Aliento

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Medically reviewed

Laura Arias

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 Aliento

Aliento is an orally administered prescription medication used in the long-term management of conditions characterized by chronic airway inflammation. It is a daily treatment intended to stabilize the respiratory system's underlying inflammatory processes.

Quick Facts Description
Active Ingredient Montelukast sodium
Form Tablet, Chewable Tablet, Oral Granules
Pharmacological Class Leukotriene Receptor Antagonist (LTRA)
Route Oral (by mouth)
Origin Synthetic Compound

What Type of Medicine is Aliento and What is its Composition?

Aliento is formally classified as a Leukotriene receptor antagonist (LTRA), a class of drugs that selectively interferes with the body's inflammatory signaling pathways. The medication contains a single active ingredient, Montelukast sodium, which acts as a highly selective antagonist of the CysLT1 receptor. The active substance is a manufactured synthetic compound, ensuring a precise, controlled chemical structure across all preparations.

The medication is available for oral administration in multiple forms: a standard tablet, a chewable tablet, and oral granules. The availability of the chewable tablet and granules is a distinguishing feature, making the Montelukast formulation accessible to diverse patient groups, including pediatric patients.

General Purpose and Core Action of Montelukast

The fundamental purpose of Aliento is to reduce the negative effects of powerful inflammatory mediators called cysteinyl leukotrienes that the body releases during allergic reactions and chronic respiratory conditions. By blocking the CysLT1 receptor, Montelukast prevents these leukotrienes from causing inflammation and the subsequent swelling and narrowing of air passages. This targeted action helps support long-term, stable breathing and reduces the persistence of inflammation in the airways. Its function is clinically recognized for contributing to the sustained control of chronic respiratory issues. It functions primarily as a maintenance medication, providing foundational support that is distinct from immediate-acting rescue or broad-spectrum anti-inflammatory agents.

Regulatory References

  1. Montelukast Leukotriene Receptor Antagonist

What side effects are possible with Aliento?

Possible side effects and safety information

Aliento (Montelukast) is associated with adverse reactions that are systematically classified by frequency and body system in official regulatory documents, such as those published by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Classification Examples of Documented Adverse Reactions
Very Common (ge 1/10) Upper respiratory infection.
Common (ge 1/100 to <1/10) Headache, abdominal pain.
Uncommon (ge 1/1,000 to <1/100) Dizziness, insomnia, somnolence, agitation, depression.
Rare/Very Rare (<1/1,000) Increased bleeding tendency, palpitations, various forms of hepatitis (liver injury), and systemic eosinophilia (sometimes consistent with Churg-Strauss syndrome).

Serious Adverse Reactions and Key Safety Considerations

Serious adverse reactions documented in regulatory labeling primarily relate to the Psychiatric Disorders System-Organ Class. Reports include events such as agitation, aggression, depression, disturbance in attention, and suicidal thinking and behavior (suicidality). These serious neuropsychiatric events have been reported across all age groups and may occur both during treatment and following its discontinuation.

Additional safety notes address Hypersensitivity reactions, including anaphylaxis and angioedema, and the potential for hepatotoxicity. For pediatric patients, specific events like somnambulism (sleepwalking) are more frequently observed.

Safety-Related Restrictions and Limitations

The medicine is strictly indicated for maintenance therapy and must not be used to treat sudden, acute asthma attacks. Regulatory documents advise that Aliento should not be abruptly substituted for inhaled or oral corticosteroids, as this has been associated with the development of systemic eosinophilia in rare cases. Patients with known hypersensitivity to the active substance are restricted from use.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile of Aliento (Montelukast sodium) based on documented clinical presentations and mandated emergency responses. In the event of a suspected or confirmed acute overdose, it is required that immediate medical attention be sought, and the local Poison Control Center or emergency services be contacted.

Documented Manifestations and Actions

Classification Aspect Official Regulatory Statement
Documented Presentations Clinical manifestations reported following acute overdose include abdominal pain, somnolence, thirst, headache, and vomiting.
Pediatric Considerations Psychomotor hyperactivity is a manifestation frequently reported in pediatric patients in the context of overdose.
Antidote Status No specific antidote is known for Montelukast sodium.
Required Management Treatment is symptomatic and supportive. Consideration may be given to procedures such as gastric lavage and activated charcoal administration, and hospital monitoring may be required.

Overdose Profile Summary

Treatment must focus on supportive care due to the lack of a known antidote. Regulatory information notes that the drug is highly protein bound, meaning that dialysis procedures are unlikely to be effective in removing the substance. The requirement to seek immediate medical attention applies to all cases of suspected acute overdose.

Therapeutic Uses of Aliento

What Aliento Treats: Main Uses and Benefits

Aliento is commonly used across three primary therapeutic domains, which include situations involving symptoms related to inflammatory or irritative states in the airways. The therapeutic role is focused on the long-term management of conditions involving symptoms related to inflammatory or irritative states.

This treatment is applied across domains where additional symptomatic support is needed for the prophylaxis and chronic treatment of persistent asthma, the management of seasonal and perennial allergic rhinitis, and the prevention of breathing difficulty related to exercise.

Quick Fact: Relief for Airway Symptoms Primary Benefit Therapeutic Scenario
Symptom Load Easing Symptoms of physical discomfort.
Functional Stability Symptoms that interfere with daily comfort.
Prophylactic Support Symptoms related to heightened physiological activity.

The medication helps address symptom clusters that may become intense or disruptive, such as recurring wheezing, coughing, and persistent nasal congestion. When applied appropriately, the treatment contributes to easing the overall symptom load and assists with maintaining functional stability.

Eligibility and Restrictions for Use

Who Can and Cannot Use Aliento (Montelukast Sodium)

Official regulatory documents define strict criteria for patient eligibility to use Aliento, focusing on age, physiological state, and specific clinical conditions.

Contraindications and Restrictions

Classification Population/Scenario
Absolute Contraindication Patients with known hypersensitivity to Montelukast sodium or any non-active ingredients.
Scenario Restriction Not indicated for use in the reversal of acute asthma attacks (bronchospasm).
Comorbidity Restriction Chewable tablets contain aspartame; caution is required for individuals with Phenylketonuria (PKU).

Age and Physiological Eligibility

Aliento is approved for a wide range of ages, but specific minimum age limits apply based on the condition being treated. Safety and effectiveness are not established for treating asthma in children under 12 months of age.

Population Group Eligibility Status
Asthma Prophylaxis Approved for patients 12 months of age and older.
Allergic Rhinitis Approved for patients as young as 6 months of age (Perennial Allergic Rhinitis).
Older Adults (Geriatric) No dosage adjustment is necessary; use is allowed under standard conditions.
Pregnancy/Lactation Use is advised only if clearly needed; caution is required for nursing mothers due to excretion in human milk.

Usage is permitted for patients with renal insufficiency or mild-to-moderate hepatic insufficiency without requiring a dosage change.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documentation structures the interaction profile of Aliento based on two main pharmacological considerations: agents that significantly alter its blood concentration and agents that increase the risk of bleeding.

Contraindicated Combinations and Avoidance

Category Mechanism and Implication
Combined P-gp and Strong CYP3A Inhibitors (e.g., specific azole antimycotics, HIV protease inhibitors) These agents significantly increase Aliento exposure by inhibiting both the P-glycoprotein efflux pump and the CYP3A enzyme pathway, a pharmacokinetic change that contraindicates co-administration due to a high risk of adverse effects.
Combined P-gp and Strong CYP3A Inducers (e.g., rifampin, enzalutamide) These agents significantly decrease Aliento exposure via dual P-gp/CYP3A induction, which should be avoided due to the resulting risk of reduced therapeutic effect.

Use with Caution and Monitoring Required

Co-administration with other medications that affect blood clotting, including other anticoagulants (e.g., heparin, warfarin), NSAIDs, aspirin, or other antiplatelet agents, carries a documented increased risk of bleeding and necessitates careful assessment and monitoring. Furthermore, in patients with compromised renal function (CrCl 15 to <80 mL/min), co-administration with moderate combined P-gp and CYP3A inhibitors is generally not recommended unless closely supervised.

Mechanism of Action

Targeting the CysLT1 Receptor via Antagonism

Aliento functions as a highly selective antagonist of the CysLT1 receptor (Cysteinyl Leukotriene Receptor Type 1). By physically occupying this receptor, the drug effectively blocks the binding of the endogenous inflammatory mediators ( LTC4, LTD4, and LTE4), which are key activators of the leukotriene signaling pathway. This molecular interference prevents the initiation of the downstream cellular response.

Modulation of Airway Smooth Muscle and Edema

The blockade of the CysLT1 receptor directly interrupts the signals that cause airway smooth muscle to contract and small blood vessels to become leaky. This mechanism produces two key physiological consequences: preventing CysLT-mediated loss of airway patency by blocking constriction and mitigating mucosal swelling by reducing fluid extravasation into the tissue. The resulting physiological adjustments define the reduction of chronic, excessive mediator activity on the respiratory passages.

Functional Specificity and Mechanism Limitations

This mechanism is characterized by its high specificity to the CysLT pathway, meaning it does not interfere with inflammatory processes driven by other mediators, such as histamine or prostaglandins. Due to its reliance on preemptive receptor blockade, this mechanism operates primarily as a long-term modulator of the physiological process and is functionally constrained from producing rapid reversal of pre-established muscle contraction.

Dosage and Administration Information

Official Administration Guidelines

Aliento (Montelukast) is administered orally and is intended for once-daily, continuous administration as a long-term maintenance treatment, not for the relief of acute episodes. The required dosage is strictly fixed by age cohort. Adults and adolescents aged 15 years and older receive 10 mg once daily. Pediatric patients aged 6 to 14 years receive 5 mg, and those aged 2 to 5 years receive 4 mg daily.

Dosing Schedule and Timing

The timing for the daily dose is conditional: when used for chronic airway issues or a combination of chronic airway and nasal symptoms, the medication must be taken in the evening. If used exclusively for allergic rhinitis, the time of administration may be individualized. No numerical dosage adjustment is required for older adults or for patients with mild-to-moderate kidney or liver impairment.

Form-Specific Instructions

Administration requires form-specific handling. The 10 mg film-coated tablet may be taken with or without food and must be swallowed whole. Chewable tablets must be chewed before swallowing, and it is suggested to take them one hour before or two hours after food. Oral granules must be administered within 15 minutes of opening the packet and can be mixed with a spoonful of specified cold, soft foods or small amounts of breast milk/formula. If a dose is missed, it must be skipped, and the patient should resume the next scheduled dose at the regular time; two doses must not be taken at once.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Aliento (Montelukast)

The clinical evaluation of Aliento (Montelukast) has been performed through numerous scientific investigations, primarily using randomized controlled trials (RCTs) and systematic reviews published in peer-reviewed scientific literature. The research describes the study of this medicine for long-term management of chronic respiratory conditions.

Clinical Evidence for Chronic Management of Persistent Asthma

Research examined Aliento's role in the long-term management of persistent asthma, a condition characterized by fluctuating or episodic manifestations. Studies were conducted involving adults, adolescents, and children as young as one year old. Researchers monitored physiological strain and outcomes related to functional status. Primary outcomes monitored changes in objective lung function measures, such as the Forced Expiratory Volume in 1 second (FEV1), along with patient-reported outcomes describing perceived discomfort and frequency of rescue inhaler use.

Against Placebo: Studies reported that individuals receiving Aliento had measured differences in FEV1 and PEFR compared to those on placebo. Trials described patterns of less frequent self-reported asthma symptoms and a lower rate of rescue inhaler use in the Montelukast groups. Research examined whether the combination was associated with changes in symptom scores and lung function when Aliento was used as an add-on therapy to inhaled corticosteroids (ICS).

Research for Allergic Rhinitis and Exercise-Induced Bronchoconstriction

Aliento was evaluated in studies for its potential role in managing seasonal and perennial allergic rhinitis, a condition involving periods of heightened symptoms. Research explored outcomes related to physical discomfort, including changes in nasal and ocular symptom scores. Research observed measured differences in symptom indicators compared to placebo. Research explored Aliento for allergic rhinitis, particularly in individuals who have an inadequate response to, or cannot tolerate, alternative first-line treatments.

Studies also explored Aliento for its use in conditions associated with acute or disruptive episodes, specifically breathing difficulty related to exercise-induced bronchoconstriction (EIB). Controlled challenge studies reported that a single dose of Aliento was associated with measured differences in the maximum drop in FEV1 after the exercise challenge, compared to those receiving placebo.

Frequently Asked Questions (FAQ)

Common questions about Aliento (FAQ)


Q: What is the main reason a doctor might prescribe Aliento?

Regulatory documents state that Aliento is indicated for the long-term management and prevention of asthma symptoms. It is also approved for preventing breathing difficulties associated with exercise, and for the treatment of allergic rhinitis, commonly known as hay fever. Official information describes Aliento as a medicine used for chronic, ongoing treatment and not for immediate-relief of acute symptoms.

Q: How long does it usually take to notice what Aliento is intended to do?

Aliento is a long-term maintenance drug designed to modulate underlying inflammation, rather than provide immediate relief. Regulatory-cited clinical data shows that a component of the drug’s action, called bronchodilation (opening the airways), can begin within two hours of taking a dose. However, the full clinical benefit for managing chronic conditions typically takes longer to achieve with consistent use.

Q: Do over-the-counter supplements interact with Aliento?

Regulatory documents primarily focus on known interactions with other prescription medications that affect how the medicine is processed by the body. Because many different types of over-the-counter supplements and herbal products exist, official patient materials suggest discussing all non-prescription items with a healthcare provider or pharmacist.

Q: Can Aliento be used by patients who have had liver problems?

Official documents note that no dosage change is typically required for patients with mild to moderate liver impairment. However, rare reports of liver injury (hepatitis) associated with the medicine have been documented. The consideration of pre-existing liver conditions is part of the clinical assessment process prior to using Aliento.

Q: Is Aliento only for the specific condition mentioned in the official uses?

Aliento is only approved and indicated for the conditions specifically described in the regulatory documents, which are the long-term management of asthma, the prevention of exercise-induced breathing difficulty, and the treatment of allergic rhinitis. Official prescribing information is limited to these approved uses.

Q: Do people typically feel any immediate effects after starting Aliento?

The official documentation describes this medicine as a long-term maintenance therapy for chronic conditions. It is not intended for use in sudden or acute symptoms, such as an asthma attack. While the medicine begins working in the body quickly, it is not consistently associated with a specific, immediate physical sensation of relief.

Q: Is there a generic version of Aliento available?

Yes, the active ingredient in Aliento is montelukast sodium. This active substance has FDA-approved generic versions available. These generic versions are supplied in various dosage forms, including standard tablets, chewable tablets, and oral granules.

Q: Is it true that Aliento has a 'Black Box Warning' or special safety statement?

Yes. The FDA and other regulators have required a Boxed Warning on the official product labeling. This warning highlights the risk of serious neuropsychiatric events, such as agitation, depression, suicidal thoughts, and changes in behavior, which have been reported in all age groups.

Q: Can people with asthma or other breathing problems use Aliento?

Regulatory documents state that Aliento is specifically indicated for the long-term prevention and management of asthma symptoms. It is used to help control chronic airway inflammation, but it must not be used as a treatment for acute, sudden breathing problems or attacks.

Q: Do lifestyle factors like smoking affect how Aliento works?

While some clinical research has examined the use of the drug in active smokers, official labeling does not include specific dosage adjustments or warnings related to smoking as a lifestyle factor impacting the drug’s effectiveness. The official prescribing information does not list smoking as a contraindication.

Q: Is Aliento associated with weight gain or weight loss?

Regulatory summaries of clinical trials for the medicine indicate that neither weight gain nor weight loss was reported as a common side effect of the tablets or chewable tablets during the studies. The product label does not list weight change as a common adverse reaction.

Q: How reliable is the research evidence supporting the use of Aliento?

The clinical evaluation for Aliento is described as being performed through standard scientific investigations. This research primarily uses methods such as randomized controlled trials (RCTs) and systematic reviews, which assess patient outcomes related to lung function and physical symptoms.

Q: Does Aliento interact with birth control pills?

Official regulatory documents indicate that specific studies have examined the co-administration of the drug with oral contraceptives. These studies found that the drug does not cause clinically significant changes in the concentration of these contraceptives.

Q: Can Aliento be taken with antacids or heartburn medicine?

Official pharmacokinetic studies, which track how the body processes the medicine, do not report a known interaction between Aliento and antacids. Based on this information, no dosage adjustment is typically required when co-administering the drugs.

Q: What does it mean if Aliento has a 'half-life' of several hours?

Half-life is a scientific term used to describe the time it takes for the concentration of the medicine in the blood to decrease by half. Official documents state that Aliento has a mean plasma half-life generally ranging from 2.7 to 5.5 hours, which supports its established once-daily administration schedule.

How should Aliento be stored and disposed of?

Official Storage and Disposal Requirements

The storage of Aliento (Montelukast sodium) is defined by strict regulatory conditions to maintain the product's stability. The medicine must be stored at Controlled Room Temperature, specifically between 20°C and 25°C (68°F and 77°F).

It is mandatory to protect the product from light and moisture and keep it in the original packaging to ensure its integrity. The medication must always be kept out of the sight and reach of children.

For the Oral Granules, regulatory documents require the dose be administered immediately after opening the sachet, or within 15 minutes if mixed with food.

Disposal must be conducted in accordance with local requirements; unused or expired medicine must not be thrown into wastewater or household rubbish.

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

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