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Intal (BRONCHODILATOR)

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Intal (BRONCHODILATOR)

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Treatment option: Asthma

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.

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Overview of Intal (BRONCHODILATOR)

Property Description
Active Ingredients Salbutamol, Sodium Cromoglycate
Form Inhalation solution, Inhaler (Aerosol), Powder
Pharmacological Class Bronchodilator; Mast Cell Stabilizer
General Purpose Airway opening and stabilization
Origin Synthetic

What Type of Medicine is Intal (BRONCHODILATOR)?

Intal is classified as an anti-asthmatic combination drug delivered via the inhalation route, characterized by the pairing of two distinct synthetic active ingredients: Salbutamol and Sodium Cromoglycate. This composition defines Intal as a unique product, merging two critical pharmacological classes for comprehensive respiratory management: Salbutamol acts as a Selective Beta-2 Adrenergic Agonist, while Sodium Cromoglycate is recognized as a Mast Cell Stabilizer.

The strategic combination of these two agents in an inhaled form has been clinically recognized for providing integrated respiratory management that addresses both immediate symptoms and underlying airway sensitivity, a common need for patients. This medication is typically supplied as a metered-dose inhaler (Aerosol) or a nebulizer solution, and is a prescription-only medicine, differentiating its regulatory status from over-the-counter options.

Intal’s Dual Composition and Primary Therapeutic Goal

The primary therapeutic goal of the Intal formulation is to provide integrated management through its unique composition: achieving rapid airway opening alongside cellular stabilization. The Salbutamol component provides fast relief by relaxing tight airway muscles, acting as a functional "rescue" component in the mixture. Inhaled Salbutamol is characterized by its rapid action in providing relief.

The Sodium Cromoglycate component serves as the protective agent; its general purpose is to reduce airway sensitivity by preventing the degranulation of mast cells and the subsequent release of inflammatory chemicals. Sodium Cromoglycate acts to stabilize cells involved in allergic reactions, helping to reduce the body's overreaction to triggers. By addressing both the physical constriction and the underlying cellular initiation of irritation, the combination supports easier and more stable breathing, a strategy favored in managing chronic respiratory conditions.

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What side effects are possible with Intal (BRONCHODILATOR)?

The official safety profile for the Salbutamol and Sodium Cromoglycate combination is structured by regulatory bodies to categorize risks based on frequency, physiological system, and specific patient factors.

Adverse Reaction Scope

The most frequently documented adverse reactions, classified as Common in regulatory documents, include tremor, headache, tachycardia (increased heart rate), cough, and muscle cramps. Effects classified as Uncommon include palpitations and mouth/throat irritation.

System-Organ Class Common Adverse Reactions
Nervous System Disorders Tremor, Headache
Cardiac Disorders Tachycardia, Palpitations (Uncommon)
Respiratory Disorders Cough, Throat Irritation
Musculoskeletal Disorders Muscle Cramps

Serious Adverse Reactions and Safety Constraints

Official labeling highlights the risk of Paradoxical Bronchospasm, which is an immediate, life-threatening worsening of breathing after inhalation. Other serious reactions include severe Hypersensitivity Reactions such as angioedema (swelling) and collapse.

Time-related safety patterns state that effects like tremor and tachycardia may be more pronounced at the start of treatment or following a dose increase. Increasing reliance on the bronchodilator component is noted as potentially signaling a deterioration of the underlying respiratory condition.

Population-specific cautions are documented for patients with pre-existing conditions, including cardiovascular disorders (e.g., hypertension, arrhythmias), hyperthyroidism, and diabetes mellitus.

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Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Intal (BRONCHODILATOR)

Property Description
Documented Overdose Presentations Manifestations are primarily due to the Salbutamol component, including tachycardia, fine tremor, palpitations, CNS stimulation, restlessness, and headache. Metabolic effects involve hypokalemia (serum potassium shift) and hyperglycemia.
Physiological Systems Affected (as stated in label) Cardiovascular system (e.g., cardiac arrhythmias, myocardial ischaemia), Metabolic system, and Nervous system. The Sodium Cromoglycate component is documented as having no clinical syndrome associated with an overdosage.
Dose-related or Exposure-related Factors Overdose is associated with exceeding the prescribed dose. Regulatory warnings note that excessive use of sympathomimetic agents has been associated with reported fatalities.
Emergency-response Statements (as written in official documents) Seek emergency medical attention immediately for suspected overdose or symptoms of worsening heart disease. Immediate medical assistance must be sought for sudden and increasing deterioration of asthma symptoms.

Overdose Classifications (High-Level)

Property Description
Severity Classification (as defined in official documents) Overdose may be associated with life-threatening events, including cardiac arrest and potentially serious hypokalemia.
Supportive Management Measures Management is restricted to symptomatic and supportive treatment. Monitoring of serum potassium levels is recommended due to the metabolic risk.

Official Overdose Statements:

  • The primary risks of excessive use relate to the cardiac system and severe metabolic changes.
  • Potentially serious hypokalemia and cardiac arrhythmias are documented clinical consequences.
  • Immediate medical assistance is required if the patient experiences worsening symptoms or a suspected overdose.

Connection to the overall overdose profile: The official regulatory profile for this combination drug centers on the potential for severe, dose-related cardiovascular and metabolic toxicity from the bronchodilator component. These documented risks define the requirement for immediate medical intervention and specific monitoring, such as serum potassium levels, during the management of an overdose situation.

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Therapeutic Uses of Intal (BRONCHODILATOR)

What Intal Treats: Main Uses and Benefits

Intal (Salbutamol + Sodium Cromoglycate) is considered relevant in clinical settings that involve acute or unstable symptom patterns, and assists in managing chronic respiratory conditions. It provides symptomatic relief and supportive management of underlying airway sensitivity. Its application includes moderate-to-severe asthma, where it is focused on areas where short-term symptom management is appropriate and can help maintain functional stability.

The medication is commonly used to manage conditions presenting with episodic or fluctuating manifestations, including bronchial asthma (persistent and severe forms), Chronic Obstructive Pulmonary Disease (COPD) manifestations, allergic rhinitis, and exercise-induced bronchospasm (EIB).

Quick Fact: Relief for Bronchial Distress

The medication provides support that helps ease the overall symptom burden of clusters that may become intense or disruptive, such as wheezing, acute shortness of breath, and uncomfortable chest tightness. This use assists with maintaining functional stability when symptoms interfere with routine activities.

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Eligibility and Restrictions for Use

The population eligibility for Intal (Cromolyn Sodium Inhalation) is strictly defined by regulatory documents based on absolute prohibitions, age criteria, and organ function status. The medicine is contraindicated for any patient with known hypersensitivity to cromolyn sodium or any other component in the preparation. Furthermore, due to its function as a prophylactic agent, the drug has no role in the treatment of an acute attack of asthma or status asthmaticus and must be initiated only after an acute episode is controlled.

Eligibility is also restricted by age and health conditions:

Eligibility Rule Regulatory Status
Minimum Age (Inhaler) Not established in children below 5 years.
Minimum Age (Nebulizer) Not established in children below 2 years.
Renal/Hepatic Impairment Requires caution and may necessitate a decreased dosage.
Pregnancy Status Category B; use only if clearly needed.
Nursing Mothers Requires caution; excretion in human milk is not known.

This structure ensures that use is limited to patients who lack documented non-eligibility conditions and fall within the established, label-approved age groups.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation on Intal (cromolyn sodium) focuses primarily on constraints related to its formulation and patient-specific conditions, rather than a broad list of drug-drug interactions. The drug is considered to have minimal systemic absorption from inhalation, which limits the potential for many chemical interactions with other medications.

Interaction Type Constraint / Requirement
Physical Compatibility Do not mix Intal Nebulizer Solution with other medicines in the nebulizer. Stability and safety when combined with other drugs have not been established.
Impaired Organ Function Due to the drug's excretion via the biliary and renal routes, patients with impaired hepatic or renal function may require specific consideration.

No specific medicinal product classes are cited in official labeling as being highly clinically significant or contraindicated for co-administration. The most critical instruction is procedural, emphasizing the lack of established safety when mixing the nebulizer solution with other liquid medications. The mention of potential interaction with impaired organ function refers to a need to consider a change in administration due to altered drug clearance.

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Mechanism of Action

Intal, which contains cromolyn sodium, is a mast cell stabilizer. Its primary biological target is the mast cell membrane, particularly in the pulmonary and gastrointestinal mucosa following administration. The molecule functions by inhibiting the degranulation process of sensitized mast cells.

Mechanistically, the interaction involves the modulation of intracellular signaling pathways linked to IgE receptor cross-linking. Cromolyn sodium indirectly blocks the transmembrane influx of calcium ions (Ca^2+) into the mast cell. This inhibition of Ca^2+ mobilization prevents the subsequent fusion of granular membranes with the plasma membrane.

The downstream cascade is characterized by the inhibition of chemical mediator release. Specifically, the drug prevents the exocytosis of preformed inflammatory mediators, including histamine and tryptase, and inhibits the de novo synthesis and release of lipid mediators, such as leukotrienes. This cessation of mediator discharge results in system-level physiological modulation by reducing the localized concentration of pro-constrictive and pro-inflammatory agents in the airway tissue.

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Dosage and Administration Information

The administration of Intal (Salbutamol and Sodium Cromoglycate combination) is characterized by the route, frequency, and specific handling procedures. The medicine is used on a continuous, prophylactic basis for the mast cell stabilizer component.


Administration Scope

Instruction Detail
Route of Administration Oral Inhalation via metered-dose inhaler (MDI) or nebulization, as directed.
Dosing Schedule (Maintenance) Two metered inhalations four times daily (QID) at regular intervals.
Timing in relation to meals Not tied to meals, but requires regular intervals throughout the day.
Preparation requirements Nebulizer solution requires a power-driven nebulizer with adequate flow rate. MDIs must be primed before first use or after prolonged non-use.
Age-group administration Inhaler (MDI) is generally for patients 5 years of age and over. Nebulizer solution is for patients 2 years of age and older. Dosage reduction may be considered for patients with impaired renal or hepatic function.
Missed-dose rules If a dose is missed, take it as soon as possible, but do not double doses.
Special procedural conditions The nebulizer solution is not for injection. The inhaled product is not effective if swallowed as it is poorly absorbed from the gastrointestinal tract.

Resulting Procedural Structure

Official step sequence:

  • Administer the drug via oral inhalation only, ensuring the appropriate device is used (MDI or nebulizer).
  • For maintenance, follow the four times daily schedule, ensuring consistent spacing between doses.
  • If a separate bronchodilator is prescribed, it should be administered prior to the prophylactic inhalation.
  • For prevention of exercise-induced symptoms, administer the dose 10 to 60 minutes before the anticipated exposure.
  • If discontinuing the medicine, a gradual withdrawal over approximately one week is recommended.

Connection to the overall use protocol: The official instructions mandate that the medicine be used on a continuous, regular daily basis for the prophylactic component to achieve its effect, which typically requires several weeks of administration. The protocol defines the administration route, specific dosing frequency, and required dose sequencing to ensure proper delivery.

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Recent Clinical Evidence

Intal (Cromolyn Sodium): Recent Clinical Evidence

Intal, which contains cromolyn sodium, is a synthetic compound that acts as a mast cell stabilizer. It is used in the preventive management of bronchial asthma and is specifically noted for its use in preventing bronchospasm induced by exercise, cold air, or other precipitating factors. Clinical evidence focuses on its prophylactic role, as it has no intrinsic bronchodilator activity.


Efficacy and Therapeutic Role

Research has explored the drug's activity in inhibiting the release of inflammatory mediators from mast cells, such as histamine and leukotrienes. This action is distinct from bronchodilators, which act directly on airway muscles, and corticosteroids, which provide a broader anti-inflammatory effect.

Studies have demonstrated that cromolyn sodium can attenuate bronchospasm caused by inhaled antigens and specific environmental triggers. While some early trials reported significant improvements in pulmonary function, overall results suggest that a satisfactory response is indicated by a reduction in the frequency of asthma symptoms and a decreased need for other supportive medications.


Safety and Tolerability Profile

Cromolyn sodium has an established safety profile across its various formulations. Clinical experience and adverse event monitoring suggest that reactions are generally rare and mild.

Common Reported Events (Inhaled)
Throat irritation or dryness
Cough
Wheezing (transient)

Because the drug is poorly absorbed into the bloodstream after inhalation, the incidence of systemic side effects is low. The therapeutic effect relies on regular, consistent use, with patient response often becoming fully evident after several weeks of continuous administration.

Key Studies & References Cromolyn and Nedocromil in Children with Asthma - Pediatric Pharmacotherapy (Review)

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Frequently Asked Questions (FAQ)

Common questions about Intal (BRONCHODILATOR) (FAQ)

Q: What kind of environmental triggers can Intal help prevent reactions to?

Official documents indicate that this medication is used to reduce the likelihood of bronchospasm caused by a variety of triggers. These include specific physical causes described in studies, such as exercise and cold dry air. It is also noted to help prevent reactions from exposure to sulfur dioxide, certain chemicals, environmental pollutants, and common allergens like animal dander.

Q: What are the signs of a serious or severe reaction to Intal that require attention?

Serious reactions highlighted in regulatory documents include laryngeal edema (swelling of the voice box) and angioedema (swelling). The labeling describes immediate signs of a severe allergic reaction, which include hives, difficulty breathing or swallowing, and swelling of the face, lips, tongue, or throat.

Q: What is the difference between the Intal metered-dose inhaler and the nebulizer solution?

Intal may be provided in two forms: a nebulizer solution and a metered-dose inhaler (MDI) aerosol. The nebulizer solution is typically a clear, colorless, aqueous solution that requires use with a machine. The MDI is an aerosol product. Both are considered to have the same therapeutic purpose, though they may have different age restrictions for use.

Q: Are there different forms of Intal (e.g., capsule, liquid) and what are their intended uses?

Yes, the active ingredient cromolyn sodium is used in different forms for different purposes. The oral capsule or solution form, known by the brand Gastrocrom, is prescribed to treat the symptoms of mastocytosis. The intended use of the capsule powder is oral administration, mixed with water and taken by mouth.

Q: Why do some sources refer to Intal as a 'controller' medicine?

The term 'controller' is often used to describe medications taken regularly to prevent symptoms and reduce airway sensitivity. Intal's function is prophylactic (preventive) in nature, acting as a mast cell stabilizer to prevent the release of inflammatory mediators. This long-term, protective action fits the general description of a controller medication.

Q: Is it important to keep using Intal even when asthma symptoms are stable?

The medication is intended for continuous, preventive use, not for immediate relief. Regulatory documents note that asthma symptoms may recur if the medication is reduced below the recommended dosage or discontinued. This indicates that consistent administration is noted as key to maintaining the protective effect.

Q: Does Intal address inflammation in the airways?

While the medication is distinct from corticosteroids, its active ingredient, cromolyn sodium, is chemically designated as an inhaled anti-inflammatory agent. It works by preventing the release of various chemicals that trigger airway irritation.

Q: Does Intal contain corticosteroids or is it a steroid-free option?

Intal’s active ingredient is cromolyn sodium, a mast cell stabilizer. Official labeling describes this substance as an anti-inflammatory agent, but states that it has no intrinsic bronchodilator or antihistaminic activity. Based on its chemical structure and pharmacological action, the drug is not classified as a corticosteroid.

Q: Are there any reported long-term safety concerns associated with the use of Intal for many years?

Regulatory experience with the drug indicates that long-term use has not been associated with significant adverse effects. Non-clinical studies in animals also showed no evidence of carcinogenesis (cancer risk).

Q: Is it normal to notice an unusual or unpleasant taste in the mouth when using Intal?

According to official drug information, a potential side effect that may be reported with the use of inhaled cromolyn sodium is a bad or unpleasant taste in the mouth. This is generally a mild, non-serious reaction.

Q: Does Intal interact with common over-the-counter pain medications?

Due to minimal systemic absorption into the bloodstream from inhalation, the potential for significant drug-drug interactions with other medicinal products is generally considered low. Regulatory documents recommend that a healthcare provider be informed of all prescription and over-the-counter medicines being used.

Q: Can Intal be used safely with other maintenance asthma medications?

Asthma management frequently requires a combination of drugs to control symptoms. Regulatory documents do not cite major contraindications with other drug classes. Official guidance emphasizes using all medications exactly as directed by a healthcare provider.

Q: Is Intal commonly prescribed for conditions other than bronchial asthma?

Yes. While the inhaled form is for asthma prevention, the oral formulation of cromolyn sodium is also indicated for the treatment of mastocytosis. This condition involves an excessive accumulation of mast cells in the body.

Q: Why is it described that Intal must be used at regular intervals throughout the day?

Official patient information states that the medication is taken at regular intervals to keep a steady amount of the drug in your body at all times. This consistent schedule is intended to keep a steady amount of the drug in the body, which helps to maintain the continuous prophylactic effect required for prevention.

Q: Does the Intal inhaler contain propellants or other inactive ingredients that patients should be aware of?

Specific inactive ingredients vary by formulation. The inhalation solution vials are manufactured from low-density polyethylene (LDPE) resin and contain Purified Water. The complete list of ingredients for a specific product type is contained within the official product labeling.

Q: Are there studies on whether Intal can help reduce the required dose of inhaled steroids?

A satisfactory response to therapy may be indicated by a decreased requirement for other drugs used in asthma treatment. This includes a decreased requirement for corticosteroids.

Q: How is Intal generally classified in major international treatment guidelines?

Intal is recognized for offering a new approach to asthma management through mast cell stabilization, distinct from bronchodilators and steroids. It is considered an important adjunct (supplemental) option for long-term prophylactic therapy, often used as an alternative non-corticosteroid choice.

Q: What is the meaning of the term 'bronchial asthma' in the context of Intal's indication?

Intal is indicated for the prevention of bronchial asthma attacks. This typically refers to the chronic respiratory condition characterized by recurrent symptoms such as shortness of breath, wheezing, and coughing.

Q: What kind of specific safety monitoring is recommended for patients using Intal long-term?

While there is no standard long-term monitoring protocol specified for all users, specific consideration is advised for patients with impaired renal or hepatic function, as this may necessitate closer monitoring of kidney or liver function.

Q: Is Intal known to cause drowsiness or dizziness?

The official adverse reaction list for the active ingredient, cromolyn sodium, does include dizziness as a potential side effect, though it is reported very rarely (in less than 1 in 10,000 patients). Drowsiness is generally not listed among the recognized common or uncommon side effects.

Q: Can Intal be used if someone is allergic to other common medications?

Regulatory documents state that the medication is contraindicated only in patients who have shown hypersensitivity to cromolyn sodium or any other component in the preparation. Other medication allergies are not listed as a contraindication.

Q: Are there any interactions noted between Intal and tobacco use?

Official patient information advises individuals with asthma to not smoke. The patient information notes that asthmatic patients are advised to avoid staying in the same room with people who smoke, as tobacco smoke can act as an asthma trigger.

Q: What evidence exists regarding Intal's effectiveness for non-allergic (intrinsic) asthma?

Studies on the medication's effectiveness suggest that younger patients with extrinsic (allergic) asthma may respond more favorably than older patients who have intrinsic (non-allergic) asthma. The prophylactic effect may vary based on the underlying cause of the asthma.

Q: How is the use of Intal generally managed in older (geriatric) patient populations?

Official documents state that caution and specific consideration are required for elderly patients. This often includes renal function monitoring and a gradual titration to a lower starting dose due to potential changes in drug clearance with age.

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How should Intal (BRONCHODILATOR) be stored and disposed of?

How to Store and Dispose of Intal (BRONCHODILATOR)?

Official regulatory guidelines define specific conditions to maintain the stability and integrity of Intal (Sodium Cromoglycate).


Mandatory Storage Requirements

Condition Inhaler (Aerosol) Inhalation Solution
Temperature Store below 30 C. Store at 20 C to 25 C.
Environment Protect from heat, sunlight, and moisture. Protect from light; keep vials in foil pouch.
Prohibited Do not refrigerate or freeze. Do not use if solution is discolored or contains precipitate.

Disposal and Safety Constraints

Child Safety: It is mandatory to keep this and all medications out of the reach of children.

Handling & Disposal: The inhaler must be discarded once the labeled maximum number of actuations is reached. Never puncture the canister or throw it into a fire. Unused or expired medication should be returned to a pharmacist for proper disposal.

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

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