Clast

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Clast

What is Clast? (Montelukast)

Property Description
Active ingredient Montelukast sodium
Form Tablet, Chewable tablet, Oral granule
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
General purpose Long-term control of airway inflammation
Origin Synthetic compound

Clast: Definition and Pharmacological Class

Clast is a prescription medication whose active substance is Montelukast sodium, a highly selective, orally active synthetic compound. It is globally recognized as a Leukotriene Receptor Antagonist (LTRA) and is categorized as a leukotriene modifier. This class of medicine is generally reserved for prescription use.

Clast is a single-ingredient product designed for the oral route of administration. Its various forms—including film-coated tablets, chewable tablets, and oral granules—are distinctive features, as these options facilitate consistent daily administration. LTRAs serve as a non-corticosteroid therapeutic option within this pharmacological category.


How Montelukast Functions and Its General Purpose

Montelukast's primary function is a targeted action to block the effects of potent inflammatory messengers called leukotrienes. These substances are naturally released by the body and can cause airway tightening and tissue inflammation in the respiratory system. LTRAs specifically target the pathway involved in inflammatory responses in the lungs.

By binding to the CysLT1 receptor, the medicine helps to prevent leukotrienes from causing their full negative effect. The general purpose of Clast is to provide maintenance therapy for long-term control; the medicine is taken daily to maintain stable airway function and reduce airway reactivity over time.

Regulatory References

  1. Montelukast Drug Information (NIH MedlinePlus)

What side effects are possible with Clast?

The official safety profile of Clast (Montelukast) outlines adverse reactions classified by frequency and System-Organ Class, based on regulatory standards like the Summary of Product Characteristics (SmPC) and FDA labeling.

Adverse Reaction Classifications

The most frequently documented adverse events include upper respiratory infection (classified as very common) and headache, abdominal pain, and fever (classified as common). Other common reactions affecting the Gastrointestinal system include diarrhea and nausea.

Uncommon side effects, which may affect up to 1 in 100 people, include dizziness, insomnia, dry mouth, and various hypersensitivity reactions (e.g., urticaria). Rare and very rare events are also documented, encompassing conditions like palpitations, seizures, and increased bleeding tendency.

Serious Safety Considerations

Regulatory authorities highlight the potential for serious neuropsychiatric events in all age groups. These reports include changes in mood and behavior such as agitation, anxiety, depression, dream abnormalities (including nightmares), hallucinations, memory impairment, and suicidal thinking and behavior. Some of these symptoms have been reported to persist even after the medicine is stopped.

The regulatory labels also describe the potential for severe systemic reactions, including the development of systemic eosinophilia sometimes presenting with features of Churg-Strauss Syndrome (a form of blood vessel inflammation), and rare forms of hepatitis (liver injury).

Specific Regulatory Restrictions

Clast is not indicated for the reversal of acute asthma attacks. It must not be abruptly substituted for inhaled or oral corticosteroids. Patients with known aspirin sensitivity must continue to avoid aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). No dosage adjustment is required for patients with mild to moderate hepatic or renal impairment; however, data are lacking for severe hepatic impairment.

Overdose and Emergency Response

The official documentation for Clast (Montelukast) overdose describes specific clinical manifestations and mandates a strict management protocol. When an overdose is suspected, immediate medical attention is required to ensure necessary supportive care is instituted.

The most frequently reported adverse experiences in cases of overdosage, received across both adult and pediatric patients, have included a cluster of symptoms such as abdominal pain, somnolence (drowsiness), thirst, headache, and vomiting. Additional documented manifestations reported in official labeling include psychomotor hyperactivity. Acute overdose reports involve doses as high as 1000 mg in adults, with clinical findings generally consistent with the overall established safety profile of the medicine.

Management and Emergency Response

Response Component Official Regulatory Statement
When to Seek Help Seek immediate medical attention and contact a healthcare provider or poison control center if overdose is suspected.
Antidote Availability No specific antidote is known for Montelukast overdose; treatment is purely supportive.
Mandated Procedures Management requires the employment of clinical monitoring and usual supportive measures. Procedures such as the removal of unabsorbed material from the gastrointestinal tract may be performed.

The regulatory guidance defines the overdose profile around these documented symptoms and the critical need for professional medical supervision. Since no specific reversal agent exists, the focus of official management is entirely on symptomatic supportive measures and continuous clinical monitoring.

Therapeutic Uses of Clast

Clast is generally used in therapeutic domains involving certain distressing symptoms of chronic respiratory and allergic conditions. It is commonly applied across conditions presenting with systemic or localized discomfort, specifically including supporting the long-term management of persistent asthma, the symptomatic relief of seasonal and perennial allergic rhinitis, and the prophylaxis against exercise-induced bronchoconstriction (EIB).


The medication is generally applied as a maintenance therapy to address symptom clusters that may become intense or disruptive, such as recurrent wheezing, episodes of coughing, nasal congestion, and itchy eyes.

“Clast is relevant when supportive symptom management is appropriate, helping patients cope more steadily with difficult episodes.”

This therapeutic support contributes to easing the overall symptom load and may assist with maintaining functional stability during symptomatic periods, which supports general well-being.


Quick Fact: Relief for Chronic and Episodic Symptoms

Clast is considered relevant in clinical settings that involve recurrent or episodic manifestations, helping to maintain a sense of stability when symptoms are more noticeable and ease the discomfort associated with intensified allergic symptoms. This provides supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH DailyMed drug information

Eligibility and Restrictions for Use

Who Can and Cannot Use Clast?

This section details the official eligibility and non-eligibility rules for Clast (Montelukast) as documented in government regulatory prescribing information. Eligibility is strictly defined by age, indication, existing conditions, and known sensitivities.


Contraindications and Restrictions

Classification Population/Condition Official Regulatory Status
Absolute Contraindication Patients with known hypersensitivity to Montelukast or any excipients. Must not be used
Acute Condition Exclusion Patients experiencing acute asthma attacks or status asthmaticus. Not indicated (Not a rescue medicine)
Formulation Restriction Patients with Phenylketonuria (PKU). Conditional use (Chewable tablets contain aspartame)

Age-Specific Eligibility

Eligibility begins as early as 6 months for specific conditions (perennial allergic rhinitis), rising to 6 years for prevention of Exercise-Induced Bronchoconstriction (EIB). Safety and efficacy are not established in infants under 6 months of age. No specific dosage adjustment is recommended for older adults.

Use in Special Populations

Clast should only be used during pregnancy if the potential benefit is determined to clearly justify the potential risk to the fetus. Use during lactation requires caution, as the drug is known to be excreted into human milk in small amounts. Patients with renal impairment or mild-to-moderate hepatic impairment typically require no dosage adjustment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns of Clast (Montelukast) with other medicinal products and substances, as noted in government regulatory labeling.


Pharmacokinetic Modification

Pharmacokinetic interactions, which alter drug exposure, are primarily based on the modulation of Cytochrome P450 (CYP) enzymes. Co-administration with specific medicines is documented to alter the plasma concentration of Montelukast:

  • Gemfibrozil (a CYP2C8 inhibitor) results in a substantial interaction, documented as an approximately 4.3-fold increase in Montelukast plasma exposure ( AUC).
  • Phenobarbital (a potent enzyme inducer) results in a pharmacokinetic interaction that decreases the Montelukast plasma concentration, documented as a reduction of the AUC by approximately 40%.
  • Other potent enzyme inducers, such as Rifampin, may similarly decrease Montelukast concentrations.

Other Interaction-Related Restrictions

Aspirin and NSAIDs: Patients with a known aspirin sensitivity are required to continue their avoidance of aspirin and other non-steroidal anti-inflammatory agents (NSAIDs). This is due to a restriction noting that Montelukast has not been shown to prevent the bronchoconstrictor response in these sensitive individuals.

Corticosteroids: Montelukast must not be abruptly substituted for inhaled or oral corticosteroid therapy. This is an official procedural constraint regarding usage transition.

Food: The oral absorption of Montelukast is not clinically affected by co-administration with food, including a high-fat meal. Formal interaction studies have also documented no clinically important effects on the pharmacokinetics of co-administered Theophylline, Warfarin, Digoxin, or Prednisone/Prednisolone.

Mechanism of Action

Clascoterone, an androgen receptor inhibitor, selectively targets androgen receptors (AR) located within the pilosebaceous units of the skin. The drug, which is cortexolone-17alpha propionate, acts as a competitive antagonist by binding to the AR.

This interaction blocks the binding of endogenous androgens, primarily dihydrotestosterone (DHT), to the receptor. Upon AR blockade, the typical androgen-mediated intracellular pathways are disrupted. This results in the suppression of androgen-dependent gene transcription and subsequent protein synthesis downstream. The primary intracellular consequences include the inhibition of lipid synthesis (sebum production) and the reduction of inflammatory cytokine production within the sebaceous gland and surrounding tissue.

The systemic-level physiological consequence is a localized, tissue-specific modulation of androgen signaling limited primarily to the skin, minimizing effects on other AR-expressing tissues.

Dosage and Administration Information

Clast (montelukast) is a medicine for long-term, continuous oral administration, guided by specific rules regarding dosage, frequency, and timing. The route for all available forms—including the film-coated tablets, chewable tablets, and oral granules—is oral. The medication is administered once daily (q.d.), which reflects its intended purpose as a maintenance therapy to sustain consistent control.

Dosing and Administration

Age Group Standard Daily Dose Dosing Form
Adults and Adolescents (15 years) 10 mg Film-Coated Tablet
Children (6–14 years) 5 mg Chewable Tablet
Children (6 months–5 years) 4 mg Chewable Tablet or Oral Granules

For chronic conditions such as asthma, the dose is designated for administration in the evening. For the prophylaxis of exercise-induced bronchoconstriction, a dose must be taken at least two hours before exercise.

Administration with respect to food depends on the formulation: the film-coated tablet can generally be taken with or without food. However, the oral granules must be consumed within 15 minutes of opening the packet, and must only be mixed with permitted cold or room-temperature soft foods or liquids, such as baby formula or breast milk. The overall use protocol emphasizes that treatment is intended for chronic use and should be continued daily without interruption, even during periods when symptoms are well-controlled.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Clast

Evidence for use in Intermittent Claudication (Peripheral Artery Disease)

Research exploring the use of Clast for intermittent claudication, a condition marked by outcomes related to physical discomfort and functional limitations when walking, primarily relies on short-term, randomized controlled trials (RCTs). These studies were used in research exploring how symptoms change over time, measuring outcomes such as changes in the distance participants could walk without pain. Findings describe patterns observed in the studies where participants receiving the drug were evaluated for changes in their walking distance compared to the placebo group. Research examined the rates of serious cardiovascular events in both the drug group and the placebo group over the short term.

Evidence for use in Relapsing Multiple Sclerosis (MS)

The evidence supporting the use of Clast for relapsing forms of Multiple Sclerosis is derived from initial short-term Phase 3 RCTs and subsequent long-term, observational cohort studies that followed the original trial participants. This research examined outcomes related to systemic or functional imbalance, such as the frequency of relapses and the rate of disability progression. Findings describe patterns observed in the studies where patients receiving the drug were monitored for episodic or acute changes and the rate of disability progression, and the data was compared to the placebo group over the main study period.

Durability of Effect and Long-Term Follow-up

Research has explored the durability of the effect of Clast long after the initial treatment period has ended. For Relapsing MS, long-term follow-up data extending nearly a decade are available. This research highlights changes measured over years, with findings describing patterns where patient-reported outcomes appeared to be sustained in some individuals. For Intermittent Claudication, the follow-up durations were limited in the core efficacy trials. One longer post-marketing study was stopped early; coupled with low patient adherence, long-term effects are not fully established.

What is Still Uncertain About Clast Research

Despite the available data, several areas of uncertainty remain. Research is ongoing to fully characterize the long-term profile of Clast, particularly for events that may take many years to appear. The research methods used for long-term follow-up are less controlled than initial RCTs, meaning the certainty remains low when trying to rule out rare or delayed outcomes. Furthermore, comparative evidence is lacking for many aspects. This evidence highlights what is known—and what is still uncertain—and research provides context but not individual predictions about a personal outcome.

Frequently Asked Questions (FAQ)

Common questions about Clast (FAQ)


Q: What is the main difference between Clast and other medicines used for the same condition?

Official documents describe Clast (Montelukast) as belonging to a class of medicines called a Leukotriene Receptor Antagonist (LTRA). This targeted action makes it a non-corticosteroid therapeutic option used for the long-term management of certain conditions.


Q: How quickly does Clast usually start to work?

According to official drug information, the medicine has been shown to cause bronchodilation (opening of the airways) as soon as within 2 hours of administration. The medicine is intended for continuous long-term control rather than for immediate relief.


Q: Is Clast safe to take every day for a long time?

According to official product information, this medicine is approved for chronic treatment. Regulatory documents state that it is intended for long-term use as a maintenance therapy.


Q: Can Clast cause long-term side effects or health problems?

Regulatory authorities have noted that serious neuropsychiatric events (mood and behavior changes) have been reported in post-marketing data. It has been reported that some of these symptoms may remain even after the medicine is stopped.


Q: Does Clast interact with common over-the-counter pain relievers like ibuprofen or acetaminophen?

Official information indicates that patients with a known aspirin sensitivity are advised to continue to avoid aspirin and other non-steroidal anti-inflammatory agents (NSAIDs). This is due to a restriction noting that the medicine has not been shown to prevent the bronchoconstrictor response in these sensitive individuals.


Q: Is it safe to use Clast if I also take vitamin supplements or herbal remedies?

Regulatory information indicates that Clast can interact with certain herbal supplements, such as the enzyme inducer St. John’s wort. These interactions may decrease the medicine’s plasma concentration and potentially reduce its intended effectiveness. Patients should inform their healthcare professional about all supplements taken.


Q: Does Clast interact with alcohol?

Official information does not indicate a known clinical interaction with alcohol. However, alcohol use has been noted as a potential confounding factor in some post-marketing reports related to liver function.


Q: Can Clast affect my blood pressure or heart rate?

The official safety profile lists palpitations (changes in heart rhythm or heart rate) as a rare adverse reaction. However, changes in blood pressure are not directly listed among the officially classified adverse events for this medicine.


Q: Are there known reasons why a patient would have to stop taking Clast?

Regulatory authorities advise that the risks and benefits of continuing treatment should be evaluated if serious neuropsychiatric events occur during therapy. Additionally, the official use protocol states the medicine should not be abruptly substituted for inhaled or oral corticosteroids.


Q: Is there a generic version of Clast available?

The active ingredient in Clast is Montelukast sodium. This substance is widely available both under the brand name (Clast) and as a generic prescription drug.


Q: What is the typical timeframe for seeing the full 'benefit' of Clast?

The medicine is classified as maintenance therapy for long-term control. While efficacy has been documented in clinical trials, a single, universal timeframe for seeing the 'full benefit' is not explicitly defined in the official regulatory label.


Q: Is it normal to feel tired or dizzy when first starting Clast?

Official safety labels report adverse events that include dizziness (uncommon) and headache and fatigue (common). This profile is reported in patients using the medicine.


Q: Can Clast affect my ability to drive or operate machinery?

Official guidance warns that because the medicine is associated with adverse reactions like dizziness and seizures, patients should be aware of potential risks related to operating machinery.


Q: What if I forget to take a dose of Clast?

According to official administration instructions, if a dose is missed, the patient should take the next dose at the regular time. Regulatory instructions state that patients should avoid taking two doses to make up for the missed dose.


Q: Will Clast still work if I crush or split the tablet?

The medicine is manufactured in distinct forms, including film-coated tablets and chewable tablets. The instructions for altering the form, such as mixing with food or liquid, only apply to the oral granules.


Q: Is it true that Clast is often prescribed for conditions other than the main one listed?

Regulatory documents list research that has examined the use of Clast for conditions outside of its primary approved indications. Studies have explored its role in areas such as Intermittent Claudication and Relapsing Multiple Sclerosis.


Q: Does Clast have different safety profiles based on gender?

Official product information states that the pharmacokinetics of Montelukast, which describes how the drug is processed by the body, are generally similar in males and females.


Q: Is Clast considered a 'new' drug, or has it been around for a long time?

Montelukast is described by regulatory authorities as a longtime therapy that has been in use for many years. It has an established history, with available data spanning decades of use.


Q: What kind of tests or monitoring is typically needed while taking Clast?

Regulatory documents describe the potential for severe reactions, including systemic eosinophilia and features of Churg-Strauss Syndrome. The official information indicates that patients receiving the medicine may need monitoring for these serious conditions.


Q: Can I take Clast if I have a history of allergies to other medicines?

The official absolute contraindication is a known hypersensitivity to Montelukast or any of its non-active ingredients. The regulatory text does not provide general instructions regarding a patient's history of allergies to other unrelated medicines.


Q: How reliable is the research evidence supporting Clast's use?

The core research evidence is typically based on short-term, randomized controlled trials (RCTs). The official documentation also highlights that the certainty remains low when trying to rule out rare or delayed long-term outcomes.


Q: What information is available about discontinuing Clast safely?

The official protocol states that the medicine should not be abruptly substituted for inhaled or oral corticosteroid therapy. No other general discontinuation procedure is detailed in the safety information.


Q: Do other medications need to be stopped before starting Clast?

The use protocol includes the constraint that the medicine should not be abruptly substituted for inhaled or oral corticosteroid therapy. No other specific medication cessation is mandated prior to starting.


Q: What happens if I take Clast for a while and it doesn't seem to be working?

Official labels advise that for some conditions, the medicine should be reserved for patients not treated effectively with alternatives. If the medicine does not seem to be working, regulatory labels advise that healthcare professionals should evaluate the risks and benefits of continuing treatment.


Q: How is the safety of Clast monitored by official health bodies after approval?

Regulatory agencies continually monitor the safety of the medicine by reviewing available clinical data and post-marketing reports. This monitoring process can result in official label updates, such as the addition of a Boxed Warning, based on continued safety assessment.


Q: What is the difference between an allergy to Clast and a common side effect?

Official documents classify hypersensitivity (an allergy) to the drug or its excipients as an absolute contraindication, meaning the medicine must not be used. Common side effects, such as headache or upper respiratory infection, are separate adverse reactions listed in the general safety profile.


Q: Has Clast been tested for interactions with natural supplements like St. John's wort?

Official information notes that co-administration with herbal enzyme inducers, such as St. John’s wort, has been examined. Official information indicates that these substances may reduce the plasma concentration and the effectiveness of the medicine.

How should Clast be stored and disposed of?

Clast (Montelukast sodium) must be stored and disposed of according to strict official regulatory guidelines to maintain its integrity and potency.

Storage Conditions

Item Official Regulatory Requirement
Temperature Store at 20 C to 25 C (68 F to 77 F); excursions between 15 C and 30 C are permitted.
Protection Must be protected from moisture and light; store in the original container or blister pack.
Stability Oral granules must be administered within 15 minutes after opening the packet or mixing with food/liquid; they must not be stored for later use.
Safety Keep the medicine out of the sight and reach of children.

Disposal

Unused or expired product must be discarded in accordance with local regulations for pharmaceutical waste. Disposal into wastewater, such as flushing down the toilet, is prohibited unless specifically recommended by official governmental disposal guidance.

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

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