Brokast

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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 Brokast

What is Brokast? (Montelukast)

Property Description
Active ingredient Montelukast sodium
Form Oral tablets or granules
Pharmacological class Leukotriene receptor antagonist (LTRA)
General purpose Chronic airway management
Origin Synthetic small molecule

Brokast Identity: A Montelukast Sodium Medicine

Brokast is the trade name for a single-ingredient, synthetic medication whose active component is Montelukast sodium. It is a prescription-only medicine administered via the oral route, typically formulated as oral tablets (film-coated or chewable) or granules for easy swallowing. This oral delivery provides systemic therapy designed for chronic management rather than immediate symptom relief. Its formulation as either chewable tablets or granules reflects its recognized use in different patient groups.


What Type of Drug is Brokast? (The Pharmacological Class)

Brokast is formally classified as a leukotriene receptor antagonist (LTRA), also known as a leukotriene modifier. This category of drugs functions as an anti-asthmatic and anti-allergic medication. The drug’s core action involves the selective blockade of CysLT1 receptors in the body, which are activated by inflammatory mediators called leukotrienes. This mechanism is clinically recognized for its ability to counteract inflammatory responses in the airways. The targeted action on leukotrienes provides a specific pathway interruption for chronic airway inflammation.


The General Purpose: Maintaining Airway Function

The general purpose of Brokast is to provide essential, foundational support for the management of chronic conditions affecting the respiratory system. The medication helps control the underlying, continuous biological processes of bronchial constriction and inflammation by inhibiting leukotriene effects. This systemic strategy aids in promoting and maintaining airway function and consistent airflow over the long term, serving as a reliable daily component of an overall management plan.

Regulatory References

  1. Montelukast - StatPearls - NCBI Bookshelf - NIH

What side effects are possible with Brokast?

Possible Side Effects and Safety Information

Brokast (a combination product containing montelukast and levocetirizine) is associated with officially documented adverse reactions that affect multiple organ systems. The reporting structure typically follows the MedDRA System Organ Classification, with specific frequency bands used by regulatory agencies like the EMA and FDA.

Serious and Clinically Significant Adverse Reactions

The most serious safety consideration is the risk of neuropsychiatric adverse events associated with montelukast, one of the active components. These are considered serious enough to warrant a Boxed Warning in regulatory labeling. Reported events have included agitation, aggressive behavior, depression, insomnia, hallucinations, and suicidal thoughts or actions. Patients and caregivers should be aware of these risks.

Common Adverse Reactions

Common adverse reactions, typically observed in at least 1 in 100 patients, primarily involve the following systems:

  • Gastrointestinal Disorders: Stomach pain, nausea, and diarrhea.
  • General Disorders: Fatigue, headache, and fever (pyrexia).
  • Psychiatric Disorders: Sleepiness or drowsiness, which is also a key safety note regarding driving and operating machinery.
  • Respiratory: Upper respiratory tract infection, cough, or inflammation of the pharynx.

Population-Specific Safety Considerations

Pregnancy and Breastfeeding: Brokast should be used with caution in pregnant or breastfeeding women. While available data for one component (montelukast) are generally reassuring regarding major malformations, the overall benefit-risk must be carefully assessed, as poorly controlled underlying conditions (like asthma) pose risks to both the mother and the fetus.

Elderly and Patients with Kidney Impairment: Caution is required in patients aged 65 and older, as well as those with kidney disease. Appropriate dose adjustments and careful monitoring of kidney function are often necessary to prevent accumulation and potential adverse effects.

Overdose and Emergency Response

Overdose scope

Classification Regulatory Details
Documented overdose presentations Gastrointestinal effects such as abdominal pain, vomiting, nausea, and thirst; Central Nervous System (CNS) manifestations including headache, agitation, restlessness, and drowsiness (somnolence)
Physiological systems affected Gastrointestinal system, Nervous System (CNS)
Dose-related or exposure notes Overdose has been reported in both adults and pediatric patients, including exposures up to 1000 mg in some cases.
Population-specific overdose notes Analysis of high-dose exposures in children revealed no unique severe or life-threatening events, with findings consistent with the general safety profile.

Overdose classifications (high-level)

Classification Regulatory Details
Severity classification No specific unique severe or life-threatening outcomes have been reported in the regulatory review of high-dose exposure cases.
Regulatory basis FDA Prescribing Information, EMA/MHRA Summary of Product Characteristics
Overdose-context constraints No specific antidote is known for Montelukast overdose. Treatment is restricted to symptomatic and supportive management.

Resulting overdose structure

Official overdose statements:

  • Overdose may present with documented clinical signs primarily affecting the nervous and gastrointestinal systems.
  • Upon suspicion of an overdose, immediate action is required to seek emergency medical attention or to contact the Poison Help line.
  • Since no specific antidote is known, regulatory guidance dictates that the management of overdose must be symptomatic and supportive.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents establish the Montelukast overdose profile by identifying specific documented clinical manifestations and confirming the lack of a known specific antidote. The required emergency actions are strictly defined as seeking immediate medical attention or contacting the Poison Help line, which ensures patients receive necessary symptomatic and supportive care as outlined in official labeling.

Therapeutic Uses of Brokast

What Brokast Treats: Main Uses and Benefits

Brokast is relevant in clinical contexts involving inflammatory or irritative processes of the respiratory tract. It is commonly used when symptoms create noticeable physiological strain. The medication is used in situations involving certain distressing symptoms, including the chronic management of asthma, symptom relief for both seasonal and perennial allergic rhinitis, and preventative support for breathing difficulties linked to strenuous exercise.

The medication is applied in addressing symptoms related to physical discomfort in the lower airways, such as wheezing and chest tightness, and helps manage symptom clusters in the nasal passages, including congestion and sneezing. This provides support that helps ease the overall symptom burden, contributing to improved day-to-day comfort during symptomatic periods. This approach is relevant when symptoms become temporarily overwhelming and short-term symptom stabilization is important.


Quick Fact: Symptomatic Relief for Allergic Nasal Symptoms Brokast helps address symptom clusters that may become intense or disruptive, such as persistent runny nose and nasal congestion, which are common manifestations of allergic rhinitis.

Regulatory References

  1. NIH MedlinePlus

Eligibility and Restrictions for Use

Official Eligibility Profile

Brokast eligibility is strictly defined by regulatory age limits and specific health conditions. The drug is contraindicated and must not be used in patients with a known hypersensitivity to Montelukast sodium or any component of the formulation.

Category Official Regulatory Status
Absolute Contraindication Cannot be used to treat an acute asthma attack; it is for chronic management only.
Age-Related Rules Use is not established for infants younger than 6 months for any indication. Minimum age varies by condition: ge 6 months for Perennial Allergic Rhinitis, ge 12 months for Asthma, and ge 6 years for Exercise-Induced Bronchoconstriction (EIB).
Geriatric Use Patients ge 65 years old are eligible with no dosage adjustment required.
Liver/Kidney Conditions Patients with renal insufficiency or mild-to-moderate hepatic impairment are eligible, as no dosage adjustment is necessary. Use is not established in severe hepatic insufficiency patients.
Pregnancy/Lactation Use is conditional, permitted only if it is considered clearly essential.
Excipient Restrictions Chewable tablets are restricted for patients with Phenylketonuria (PKU) due to the presence of aspartame.

Eligibility for Allergic Rhinitis is officially reserved by regulators for patients with an inadequate response or intolerance to alternative therapies. The prescribing information explicitly establishes these limitations, defining the approved boundaries for use.

What should I know about interactions with other medicines?

Brokast’s interaction profile is primarily defined by official regulatory findings concerning the drug’s metabolism and specific therapeutic constraints. The systemic clearance of Brokast is mediated by specific Cytochrome P450 (CYP) enzymes, chiefly CYP 2C8, which accounts for the most significant pharmacokinetic interactions.

Interaction Type Interacting Substance(s) Regulatory Outcome
Exposure Increase Gemfibrozil (CYP inhibitor) Increases Brokast systemic exposure by approximately 4.4-fold.
Exposure Decrease Phenobarbital, Rifampicin, Phenytoin (CYP inducers) Decrease Brokast systemic exposure. Caution is specifically advised when co-administering these inducers, particularly in children.
Pharmacodynamic Rule Aspirin, NSAIDs Patients with documented aspirin sensitivity must continue avoidance of these products while receiving therapy.
Timing Rule Brokast (additional dose) A subsequent dose taken for the prevention of Exercise-Induced Bronchoconstriction (EIB) must not be taken within 24 hours of a previous dose.
No Effect Status Theophylline, Warfarin, Prednisone, Oral Contraceptives The clinical dose of Brokast did not demonstrate a clinically important effect on the pharmacokinetics of these medicinal products.

This official interaction structure highlights substances that both increase (Gemfibrozil) and decrease (CYP inducers) drug levels, alongside mandatory rules for maintaining established anti-asthma therapy (NSAID avoidance). The regulatory documents confirm that the drug’s tablets are not influenced by a standard meal.

Mechanism of Action

Targeted Blockade of the CysLT1 Receptor

Brokast's mechanism is defined by its action as a highly selective antagonist (blocker) of the Cysteinyl Leukotriene Type 1 Receptor ( CysLT1). By binding to this primary molecular target, Montelukast prevents the endogenous inflammatory mediators, the leukotrienes ( LTC4, LTD4, LTE4), from attaching to the receptor and initiating signal transduction.


Modulation of Airway Muscle Tone and CysLT-Mediated Responses

This molecular blockade initiates a cascade that influences two key physiological processes: smooth muscle signaling and CysLT-mediated inflammatory responses. The drug limits the leukotriene-mediated stimulus for bronchial smooth muscle contraction and attenuates the CysLT-mediated recruitment of inflammatory cells and vascular permeability in the airways. The resulting physiological effect is the reduction of CysLT-mediated signaling that underlies airway hyperresponsiveness by limiting CysLT-driven smooth muscle contraction and vascular leakage.


Mechanistic Constraints

The mechanism involves continuous physiological modulation through leukotriene pathway suppression. Because it is an antagonist and not a direct muscle activator, it is mechanistically constrained and lacks the beta2-agonistic action required to reverse acute, established smooth muscle spasm.

Dosage and Administration Information

Official Administration Guidelines for Brokast

The administration of Brokast (Montelukast) is typically based on a once-daily oral schedule for chronic use. The primary goal of these instructions is to ensure continuous therapeutic presence, and the medicine is not intended for the management of acute respiratory events.

Feature Standard Guidelines
Route of administration Oral use only.
Dosing schedule Adults and adolescents (ge 15 years): 10 mg once daily. Children (6 to 14 years): 5 mg once daily (chewable tablet). Children (6 months to 5 years): 4 mg once daily (chewable tablet or granules).
Timing in relation to meals Film-coated tablets and chewable tablets may be taken with or without food.
Preparation requirements Oral granules must be administered immediately, within 15 minutes of opening the packet. They can be given directly or mixed with a spoonful of specific soft foods (applesauce, carrots, rice, or ice cream) or liquids.
Age-group rules Dosing strength and formulation are determined by age; no dose adjustment is generally required for older adults or in cases of mild-to-moderate hepatic or renal impairment.
Missed-dose rules If a scheduled daily dose is missed, it should not be supplemented by taking an extra dose. The patient should simply resume the usual once-daily regimen with the next scheduled dose.
Special procedural conditions The daily dose is typically administered in the evening when used for asthma or dual asthma/allergic rhinitis management. When used for exercise-induced symptoms, a single 10 mg dose must be taken at least 2 hours before exercise, but no additional dose should be taken within 24 hours if the patient is already on a daily regimen.

Connection to the overall use protocol:

The administration protocol establishes Brokast as a once-daily oral medicine taken at a fixed time determined by the indication being managed. This structure emphasizes consistent administration over time for chronic support and strictly limits its use as an acute, on-demand medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Brokast

Research evidence for Brokast (Montelukast) is primarily based on findings from short-term, randomized controlled trials (RCTs) and systematic reviews that synthesize findings across multiple studies. This overview describes the research landscape for its approved uses, focusing on what was studied and the patterns of change observed, without offering clinical advice or making claims about individual outcomes.


Research Evidence for the Chronic Management of Asthma

Research for asthma involved numerous RCTs and comprehensive meta-analyses. These studies examined key measures of lung function, such as the Forced Expiratory Volume in 1 second (FEV1), and monitored outcomes describing episodic or acute changes, specifically noting the frequency of rescue medication use and asthma exacerbations. Studies also examined Brokast as an add-on therapy for patients already taking inhaled corticosteroids (ICS), with findings indicating that some trials monitored functional measurements in this setting.

What remains uncertain: Long-term outcomes are not fully established through the initial large-scale RCTs, as follow-up durations were limited. The evidence base reports that the measured outcomes in functional measures varied when compared with those observed in groups using ICS in similar study designs.


Research Evidence for Allergic Rhinitis (Seasonal and Perennial)

The evidence base for the study of allergic rhinitis primarily comes from short-term, placebo-controlled RCTs. Studies explored changes in overall symptom intensity and patient-reported outcomes describing perceived discomfort. Trials reported measurements of symptom scores that differed between the study groups and placebo groups. The evidence quality varies across studies, and data are still emerging for its role compared to other widely used medication classes in long-term management.


Research Evidence for Prevention of Exercise-Induced Bronchoconstriction (EIB)

Research for this specific indication focused on functional outcomes using highly controlled, cross-over design studies. Studies monitored the difference in the maximum percent fall in FEV1 following a standardized exercise challenge. Research described patterns related to a difference in lung function reduction in the observed populations. Research also explored changes in short-term symptoms, with data indicating patterns observed up to 24 hours post-administration. The use of highly controlled laboratory conditions means that the research may not fully characterize the functional response under varied, real-world exercise environments.

Frequently Asked Questions (FAQ)

Common questions about Brokast (FAQ)

Q: How long does it typically take for Brokast to start working after I begin treatment?

According to official product information, the active ingredient in Brokast is quickly absorbed, typically reaching its highest levels in the bloodstream within 2 to 4 hours after you take a dose. In clinical studies for asthma management, signs of functional improvement were observed within the first day of treatment, although individual response times may vary.


Q: Does Brokast have any common ingredients (like lactose or gluten) that people should be aware of?

Regulatory documents indicate that the film-coated tablets contain lactose monohydrate as an inactive ingredient. The chewable tablets also contain aspartame, which is a source of phenylalanine, and is contraindicated for use in patients with Phenylketonuria (PKU). Specific information regarding the presence of gluten is not typically detailed in the required labeling.


Q: What are the common signs that Brokast is actually working for me?

Clinical studies monitored specific outcomes to determine effectiveness. These patient-reported changes included a decrease in the number of daytime asthma symptoms and a reduction in the need to use beta-agonist rescue medication. For some patient populations, a decrease in the frequency of nocturnal awakenings due to asthma was also noted.


Q: What if I accidentally take two doses of Brokast in one day?

The official product information addresses accidental overdose, noting that symptoms observed in studies were generally consistent with known side effects. These have included abdominal pain, sleepiness, thirst, and headache. In the event of accidentally taking more than the prescribed amount, contacting a healthcare professional is generally recommended.


Q: Is Brokast safe to use during pregnancy and when breastfeeding?

The decision to use Brokast during pregnancy and breastfeeding is determined by a healthcare professional. Official information states that while data on the active ingredient is largely reassuring concerning major birth defects, it should only be used if the potential benefit is believed to clearly justify any potential risk. The active component has been found in the milk of nursing animals, though human data may vary.


Q: Can Brokast be used for immediate relief during an asthma attack?

No. Brokast is not indicated for the immediate treatment of an acute asthma attack or sudden shortness of breath. Official guidance states that Brokast should not be used for acute attacks and patients are advised to have appropriate short-acting inhaled beta-agonists (rescue medication) available.

How should Brokast be stored and disposed of?

Storage and Disposal Requirements

Brokast (montelukast sodium) must be stored and handled according to specific conditions defined in regulatory labeling to maintain its stability and effectiveness.

Storage Condition Requirement
Temperature Store at controlled room temperature: 20 C to 25 C (68 F to 77 F).
Protection Keep in the original container and protect from moisture.
Child Safety Keep this and all drugs out of the reach of children.
Granule Stability Oral granules must be administered within 15 minutes of opening the packet or mixing; do not store the prepared dose.

Disposal of unused or expired product should prioritize drug take-back programs. If a take-back program is unavailable, the medication must be secured by mixing it with an undesirable substance (such as kitty litter) and placing it in a sealed container before discarding it in the household trash, as specified by official guidelines.

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

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