Сингуляр

Quick links to important sections

Сингуляр

Selected form

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Сингуляр

Quick Facts

Property Description
Active ingredient Montelukast (as Montelukast Sodium)
Form Tablets (film-coated, chewable), Granules
Pharmacological Class Leukotriene Receptor Antagonist (LTRA)
Common Purpose Long-term maintenance control of airway symptoms
Origin Synthetic Compound

What Type of Medicine is Montelukast? (Identity and Class)

Сингуляр (Singulair) is the original brand name for the active, synthetic drug Montelukast, a prescription-only compound used for long-term maintenance treatment. It belongs to the pharmacological class of a Leukotriene Receptor Antagonist (LTRA). This classification is key to its action; it means the drug blocks the effects of inflammatory mediators called leukotrienes, a mechanism utilized for controlling chronic airway inflammation.

Montelukast works by selectively binding to the cysteinyl leukotriene 1 (CysLT1) receptor. This action confirms the drug is primarily utilized as a controller medication that focuses on chronic prevention, rather than an acute rescue medicine for immediate relief.

Forms and Composition (Differentiating Factor)

The medicine is a single-ingredient product, containing only Montelukast (as montelukast sodium). It is designed for the oral route of administration, distinguishing it from inhaled treatments, and is widely known for its multiple dosage forms, including chewable tablets and oral granules. This range of forms provides a distinct advantage in targeting patient groups who may have difficulty swallowing standard pills.

General Therapeutic Purpose

The general therapeutic purpose of Montelukast is to help provide sustained, continuous maintenance control over inflammatory processes within the airways. A typical use scenario involves regular, daily intake to stabilize breathing and reduce the chronic irritation of the air passages. By interrupting the signaling pathway of leukotrienes, the medication aids in preventing the swelling and constriction of the air passages over time, contributing to easier breathing and overall stability of the respiratory function.

What side effects are possible with Сингуляр?

Possible Side Effects and Safety Information

The safety profile of Montelukast (Сингуляр) is defined by officially documented adverse reactions, which are classified by frequency and body system involvement in regulatory labeling.

Serious Safety Information

The U.S. Food and Drug Administration (FDA) requires a Boxed Warning for Montelukast regarding the risk of serious neuropsychiatric adverse events. These events include, but are not limited to, changes in mood and behavior such as agitation, aggressive behavior, depression, dream abnormalities, insomnia, and the potential for suicidal thoughts and actions. These symptoms may continue if treatment is not withdrawn.

Cases of systemic eosinophilia, sometimes presenting with features consistent with Churg-Strauss syndrome (a form of vasculitis), have been reported. Severe hepatitis (liver injury) is also documented as a very rare reaction.

Adverse Reactions by Frequency

Adverse reactions are classified by regulatory authorities based on their reported frequency. Safety classifications may vary by region; the following terminology is based on official labeling:

Frequency Category Representative Adverse Reactions
Very Common Upper respiratory infection
Common Headache, abdominal pain, diarrhea, nausea, vomiting, fever
Uncommon Dizziness, drowsiness, dry mouth, asthenia/fatigue, rash, mood changes (e.g., anxiety, depression), bruising
Rare Increased bleeding tendency, tremor, palpitations
Very Rare Suicidal thinking and behavior, hallucinations, disorientation, hepatitis, Churg-Strauss Syndrome

Specific Safety Considerations

Montelukast is not indicated for use in treating an acute asthma attack; it is for long-term maintenance. For patients with Phenylketonuria (PKU), the chewable tablet form contains phenylalanine, which must be considered. Additionally, patients with known aspirin sensitivity must continue to avoid aspirin and non-steroidal anti-inflammatory agents while taking this medicine, as documented in regulatory guidelines.

Overdose and Emergency Response

Overdose and When to Seek Help

This information is based strictly on formal documentation provided by government regulatory authorities regarding Montelukast overdose.

Documented Clinical Manifestations

In the majority of reported overdose cases, no adverse experiences were observed. Where effects did occur, they were generally consistent with the known safety profile of the medicine. These manifestations, reported in both adult and pediatric patients, include:

System Manifestations
Gastrointestinal Abdominal pain, vomiting, thirst
Neurological/Psychiatric Somnolence (drowsiness), headache, psychomotor hyperactivity (agitation, restlessness)

Required Emergency Actions

Regulators mandate specific actions in the event of a suspected or known overdose, even if no symptoms are present:

  • Urgent Medical Attention: Patients must seek emergency medical attention or call a Poison Help line immediately.
  • Supportive Measures: Management involves the institution of usual supportive measures, including clinical monitoring and the removal of any unabsorbed material from the gastrointestinal tract.

Antidote and Specific Treatment

No specific antidote is available or officially documented for Montelukast overdose. Regulatory information states that it is not known whether the drug is removable by peritoneal or hemodialysis. Treatment is therefore procedural and focused on managing the documented symptoms and providing supportive care under medical supervision.

Therapeutic Uses of Сингуляр

What Сингуляр Treats: Main Uses and Benefits

The general therapeutic role of this medication is the long-term management of chronic respiratory and allergic conditions. It is relevant for easing groups of symptoms associated with chronic asthma, seasonal allergic rhinitis, perennial allergic rhinitis, and the acute prevention of exercise-induced breathing difficulty.

In the context of asthma, the medicine is applied across domains where additional symptomatic support is needed for persistent symptoms like wheezing, chest tightness, and coughing. It contributes to easing the overall symptom load and may assist with managing recurrent manifestations, supporting general well-being during symptomatic phases.

For allergy sufferers, it is used for managing symptom clusters such as sneezing, persistent runny nose, and nasal congestion, which are symptoms that may interfere with daily comfort. This provides supportive relief and is also applied in specific clinical scenarios, such as when supporting breathing function during physical exertion.

“This medication is applicable within clinical settings that involve acute or disruptive symptom patterns, and supports patients during difficult episodes by easing distress.”


Quick Fact: Relief for Respiratory and Allergy Symptoms

Property Description
General Focus Long-term maintenance control of airway symptoms and management of allergy manifestations.
Asthma Benefit Contributes to easing the overall symptom load and helps manage the frequency of disruptive episodes.
Allergy Benefit Supports comfort by addressing nasal symptoms like congestion and runny nose.
Specific Use Assists with maintaining functional stability when applied in contexts that involve physical exertion.

Eligibility and Restrictions for Use

This information details the officially documented eligibility rules for Сингуляр (montelukast) based strictly on regulatory documents.

Populations That Must Not Use the Medicine

Use of montelukast is contraindicated for patients with a known hypersensitivity or allergy to the active substance or any other component in the medicine. The medicine must not be used to treat an acute asthma attack or status asthmaticus; appropriate rescue medication must be kept readily available.

Eligibility Based on Age and Condition

Eligibility for treatment is defined by the patient's age for the specific approved condition:

Condition Minimum Eligible Age
Chronic Asthma 12 months and older
Exercise-Induced Bronchoconstriction (EIB) 6 years and older
Seasonal Allergic Rhinitis 2 years and older
Perennial Allergic Rhinitis 6 months and older

Safety and effectiveness are not established for patients below these minimum ages for each respective indication.

Use Restrictions and Special Considerations

  • Allergic Rhinitis: For allergic rhinitis, the use of montelukast is restricted to patients who have had an inadequate response to, or an inability to tolerate, alternative treatments.
  • Phenylketonuria (PKU): Patients with PKU should be aware that the chewable tablet formulations contain phenylalanine.
  • Hepatic Impairment: No routine adjustment is recommended for mild-to-moderate impairment; severe hepatic impairment has not been evaluated.
  • Pregnancy/Lactation: Use during pregnancy and breastfeeding is generally not recommended unless considered clearly essential.

What should I know about interactions with other medicines?

The official regulatory profile for Montelukast is defined primarily by pharmacokinetic (PK) modifications involving cytochrome P450 (CYP) enzymes. The medicine is documented as a substrate of CYP2C8, CYP2C9, and CYP3A4.

Documented Exposure Modification

Co-administration with certain medicinal products can formally alter Montelukast's systemic exposure. For instance, the strong CYP inhibitor Gemfibrozil increases Montelukast exposure by approximately 4.4-fold. Conversely, the CYP inducer Phenobarbital decreases systemic exposure by about 40%, and caution is formally advised with strong CYP inducers such as Rifampicin and Phenytoin.

Mandatory Restrictions and Substance Cautions

Regulatory documents include mandatory requirements regarding administration timing. Montelukast must not be abruptly substituted for either oral or inhaled corticosteroids. A pharmacodynamic restriction requires individuals with known aspirin sensitivity to continue to avoid aspirin and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) while taking this medicine. The chewable tablet forms contain phenylalanine, which is an important consideration for patients with Phenylketonuria (PKU).

Absence of Clinically Important Interactions

Official statements confirm that Montelukast has no clinically important effects on the pharmacokinetics of Theophylline, Warfarin, Digoxin, or Oral Contraceptives. Furthermore, the medicine may be taken without regard to food or meals.

Mechanism of Action

Selective Blockade of the Cysteinyl Leukotriene Pathway

The fundamental mechanism involves the highly selective competitive antagonism of the Cysteinyl Leukotriene Type-1 ( CysLT1) receptor. Montelukast binds to this receptor with high affinity, directly blocking the ability of endogenous inflammatory mediators, primarily leukotriene D4 ( LTD4), to initiate their biological signals. This molecular action is applied in systems where the leukotriene pathway contributes to heightened physiological responses.

Modulation of Airway Tone and Fluid Dynamics

By halting the CysLT1-mediated signal, Montelukast interrupts the cascade that leads to tissue dysfunction. This action prevents leukotriene-mediated contraction of the airway smooth muscle, resulting in modulation of airway tone. Concurrently, the mechanism limits the increase in vascular permeability, resulting in inhibition of leukotriene-mediated extravasation of fluid into the respiratory and nasal mucosa.

Mechanistic Limitation to Chronic Regulation

This mechanism is geared toward the sustained, chronic regulation of the leukotriene inflammatory pathway. The antagonism focuses on preventing future signaling and limiting the background inflammatory burden. Consequently, the mechanism lacks the rapid kinetics required to engage and reverse an established, acute smooth muscle contraction mediated by alternative receptor systems.

Dosage and Administration Information

Official Administration Guidelines (Sингуляр)

This medication is administered orally once daily, and the specific dosage strength and timing are defined by the patient's age and condition.

Age Group Dosage Strength Administration Rule
Adults and Adolescents (15 years) 10 mg film-coated tablet Once daily.
Pediatric (6 to 14 years) 5 mg chewable tablet Once daily.
Pediatric (2 to 5 years) 4 mg chewable tablet or 4 mg granules Once daily.
Infants (6 to 23 months) 4 mg oral granules only Once daily.

Timing and Formulation Requirements

For chronic conditions, the dose must be taken once daily in the evening. However, for certain conditions (e.g., Seasonal Allergic Rhinitis alone), the time of administration may be individualized to suit the patient's needs. Film-coated tablets may be taken with or without food. Chewable tablets must be chewed before swallowing.

Oral Granules Preparation

The 4 mg oral granules must be administered within 15 minutes of opening the packet. They may be taken directly in the mouth, or mixed with a spoonful of cold or room temperature soft food, such as applesauce, rice, or ice cream. The granules can also be dissolved in one teaspoonful (5 mL) of cold or room temperature baby formula or breast milk. The granules should not be dissolved in any other liquid, and any prepared mixture must not be stored for future use; unused portions must be discarded.

Prevention of Exercise-Induced Bronchoconstriction (EIB)

For the acute prevention of EIB, a single dose must be taken at least 2 hours before exercise. No additional dose should be taken within 24 hours of a previous dose. Patients already on a once-daily regimen for another condition should not take an extra dose for EIB prevention.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Сингуляр (Montelukast)

Evidence for Use in Chronic Asthma

The research base for Montelukast's study in chronic asthma is built upon Randomized Controlled Trials (RCTs) and systematic reviews. This research primarily examined Montelukast in long-term study protocols in individuals with persistent asthma. Studies monitored objective outcomes like forced expiratory volume in one second (FEV1), which reflects breathing function, and tracked patient-reported daytime and nighttime symptom scores and the frequency of asthma exacerbations. Findings describe patterns observed in the studies that monitored measured differences in lung function and symptom scores compared to the placebo group. Research has been applied in studies for children and adolescents, with some trials involving pediatric populations as young as 12 months.

Evidence for Use in Allergic Rhinitis (Seasonal and Perennial)

The research for allergic rhinitis, a condition characterized by fluctuating manifestations, was evaluated using controlled clinical trials. Studies monitored outcomes related to physical discomfort, focusing on changes measured in nasal symptoms (congestion, sneezing) and rhinoconjunctivitis-related quality of life. The studies explored patterns related to symptom changes across different conditions. The comparative evidence remains an area of ongoing research, as data show patterns that are not uniformly comparable to those observed with topical nasal steroids for all symptom types.

Evidence for Prevention of Exercise-Induced Breathing Difficulty

The research into exercise-induced breathing difficulty, an acute episodic condition, was conducted through specific acute challenge studies. A principal outcome monitored was the maximum percent fall in lung function (FEV1) after participants completed a standardized exercise challenge. The data collected includes observations on the duration of changes in lung function in the hours following physical exertion. However, the evidence is limited to the preventive use of the medicine taken before exercise.

Long-Term Data, Subgroups, and Uncertainty

Data for long-term effects, specifically beyond the intermediate time frames of one year, remain limited. Long-term data describing patterns of durability and outcomes are limited, with post-marketing data having lower certainty due to differences in research methods. Data for specific subgroups, such as older adults, remain insufficient and limited compared to those for younger populations. Observed findings were mixed regarding some patient-reported outcomes, which included reports of inter-individual variability in patterns among patients.

Key Studies & References

  1. Label: MONTELUKAST SODIUM tablet, film coated - Full Prescribing Information
  2. The role of inhaled corticosteroids and montelukast in children with mild-moderate asthma: results of a systematic review with meta-analysis
  3. Efficacy of Montelukast in Allergic Rhinitis Treatment: A Systematic Review and Meta-Analysis
  4. Montelukast in Exercise-Induced Bronchospasm - 2004 (Trial NCT00090142)

Frequently Asked Questions (FAQ)

Common questions about Сингуляр (FAQ)


Q: How soon does Singulair usually start to work?

Official documents indicate that the active substance, Montelukast, is rapidly absorbed, reaching maximum concentration in the blood within two to four hours after administration. Clinical studies have shown measured improvements in breathing function (FEV1) within one day of starting the medication for asthma. The long-term therapeutic effect is associated with continuous daily administration, as described in official documents.


Q: Should Singulair be taken continuously or only during flare-ups?

Singulair is officially designated for the long-term maintenance treatment of chronic conditions, such as asthma and allergic rhinitis. For these purposes, official product information describes that it is administered daily, as it is not intended for use in managing acute attacks or sudden symptom flare-ups.


Q: What's the difference between Singulair and other allergy medicines?

Singulair belongs to the pharmacological class known as a leukotriene receptor antagonist. Its mechanism of action works by blocking the effects of specific inflammatory chemicals called leukotrienes. This mechanism is chemically distinct from other common allergy treatments, such as antihistamines.


Q: Can Singulair be taken with other cold medicines?

Official drug interaction data for Singulair do not list common over-the-counter cold medicine ingredients as having a known interaction. However, because the full data on every possible combination may be unknown, regulatory documents describe the importance of disclosing all medications, including non-prescription remedies like cold medicines, to a healthcare provider.


Q: Does Singulair cause drowsiness?

According to official regulatory documents, drowsiness is listed as an uncommon adverse reaction that has been reported during the use of Singulair. Patients should observe how the medicine affects them.


Q: How long can Singulair be taken without a break?

Singulair has been examined in clinical studies for the long-term management of asthma and allergic rhinitis, with some data collected over periods of one year. The duration of administration is typically established by a healthcare provider, taking into account the patient's condition.


Q: Why is Singulair taken in the evening?

For the management of chronic asthma, the official administration instructions state that the dose is administered once daily in the evening. This timing is generally advised because asthma symptoms often worsen during the nighttime and early morning hours. For allergic rhinitis, the time of administration may sometimes be adjusted based on individual patient needs.


Q: Can Singulair affect body weight or appetite?

Changes in body weight or appetite are not listed in the official regulatory documents as commonly or uncommonly reported side effects. Concerns regarding changes in weight or appetite while on this medication are typically reviewed by a healthcare provider.


Q: Are there generics (analogs) of Singulair with the same active substance?

Yes, the active drug in Singulair is Montelukast sodium. Official drug registries confirm the existence of multiple generic versions (analogues) that contain the exact same active substance, as Singulair is the original brand name.


Q: Can Singulair interact with herbal supplements?

Singulair’s concentration in the body can be affected by substances that influence certain liver enzymes, known as CYP450. While specific herbal supplements are not detailed in official drug interaction lists, regulatory documents generally emphasize the importance of disclosing the use of all supplements and herbal remedies to a healthcare provider.


Q: What should I do if I miss a dose of Singulair?

Official prescribing information describes that if a dose is missed, administration of the next dose occurs at the usual scheduled time. There are no regulatory instructions to take two doses or double the next dose to make up for a missed dose.


Q: Can I drink alcohol while taking Singulair?

Official documents do not contain a direct prohibition against consuming alcohol while taking Singulair. However, given that rare, serious adverse events like hepatitis (liver injury) are documented, questions regarding alcohol consumption while taking this medication are typically directed to a prescribing physician.


Q: Are children allowed to take Singulair, and from what age?

Eligibility for Singulair is determined by the child's age and the specific condition being treated. For chronic asthma, the medicine is approved for children as young as 12 months; for seasonal allergic rhinitis, it is approved from 2 years; and for perennial allergic rhinitis, it is approved from 6 months of age.


Q: Is Singulair used to treat only seasonal or perennial allergy?

According to the official therapeutic indications, Singulair can be used for the treatment of symptoms associated with both seasonal and perennial (year-round) allergic rhinitis, subject to the appropriate age requirements for each indication.


Q: Can I become addicted to Singulair?

Regulatory documents do not classify Montelukast as a substance that causes physical dependence or addiction. Information on drug abuse and dependence typically indicates that there is no known risk of forming an addiction to this medication.


Q: What happens if I suddenly stop taking Singulair?

Official warnings state that Singulair must not be abruptly discontinued or used to replace inhaled or oral corticosteroids. The decision to discontinue administration, especially if neuropsychiatric symptoms are present, involves consultation with a healthcare professional.


Q: Should I take Singulair during an asthma attack?

No. Singulair is not indicated for the treatment of an acute asthma attack. The medication is for long-term maintenance control only. Rescue medication is typically kept available for use during an acute episode.


Q: Why do doctors prescribe Singulair instead of inhalers?

Official documents state that for allergic rhinitis, Singulair is generally reserved for patients who have had an inadequate response to or an inability to tolerate alternative first-line therapies. This indication suggests the drug may be reserved for use when alternative approaches are inadequate or not tolerated.


Q: What information about Singulair is available in official regulatory sources?

Official regulatory sources, such as the U.S. FDA and the European Medicines Agency (EMA), provide comprehensive information on the medicine. This includes details on indications, dosing, contraindications, safety warnings (including the Boxed Warning for neuropsychiatric events), drug interactions, and clinical study data.


Q: Can I take Singulair if I have kidney problems?

The official prescribing information notes that no dose adjustment for Singulair is required for patients with impaired kidney function. Prescribing decisions are typically made by a physician who considers all co-existing health conditions.


Q: Does Singulair help with food allergies?

No. The official therapeutic indications for Singulair are limited to chronic asthma, allergic rhinitis (seasonal and perennial), and the prevention of exercise-induced bronchoconstriction. Food allergy is not listed as an approved indication for the medication.


Q: Can Singulair be taken in the summer for prevention?

Singulair is indicated for the treatment of seasonal allergic rhinitis, which commonly occurs during the warmer months of the year. The medicine is generally used as a supported, continuous therapy during the period when the patient is exposed to relevant seasonal allergens.

How should Сингуляр be stored and disposed of?

Official Storage and Disposal Requirements

Singulair (Montelukast Sodium) must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F), with excursions permitted up to 30 C (86 F). The medicine must be kept in its original container and protected from light and moisture.

Constraint Requirement
Temperature Store between 20 C and 25 C.
Protection Protect from light and moisture.
Packaging Keep in original, tightly closed container.
Child Safety Keep out of the reach of children.

For the oral granule formulation, once the packet is opened or mixed with food or liquid, the entire dose must be administered within 15 minutes and must not be stored for future use. Any unused portion of the mixed granules must be discarded. Disposal of expired or unused medicine should be carried out according to local regulatory requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Сингуляр found in:

A-Z Index: