Intal 2%

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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 Intal 2%

Property Description
Active Ingredient Sodium Cromoglycate (Cromolyn Sodium)
Form 2% Aqueous Solution for Nebulizer
Pharmacological Class Mast Cell Stabilizer
General Purpose Prophylactic (Preventive) antiallergic management
Origin Synthetic Compound (Chromone derivative)

What is Intal 2% and Its Pharmacological Identity?

Intal 2% is a prescription pharmaceutical preparation supplied as a sterile aqueous solution containing the active chemical entity, Sodium Cromoglycate (also known as Cromolyn Sodium). The medicine is classified as a Mast Cell Stabilizer, a designation clinically recognized for its unique mechanism in controlling allergic inflammation. This compound is a synthetic derivative originating from the chromone class of small molecules.

Composition and Form: Understanding the 2% Nebulizer Solution

Intal 2% is a single-ingredient product where the 2% concentration signifies the amount of the active ingredient present, precisely 2 grams of Sodium Cromoglycate per 100 milliliters of solution, suspended in an aqueous base. The specific formulation of this nebulizer solution is designed for the inhalation route, a feature that distinguishes it from other forms, such as nasal or ophthalmic preparations of the same drug. This targeted pulmonary delivery is essential for its intended use in managing respiratory conditions.

General Purpose: What Does Intal 2% Help to Do?

The general purpose of Intal 2% is the preventive management of allergic and inflammatory responses, strictly defining its role as a prophylactic treatment. As a Mast Cell Stabilizer, the medication works by inhibiting a process called degranulation, stopping specific immune cells from suddenly releasing potent inflammatory chemicals, such as histamine and leukotrienes, when triggered. This mechanism is widely supported by pharmacological studies and confirms that the medicine helps to stabilize the airways, reducing the underlying responsiveness to various stimuli before symptoms fully manifest.

Regulatory References

  1. Cromolyn Oral Inhalation: MedlinePlus Drug Information

What side effects are possible with Intal 2%?

Possible Side Effects and Safety Information

The safety profile of Intal 2% (Cromolyn Sodium Inhalation Solution) is based on official government regulatory documents. Side effects are classified by their frequency of occurrence and the body system affected.

Common and Expected Adverse Reactions

The most frequently reported adverse reactions are typically local and transient, meaning they are mild and usually resolve quickly. These include:

  • Cough (reported in approximately 1 in 5 patients)
  • Mild wheezing
  • Throat irritation or dryness
  • Bad or unpleasant taste
  • Nausea
  • Nasal congestion

Rare and Serious Adverse Reactions

Certain rare but serious adverse reactions have been documented in the regulatory safety profile:

  • Anaphylactic reactions (severe, potentially life-threatening allergic reactions).
  • Severe Bronchospasm, which may require discontinuation of the medication.
  • Development of pulmonary infiltrates with eosinophilia (a rare lung condition).

Other rare, postmarketing reports have included laryngeal edema, angioedema, nephrosis, and certain vasculitis syndromes.

Population-Specific Safety Considerations

Specific caution and limitations are noted for certain patient groups:

  • Pediatric Use: The safety and effectiveness of the nebulizer solution have not been established in children under 2 years of age. For the inhaler, safety is not established for children under 5 years.
  • Pregnancy/Lactation: Use during pregnancy is only recommended if clearly needed, as adequate, controlled studies are lacking. It is not known if the drug is excreted in human milk.
  • Organ Impairment: Dosage reduction or discontinuation should be considered in patients with impaired renal or hepatic function.

Safety-Related Restrictions

Intal 2% is strictly not indicated for the treatment of an acute asthma attack or status asthmaticus. It has no role in immediate relief of severe, sudden breathing difficulty.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation for Sodium Cromoglycate Inhalation Solution (Intal 2%) provides specific guidance regarding overdosage. The prescribing information confirms that there is no specific clinical syndrome formally associated with an overdosage of cromolyn sodium. Acute toxicity testing has demonstrated that the substance has an extremely low order of toxicity across various routes of administration, including inhalation, suggesting minimal acute risk.


Documented Overdose Profile

Classification Feature Official Regulatory Statement
Documented Overdose Syndrome No specific clinical syndrome is associated with overdosage.
Toxicity Profile Classified as having an extremely low order of toxicity.
Management Restricted to symptomatic and supportive treatment.
Antidote No specific antidote is officially documented.

Emergency Action Requirement

Despite the minimal toxicity profile, regulatory authorities mandate that in the event of any suspected over-exposure or overdose, individuals must seek emergency medical attention or contact a Poison Help center immediately. Urgent medical help is required when an overdose is suspected, and subsequent care is limited to providing necessary symptomatic and supportive measures.

Therapeutic Uses of Intal 2%

What Intal 2% Treats: Main Uses and Benefits

The medication is applied as a prophylactic agent in the management of bronchial asthma and is relevant in clinical settings that involve recurrent or episodic manifestations. It is used across patient groups, including pediatric patients and adults, in situations involving certain distressing symptoms where patients' manifestations are sufficiently frequent to require a continuous program of medication. The primary therapeutic benefit is that it may assist with managing the frequency of symptoms and episodes over time.

This treatment is commonly used to help with symptom clusters that may appear suddenly or intensify following exposure to specific external factors. It is relevant when supportive symptom management is appropriate for preventing acute bronchoconstriction. This supportive use is applied in scenarios where additional symptomatic assistance is needed. The medicine is relevant in managing conditions presenting with acute episodes, including different types of bronchial asthma. This approach supports patients during episodes of heightened discomfort and helps maintain a sense of stability when symptoms are more noticeable.

“This medication may be part of symptomatic management applied across domains where additional symptomatic support is needed.”


Quick Fact: Support for Symptoms Related to Airway Constriction

  • Intal 2% is relevant for easing symptoms that interfere with daily comfort, such as wheezing, chest tightness, and a recurrent cough, by supporting the patient during difficult episodes and helping to manage symptoms related to inflammatory or irritative states.

Eligibility and Restrictions for Use

Intal 2% (cromolyn sodium ophthalmic solution) is primarily used for the preventative treatment of certain allergic eye conditions, such as vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. Its use is generally reserved for patients with a diagnosed allergic eye condition.


Who Can Use It

  • Adults and children typically 4 years of age and older.
  • Patients experiencing signs and symptoms of seasonal or perennial allergic conjunctivitis who benefit from a mast cell stabilizer.

Who Cannot or Should Use Caution

Condition Recommendation
Hypersensitivity/Allergy Contraindicated in patients with a known allergy to cromolyn sodium or any other ingredient in the formulation.
Children Under 4 Safety and effectiveness have generally not been established in this age group.
Eye Injury or Infection Should not be used for the treatment of acute eye injury or infection. Consult a physician immediately if symptoms of injury or infection occur.
Contact Lens Wearers Soft contact lenses should not be worn during treatment, as the preservative (often benzalkonium chloride) can be absorbed by the lens material. Patients should refrain from wearing lenses during active symptoms.
Pregnancy and Breastfeeding Use only if clearly needed and the potential benefits justify the potential risks, as there are no adequate and well-controlled studies in pregnant women. Caution should be exercised in nursing mothers.

What should I know about interactions with other medicines?

Intal 2% (cromolyn sodium inhalation solution) is a prophylactic agent used to help manage bronchial asthma. Due to its mechanism of action as a mast cell stabilizer and its very limited systemic absorption when inhaled, it has a minimal profile for drug-drug interactions. Authoritative regulatory documents do not list specific pharmaceutical products or drug classes that are known to have clinically significant systemic interactions when used concomitantly with inhaled cromolyn sodium.

However, a crucial procedural restriction is noted in official labeling. Intal 2% solution should not be mixed with other medicines in your nebulizer. The safety and stability of the product when compounded with other inhalation solutions have not been established by the manufacturer, and mixing could compromise the efficacy or safety of the inhaled medications.

Patients should inform their healthcare provider about all prescription drugs, non-prescription medicines, vitamins, and herbal products they are currently using. In general, cromolyn sodium can be used as an adjunct to other asthma treatments, such as bronchodilators and corticosteroids, and is often added to an existing treatment regimen. Adjustments to concomitant medication dosages, such as corticosteroids, may be attempted by a doctor after a positive clinical response to Intal has been established, but this must be done gradually and under medical supervision.

Mechanism of Action

Cellular Target and Cascade Modulation

Intal 2%, which contains cromolyn sodium, is classified as a mast cell stabilizer. Its primary biological target is the mast cell, a type of white blood cell central to inflammatory responses. The compound acts by modulating the biophysical properties of the mast cell membrane. This alteration is hypothesized to involve the inhibition of calcium ion influx into the cell.

Since the influx of calcium is an essential step in the cascade that triggers mast cell degranulation, Intal 2% prevents this process. By blocking degranulation, the drug inhibits the release of pre-formed and newly synthesized pro-inflammatory mediators, including histamine, leukotrienes, and proteases, into the surrounding tissue.

This cellular mechanism results in the system-level physiological consequence of modifying the downstream inflammatory response and suppressing local tissue inflammation. The action is purely prophylactic, focusing on the suppression of cellular processes that precede the release of inflammatory agents.

Dosage and Administration Information

Intal 2% (cromolyn sodium ophthalmic solution) is for use in the eyes only and must be administered strictly as prescribed by a healthcare provider. Consistent use at regular intervals is essential for the medication's effectiveness in managing allergic ocular conditions such as vernal conjunctivitis and vernal keratitis.

Standard Dosing

The typical dosage for adults and children four years of age and older is 1 to 2 drops instilled into each affected eye, four to six times a day, at regular intervals.

Age Group Usual Dose (Per Eye) Frequency
Adults and Children 4 years 1-2 drops 4-6 times daily

Administration Instructions

  1. Preparation: Wash your hands thoroughly before handling the bottle.
  2. Application: Tilt your head back, create a small pocket by gently pulling down the lower eyelid, and squeeze the prescribed number of drops into the pocket. Avoid touching the dropper tip to your eye, eyelid, or any other surface to prevent contamination.
  3. Post-Application: Close your eye for two to three minutes without blinking or squeezing the lids. Gentle pressure applied to the inner corner of the eye (tear duct) for about one minute can help keep the solution in the eye.

Important Considerations

  • Treatment Duration: Symptomatic improvement is often observed within a few days, but up to six weeks of continuous use may be necessary to achieve the full therapeutic effect. Continue treatment as long as directed to maintain improvement.
  • Missed Dose: If a dose is missed, administer it as soon as you remember. If it is nearly time for the next scheduled dose, skip the missed dose and resume your regular schedule. Do not use a double dose.
  • Contact Lenses: Soft contact lenses should not be worn during the treatment period or when eye allergy symptoms are present. Wait at least 10 minutes before using any other eye drop medication unless advised otherwise by your physician.

Recent Clinical Evidence

Research evidence / Overview of studies for Intal 2%

Evidence for use in Asthma Prophylaxis

Research has examined Intal 2% in studies exploring how symptoms change over time in individuals with chronic asthma, a condition characterized by fluctuating or episodic manifestations. The majority of research available consists of short-term RCTs (Randomized Controlled Trials), which were evaluated in populations of children and adults experiencing varying symptom levels. These studies explored outcomes related to systemic or functional imbalance, such as lung function measurements, and also applied in studies examining patient-reported experiences of breathing difficulty. The findings describe patterns observed in the studies where individuals were associated with changes measured during the study period, particularly in outcomes reflecting daily functioning or activity level. What remains uncertain is the long-term application, as follow-up durations were limited.


Evidence for use in Exercise-Induced Bronchospasm (EIB)

Research exploring the use of Intal 2% in studies focusing on Exercise-Induced Bronchospasm (EIB) typically involves controlled studies. The key outcomes monitored physiological strain or stress and acute changes in lung capacity. The research highlights changes measured during the study period. These studies describe patterns related to how the specific measurements of physiological strain varied in the observed groups. However, the results apply only to the populations studied, and comparative evidence is lacking to fully understand the findings relative to other studied approaches.


Evidence for use in Allergic Rhinitis

For allergic rhinitis, a condition where symptoms may vary in intensity, research has explored studies examining patient-reported symptoms. These trials were evaluated in adult and pediatric populations. The studies explored outcomes linked to inflammatory or irritative states such as nasal congestion, which were measured using scales applied in studies examining patient-reported experiences. Findings indicate that symptom reports may have evolved during the short observation periods. What remains uncertain is the durability of the reported changes, as follow-up durations were limited.


What is still uncertain about Intal 2%

Research focusing on extended use of Intal 2% is limited. This means long-term effects are not fully established, and there is limited information for long-term outcomes related to sustained daily functioning. Comparative evidence is lacking across the research landscape. Additionally, data for certain groups remain insufficient, including older adults, and individuals with complex co-existing conditions, indicating that research is ongoing and further data is needed.

Frequently Asked Questions (FAQ)

Common questions about Intal 2% (FAQ)


Q: What is the full list of ingredients in Intal 2% nebulizer solution besides the active drug?

According to official product information, the active ingredient is Cromolyn Sodium, USP. The solution contains Water for Injection, USP, which serves as the base, and has a target pH of 5.5. The product is normally clear and colorless to pale yellow.

Q: How long does it take for Intal 2% eye drops to start working?

Official regulatory studies indicate that a reduction in symptoms like itching, tearing, and redness is usually evident within a few days of initiating treatment. However, longer treatment up to six weeks is sometimes reported as needed to achieve the full therapeutic effect, according to label information.

Q: Can Intal 2% be purchased over the counter, or is a prescription required?

Official government documents classify Intal 2% (Cromolyn Sodium Inhalation Solution) as a HUMAN PRESCRIPTION DRUG. This means a prescription from a healthcare provider is required to obtain this medicine.

Q: What is the appearance of a discolored Intal 2% solution?

The solution is expected to be clear, colorless to pale yellow when it is stable. The official product label instructs users not to use the solution if it appears discolored or contains any visible precipitate. Any change from its normal appearance is a reason not to use the solution, as indicated on the label.

Q: How should Intal 2% ophthalmic solution be safely disposed of?

Specific disposal guidance for the ophthalmic solution is often not detailed on the primary product label. In line with general regulatory guidance for unused medicines, the product should ideally be disposed of via an authorized drug take-back program. If a program is unavailable, the product should be mixed with an undesirable substance, placed in a sealed container, and disposed of in the household trash, following local guidelines.

How should Intal 2% be stored and disposed of?

Storage and Disposal of Intal 2% (Cromolyn Sodium Inhalation Solution)

The official labeling mandates specific storage conditions to maintain the quality and stability of Intal 2% Nebulizer Solution.

Required Storage and Handling

Condition Requirement
Temperature Store at Controlled Room Temperature, 20^circ to 25 C (68^circ to 77 F).
Protection Must be protected from light.
Packaging Unit-dose vials must be retained in the foil pouch until the time of use.
Stability Check Do not use the solution if it is discolored or contains a precipitate.
Child Safety Keep out of the reach of children.

Official Disposal Instructions

Unused or expired Intal 2% should be disposed of using an authorized drug take-back program. If such a program is not available, the medicine may be mixed with an undesirable substance, placed in a sealed container, and disposed of in the household trash, following regulatory guidelines for non-hazardous medicines.

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

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