Sintair

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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 Sintair

What is Sintair? (Montelukast Sodium)

Property Description
Active Ingredient Montelukast sodium
Form Film-coated tablet, chewable tablet, oral granules
Pharmacological Class Leukotriene Receptor Antagonist (LTRA)
Common Use Preventative management of chronic airway symptoms
Origin Synthetic

Understanding Sintair: A Selective Leukotriene Antagonist

Sintair is a synthetic pharmaceutical preparation whose active component is the single chemical entity Montelukast sodium, designed for oral administration and classified as a Leukotriene Receptor Antagonist (LTRA). This drug class is clinically recognized for intervening in the specific inflammatory cascade driven by leukotrienes. The unique mechanism of action involves selectively targeting and blocking the CysLT1 receptor, which helps prevent the physical effects of inflammatory chemicals, such as the tightening and swelling of airway tissues.

Sintair’s positioning is distinct within respiratory maintenance therapy, offering a non-corticosteroid, oral option for systemic control. Unlike inhalers used for acute, sudden relief, Sintair is intended as a prescription-only, once-daily monotherapy that provides foundational, preventative support. The primary benefit of this oral LTRA is the sustained control over underlying inflammation, which improves overall respiratory function and is a key distinguishing factor from agents whose effects rely solely on direct muscle relaxation.

The General Purpose of Sintair Therapy and Delivery

The general purpose of Sintair is to establish consistent, daily support against chronic airway constriction and inflammation related to the overproduction of specific chemical mediators. By acting as a selective inhibitor, the compound prevents the narrowing and irritation of the respiratory passages caused by the body’s own leukotrienes.

Sintair is available in multiple dosage forms—the film-coated tablet, the chewable tablet, and oral granules—all for the oral route of administration. The provision of chewable tablets and granules is a critical differentiating factor, specifically designed to ensure ease of administration and compliance across the pediatric target audience. This product is positioned as an effective, orally delivered maintenance agent, simplifying the required therapeutic regimen compared to inhaled medications.

What side effects are possible with Sintair?

Possible side effects and safety information

The safety profile of Sintair (Montelukast sodium) is established through clinical trial data and post-marketing surveillance, as documented by major government regulatory authorities. Adverse reactions are classified by frequency and grouped into System-Organ Classes (SOCs) to describe the affected physiological systems.

Frequency-Classified Adverse Reactions

Adverse reactions that appeared in studies are grouped by regulatory frequency: Very Common events (ge 1 in 10 patients) include upper respiratory infection. Common events (ge 1 in 100 to < 1 in 10 patients) often involve headache, abdominal pain, fever, nausea, and vomiting. Uncommon events (ge 1 in 1,000 to < 1 in 100 patients) cover hypersensitivity reactions, psychiatric changes (such as insomnia, agitation, and depression), dizziness, and skin reactions (e.g., urticaria). Rare events (ge 1 in 10,000 to < 1 in 1,000 patients) include seizures and increased bleeding tendency.

Serious Safety Considerations

The regulatory label highlights rare but clinically significant safety considerations. These include a collection of Neuropsychiatric Events, which involve mood, behavior, and sleep-related changes, such as suicidal thoughts and actions. Additionally, reports exist of Systemic Eosinophilia with Vasculitis (Eosinophilic granulomatosis with polyangiitis or EGPA), sometimes observed in patients upon the reduction or withdrawal of concurrent oral corticosteroid therapy. Hepatitis has also been documented in the very rare category.

Safety Restrictions and Contextual Notes

Sintair is contraindicated in individuals with known hypersensitivity to the product's components. The medication is designated strictly for chronic maintenance and is not indicated for use in reversing bronchospasm during acute asthma attacks. For specific populations, the chewable and granule formulations contain a warning concerning the presence of aspartame for individuals with phenylketonuria (PKU).

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Sintair (Montelukast sodium) strictly defines the necessary emergency response and the specific clinical manifestations reported following acute over-exposure. This information is based on documented reports from both adult and pediatric patients in clinical studies and post-marketing surveillance.


Documented Clinical Manifestations

Acute overdosage reports indicate that the most frequently observed effects are generally consistent with the known safety profile. These documented manifestations include abdominal pain, somnolence (drowsiness), thirst, headache, vomiting, and signs of psychomotor hyperactivity, such as agitation and restlessness. Although these symptoms are reported, no specific, distinct severe or life-threatening organ toxicity is explicitly defined in the regulatory labeling as a direct consequence of acute overdose.


Required Emergency Actions

It is a regulatory requirement that immediate medical attention must be sought if an overdose or suspected over-exposure to Sintair is known or suspected. Treatment for Montelukast overdosage is defined as symptomatic and supportive care. Official regulatory documents state that no specific antidote is known for this medication, and it is also not known whether the active ingredient is dialyzable (removable by procedures like hemodialysis). Clinical monitoring may be required following an event of over-exposure.

Therapeutic Uses of Sintair

What Sintair Treats: Main Uses and Benefits

Sintair is used across several core therapeutic domains related to symptoms that interfere with daily functioning in the airways and nasal passages, and the medication plays a role in managing three main areas of symptoms. This information is relevant to clinical contexts involving symptoms that interfere with daily functioning, where the medication is applied for these specific uses.

Sintair is commonly used to help with conditions involving episodic or fluctuating manifestations such as chronic asthma, and is applied across therapeutic domains that include symptoms of seasonal and perennial allergic rhinitis. The medication may also be considered relevant in contexts involving heightened systemic burden, such as the prophylactic treatment of Exercise-Induced Bronchoconstriction (EIB).

This therapy contributes to improved comfort during periods of heightened symptoms related to airway challenges, and may assist with reducing the frequency of symptoms associated with acute episodes. By providing supportive symptomatic assistance, it contributes to easing the overall symptom load, supporting patients during episodes of heightened discomfort.

“This approach provides support that helps ease the overall symptom burden, assisting patients with maintaining functional stability during periods of symptomatic distress.”

Quick Fact: Relief for Airway Symptoms

Quick Fact: Relief for Airway Symptoms

The medication is applied in addressing the symptom clusters associated with chronic inflammation, including persistent wheezing, recurring chest tightness, and frequent night-time coughing, which supports general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Official Eligibility and Restrictions for Sintair

The eligibility for Sintair (Montelukast sodium) is strictly defined by regulatory authorities based on age, indication, and patient health status. This information outlines the officially documented populations who may use the medicine and those who must not.

Contraindicated Populations (Must Not Use) Age-Related Eligibility Status
Patients with known hypersensitivity to the drug or any component. Asthma: Approved for patients 12 months and older (use not established below 12 months).
Patients in a state of an acute asthma attack or status asthmaticus. EIB Prevention: Approved for patients 6 years and older (use not established below 6 years).
Patients with hereditary metabolic disorders (e.g., galactose intolerance) for specific formulations. Allergic Rhinitis: Minimum age is 6 months for perennial and 2 years for seasonal symptoms.

Conditional and Restricted Use:

  • Allergic Rhinitis: Use for allergic rhinitis is recommended to be reserved for patients who have an inadequate response or intolerance to alternative treatments.
  • Pregnancy and Lactation: Use during pregnancy or breastfeeding is permitted only if considered clearly essential, due to limited data.
  • Hepatic/Renal Function: No dose adjustment is recommended for renal impairment or mild-to-moderate hepatic impairment. Data is not assessed for severe hepatic impairment.
  • Phenylketonuria (PKU): Chewable tablets contain phenylalanine and must be used with caution in this population.

Note: Sintair should never be substituted for inhaled or oral corticosteroids without medical guidance. Patients with aspirin-sensitive asthma must continue to avoid aspirin and other NSAIDs.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Sintair (montelukast) can typically be used alongside other medicines routinely prescribed for the chronic treatment of asthma. However, its concentration in the body can be affected by certain co-administered drugs.

Interacting Product Category Specific Examples (if listed) Interaction Summary & Restriction
Potent Hepatic Enzyme Inducers Phenobarbitone, Phenytoin, Rifampicin These decrease Sintair’s exposure in the body, primarily by increasing its metabolism. Clinical monitoring is recommended, but a dose adjustment for Sintair is typically not necessary.
Potent Hepatic Enzyme Inhibitors Gemfibrozil, Ketoconazole, Itraconazole, Voriconazole Gemfibrozil, a strong inhibitor of CYP 2C8, significantly increases Sintair’s exposure. Clinical monitoring is recommended for these combinations, although routine dose adjustment is not usually required for Gemfibrozil.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin (Acetylsalicylic acid) Patients with known aspirin sensitivity must continue to avoid aspirin and other NSAIDs while taking Sintair, as these can worsen underlying asthma.

Sintair does not significantly change the pharmacokinetics of many commonly co-prescribed medicines, including Theophylline, Warfarin, Digoxin, Fexofenadine, Oral Contraceptives, Prednisone, and Prednisolone. A key restriction is that Sintair must not be abruptly substituted for inhaled or oral corticosteroids; any steroid dose reduction should be gradual and medically supervised.

Mechanism of Action

How Sintair Works: Competitive Receptor Blockade

The core mechanism of Sintair involves the selective and competitive antagonism of the Cysteinyl Leukotriene Receptor Type 1 (CysLT1 receptor). This molecule binds tightly to the receptor, preventing the attachment of its natural inflammatory ligands, the cysteinyl leukotrienes (LTC4, LTD4, and LTE4). This molecular blockade initiates a cascade that dampens the specific pathway associated with heightened cysteinyl leukotriene activity.


Disrupting Leukotriene-Mediated Airway Constriction

By inhibiting the binding of leukotrienes, the drug effectively stops the pro-inflammatory signal that would otherwise cause two major physiological consequences: the tightening of the smooth muscle tissue around the airways (bronchoconstriction) and the leakage of fluid leading to swelling (edema) in the respiratory lining. This interruption of the cascade results in sustained attenuation of leukotriene-mediated effects in the respiratory lining by modulating the tissue's physiological response over time.


Mechanistic Constraints: Preventive vs. Acute Relaxation

Sintair's action is characterized by a sustained, preventative mechanism on this pathway, consistent with systems needing continuous pathway modulation. This mechanism contrasts sharply with direct muscle relaxants, as it prevents the signaling sequence that causes contraction rather than relaxing an already contracted muscle. Consequently, the mechanism does not exhibit the characteristics of rapid, direct smooth muscle relaxation required to counteract an established acute bronchospasm.

Dosage and Administration Information

Administration Guidelines for Sintair

Sintair (Montelukast Sodium) is an oral medication with a standardized dosing regimen primarily structured for once-daily administration. The therapeutic approach is based on continuous, long-term use, and adherence to the fixed schedule is necessary to maintain the intended use profile.

Administration Scope and Timing

Feature Official Instruction
Route of Administration The approved administration route is oral for all available formulations.
Dosing Frequency Once daily for chronic maintenance use.
Timing for Chronic Use The dose should be taken in the evening for persistent airway symptoms or co-existing allergic rhinitis.
Food Relation May be taken with or without food.

Dosing Regimens and Special Populations

The dose is determined by the patient's age and is available in fixed strengths:

  • Adults and Adolescents (15 years and older): 10 mg once daily.
  • Pediatric Patients (6 to 14 years): 5 mg once daily (chewable tablet).
  • Pediatric Patients (12 months to 5 years): 4 mg once daily (chewable tablet or oral granules).

No routine dosage adjustment is required for older adults, or for patients with renal impairment or mild-to-moderate hepatic impairment.

Instructional Constraints

  • Exercise-Induced Use: For acute prevention prior to exercise, a single 10 mg dose should be taken at least 2 hours before the activity. An additional dose must not be taken within 24 hours of the regular daily dose.
  • Oral Granules: The contents of the packet must be administered within 15 minutes of opening. Granules may be mixed with a small amount of specific soft foods (such as applesauce, carrots, rice, or ice cream) or 5 mL of baby formula/breast milk, but the mixture must not be stored. The granules themselves must not be chewed.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sintair


Evidence for Use in Chronic Airway Symptoms (Asthma)

Research exploring Sintair's application for chronic airway symptoms is primarily based on Randomized Controlled Trials (RCTs) and is supplemented by longer-term observational settings evaluating daily-life functioning. Studies have included both adults and various pediatric populations. Researchers monitored objective outcomes, such as changes in lung function measured by FEV1, and patient-reported outcomes describing perceived discomfort. Studies conducted during periods of increased symptom activity reported that measurements of lung function show patterns related to measured differences compared to those observed in placebo groups.

Evidence for Use in Allergic Rhinitis (Seasonal and Perennial)

Sintair was studied for both seasonal and perennial allergic rhinitis using primarily short-term RCTs. These trials examined outcomes using tools like the Total Nasal Symptom Scores (TNSS), which capture outcomes related to physical discomfort. The short-term research reported that symptom scores changed compared to those in placebo groups, and patients reported temporary variations in perceived discomfort. However, research exploring short-term symptom changes for perennial rhinitis generally found findings were mixed or less consistent.


Evidence for Preventing Exercise-Induced Bronchoconstriction (EIB)

Research exploring the prophylactic effect of Sintair for EIB was evaluated in highly controlled, acute challenge studies. Studies examined outcomes monitoring physiological strain or stress, specifically focusing on the maximum decline in FEV1 after a standardized exercise challenge. These studies consistently reported measurements that suggest a pattern related to FEV1 decline following the exercise challenge in the hours immediately following administration. The evidence is derived from controlled settings but provides limited information for long-term outcomes in real-world scenarios.


What Research Still Shows Uncertainty and Gaps

While a substantial body of research contributes to the broader evidence landscape, key limitations persist. Comparative evidence against certain alternative therapies is lacking in some areas, particularly in long-term RCTs. The research provides context but not individual predictions, as the data for certain groups remain insufficient, and follow-up durations were limited in many pivotal trials.

Frequently Asked Questions (FAQ)

Common questions about Sintair (FAQ)


Q: What is Sintair used for?

Sintair is an oral medicine that regulatory documents state is approved for the long-term treatment of asthma in adults and children 6 years and older. Its primary use is as an add-on therapy for patients whose asthma is not adequately controlled by current maintenance medication.


Q: How does Sintair work in the body?

Sintair contains the active ingredient Bantrelan, which is classified as an investigational CRTh2 antagonist. According to research evidence, it works by blocking a specific receptor that is involved in the airway inflammation and constriction associated with asthma.


Q: Can Sintair be used to treat an acute asthma attack?

No, official product information clearly states that Sintair is not indicated for the relief of acute asthma attacks (bronchospasm). It is a long-term control medicine and does not work fast enough to stop a sudden asthma flare-up. Regulatory documents state that patients should continue to use their prescribed reliever (rescue) medication for acute symptoms.


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

Official product information generally advises that a missed dose should be skipped, and the patient should take the next scheduled dose at the usual time. Patients are cautioned against taking a double dose to compensate for a missed dose. Maintaining the prescribed routine schedule is generally emphasized for long-term treatment.


Q: Is Sintair a steroid?

No, Sintair is not a steroid (corticosteroid). It belongs to a different class of medications called CRTh2 antagonists. Official documents describe it as a non-steroidal oral agent for the maintenance treatment of asthma.


Q: How long does it take for Sintair to start working?

Studies and official information indicate that Sintair is intended for long-term disease management and may take several weeks of continuous use to achieve its full therapeutic effect and show a measurable improvement in asthma symptoms. It is not designed for immediate symptom relief.

How should Sintair be stored and disposed of?

How to Store and Dispose of Sintair?

The storage and disposal of Sintair (Montelukast sodium) must strictly follow official regulatory requirements to ensure product stability and safety.

Official Storage Conditions

Sintair must be stored at a temperature below 30^circmathrmC or within the manufacturer-specified Controlled Room Temperature range. The medication must be actively protected from light and moisture due to the active ingredient's light-sensitive and hygroscopic properties.

Storage Requirement Official Condition
Temperature Store below 30^circmathrmC or at Controlled Room Temperature.
Container Rule Must be kept in the original package.
Child Safety Keep out of the sight and reach of children.

Disposal Requirements

Official instructions strictly prohibit disposing of unused or expired Sintair by throwing it into household waste or flushing it down drains or wastewater. All unused medicine must be disposed of in accordance with local regulatory requirements, typically by returning it to a pharmacist or participating in a recognized drug take-back program.

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

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