Gastrocrom

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Gastrocrom

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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 Gastrocrom

Quick Facts: Gastrocrom (Sodium Cromoglycate)

Property Description
Active ingredient Sodium Cromoglycate (Cromolyn Sodium)
Form Oral Solution Concentrate (Liquid)
Pharmacological class Mast Cell Stabilizer / Antiallergic Agent
General purpose Prevention and Maintenance Therapy
Origin Synthetic Compound (Chromone Derivative)

Gastrocrom: Identity, Chemical Composition, and Origin

Gastrocrom is a specialized prescription medication characterized by its single active ingredient, Sodium Cromoglycate, also widely known as Cromolyn Sodium. This compound is a synthetic small molecule, manufactured chemically as a chromone derivative. The distinctive formulation is an oral solution concentrate, packaged in single-use ampules, designated for oral administration after dilution. Pharmacological studies highlight that Sodium Cromoglycate is characterized by poor systemic absorption from the gastrointestinal tract, ensuring that the active compound concentrates its therapeutic effect locally within the gut lining. This specialized low-absorption property is clinically recognized as its differentiating feature.

What Type of Medicine is Gastrocrom? (Pharmacological Class)

Gastrocrom is categorized as a Mast Cell Stabilizer, a type of Antiallergic Agent. This pharmacological class works prophylactically by targeting mast cells—immune cells highly concentrated in the digestive lining—to prevent them from undergoing degranulation. By inhibiting this key process, the medicine stops the early, uncontrolled release of potent inflammatory substances, such as histamine and leukotrienes. This mechanism of stabilizing the cell membrane provides a unique therapeutic strategy compared to drugs that only manage symptoms after the allergic process has begun.

The General Purpose of Gastrocrom in Maintenance Therapy

The general purpose of using Gastrocrom is its application as maintenance therapy for achieving long-term control over chronic immune hyperactivity, especially in the digestive system. It functions as a preventative compound aimed at consistently reducing the sensitivity and reactivity of the gut, which is a typical use scenario for managing underlying mast cell-driven conditions. Its goal is to quiet the immune over-responsiveness, establishing a stable baseline, making it essential for routine, ongoing management rather than for addressing acute, immediate symptoms.

Regulatory References

  1. NIH DailyMed (Gastrocrom Oral Concentrate)

What side effects are possible with Gastrocrom?

Possible Side Effects and Safety Information: Gastrocrom

The safety profile of Gastrocrom (Sodium Cromoglycate oral solution) is characterized by officially documented adverse reactions primarily affecting specific physiological systems. Frequency classifications help to categorize these effects based on regulatory standards.


Adverse Reaction Classification

Classification System-Organ Class Examples of Officially Listed Reactions
Common Nervous System Disorders, Skin, Musculoskeletal, Gastrointestinal Headache, rash, stomach discomfort, joint pain (arthralgia), nausea.
Uncommon Gastrointestinal Disorders Vomiting, abdominal pain, diarrhea.
Not Known Immune System Disorders Angioedema (swelling).

Serious Adverse Reactions and Safety Constraints

The regulatory label documents the potential for serious adverse reactions, including anaphylaxis and angioedema, which represent severe allergic responses. The label also notes that administration may lead to the exacerbation of systemic mastocytosis symptoms.

Treatment must be discontinued immediately if signs of anaphylaxis or other severe allergic reactions appear, which is a critical safety constraint in the official prescribing information.

Population-Specific Safety

Safety and effectiveness have not been established in pediatric patients under 2 years of age. Furthermore, due to the drug's characteristic minimal systemic absorption, no specific safety considerations are officially noted for older adults or individuals with renal or hepatic impairment.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The official overdose profile for Gastrocrom (Sodium Cromoglycate oral solution) is structured based on the regulatory analysis of the drug's acute toxicity.

Feature Official Regulatory Statement
Documented Manifestations Due to the limited absorption of the drug from the gastrointestinal tract, the acute toxic dose is considered very high. Specific systemic manifestations are not formally listed in regulatory documentation.
Required Emergency Action Emergency medical attention should be sought, or a Poison Control Center must be contacted immediately in the event of a suspected overdose.
Management Strategy Management should be symptomatic and supportive. Medical observation is required, and intervention is limited to treating any symptoms that may arise.
Antidote Information No specific antidote is known or documented for managing an overdose of the oral solution.

The overdose profile is defined primarily by its low systemic risk, a property that stems from its very poor absorption from the gastrointestinal tract. This pharmacological characteristic means the acute toxic dose is considered high, and specific severe systemic manifestations of toxicity are not typically listed in regulatory documentation. Despite the low expected toxicity, regulators strictly mandate that immediate medical help be sought upon any suspicion or confirmation of an overdose. The required medical approach, as outlined in official documents, involves providing both clinical observation and strictly symptomatic and supportive treatment, as there is no specific antidote known for this compound. Seeking urgent assistance is the primary mandated response to ensure appropriate medical oversight is provided in all overdose situations.

Therapeutic Uses of Gastrocrom

What Gastrocrom Treats: Main Uses and Benefits

Gastrocrom (cromolyn sodium oral solution, concentrate) is a medicine used in situations involving certain distressing symptoms primarily for the management of patients with mastocytosis. The medication is applied across domains where additional symptomatic support is needed. This medication is used in the management of this condition, which is characterized by periods of heightened symptoms, and the primary goal of its use is the long-term management of these chronic, mast cell-mediated symptoms, establishing a stable baseline.

This treatment is relevant for easing a range of symptoms related to physical discomfort and symptoms linked to organ-specific functional stress. Clinically, this may assist with gastrointestinal complaints such as diarrhea, abdominal pain, nausea, and vomiting, as well as systemic symptoms like flushing, headaches, urticaria, and itching in some patients. The treatment supports the patient by easing the overall symptom burden during acute or disruptive episodes, functioning as a crucial part of maintenance therapy.


Quick Facts: Therapeutic Support

Primary Goal Long-term symptomatic management of chronic mast cell conditions.
Symptom Focus Helps address symptom clusters that may become intense or disruptive, especially gastrointestinal distress and systemic imbalance (flushing, itching).
Clinical Context Maintenance therapy; applied in scenarios where additional management of discomfort is required.

Eligibility and Restrictions for Use

Who Can and Cannot Use Gastrocrom?

Official regulatory documentation defines the eligible patient populations and specific restrictions for Gastrocrom (cromolyn sodium oral solution).

Absolute Contraindication

The medicine is contraindicated in patients who have demonstrated hypersensitivity to cromolyn sodium or any components of the oral solution. Use is strictly prohibited for these individuals.

Age-Group Eligibility

Gastrocrom is approved for use in adults and children aged 2 years and older. Its use is not recommended for pediatric patients under 2 years of age, and is reserved only for severe disease where the potential benefits clearly outweigh the risks. For elderly patients, official labeling advises cautious dose selection due to the higher frequency of age-related decreases in organ function.

Condition-Based Restrictions

Use is restricted in patients with decreased renal (kidney) or hepatic (liver) function. The recommended dosage must be decreased in these populations, as the drug's excretion relies on these two organ systems.

Pregnancy and Lactation Status

Use during pregnancy is conditional. Regulatory agencies advise that the medicine be used only if clearly needed due to the absence of adequate, controlled studies. Furthermore, caution should be exercised when the medicine is administered to nursing mothers.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The official regulatory profile for Gastrocrom (Cromolyn Sodium Oral Solution) is distinct due to the medicine’s fundamental pharmacokinetic property: poor systemic absorption. Less than one percent of the oral dose is absorbed from the gastrointestinal tract. This low absorption rate is the basis for the absence of formally documented, clinically significant systemic drug–drug interactions, including those mediated by CYP enzymes or drug transporters, in the official prescribing information.

Administration Restrictions

Constraint Type Officially Documented Requirement
Preparation Restriction The solution concentrate must not be mixed with substances like fruit juice, milk, or food. This restriction is a mandatory procedural constraint intended to ensure the medicine functions as required.
Timing Rule The medicine must be administered as a diluted solution one-half hour before meals and at bedtime.

Population-Specific Considerations

While formal systemic interactions are not listed, the drug's interaction profile includes considerations related to its elimination. Since Gastrocrom is cleared from the body via both renal (kidney) and biliary (liver) excretion routes, specific notes apply to certain populations. Caution is officially advised for patients diagnosed with renal impairment or hepatic impairment, as reduced function in these organs may lead to altered clearance and potentially increased systemic levels of the drug.

Mechanism of Action

How Gastrocrom Works: Mechanism of Action

Cellular Targeting and Mast Cell Stabilization

The core mechanism of Gastrocrom (cromolyn sodium) is the stabilization of mast cells within the lining of the gastrointestinal (GI) tract. This interaction prevents the mast cells from undergoing degranulation upon activation.


Molecular Cascade: Blocking Mediator Release

Gastrocrom modulates molecular signaling by inhibiting the influx of calcium ions (Ca^2+) into the mast cell. By blocking this essential early step, the drug prevents the cellular process of exocytosis, which stops the release of preformed inflammatory mediators like histamine and leukotrienes.


Localized Peripheral Effect and Physiological Dampening

Because Gastrocrom is minimally absorbed into the bloodstream, its action is confined to the peripheral GI mucosa. This localized effect leads to a reduction in local mediator release and decreased mediator-driven vascular permeability within the GI tissue.

Dosage and Administration Information

How to use Gastrocrom: Official Administration Guidelines

Gastrocrom (cromolyn sodium oral solution, concentrate) is administered strictly via the oral route (ingestion), following a highly consistent, high-frequency schedule for maintenance use. The administration protocol is designed to maximize local action within the gastrointestinal tract and requires strict adherence to preparation and timing rules.


Official Dosing and Frequency

The standard regimen is a divided daily dose, taken four times per day (Q.I.D.), with doses spaced by approximately four to six hours to ensure continuous coverage.

Population Standard Single Dose Total Daily Dose Frequency
Adults 200 mg 800 mg Four times daily
Children (2–12 years) 100 mg 400 mg Four times daily

For children under 2 years of age, use is generally not recommended due to limited available data.


Administration Requirements

Each dose, which consists of the contents of one single-use ampule, must be diluted with a glass of water and stirred before being consumed. The dosing must occur 30 minutes before meals and at bedtime. This specific timing relative to food intake is a mandatory component of the usage instructions. The medication is used as long-term maintenance therapy, and full assessment of its effects requires continuous, regular use for two to six weeks. If a dose is missed, the next dose is taken at the regular time, and the amount is not doubled.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Gastrocrom

Evidence for Mastocytosis Symptoms

The research was studied for the symptomatic management of mastocytosis. This group of conditions is characterized by fluctuating or episodic manifestations associated with mast cell activity. The core evidence is based on a limited number of randomized, controlled clinical trials (RCTs). These trials are considered the standard for gathering evidence on how symptoms change over time when receiving a study drug compared to a control.

The controlled trials was studied for people experiencing conditions involving periods of heightened symptoms, which may include intense gastrointestinal symptoms, such as persistent diarrhea, abdominal pain, nausea, and vomiting. The studies also examined systemic symptoms, such as frequent flushing and hives (urticaria). The research describes how patients reported their experience when receiving the study drug in these defined settings.


Study Design and Outcomes Examined

To evaluate the drug, researchers applied study designs that included placebo-controlled settings, where the drug was compared against an inactive substance. Some key trials also utilized a crossover design, allowing researchers to monitor each patient during a period on the study drug and a period on a control, offering a way to observe individual symptom patterns.

The main patient-reported outcomes describing perceived discomfort were based on experiences, where participants were asked to score the severity of their symptoms daily. The studies also included an evaluation of physiological markers, such as measuring histamine levels in the urine. However, findings were mixed regarding how well these laboratory measures correlated with the symptoms the patients reported.


Areas of Research Uncertainty and Study Limitations

Researchers and regulators have identified several key limitations. Foremost, mastocytosis is a rare condition, meaning the sample sizes were modest in the available controlled studies. Consequently, the results apply only to the populations studied, and subgroup findings are uncertain due to limited data.

Furthermore, the follow-up durations were limited in the main clinical trials. This means data for long-term outcomes are not fully established; the effects of chronic use over many years were not evaluated in controlled trials in these specific research settings. The research highlights what is known—and what is still uncertain—about this medication.

Key Studies & References

  1. Cromolyn Sodium Oral Solution, Concentrate - DailyMed Drug Label

Frequently Asked Questions (FAQ)

Common questions about Gastrocrom (FAQ)

Q: Is Gastrocrom the same as Nasalcrom or Opticrom?

A: Gastrocrom contains cromolyn sodium, which is the same active ingredient found in other products like Nasalcrom (used in the nose) and Opticrom (used in the eye). However, Gastrocrom is a specialized oral solution formulation. The different formulations are approved for use in different parts of the body and for different indicated conditions.

Q: Is Gastrocrom a type of steroid?

A: According to the official product information, Gastrocrom is categorized as a mast cell stabilizer and an antiallergic agent. Regulatory documents explicitly state that the medication has no inherent glucocorticoid activity, which means it is not a steroid.

Q: How long does it typically take to see potential effects from Gastrocrom?

A: Regulatory information advises that the full effect of the medication is usually evident after two to four weeks of continuous treatment. While some individuals may show an almost immediate response, the product is intended for long-term maintenance, and consistent use for several weeks is usually needed to assess its benefits.

Q: Is Gastrocrom safe for children to use?

A: The medication is approved for use in pediatric patients who are 2 years of age and older. Use in children younger than 2 years is generally not recommended by official sources and is reserved only for severe conditions where the potential benefits may be determined to outweigh potential risks.

Q: Can older adults use Gastrocrom safely?

A: Official labeling advises caution when determining the appropriate dose for older adults due to the higher frequency of age-related decreases in organ function, particularly affecting the kidneys (renal) or liver (hepatic), which are responsible for clearing the drug from the body.

Q: Is Gastrocrom absorbed into the body, or does it stay in the gut?

A: Gastrocrom is described in regulatory documents as poorly absorbed from the gastrointestinal tract. Less than one percent of the oral dose is absorbed systemically into the bloodstream. This low absorption means that the active compound is primarily concentrated locally within the gut lining to achieve its therapeutic effect.

Q: Does research evidence show similar results across different patient groups?

A: Studies and official information indicate that the condition Gastrocrom was studied for is rare, meaning the clinical trials conducted used modest sample sizes. Therefore, the results apply specifically to the populations studied in the research, and findings related to subgroups of patients are considered uncertain due to limited data.

Q: What are people referring to when they mention a 'loading phase' for Gastrocrom?

A: The term refers to the initial period where a consistent, scheduled dosing is required. Official guidance indicates that once a satisfactory control of symptoms is achieved, typically after two to three weeks, the dose may be reduced to the minimum required to maintain the effect.

Q: Are there any official restrictions on driving while using Gastrocrom?

A: There is no explicit statement in the official prescribing information restricting activities like driving. However, adverse reactions reported by patients have included transient headache and dizziness. Patients are advised to be aware of how the medicine may affect them before operating machinery or driving.

Q: What happens if I stop taking Gastrocrom suddenly?

A: Regulatory guidance emphasizes that the medication's beneficial effect is dependent upon administration at regular intervals. For conditions like mastocytosis, the dosage must be maintained to prevent a recurrence or relapse of symptoms.

Q: Does Gastrocrom have a black box warning?

A: The official FDA label does not contain a Black Box Warning. The label does, however, document the potential for serious adverse reactions, including severe allergic responses like anaphylaxis and angioedema.

Q: Do I need a special prescription from a specialist for Gastrocrom?

A: Official documents classify Gastrocrom as a prescription medication. Regulatory bodies do not specify that the prescription must be initiated by a specialist; however, the medicine is usually managed by a healthcare provider experienced in treating the underlying condition.

Q: Why is Gastrocrom sometimes used by patients with digestive problems?

A: The medicine is officially indicated for the management of mastocytosis. Its use is associated with a reduction in mast cell activity within the lining of the gastrointestinal tract, which can help manage related gastrointestinal symptoms such as persistent diarrhea, nausea, vomiting, and abdominal pain in some patients.

Q: Are there any specific foods or drinks to avoid while using Gastrocrom?

A: Regulatory documents list no broad dietary restrictions associated with taking the medication. However, official preparation instructions strictly mandate that the solution must be mixed with a glass of water and must not be mixed with fruit juice, milk, or food.

Q: Is it possible to have an allergic reaction to Gastrocrom?

A: Yes. The medicine is contraindicated (use is prohibited) in patients who have previously shown hypersensitivity to it. The potential for serious allergic reactions, including anaphylaxis, is also documented in the official safety information.

Q: What is the expiration date advice for Gastrocrom after opening the ampule?

A: The medication is packaged in single-use ampules. Administration instructions require that the contents of the ampule must be squeezed into water, stirred, and all of the diluted liquid must be consumed immediately. The solution is designed to be prepared only when ready for use.

Q: Can Gastrocrom cause drowsiness or fatigue?

A: While drowsiness is not listed as a common effect, postmarketing reports found in regulatory labels mention that patients have experienced fatigue. The safety profile also includes classifications for dizziness and other reactions that may affect alertness.

Q: What is the typical duration of treatment with Gastrocrom?

A: The regulatory label indicates that Gastrocrom is intended for use as long-term maintenance therapy. The treatment is used for ongoing, long-term management rather than for a fixed short period, as advised in regulatory information.

Q: Is the taste of the Gastrocrom solution always noticeable?

A: Official descriptions of the solution state that the active ingredient, cromolyn sodium, may leave a slightly bitter aftertaste for some users.

Q: Does Gastrocrom need to be refrigerated?

A: No. Official storage instructions state that the solution should be kept at Controlled Room Temperature (typically 20 C to 25 C). The product must also be kept from freezing.

Q: Can Gastrocrom cause mood changes or anxiety?

A: Official regulatory labels include reports of adverse events classified under Psychiatric disorders. These postmarketing reports have documented experiences such as anxiety, depression, psychosis, hallucinations, and behavior change.

Q: Is it true that Gastrocrom has been available for a long time?

A: Yes. The Food and Drug Administration (FDA) originally approved the oral concentrate formulation (Gastrocrom) in February 1996.

Q: Can I dilute Gastrocrom in something other than water?

A: Official administration instructions explicitly state that the solution must be diluted into a glass of water. They also include a specific restriction against mixing the solution with fruit juice, milk, or food.

Q: Is it normal to feel a change right away after taking Gastrocrom?

A: The official statement notes that the full therapeutic effect of the drug is usually evident only after several weeks of continuous use. However, the regulatory documents also acknowledge that some patients may show an almost immediate response, indicating that a rapid feeling of change is possible but is not the typical timeframe for full assessment.

How should Gastrocrom be stored and disposed of?

How to Store and Dispose of Gastrocrom?

Gastrocrom (cromolyn sodium oral concentrate) must be stored under specific conditions to maintain product quality, as defined in official regulatory documents.

Storage and Handling Requirements

Requirement Official Instruction
Temperature Store at Controlled Room Temperature (typically 20 C to 25 C).
Protection Protect from light and keep from freezing (Do not freeze).
Stability Do not use if the solution contains a precipitate (particles or cloudiness) or becomes discolored.
Packaging Keep the unit dose ampules in the foil pouch until ready for use.
Safety Keep out of the reach of children.

Disposal of Unused Medicine

To dispose of Gastrocrom that is no longer needed, the medicine should be removed from its original container, mixed with an undesirable substance (such as dirt or used coffee grounds), and placed into a sealed bag or container before being thrown in the household trash. Personal information should be scratched out on the empty medicine packaging.

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

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