Sintrine

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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 Sintrine

Quick Facts

Property Description
Active ingredient Montelukast sodium
Form Film-coated tablets, chewable tablets, oral granules
Pharmacological class Leukotriene receptor antagonist (LTRA)
Common use Prophylactic maintenance therapy
Origin Synthetic compound

Identity, Classification, and Origin

Sintrine is a synthetic, prescription-only medicine whose active ingredient is Montelukast, typically formulated as Montelukast sodium for pharmaceutical stability. The drug is classified as a Leukotriene receptor antagonist (LTRA), a high-level pharmacological designation. Sintrine is a single-ingredient product, and as a non-steroidal compound, it acts independently of corticosteroids in controlling certain inflammatory responses.

The foundational identity of Montelukast involves selective binding to the CysLT1 receptor, an action that is clinically recognized for its role in mitigating the effects of potent inflammatory mediators called cysteinyl leukotrienes (CysLTs). Research confirms that this mechanism positions the drug as an effective modulator of the leukotriene pathway, meaning the medicine is specifically designed to continuously block the chemical signals that can otherwise cause inflammation and tightening of certain breathing passages in the body.

Composition and General Purpose

Sintrine is supplied for oral administration in various dosage forms, specifically film-coated tablets, chewable tablets, and oral granules. This range of options is a feature designed to meet the needs of its full target audience, including both adults and pediatric patients. The primary composition includes the active Montelukast sodium along with pharmaceutical excipients necessary for stable oral forms. The overall purpose of this drug is to serve as a prophylactic agent intended for maintenance therapy to stabilize and support clear breathing over time. This type of medication is designed for ongoing management, which is typical for LTRAs used when continuous control of airway inflammation is needed.

Regulatory References

  1. Montelukast - StatPearls - NCBI Bookshelf
  2. Montelukast: MedlinePlus Drug Information

What side effects are possible with Sintrine?

Possible Side Effects and Safety Information

Sintrine (Montelukast) has an official spectrum of possible adverse reactions, which are classified by frequency and affect various physiological systems as documented in government regulatory sources.

Classification of Adverse Reactions

The most frequently reported adverse reaction, classified as very common, is upper respiratory infection. Reactions classified as common may affect up to 1 in 10 people and include headache, abdominal pain, diarrhea, nausea, and fever. Less frequent (uncommon) reports include psychiatric disorders such as insomnia, anxiety, agitation, and depression, along with dizziness and rash. Rare effects include palpitations and an increased bleeding tendency.

Serious Safety Considerations

Regulatory documents highlight the potential for serious adverse reactions. Very rare events include severe neuropsychiatric events such as suicidal thinking and behavior, hallucinations, and severe depression. Systemic eosinophilia, sometimes presenting as Churg-Strauss syndrome (a form of vasculitis), is also officially documented, often associated with the reduction or withdrawal of oral corticosteroids. Hepatitis is listed as a very rare effect.

Population-Specific and General Safety Notes

No routine dosage adjustment is required for older adults or individuals with renal or mild-to-moderate hepatic impairment. For patients with aspirin-sensitive asthma, the official labeling requires the continued avoidance of aspirin and other non-steroidal anti-inflammatory drugs. The chewable formulation contains aspartame, a source of phenylalanine, which is a consideration for patients with phenylketonuria (PKU).

Overdose and Emergency Response

Overdose scope

Feature Official Regulatory Statement
Documented overdose presentations Clinical findings in overdosage reports are consistent with the drug’s known safety profile; the majority of reports did not involve unique or severe adverse experiences.
Physiological systems affected Manifestations most frequently reported were related to the Central Nervous System (CNS) and Gastrointestinal (GI) systems, including: somnolence, headache, psychomotor hyperactivity, abdominal pain, vomiting, and thirst.
Dose-related or exposure-related factors Overdosage has been reported in both adults and children, with documented doses in children as high as 1,000 mg.
Emergency-response statements Treatment involves employing the usual supportive measures, instituting supportive therapy, if required, and considering the removal of unabsorbed material from the gastrointestinal tract.
When immediate medical help is required Seek emergency medical attention for any suspected overdose. Immediately call emergency services if the individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Overdose classifications (high-level)

Classification Detail Official Regulatory Statement
Severity classification Overdosage manifestations align with the drug’s known safety profile.
Overdose-context constraints No specific information is available on the treatment of overdosage; therefore, no specific antidote is known.

Resulting overdose structure

Official overdose statements:

  • The most frequently reported manifestations in acute overdose cases are primarily CNS and GI-related, including somnolence, headache, abdominal pain, vomiting, and psychomotor hyperactivity.
  • No specific antidote is known, and the clinical findings were consistent with the drug's established safety profile.
  • Management requires immediate medical attention and is procedural, involving supportive measures and clinical monitoring.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the Sintrine overdose profile by detailing the documented CNS and GI manifestations reported in post-marketing experience. As no specific antidote is available, official guidance mandates that individuals must seek emergency medical attention for suspected overdose, after which treatment is structured around employing supportive care and clinical monitoring.

Therapeutic Uses of Sintrine

What Sintrine Treats: Main Uses and Benefits

Sintrine (Montelukast) is commonly used as a prophylactic medication for the long-term management of conditions presenting with systemic or localized discomfort in the respiratory and allergic domains. The medicine may assist with preventing symptoms across three primary areas: chronic asthma, Exercise-Induced Bronchoconstriction (EIB), and Allergic Rhinitis (both seasonal and perennial).

The medication is applied in addressing symptoms related to heightened physiological activity, such as recurring wheezing, chest tightness, persistent coughing, profuse sneezing, and nasal congestion. By supporting the patient with chronic symptoms, the medication provides support that may assist with maintaining functional stability and contributes to easing the overall symptom load. The central benefit is to help patients cope more steadily with symptom fluctuations. The medication is considered relevant during phases when symptoms become more noticeable or when episodic prevention is required.


Quick Fact: Relief for Respiratory and Allergic Discomfort
Primary Therapeutic Goal Supports the management of symptoms that interfere with daily comfort.
Core Symptom Clusters Wheezing, chest tightness, coughing (asthma); Sneezing, runny/stuffy nose, itchy eyes (rhinitis).
Key Clinical Scenarios Long-term asthma maintenance; Supportive relief in scenarios requiring short-term symptomatic assistance; Seasonal and year-round allergy management.

Regulatory References

  1. NIH MedlinePlus overview of Montelukast

Eligibility and Restrictions for Use

Eligibility and Contraindications

The official eligibility profile for Sintrine (Montelukast) is defined by strict population rules outlined in regulatory documents. Sintrine is contraindicated for patients with known hypersensitivity to the active substance or any formulation component. It must never be used for the treatment of acute asthma attacks or status asthmaticus, as it is intended solely for chronic maintenance therapy.

Age and Pediatric Limitations: Use is established for adults and adolescents (ge 15 years). Pediatric eligibility varies by condition, with the minimum established age ranging from 6 months for certain allergies to 12 months for asthma. Safety and effectiveness are not established for infants below these respective age thresholds.

Physiological Restrictions: Use during pregnancy and lactation is restricted and permitted only if considered clearly essential by the prescribing authority. No dosage adjustment is necessary for patients with renal impairment or mild to moderate hepatic impairment, though use has not been assessed for individuals with severe hepatic impairment.

Specific formulations may also be contraindicated for patients with certain hereditary metabolic disorders, such as galactose intolerance, or require caution for those with Phenylketonuria (PKU).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Sintrine ( montelukast) can generally be administered alongside other standard medications used for the chronic management and prevention of asthma, including inhaled and oral corticosteroids, theophylline, short-acting beta-agonists, and oral contraceptives. Studies have shown that Sintrine does not significantly alter the concentration of medicines like warfarin, digoxin, fexofenadine, or prednisone in the body.

However, potential interactions exist with products that strongly affect certain liver enzymes ( Cytochrome P450). Sintrine is metabolized by enzymes, primarily CYP2C8, but also by CYP3A4 and CYP2C9.

Interacting Product Category Example Medicines Interaction Effect
Potent Enzyme Inducers Phenytoin, Phenobarbital, Rifampicin Significantly decrease the concentration of Sintrine in the bloodstream. Clinical monitoring is advised.
Potent CYP2C8 Inhibitors Gemfibrozil Substantially increase the concentration of Sintrine. No routine dose change is typically needed, but physicians should monitor for increased adverse effects.

Restriction: Patients with a known hypersensitivity to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are advised to continue avoiding these agents while taking Sintrine. Sintrine must not be used to treat sudden, acute asthma attacks. If other anti-asthma medicines are being taken, their dosage should not be reduced or stopped suddenly without professional medical guidance. (198 words)

Mechanism of Action

Targeted Blockade of Cysteinyl Leukotriene Receptors

Sintrine (Montelukast) acts as a highly selective competitive antagonist at the Cysteinyl Leukotriene Receptor type 1 (CysLT1), the primary target for potent inflammatory mediators released from cells like mast cells and eosinophils. This engagement focuses on mechanisms that regulate signaling by preventing leukotrienes, such as LTD4, from binding to and activating the CysLT1 receptor. The resulting physiological effect is the inhibition of leukotriene-mediated bronchoconstriction and leads to a reduction in leukotriene-mediated smooth muscle contraction.

Modulation of Airway Inflammatory Cascades

By suppressing the initial signaling events at the CysLT1 receptor, Sintrine modifies early molecular steps that shape systemic physiological outcomes in the airways. This modulation impacts cascades associated with inflammatory responses, including those that increase the leakiness of small blood vessels and stimulate the movement of inflammatory cells into the airway lining. This mechanism leads to a reduction in airway swelling (edema) and diminished cellular inflammation, resulting in a modulation of CysLT1-driven inflammatory processes.

Mechanistic Constraints and Action Profile

The drug's mechanism is aligned with domains requiring continuous, long-term pathway adjustment, rather than rapid adjustment of muscle tone. Because its action is based on competitive blockade, it is mechanistically insufficient to reverse acute, severe bronchospasm, as it lacks the rapid signal initiation required for rescue medication. This specific mechanistic profile provides sustained antagonism of the CysLT1 receptor.

Dosage and Administration Information

How to Use Sintrine (Montelukast)

Sintrine is an orally administered medication and is prescribed as a once-daily dose (qDay) for chronic management. The available official formulations include 10 mg film-coated tablets for adults and adolescents (ge 15 years), 5 mg and 4 mg chewable tablets, and 4 mg oral granule packets primarily for pediatric use.

Administration and Timing

For chronic respiratory management, the daily dose is typically administered in the evening. However, if the medication is used only for allergic rhinitis, the daily dose may be taken in the morning or the evening. Chewable tablets and film-coated tablets may be taken with or without food.

Specific Use Instructions

The oral granules are designed for consumption immediately upon opening the packet; they can be placed directly in the mouth or mixed with a spoonful of soft, cold, or room-temperature food or liquid and must be consumed within 15 minutes of mixing.

For the prevention of Exercise-Induced Bronchoconstriction (EIB), the official regimen is a single 10 mg dose (or 5 mg for eligible pediatric patients) taken at least 2 hours before exercise, with the critical constraint that a separate EIB dose cannot be taken within 24 hours of any previous Montelukast dose.

Population-Based Dosing

Dosage is strictly determined by age; for instance, the standard adult and adolescent dose is 10 mg, while children 6 to 14 years receive 5 mg, and children 2 to 5 years receive 4 mg. It is observed that no dosage adjustment is typically required for older adults or patients with existing renal impairment or mild-to-moderate hepatic impairment.

Recent Clinical Evidence

Research evidence / Overview of studies for Sintrine

Evidence for use in Chronic Asthma (Long-Term Management)

Research exploring how symptoms change over time in chronic asthma was studied for this medicine primarily through Randomized Controlled Trials (RCTs) and systematic reviews. These studies monitored outcomes related to physical discomfort, including lung function (such as FEV1) and patient-reported measures like rescue inhaler use. Systematic reviews noted that the magnitude of reported changes measured during the study period varied when compared to other maintenance treatments. The research describes symptom patterns in populations studied with conditions characterized by fluctuating or episodic manifestations.

Evidence for use in Exercise-Induced Bronchoconstriction (EIB)

The medicine was studied for the prevention of EIB using short-term, acute RCTs, often utilizing a crossover design with standardized exercise challenges. These trials monitored physiological strain by measuring the maximum fall in FEV1 following the challenge. Research describes measured airway response patterns observed in trials in the context of physical activity in Children and Adults (ge 6 years).

Evidence for use in Allergic Rhinitis (Seasonal and Perennial)

Research examined the medicine's use for conditions involving periods of heightened symptoms using RCTs and subsequent Meta-Analyses. Studies evaluated patient-reported outcomes for nasal and ocular symptoms. Reports noted that the magnitude of observed change in symptoms varied when compared to other medications evaluated in the research setting, and certainty remains low regarding its use in the overall management of allergic rhinitis.

Evidence in Special Populations and Research Gaps

Pediatric patients were evaluated in trials covering children as young as 12 months for asthma and 6 months for perennial allergic rhinitis. The results apply only to the populations studied, and data for certain groups remain insufficient, such as studies focusing specifically on older adults or individuals with complex comorbid conditions. Long-term effects are not yet fully established by controlled trials; comparative evidence is lacking, particularly when the medicine is used alone. Evidence quality varies, as multiple external factors may influence data in observational settings.

Key Studies & References

  1. Montelukast: risk of mental disorders vs. efficacy – a meta-analysis (Frontiers in Pharmacology)
  2. The role of inhaled corticosteroids and montelukast in children with mild-moderate asthma: results of a systematic review with meta-analysis (NCBI Bookshelf)

Frequently Asked Questions (FAQ)

Common questions about Sintrine (FAQ)

Q: Is Sintrine a type of antibiotic or something different?

A: Sintrine is classified by regulatory authorities as a Leukotriene Receptor Antagonist (LTRA). This means its function is to block specific inflammatory substances, called leukotrienes, in the body. It belongs to a pharmacological class that is distinct from antibiotics.

Q: Are there any common foods or drinks that should be avoided when using Sintrine?

A: Official information states that Sintrine tablets can be taken with or without food. No specific common foods or drinks are listed in the product documentation that are listed as needing strict avoidance.

Q: Is it okay to have coffee or caffeine while using Sintrine?

A: The official product information does not list a known drug interaction between Sintrine and caffeine or coffee. The regulatory documents do not provide specific guidance regarding the use of caffeine.

Q: Does Sintrine interact with birth control pills?

A: Studies mentioned in the regulatory documents indicate that Sintrine does not significantly change the concentration of oral contraceptives (birth control pills) in the body.

Q: Does Sintrine need to be taken at the exact same time every day?

A: Sintrine is prescribed as a once-daily dose to support continuous therapeutic effects. Regulatory documents describe the requirement as a once-daily dose, often specifying a general time of day (such as the evening for chronic respiratory management).

Q: How quickly does Sintrine start to work after I take it?

A: Official information indicates that Sintrine is rapidly absorbed following administration, reaching its highest concentration in the bloodstream in about 3 to 4 hours in adults. Effects on the breathing passages have been observed in clinical trials as quickly as within 2 hours of taking a dose.

Q: What happens if I stop taking Sintrine suddenly?

A: Regulatory warnings concerning the risk of serious side effects (like neuropsychiatric events) mention that treatment discontinuation has been associated with symptom resolution in reported cases. The specific course of action is generally determined by a healthcare provider.

Q: How long does Sintrine stay in your system?

A: According to official pharmacokinetic data, the mean plasma half-life of the active ingredient in healthy young adults is documented to range between 2.7 and 5.5 hours. The half-life is the time it takes for the amount of medicine in the body to be reduced by half.

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

A: Official reports of adverse reactions list dizziness as an uncommon side effect. The adverse reactions are reported based on overall data from clinical trials and are not specifically tracked only during the initial days or weeks of treatment.

Q: What is the usual timeframe before the full effect of Sintrine is noticeable?

A: Clinical trials designed to demonstrate the full effectiveness of Sintrine for chronic conditions typically monitored patient outcomes over periods of 4 to 6 weeks. These trials represent the duration required to fully observe and assess the medicine’s sustained benefits.

Q: Is Sintrine commonly prescribed for long-term conditions?

A: Regulatory documentation describes Sintrine as a prophylactic agent intended for chronic treatment and maintenance therapy. The medicine is officially intended for ongoing management.

Q: Do studies show that Sintrine is better absorbed when taken with food?

A: Pharmacokinetic studies have shown that the absorption and peak concentration of the 10 mg tablet are not significantly influenced by the presence of a standard meal. This indicates that food does not significantly affect the initial absorption characteristics of the tablet.

Q: Are there any known issues with Sintrine and heart rhythm?

A: Official reports of adverse reactions list palpitations, which are changes in the sensation of a heartbeat, as a rare adverse event. The official product information does not specify other known issues related to overall heart rhythm.

Q: Does Sintrine have a risk of dependence or addiction?

A: Sintrine (Montelukast) is not listed as a controlled substance by regulatory bodies in the United States or comparable agencies internationally. This classification reflects that the drug is not associated with the same risks for dependence or addiction as controlled substances.

Q: Is there a generic version of Sintrine available?

A: Yes, regulatory authorities have approved generic versions of the active ingredient, montelukast sodium, for use. These generics are available in multiple dosage forms and strengths.

Q: Is Sintrine safe to take with alcohol?

A: The official product information does not list a known drug interaction between Sintrine and alcohol.

Q: Can Sintrine be split in half?

A: The official labeling describes the available dosage forms, such as film-coated tablets and chewable tablets. Regulatory guidance generally advises against tablet splitting unless the tablet is officially scored and splitting is indicated in the product labeling.

Q: How long does a typical course of Sintrine last?

A: Sintrine is indicated for chronic treatment and maintenance therapy. This means its purpose is for ongoing management of symptoms, and its use is typically continuous rather than a short, fixed course.

Q: Is Sintrine a relatively new or old drug?

A: The active ingredient in Sintrine, montelukast, was initially approved by the FDA in 1998. The drug has been available and monitored by regulatory bodies since that time.

Q: Why is Sintrine sometimes used in combination with other medicines?

A: Sintrine is classified as an LTRA indicated for maintenance therapy. Its regulatory role is that of an add-on or maintenance treatment alongside other standard medications, such as inhaled corticosteroids, for the comprehensive, chronic management of certain conditions.

How should Sintrine be stored and disposed of?

How to Store and Dispose of Sintrine (Montelukast)

Sintrine must be stored at a Controlled Room Temperature of 25 C (77 F), with permitted excursions between 15 C and 30 C (59 F and 86 F). The medicine must be kept in its original container, which should be tightly closed, and stored in an environment that provides protection from light and moisture.

Handling and Child Safety

For oral granules, the dose must be used within 15 minutes of opening the packet. Like all medicines, Sintrine must be stored out of the sight and reach of children.

Disposal

Unused or expired Sintrine should not be disposed of in wastewater or general household trash. To protect the environment, the medicine must be discarded through regulated channels, such as an official drug take-back program or by returning it to a pharmacist for appropriate pharmaceutical waste disposal.

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

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