal: beige, round, biconvex tablets, debossed with “A 73” on one side and plain on the other side. (3)
  • MedlinePlus also mentions a chewable tablet and granules (other products, not covered by this record).
Generic available
Value
yes - this record uses the Amneal Pharmaceuticals LLC generic label
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Common use one line
Prevention and long-term treatment of asthma, prevention of exercise-induced bronchoconstriction, and relief of allergic rhinitis symptoms in patients 15 years and older (label Indications).

What it is used for

Montelukast is used in people 15 years and older to prevent and treat long-term asthma, to prevent breathing trouble during exercise, and to relieve seasonal and year-round allergy nose symptoms. For allergic rhinitis it is for people who did not respond to or cannot take other treatments. It is not for an acute asthma attack. It is the generic of Singulair.
Section
1.1 Asthma; 1.2 EIB; 1.3 Allergic Rhinitis; 1.4 Limitations of Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescents 15 years of age and older. [1.1] Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. [1.2] 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. [1.3] Montelukast sodium tablets are not indicated for the treatment of an acute asthma attack. [1.4]

How it works

Montelukast blocks the CysLT1 receptor, which leukotrienes use to cause airway swelling and other effects in asthma and allergic rhinitis.
Section
12.1 Mechanism of Action
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or ß-adrenergic receptor). Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity.

Dosage: adults

Adults and teens 15 and older take one 10 mg tablet. For asthma take it once daily in the evening. To prevent exercise-induced breathing trouble take one dose at least 2 hours before exercise, and do not take another within 24 hours. For allergic rhinitis take it once daily at any time. With both asthma and allergic rhinitis take one dose once daily in the evening.
Section
2.1, 2.2, 2.3, 2.4 (sentences joined; bracketed table values are from Tables 1-4)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
For asthma, administer montelukast sodium tablets orally once daily in the evening, with or without food. [Table 1: Adult and adolescent patients 15 years of age and older: One 10 mg tablet] [2.1] For prevention of EIB, administer a single dose of montelukast sodium tablets orally at least 2 hours, before exercise. [One 10 mg tablet] An additional dose of montelukast sodium tablets should not be taken within 24 hours of a previous dose. [2.2] For allergic rhinitis, administer montelukast sodium tablets orally once daily without regard to time of food ingestion. [One 10 mg tablet] [2.3] For patients with both asthma and allergic rhinitis, administer only one montelukast sodium tablets dose orally once daily in the evening. [2.4]

Dosage: children

This tablet label gives a dose only for ages 15 and older. Chewable tablets and granules for younger children are separate products not covered here.
Section
8.4 Pediatric Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display

Dosage adjustments

Drug interaction caps
No dose change is needed with the drugs listed in the label.
Section
7 DRUG INTERACTIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
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
Kidney
No dose change is recommended for kidney problems.
Section
8.7 Renal Impairment
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
No dosage adjustment is recommended in patients with renal insufficiency [see Clinical Pharmacology (12.3)].
Liver
No dose change is recommended for mild-to-moderate liver problems.
Section
8.6 Hepatic Impairment
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
No dosage adjustment is recommended in patients with mild-to-moderate hepatic insufficiency [see Clinical Pharmacology (12.3)].
Elderly
No dose change is required for older adults.
Section
8.5 Geriatric Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
No dosage adjustment in the elderly is required.

Missed dose

Label
If you miss a dose, take the next dose at your regular time. Do not take 2 doses at the same time.
Section
2.1, 2.3, 2.4
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
Medlineplus
Skip the missed dose and keep your usual schedule. No double doses and no more than one dose in 24 hours.
Source
https://medlineplus.gov/druginfo/meds/a600014.html
Source text (exact source wording)
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than one dose of montelukast in a 24 hour period.

Overdose

Label
There is no specific treatment information. Usual supportive care is used.
Section
10 OVERDOSAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
No specific information is available on the treatment of overdosage with montelukast sodium. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.
Medlineplus
Call poison control at 1-800-222-1222, or 911 if the person has collapsed, had a seizure, has trouble breathing or cannot be awakened. Symptoms can include stomach pain, sleepiness, thirst, headache, vomiting and restlessness.
Source
https://medlineplus.gov/druginfo/meds/a600014.html
Source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Symptoms of overdose may include the following: stomach pain; sleepiness; thirst; headache; vomiting; restlessness or agitation

Storage

Store at 20° to 25°C (68° to 77°F), protected from moisture and light, in the original package. Short trips to 15° to 30°C (59° to 86°F) are permitted. Amneal label detail; other labelers may differ.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING (Storage)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Boxed warning

Montelukast can cause serious mental health events such as agitation, aggression, depression, sleep problems and suicidal thoughts or actions. Watch for behavior changes. If they happen, stop montelukast and contact a healthcare provider right away. For allergic rhinitis it is reserved for people who did not respond to or cannot take other treatments.
Heading
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
Section
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS (paragraphs joined in order)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
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)].

Contraindications

Do not use if you are allergic to any ingredient.
Section
4 CONTRAINDICATIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Montelukast sodium tablets are contraindicated in patients with hypersensitivity to any of its components.

Warnings and precautions

Serious mental and behavior events have been reported, including agitation, hostility, depression, sleep problems, hallucinations, memory problems and suicidal thoughts. They happened in people with and without past mental health problems, mostly during treatment but sometimes after stopping. Symptoms often went away after stopping but sometimes continued.
Heading
5.1 Neuropsychiatric Events
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were 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 thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after montelukast sodium discontinuation. In many cases, symptoms resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium. Therefore, continue to monitor and provide supportive care until symptoms resolve. (Sentences joined from this subsection in original order; omitted sentences are in the label.)
Do not use it to treat an acute asthma attack. Keep rescue medicine available.
Heading
5.2 Acute Asthma
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Montelukast sodium is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available.
Do not suddenly replace inhaled or oral steroids with montelukast.
Heading
5.3 Concomitant Corticosteroid Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montelukast sodium should not be abruptly substituted for inhaled or oral corticosteroids.
If you are aspirin sensitive, keep avoiding aspirin and NSAIDs.
Heading
5.4 Aspirin Sensitivity
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium.
Some people with asthma developed high eosinophil counts, sometimes with blood vessel inflammation (Churg-Strauss syndrome), sometimes when oral steroids were reduced.
Heading
5.5 Eosinophilic Conditions
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
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 events have been sometimes associated with the reduction of oral corticosteroid therapy.

Pregnancy and breastfeeding

Pregnancy
Studies in pregnant women have not established a risk of major birth defects. No developmental harm was seen in pregnant rats and rabbits at about 100 and 110 times the human dose.
Section
8.1 Pregnancy
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
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].
Lactation
Montelukast is present in breast milk. Available data do not suggest a significant risk to the infant.
Section
8.2 Lactation
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
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 reactions from exposure to montelukast sodium.

Side effects

Common
The most common reactions (5% or more and more than placebo) were upper respiratory infection, fever, headache, sore throat (pharyngitis), cough, abdominal pain, diarrhea, ear infection (otitis media), influenza, runny nose, sinusitis and otitis.
Threshold
incidence ≥ 5% and greater than placebo (listed in descending order of frequency)
Section
6.1 Clinical Trials Experience (also Highlights)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Note
This list is copied as the label states it; the label's adult 15+ asthma table (Table 5) only shows reactions at ≥1%, listed below.
Source text (exact source wording)
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.
Less common
In asthma trials, other reactions at 1% or more and above placebo included abdominal pain (2.9% vs 2.5%), dyspepsia (2.1% vs 1.1%), dizziness (1.9% vs 1.4%), cough (2.7% vs 2.4%) and rash (1.6% vs 1.2%). Headache was 18.4% vs 18.1%.
Section
6.1 Table 5 and rhinitis paragraphs
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Table 5 (adults and adolescents 15+ with asthma; montelukast 10 mg/day n=1,955 vs placebo n=1,180, %): Pain, abdominal 2.9 vs 2.5; Asthenia/fatigue 1.8 vs 1.2; Fever 1.5 vs 0.9; Trauma 1.0 vs 0.8; Dyspepsia 2.1 vs 1.1; Pain, dental 1.7 vs 1.0; Gastroenteritis, infectious 1.5 vs 0.5; Headache 18.4 vs 18.1; Dizziness 1.9 vs 1.4; Influenza 4.2 vs 3.9; Cough 2.7 vs 2.4; Congestion, nasal 1.6 vs 1.3; Rash 1.6 vs 1.2; ALT increased 2.1 vs 2.0; AST increased 1.6 vs 1.2; Pyuria 1.0 vs 0.9. Seasonal allergic rhinitis: upper respiratory infection, 1.9% of patients receiving montelukast sodium vs. 1.5% of patients receiving placebo. Perennial allergic rhinitis (frequency ≥ 1% and at an incidence greater than placebo): sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT.
Serious
Label
Serious items include mental health events, allergic reactions including anaphylaxis, seizures, liver injury, pancreatitis, low platelets and severe skin reactions.
Section
6 ADVERSE REACTIONS; 6.2 Postmarketing Experience
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Neuropsychiatric Events [see Warnings and Precautions (5.1)]. Postmarketing: 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. Nervous system disorders: drowsiness, paraesthesia/hypoesthesia, seizures. Cardiac disorders: palpitations. 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. Skin and subcutaneous tissue disorders: angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria.
Medlineplus
MedlinePlus says to call your doctor right away for these symptoms, and for those in its important warning.
Section
What side effects can this medication cause?
Source
https://medlineplus.gov/druginfo/meds/a600014.html
Source text (exact source wording)
difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, or eyes; hoarseness; itching; rash; hives; blistering, peeling, or shedding skin; flu-like symptoms, rash, pins and needles or numbness in the arms or legs, pain and swelling of the sinuses; ear pain, fever (in children)
Led to discontinuation
Section
n/a
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display

Interactions

Drugs
No dose change is needed with these drugs.
Name
Theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, NSAIDs, benzodiazepines, decongestants
Section
7 DRUG INTERACTIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
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
Phenobarbital lowered montelukast levels by about 40%. No dose change is recommended, but monitoring is reasonable.
Name
Phenobarbital, rifampin (CYP inducers)
Section
12.3 Drug Interaction Studies
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Phenobarbital, which induces hepatic metabolism, decreased the area under the plasma concentration curve (AUC) of montelukast approximately 40% following a single 10 mg dose of montelukast. No dosage adjustment for montelukast sodium is recommended. It is reasonable to employ appropriate clinical monitoring when potent CYP enzyme inducers, such as phenobarbital or rifampin, are co-administered with montelukast sodium.
Gemfibrozil raised montelukast exposure 4.4-fold, but no dose change is required.
Name
Gemfibrozil
Section
12.3 Drug Interaction Studies
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
Data from a clinical drug interaction study involving montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) demonstrated that gemfibrozil, at a therapeutic dose, increased the systemic exposure of montelukast by 4.4-fold. ... Based on available clinical experience, no dosage adjustment of montelukast is required upon co-administration with gemfibrozil
Food and alcohol
A standard morning meal did not change absorption.
Name
Food
Section
12.3 Absorption
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Source text (exact source wording)
The oral bioavailability and Cmax are not influenced by a standard meal in the morning.

Patient tips

Medlineplus
Take once a day with or without food. For asthma take in the evening. For exercise use take at least 2 hours before. Do not use it for a sudden attack. Keep avoiding aspirin and NSAIDs if aspirin makes your asthma worse. Keep taking it even if you feel well. Call your doctor right away and stop it if you notice mood or behavior changes.
Section
How should this medicine be used? / IMPORTANT WARNING
Source
https://medlineplus.gov/druginfo/meds/a600014.html
Source text (exact source wording)
Montelukast is usually taken once a day with or without food. When montelukast is used to treat asthma, it should be taken in the evening. When montelukast is used to prevent breathing difficulties during exercise, it should be taken at least 2 hours before exercise. ... Do not use montelukast to treat a sudden attack of asthma symptoms. ... If your asthma is made worse by aspirin, do not take aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) during your treatment with montelukast. ... Continue to take montelukast even if you feel well. Do not stop taking montelukast without talking to your doctor. (Ellipses join separate sentences of the same page.) Call your doctor right away and stop taking montelukast if you experience any of the following symptoms: agitation, aggressive behavior, anxiety, irritability, difficulty paying attention, memory loss or forgetfulness, confusion, unusual dreams, hallucinations ..., repeating thoughts that you cannot control, depression, difficulty falling asleep or staying asleep, restlessness, sleep walking, suicidal thoughts or actions ..., or tremor

Alternatives

Class from label
leukotriene receptor antagonist (label Highlights, Indications)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display

Frequently asked questions

Question
What is montelukast used for?
Answer
In people 15 and older it is used to prevent and treat long-term asthma, to prevent breathing trouble during exercise, and to relieve seasonal and year-round allergy nose symptoms. For allergic rhinitis it is for people who did not respond to or cannot take other treatments.
Source section
1 INDICATIONS AND USAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Question
When should I take it?
Answer
For asthma take one 10 mg tablet once daily in the evening. For exercise use take it at least 2 hours before exercise. For allergic rhinitis take it once daily at any time.
Source section
2.1, 2.2, 2.3
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Question
Can I take it with food?
Answer
Yes. It can be taken with or without food.
Source section
2.1; 12.3
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Question
What if I miss a dose?
Answer
Take the next dose at your regular time. Do not take 2 doses at the same time.
Source section
2.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Question
What is the boxed warning?
Answer
Montelukast can cause serious mental health events such as agitation, aggression, depression, sleep problems and suicidal thoughts or actions. If behavior changes or new symptoms occur, stop it and contact a healthcare provider immediately.
Source section
Boxed warning
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Question
What are the common side effects?
Answer
The label's most common reactions (5% or more and more than placebo) are upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis and otitis.
Source section
6.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Question
Can montelukast treat an asthma attack?
Answer
No. It is not for an acute asthma attack. Keep rescue medicine available.
Source section
1.4; 5.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display
Question
Is it safe in pregnancy or breastfeeding?
Answer
Studies in pregnant women have not established a risk of major birth defects. Montelukast is present in breast milk, and available data do not suggest a significant risk to the infant.
Source section
8.1, 8.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ccbbf0d6-efd9-4fdd-9e7b-e3d293062609&type=display

Sources

  • DailyMed MONTELUKAST SODIUM tablet - Amneal Pharmaceuticals LLC (primary)
    Set id: ccbbf0d6-efd9-4fdd-9e7b-e3d293062609 · Label effective or revised date: Revised: 9/2025 · Dailymed version date: Sep 21, 2026 (DailyMed publish date from list) · Fetched at: 2026-11-02 · Sections used: Highlights; boxed warning; 1-12 (get_page_text covered through 14.2); 16 storage via short slice
  • Alternate: Sandoz Inc, tablet, film coated
    Set id: 6d69e73a-76cb-4ece-9cf9-e9adb4f523b4 · Label effective or revised date: Revised: 6/2025 · Dailymed version date: Nov 17, 2025 · Fetched at: 2026-11-02 · Sections used: revised date only
  • Alternate: Rising Pharma Holdings, Inc., tablet
    Set id: 75723c5a-3c9e-468a-bc65-57b4c755889a · Label effective or revised date: Revised: 7/2024 · Dailymed version date: Aug 22, 2024 · Fetched at: 2026-11-02 · Sections used: revised date only
  • MedlinePlus Montelukast
    Label effective or revised date: Last Revised - 12/15/2021 · Fetched at: 2026-11-02 · Sections used: all patient sections
  • Drugs@FDA / openFDA
    Fetched at: 2026-11-02 · Sections used: NOT FOUND (not searched)

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug