Sintal

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Medically reviewed

Rosario Oropesa

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 Sintal

What is Sintal? (Identity and Purpose)

Property Description
Active ingredient Sodium Cromoglycate (Disodium Cromoglycate)
Form Ophthalmic Solution, Nasal Spray, Inhaler Solution, Oral Capsule
Pharmacological class Mast Cell Stabilizer, Antiallergic Agent
Common use Prophylactic (Preventive) Management of Hypersensitivity
Origin Synthetic Compound

What is Sintal and What is its Composition?

Sintal is a synthetic pharmaceutical preparation formally classified as a Mast Cell Stabilizer and an Antiallergic Agent. The medicine is a single-entity product (monotherapy) where the sole active component is Sodium Cromoglycate, also frequently referred to as Cromolyn Sodium. This chromone derivative is the core element responsible for the drug’s pharmacological action. The classification as an antiallergic mast cell stabilizer defines its primary role as a preemptive management tool, a function recognized for supporting chronic, low-grade inflammatory conditions. Due to the wide range of presentations, the preparation may be designated as either a prescription or an over-the-counter (OTC) medicine, depending on its specific formulation and local regulatory authority.

The Pharmacological Class and Purpose of Sintal

Sintal belongs to the pharmacological class of non-steroidal antiasthma drugs and functions fundamentally as a prophylactic agent. Its primary purpose is to prevent the chain of events that lead to allergic discomfort. Cromolyn Sodium prevents the release of inflammatory mediators, including histamine and leukotrienes, which trigger allergic symptoms. This means the drug works by helping to secure a stable state and generally reducing the body’s overall sensitivity to known irritants, positioning it distinctly as a tool for general maintenance.

Available Forms and Targeted Application of Sodium Cromoglycate

Sodium Cromoglycate preparations, including Sintal, are supplied in several forms designed for localized application to sensitive mucosal surfaces. These identity-level dosage forms include the Ophthalmic Solution (Eye Drops), the Nasal Spray, and various Inhaler Solutions (for nebulization or metered-dose inhalation), alongside Oral Capsules. These diverse formulations are designed for non-systemic use, facilitating targeted delivery to tissues like the conjunctiva, nasal passages, or bronchial lining. This localized focus maximizes the stabilizing effect at the site of potential exposure. Systemic absorption from these forms is minimal, making local action its defining characteristic.

What side effects are possible with Sintal?

Possible Side Effects and Safety Information

The safety profile of Sintal (Sodium Cromoglycate) is characterized by adverse reactions that are predominantly localized and transient, aligning with the drug's limited systemic absorption from most administration routes (inhalation, nasal, ophthalmic). Safety information is categorized according to frequency and affected organ systems as defined in official regulatory documents.


Documented Adverse Reactions

Classification Examples of Officially Listed Effects
Common Localized Irritation: Cough, throat irritation, transient stinging/burning upon eye instillation, and nasal irritation. Systemic: Headache, nausea, and diarrhea (especially with the oral form).
Rare Systemic hypersensitivity reactions, including anaphylaxis and anaphylactic shock. Rare inflammatory conditions such as eosinophilic pneumonia and polymyositis are also documented.

Safety Considerations for Special Populations

Official prescribing information includes specific safety guidance for certain patient groups:

  • Hepatic or Renal Impairment: Cautious dose selection is advised, and a decreased dosage may be recommended for patients with reduced organ function, reflecting the drug's excretion pathways.
  • Older Adults: Dosage selection should be cautious, typically starting at the lower end of the dosing range due to the greater frequency of decreased organ function in this population.
  • Pregnancy and Lactation: Use during pregnancy is advised only if clearly needed. Excretion into human breast milk is considered unlikely based on the drug's physicochemical properties and poor systemic absorption.

The medicine is contraindicated in patients with a known hypersensitivity to Sodium Cromoglycate or any of the product's excipients. Regulatory labeling emphasizes that instillation of the ophthalmic solution may cause transient blurring of vision.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Sintal (Sodium Cromoglycate) emphasizes a substantial margin of safety, which is fundamentally based on the active ingredient’s minimal systemic absorption from its diverse localized forms, such as inhalation, nasal spray, or oral capsule. This low systemic availability provides a high safety index.

Documented Overdose Manifestations

Status Regulatory Finding
Clinical Syndrome No specific clinical syndrome is documented as being associated with an overdosage of the active substance in official prescribing information.
Adverse Effects Regulatory documentation indicates that no specific adverse effects are generally expected following the intake of excessive amounts due to the drug’s high safety margin.

Required Emergency Actions

Despite the anticipated low toxicity, regulatory authorities mandate specific actions for accidental or excessive exposure:

  • Urgent Medical Help: You must seek immediate medical assistance, or contact a Poison Control Center, whenever accidental swallowing or significant ingestion is suspected. This is required under the official label text.
  • Management: The documented management strategy required by regulatory agencies is medical observation or supervision. This approach reflects the low risk profile and the absence of a known specific antidote for this substance. The minimal physiological impact eliminates the need for active procedural interventions in most circumstances.

Therapeutic Uses of Sintal

Sintal (Sodium Cromoglycate) is generally used in situations involving certain distressing symptoms of chronic allergic and mast cell-driven conditions. It is applied across domains where additional symptomatic support is needed, focusing on prevention, which is relevant when supportive symptom management is appropriate.

The medicine is relevant for easing symptoms associated with conditions where functional stability becomes affected, including asthma, allergic rhinitis (hay fever), vernal keratoconjunctivitis, and systemic mastocytosis. It is applied in addressing symptom clusters that may become intense or disruptive, such as respiratory symptoms, ocular discomfort, and gastrointestinal manifestations.

“Sintal is considered relevant in conditions involving episodic or fluctuating manifestations, and may assist with maintaining functional stability.”

Prophylactic Management and Symptom Relief

Sintal is relevant for easing symptoms related to heightened physiological activity, assisting with maintaining functional stability for patients dealing with these chronic issues. Applied during phases when symptoms become more noticeable, it supports general well-being during symptomatic periods. This contributes to easing the overall symptom load on patients.

Quick Fact: Relief for Respiratory and Mucosal Symptoms Sintal may assist with managing the frequency of episodes involving airway hypersensitivity and allergic mucosal discomfort (eyes and nose).

Regulatory References

  1. NIH MedlinePlus overview of Cromolyn oral inhalation

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Sintal — Official Regulatory Information

This eligibility map is based strictly on the documented rules and classifications found in government regulatory documents for Sodium Cromoglycate (Sintal).

Eligibility Scope Regulatory Statement on Use Status
Populations for whom use is contraindicated Patients with known hypersensitivity to Cromolyn Sodium or any formulation ingredient. Use of the inhaler form is contraindicated for treating acute asthma attacks or status asthmaticus.
Age-related eligibility rules Safety and effectiveness have not been established for the ophthalmic solution in children under 4 years and for the inhalation solution in children under 5 years. Use in infants less than two years of age (oral form) is generally not recommended.
Condition-specific eligibility rules Use requires caution and potential dosage decrease in patients with documented impaired renal function or hepatic function, due to the drug's excretion profile.
Pregnancy and lactation eligibility status Classified as US FDA Pregnancy Category B. Use during pregnancy should be only if clearly needed. Caution should be exercised during lactation, as it is not known whether the drug is excreted in human milk.

Official Eligibility Structure

The official eligibility profile is defined by absolute contraindications (hypersensitivity and acute respiratory crisis) and formal limitations. Eligibility is constrained by age thresholds where efficacy is not established and by physiological conditions (kidney/liver impairment) requiring special caution and potential modification. These official label statements collectively define the specific patient populations for whom the medicine is prohibited or conditional according to governmental authorities.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — Official Regulatory Information for Sintal

Interaction Scope

Classification Official Regulatory Status
Medicinal Product Interactions None known for harmful systemic drug-drug combinations.
Specific Interacting Medicines No specific medicines are explicitly listed in regulatory labeling as having a clinically significant interaction profile.
Mechanistic Basis The medicine is officially documented as not metabolized and is poorly absorbed systemically, eliminating the basis for conventional enzyme-mediated (CYP-related) interactions.
Interaction Restrictions The oral solution or capsule must not be mixed with fruit juice, milk, or food, as these may interfere with the drug's intended action.
Timing-Based Rules Administration of the oral solution or capsule requires separation from food and must be taken 30 minutes prior to a meal.
Population-Specific Notes Dosage recommendations for the oral form should be decreased in patients with documented decreased renal or hepatic function, reflecting the routes of minimal systemic clearance.

Resulting Interaction Structure

Official regulatory documents define the product’s interaction structure by its lack of systemic activity, noting that no clinically significant systemic drug-drug interactions are known. The constraints documented in prescribing information are limited to a timing-based administration rule for the oral capsule or solution relative to meals and a required dosage decrease for patients with impaired hepatic or renal clearance. The profile confirms the medicine does not engage in traditional pharmacokinetic or pharmacodynamic interactions with other medicinal substances.

Mechanism of Action

The core mechanism of Sintal (Sodium Cromoglycate) is centered on the stabilization of the mast cell membrane, a process localized primarily at mucosal surfaces. The molecule acts by interfering with the necessary calcium ion ( Ca^2+) influx required to initiate cellular activation. This molecular interaction prevents the critical signal that triggers the cell's degranulation process. This cellular stabilization results in the functional blockade of mast cell exocytosis, suppressing the release of all chemical mediators, including histamine and leukotrienes. By preventing the tissue saturation by these mediators, the mechanism acts to suppress the downstream physiological consequences of vasodilation, fluid leakage, and smooth muscle contraction. Sintal's action is entirely prophylactic, relying on the continuous, regular presence of the molecule at the target cell to maintain a stable, non-reactive state. This modulation of the immune pathway reduces the system's susceptibility to high-level allergic activation, but the mechanism is intrinsically constrained and does not counteract physiological changes caused by mediators already released.

Dosage and Administration Information

How Sintal is Used: Official Administration Guidelines

Sintal (Sodium Cromoglycate) is a prophylactic agent whose use is governed by a strict regimen of timing, frequency, and administration technique. Since it is intended to prevent rather than treat acute symptoms, continuous daily use is required to achieve the full mast cell stabilizing effect.


Administration Scope and Schedule

The medicine is administered via several approved routes, each associated with a specific use protocol. The dosing schedule is generally set at four times daily (QID), taken at regular intervals throughout the day for continuous management.

Category Official Instructions
Route of Administration Oral (solution/concentrate), Inhalation (nebulizer solution or metered-dose inhaler), Nasal (intranasal spray), and Ophthalmic (eye drops).
Standard Frequency Four times daily (QID). A single dose may be taken 10 to 60 minutes before known trigger exposure (e.g., exercise) for intermittent prophylaxis.
Timing in Relation to Meals The Oral Solution, Concentrate must be taken one-half hour before meals and at bedtime to ensure consistent absorption.

Preparation and Procedural Conditions

The preparation and handling of Sintal are route-specific and mandatory for correct dosing. Maximum therapeutic benefit is often not observed until after two to four weeks of continuous, daily use. The following requirements define the handling for specific formulations:

  • The Oral Solution, Concentrate must be diluted with water and stirred immediately before consumption. This form is strictly Not for Inhalation or Injection.
  • The Inhalation Solution (20 mg vial) requires administration via a power-driven nebulizer; hand-operated nebulizers are not suitable for proper drug delivery.
  • Pediatric Dosing for the oral form (ages 2–12) involves a lower initial dose of 100 mg QID, compared to the adult initial dose of 200 mg QID, with a maximum dose limit based on weight.

These instructions define the protocol for use, requiring adherence to the specified schedule, dilution, and administration device to maintain continuous prophylactic coverage.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sintal


Evidence for the Prophylactic Management of Asthma

The evidence base for inhaled Sodium Cromoglycate was evaluated in research exploring conditions characterized by fluctuating or episodic manifestations in the context of long-term use. Researchers primarily used Randomized Controlled Trials (RCTs) and systematic reviews to explore how symptoms change over time. These studies research examined patient-reported outcomes, such as cough and shortness of breath, alongside objective measures of lung capacity, including Forced Expiratory Volume in one second (FEV1). Findings describe patterns observed in the studies related to changes in pulmonary function metrics, and studies monitored the use of rescue medications during the trial periods. However, the evidence quality varies across studies, and long-term effects are not fully established when used as a solitary maintenance treatment.

Evidence for Exercise-Induced Bronchoconstriction (EIB)

For conditions associated with acute or disruptive episodes, such as EIB, research was evaluated in specific, acute challenge models. These studies focused on how the medicine was observed in research exploring temporary physiological imbalance immediately following exercise. Research explored whether an association was observed with changes in lung capacity, primarily by measuring the maximum decrease in lung function (FEV1) shortly after the challenge. Evidence remains limited regarding the medicine's role in daily, long-term EIB management, as follow-up durations were limited to the hours immediately following the challenge.


Evidence for Allergic Conjunctivitis

The ophthalmic solution (eye drops) was evaluated in research primarily using placebo-controlled and comparative RCTs. This research is relevant in trials assessing short-term or episodic symptom patterns related to allergic conjunctivitis. The studies research examined outcomes linked to inflammatory or irritative states, such as eye itching and redness. The research quality is described as moderate, yet sample sizes were modest in some of the older literature. Comparative evidence is lacking in large-scale trials against some of the newest classes of eye drops currently available.


Research Gaps and Uncertainties

The existing evidence base contains notable research limitation frames. The evidence quality varies across studies, and trial designs for some indications are heterogeneous. Comparative evidence against other treatments is lacking in modern, large-scale trials. Furthermore, long-term effects are not fully established across all indications, meaning the evidence highlights what is known — and what is still uncertain — about the effects of extended use.

Key Studies & References

  1. Cromolyn (inhalation route): MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Sintal (FAQ)

Q: How does Sintal compare to other medicines for the same condition?

A: This medicine belongs to the class of mast cell stabilizers and works primarily as a preventive (prophylactic) agent. Its role in therapy is distinct from treatments used for acute relief, such as bronchodilators, or medicines with a broader anti-inflammatory action, like corticosteroids. The official prescribing information helps clarify its specific role in therapy.

Q: Are there any common early side effects when first starting Sintal?

A: Official product information notes that some common side effects, such as irritation or stinging (especially with eye drops or inhalation), are often temporary or transient. If irritation persists, consult a healthcare provider for guidance.

Q: What is the official safety rating or classification for Sintal?

A: The medicine’s classification varies by formulation; some forms are sold over-the-counter (OTC), while others require a prescription (Rx). According to regulatory agencies, Sintal is not classified as a controlled substance.

Q: Does Sintal interact with common over-the-counter pain relievers?

A: Official regulatory documents indicate that there are no known clinically significant systemic drug-drug interactions. This is because the medicine is poorly absorbed into the bloodstream and is not metabolized by the body in the typical way that causes interactions.

Q: Can Sintal be taken with multivitamins or supplements?

A: Official information states that because the medicine is poorly absorbed systemically, no clinical interactions with vitamins or supplements are known. It is generally advised to inform a healthcare provider about all concurrent supplements and medicines.

Q: Can teenagers or children use Sintal?

A: Yes, official product information confirms that the medicine is approved for use by children and teenagers. The specific starting regimen and administration method vary depending on the patient's age and the medicine’s form (e.g., oral solution, eye drop).

Q: How should Sintal tablets/capsules be stored?

A: The medicine should be stored at controlled room temperature and protected from freezing and light to maintain its quality. For the oral solution, once the concentrate or capsule powder is mixed with water, it is recommended that the mixture be taken immediately and not stored for later use.

Q: Is Sintal a generic medication or only available as a brand name?

A: The active ingredient, Sodium Cromoglycate, is widely available in generic formulations. It is also sold under various brand names, depending on the manufacturer and country.

Q: What is the difference between Sintal and its generic equivalent?

A: Generic equivalents are required by regulatory agencies to contain the same active ingredient, strength, and dosage form as the brand name product. Differences between the brand and generic versions are typically related to the inactive ingredients (excipients) or the cost.

Q: Are there any ingredients in Sintal that people are commonly allergic to?

A: The medicine is contraindicated for anyone with a known hypersensitivity or allergy to the active ingredient, Sodium Cromoglycate, or any of the inactive ingredients (excipients) used in the formulation. Reviewing the full list of ingredients is advised for patients with known allergies.

Q: Do Sintal interactions affect birth control pills?

A: Since the medicine is poorly absorbed into the bloodstream and is not metabolized in the liver, official information indicates it is not known to cause enzyme-mediated interactions that could affect the efficacy of oral contraceptives.

Q: How is Sintal eliminated from the body?

A: The medicine is not metabolized by the body's enzyme system. The small amount that is absorbed into the bloodstream is rapidly cleared by the liver and kidneys, while the majority of the dose is eliminated unchanged via the feces.

Q: What are the typical results seen in clinical trials for Sintal?

A: Studies and official information indicate that clinical trials typically measure objective outcomes related to the treated condition. For respiratory uses, this often involves assessing improvements in lung function, such as forced expiratory volume in one second (FEV1), and a reduced reliance on rescue medications.

Q: Is Sintal used for anything besides the conditions listed on the label?

A: Official regulatory documents list specific allergic conditions for which this medicine is approved for preventive management. Official regulatory labeling does not include approval for conditions outside of those listed in the indications section.

Q: What should I do if I forget to take a dose of Sintal?

A: If a dose is missed, official instructions suggest taking it as soon as you remember. However, if it is nearly time for your next scheduled dose, you should skip the missed dose and resume your regular schedule. Taking a double dose to compensate for a missed dose is generally not recommended.

Q: What happens if I stop taking Sintal suddenly?

A: Because the medicine acts as a prophylactic agent that builds up protection over time, official product information notes that abrupt discontinuation may not be recommended. Stopping the medicine suddenly may cause a recurrence or worsening of the original symptoms.

Q: Can Sintal cause weight changes?

A: According to official regulatory documentation, weight change (gain or loss) is not listed as a common or reported side effect of the medicine.

Q: Does Sintal affect sleep?

A: Some adverse events reported include difficulty sleeping. Drowsiness has also been reported rarely in clinical trials, but a direct causal relationship was not always established.

Q: Is there a risk of interaction between Sintal and alcohol?

A: Official information does not list a specific drug-alcohol interaction. However, due to the general systemic effects alcohol can have on the body and on other medicines, consulting a healthcare provider regarding alcohol consumption is generally recommended.

Q: Does Sintal show up on drug tests?

A: Since this medicine is not classified as a controlled substance and is not metabolized in the body, it is generally not expected to be detected on standard drug screening tests.

Q: Where can I find the official patient information leaflet for Sintal?

A: The official Patient Information Leaflet (PIL) or Medication Guide can be found on the websites of national regulatory authorities. These authorities include the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Q: What color are Sintal tablets/capsules usually?

A: The physical appearance is noted in the official regulatory documentation for product identification. For example, the inhalation solution is typically described as a clear, colorless to pale yellow liquid.

Q: Does taking Sintal make a person drowsy?

A: Official regulatory documentation notes that drowsiness has been reported as an adverse event in clinical trials. However, this effect is rare and was not always definitively linked to the medicine's use.

Q: Can I drive or operate machinery while taking Sintal?

A: Due to the potential for rare side effects such as temporary vision blurring (with eye drops) or drowsiness, caution is advised. Individuals are generally advised to understand how the medicine affects them before engaging in activities that require full mental alertness, such as driving or operating machinery.

Q: How long does Sintal stay in the system after the last dose?

A: Official pharmacokinetic information indicates that the small amount of drug absorbed systemically is quickly eliminated. The medicine has a short elimination half-life, meaning it is generally cleared from the bloodstream within a few hours after the last dose.

Q: Can Sintal be used by people with a history of heart issues?

A: Official regulatory information does not list a history of heart issues as a specific contraindication or a condition requiring a required dosage adjustment. It is important to provide a complete medical history to a healthcare professional.

Q: Is there a maximum recommended period for taking Sintal?

A: For the management of chronic conditions, official guidelines state that the medicine is intended for continuous, long-term use. There is generally no set maximum duration of therapy, as it is used to maintain symptomatic improvement.

Q: Does Sintal have a 'Black Box Warning' from regulatory agencies?

A: No, based on the official prescribing information from the U.S. Food and Drug Administration (FDA), the medicine does not currently carry a Black Box Warning (also known as a Boxed Warning).

Q: Why is my doctor asking me to get lab work done before starting Sintal?

A: Lab work may be requested to assess your baseline organ function, particularly the kidney and liver. This is because official prescribing information advises caution and potential dosage adjustment for patients with decreased kidney or liver function.

Q: Is it possible to become dependent on Sintal?

A: Regulatory information indicates that Sintal is not classified as a controlled substance. It is not known to cause physical or psychological dependence.

Q: What is the difference between the different strengths of Sintal available?

A: The medicine is manufactured in various strengths that correspond to its specific route of administration, such as oral solution, inhalation, or eye drops. These strengths are designed to suit the specific site of action and the patient's age-appropriate initial dosing regimen.

Q: Does Sintal cause sun sensitivity or skin issues?

A: Official product information notes that rare skin issues, such as rash or hives (urticaria), have been reported. However, the regulatory documentation does not list sun sensitivity (photosensitivity) as a recognized side effect.

Q: What kind of monitoring is needed while taking Sintal?

A: Monitoring of organ function may be necessary, particularly for patients with known kidney or liver impairment. This helps healthcare providers ensure appropriate dosing is maintained during therapy.

Q: Is Sintal considered a controlled substance?

A: No, regulatory bodies, such as the U.S. Drug Enforcement Administration (DEA), do not classify this medicine as a controlled substance.

How should Sintal be stored and disposed of?

Official Storage and Disposal Requirements

The required storage and disposal of Sintal (Sodium Cromoglycate) are strictly defined by regulatory documents to maintain product integrity and safety.

Item Requirement Statement
Temperature and Environment Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), with protection from freezing and light.
Container Integrity The container must be kept tightly closed. Do not use the solution if it becomes discolored or contains a precipitate.
Shelf-Life Ophthalmic solutions must be discarded four weeks after opening the bottle.
Child Safety The medication must be kept out of the reach and sight of children.
Disposal Dispose of any unused or expired product according to local regulations. It is mandatory to not flush this medication down the toilet or pour it into a drain.

These official rules govern the stability, safe handling, and proper discarding of the medicine, ensuring compliance with pharmaceutical waste guidelines.

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

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