Кромоген

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Кромоген

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Medically reviewed

Laura Arias

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 Кромоген

Property Description
Active ingredient Sodium Cromoglycate
Form Nasal spray, eye drops, solution for inhalation
Pharmacological class Mast cell stabilizer
General use Prophylactic anti-allergic agent
Origin Synthetic compound

What Type of Medicine is Кромоген and Its Origin?

Кромоген is a synthetic, single-component medicine whose active ingredient is Sodium Cromoglycate, also known as Disodium Cromoglycate. This compound is categorized as a mast cell stabilizer used in allergic conditions, placing it within the group of prophylactic anti-allergic agents. This substance works to prevent the start of an allergic reaction rather than treating it after symptoms have begun. Кромоген is clinically recognized for providing effective maintenance therapy in specific patient groups, differentiating it from products marketed only for acute relief.

Composition and Available Forms of Кромоген

The medicine is formulated for localized delivery to allergy-affected tissues, supporting its intended route of administration via ocular, intranasal, or pulmonary application. These delivery systems involve various dosage forms, including an aqueous solution presented as eye drops and a nasal spray, along with solutions or dry powder capsules for inhalation. The composition is a single-component product where the active Sodium Cromoglycate is carried by a basic aqueous solution or a dry powder base, depending on the delivery system used. The drug is intended for use across these various localized forms, making the medicine suitable for direct application to the nasal, ocular, or bronchial mucosa to allow its specialized action to focus on the target area.

General Purpose and High-Level Therapeutic Benefit

The general therapeutic purpose of Кромоген is based on its core mechanism as a mast cell stabilizer, which enables maintenance therapy aimed at prevention. The drug works by stabilizing mast cell membranes, thereby inhibiting the rapid release of inflammatory chemicals, such as histamine, that trigger the allergic response. The resulting benefit is prophylactic: it acts to block the initial steps of the inflammatory cascade, providing consistent management to reduce the incidence and intensity of hypersensitivity reactions. A typical use scenario involves starting the medicine before the beginning of a known allergen season to establish this protective effect.

Regulatory References

  1. National Library of Medicine
  2. MedlinePlus, Cromolyn Sodium
  3. European Medicines Agency (EMA)

What side effects are possible with Кромоген?

Possible side effects and safety information

The safety profile for Кромоген (Sodium Cromoglycate) is based on official regulatory documentation, which organizes potential adverse reactions by frequency and affected body system. Many documented effects are generally mild and localized to the area of administration.


Adverse Reaction Classification

Adverse reactions are classified according to incidence based on regulatory reporting:

  • More Common: Reactions can include headache, diarrhea, and throat irritation or cough, with specific occurrences depending on the route (e.g., inhalation or oral forms).
  • Less Common/Uncommon: Officially listed effects include abdominal pain, nausea, muscle pain, and irritability.
  • Rare: Documented effects include difficulty in swallowing (dysphagia), hives (urticaria), joint pain (arthralgia), and episodes of increased difficulty in breathing.

Reactions are categorized by the systems they affect, such as Respiratory Disorders (cough, wheezing), Gastrointestinal Disorders (diarrhea, nausea), and Eye Disorders (transient stinging or burning on instillation).


Serious Adverse Reactions and Constraints

Official labels document the potential for rare, severe adverse reactions classified as serious. These include systemic hypersensitivity reactions such as anaphylaxis, angioedema, and episodes of severe bronchospasm. The regulatory safety profile defines clear constraints: the medicine has no role in the treatment of acute status asthmaticus.

Safety statements for specific groups are included in official prescribing information. For instance, the safety and effectiveness have not been established for children younger than two years (for most routes). Additionally, caution is noted for older adults and individuals with known kidney or liver problems.

Some effects, such as a localized cough following inhalation or stinging with eye drops, are described as transient, occurring immediately after administration. Symptoms of the treated condition may recur if the medicine is discontinued.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Кромоген (Sodium Cromoglycate) is defined by its low systemic risk and the resulting absence of a specific clinical overdose syndrome.

Documented Overdose Characteristics

Property Official Regulatory Statement
Documented presentations No known cases of overdosage are reported; no specific clinical syndrome has been associated with overdosage.
Toxicity Profile Low acute toxicity profile due to poor systemic absorption from the routes of administration (nasal, ocular, inhalation).
Excretion Notes Caution is advised in dosage consideration for patients with impaired renal or hepatic function, as excretion occurs via both biliary and renal routes.

Emergency Actions and Management

Regulatory authorities mandate specific actions be taken in the event of accidental ingestion or suspected overdose. Users must seek professional assistance or contact a Poison Control Center immediately.

  • Required Action: Seek immediate medical attention.
  • Antidote: No specific antidote is known or documented in official regulatory labeling.
  • Management Strategy: Treatment consists of symptomatic and supportive treatment, with medical observation recommended in cases of suspected overdosage.

The official profile mandates seeking urgent medical help to ensure appropriate supportive care, despite the low systemic toxicity reported in regulatory documents.

Therapeutic Uses of Кромоген

What Кромоген Treats: Main Uses and Benefits

Кромоген is generally considered a prophylactic anti-allergic agent, used for the consistent management of symptoms across three primary therapeutic domains where allergic hypersensitivity creates noticeable physiological strain. The medication is considered relevant for conditions presenting with systemic or localized discomfort, commonly including manifestations of allergic rhinitis, allergic conjunctivitis, and providing maintenance support for specific presentations of bronchial asthma and exercise-induced bronchospasm. Its therapeutic role includes addressing breathing difficulties associated with asthma and known triggers.

The primary therapeutic domain involves managing symptom clusters that may become intense or disruptive, such as frequent sneezing, itchy eyes, and nasal discharge. This approach provides support that helps ease the overall symptom burden during periods of heightened symptoms.

“This medication is primarily relevant when supportive symptom management is appropriate, assisting the patient during difficult episodes by easing distress.”


Quick Fact: Relief for Recurrent Symptoms

Кромоген is commonly used to help with conditions characterized by periods of heightened symptoms, offering a supportive role during seasonal or temporary exposure to allergens.

Focus on Symptom Control

It is considered relevant for managing symptoms that interfere with daily functioning, contributing to improved comfort during symptomatic periods, and is often used during phases when symptoms become more noticeable.

Regulatory References

  1. NIH MedlinePlus overview of Cromolyn Inhalation

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Кромоген — Official Regulatory Information


Eligibility Scope

Populations for whom use is allowed (as stated in label):

  • Adults (18+): Permitted for all available forms (Nasal Spray, Eye Drops, Inhalation Solution).
  • Children ge 2 Years: Approved for nasal and inhalation solutions; mathbf4 years and older for the ophthalmic solution.

Populations for whom use is contraindicated:

  • Patients with known hypersensitivity to Sodium Cromoglycate or any non-active ingredients are absolutely prohibited from use.

Age-related eligibility rules:

  • Use is not established or not recommended in children below the age mathbf2 (nasal/inhalation) or mathbf4 (ophthalmic).

Condition-specific eligibility rules:

  • Organ Impairment: Caution is advised in patients with impaired hepatic (liver) or renal (kidney) function.

Pregnancy and lactation eligibility status (if explicitly documented):

  • Pregnancy: Use is generally restricted and advised only if clearly needed.
  • Lactation: Caution should be exercised as it is not definitively known if the drug is excreted in human milk.

Eligibility-related restrictions:

  • Soft Contact Lenses (Ophthalmic Form): Must be removed prior to instillation due to the preservative Benzalkonium Chloride.

Eligibility Classifications (High-Level)

Eligibility severity classification (as defined in official documents):

  • Absolute Contraindication: Hypersensitivity.
  • Conditional Restriction: Pregnancy, Lactation, Organ Impairment.

Regulatory basis (EMA / FDA / etc.):

  • Governmental regulatory approval and labeling for specific Sodium Cromoglycate formulations.

Eligibility-context constraints (as defined in official documents):

  • Constraint linked to patient's physiological status (Pregnancy, Organ Function).

Resulting Eligibility Structure

Official eligibility statements:

  • The medicine is contraindicated by hypersensitivity and has clear minimum age requirements that vary by form.
  • Caution is mandatory for use in patients with hepatic or renal impairment and during pregnancy and lactation.

Connection to the overall eligibility profile: The official eligibility profile for Кромоген is established by a single absolute contraindication and distinct age-based minimums for each product form. These core regulatory rules are supplemented by mandatory caution statements for specific populations with organ impairment and during pregnancy and lactation, which together define the formal boundaries for permitted patient use as dictated by regulatory documents.

What should I know about interactions with other medicines?

The official regulatory profile for Кромоген (Sodium Cromoglycate) across its localized dosage forms is generally defined by an absence of known systemic interactions with other medicines.

This minimal interaction status is attributed to the drug’s pharmacological characteristic of minimal systemic absorption and rapid excretion. Regulatory documentation confirms that no clinically significant pharmacokinetic or pharmacodynamic interactions with other systemic medicinal products are documented.

Interaction-Related Restrictions Official Regulatory Information
Medicinal Product Interactions None known for systemic medicines.
Timing Restriction (Ophthalmic) Soft contact lenses must be removed before instillation of eye drops and not reinserted earlier than 15 minutes after use (due to excipient: Benzalkonium chloride).
Food/Beverage Restriction (Oral) The oral solution concentrate must not be mixed with fruit juice, milk, or food besides water, as co-ingestion may impede the medicine's proper function.
Population-Specific Interaction Notes
Impaired Renal or Hepatic Function Due to the drug's excretion via bile and urine, official labels state that consideration may be given to decreasing the dosage or discontinuing the drug in patients with impaired renal or hepatic function.

The few documented constraints are limited to administration requirements related to the specific dosage form, rather than drug-drug effects.

Mechanism of Action

️ Stabilization of the Mast Cell Membrane

The core mechanism of Кромоген (Sodium Cromoglycate) is to stabilize the cell membrane of mast cells, which are specialized immune cells residing in the respiratory and ocular mucosa. This action is achieved by modulating the permeability of the cell membrane, specifically by inhibiting the influx of calcium ions ( Ca^2+). This Ca^2+ modulation prevents the cellular activation signal that would otherwise cause the mast cell to rapidly degranulate and release its chemical contents.


Interruption of the Inflammatory Mediator Cascade

By preventing the initial degranulation process, the drug interrupts the entire allergic cascade at its earliest molecular step. This action blocks the massive, sudden expulsion of pre-formed mediators like histamine and suppresses the subsequent formation and release of newly synthesized mediators like leukotrienes. The resulting physiological effect is the prophylactic interruption of the signaling pathways that induce local fluid extravasation, vascular changes, and smooth muscle contraction, contributing to the maintenance of chemical equilibrium in the local tissue environment and limiting the progression of the inflammatory signaling cascade.

Dosage and Administration Information

How to Use Кромоген (Cromoglicic Acid) — Administration Guidelines

Кромоген (Cromoglicic acid/Sodium Cromoglycate) is administered via specific routes and schedules. Adherence to the prescribed form, route, and timing is essential for proper use.


Administration Methods and Dosing Schedules

Dosage Form Approved Route Standard Adult Frequency Administration Condition
Oral Solution (Concentrate) Ingestion Four times daily (QID) 30 minutes before meals and at bedtime.
Ophthalmic Solution (Eye Drops) Ocular/Topical Four to six times daily Remove soft contact lenses before use.
Inhalation Solution (Nebulizer) Inhalation Four times daily (QID) Administer via nebulizer only.

Preparation and Age-Specific Rules

Oral Solution Preparation and Timing: The Oral Solution concentrate must be diluted with water, juice, or milk immediately before ingestion. For patients aged 2 to 12 years, the labeled dose is lower than that for adolescents and adults, reflecting specific pediatric dosing requirements.

Procedural Constraints: The Ophthalmic Solution requires users to remove soft contact lenses prior to instillation and wait at least 15 minutes before reinsertion. Treatment success is dependent upon the medication being administered at the regularly specified intervals as directed, regardless of the chosen formulation. The oral form is strictly for oral use only and is not to be used for inhalation or injection.


Note on Missed Doses: If a dose is missed, it should be taken as soon as possible, unless it is close to the time for the next scheduled dose. Doses should not be doubled to catch up on a missed schedule.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Кромоген (Cromolyn)

The evidence base for Кромоген (cromolyn/disodium cromoglycate) has been gathered over many years and is made up of different types of studies, including controlled trials and observational reports. Research highlights what is known—and what is still uncertain. Study results reflect the specific conditions under which they were conducted and research does not determine whether an individual will respond similarly.


Evidence for Use in Asthma (Inhaled)

Research was evaluated in patients with asthma, especially in children and adolescents. Studies conducted include short-term Randomized Controlled Trials (RCTs) and systematic reviews. These trials were used in research exploring how symptoms change over time, focusing on outcomes such as pulmonary function measures (like lung capacity) and patient-reported outcomes describing perceived discomfort. Studies monitored reported changes in symptom severity and recorded reductions in the use of rescue medication during the observed time intervals. However, research highlights that findings were mixed across different studies, and comparative evidence with newer therapies is often limited, as many key studies were conducted several decades ago.


Evidence for Use in Mast Cell Diseases (Oral)

Oral Кромоген was studied for conditions characterized by fluctuating or episodic manifestations linked to mast cell activation, such as systemic mastocytosis. The evidence base mainly includes smaller, non-randomized observational reports and pharmacokinetic (PK) studies which research examined how the medicine is absorbed in the body. The studies reported measurements of low systemic bioavailability for the oral formulation. Studies examined short-term changes in patient-reported outcomes describing physical discomfort like abdominal pain and flushing, with some reports describing patterns related to symptom intensity. However, the data for patient outcomes are still emerging, meaning certainty remains low regarding definitive clinical patterns.


What is Still Uncertain About Кромоген

Evidence highlights what is known—and what is still uncertain—about Кромоген. The main limitations in the evidence landscape include the modest sample sizes in many of the key studies and that follow-up durations were limited for many clinical trials, meaning the long-term changes and outcomes are not fully established. The evidence quality varies across studies, and comparative evidence is lacking against newer therapeutic options in many areas. Overall, research provides context but not individual predictions, and certainty remains low in several aspects, underscoring the need for more large-scale, updated research to address these specific gaps.

Key Studies & References

  1. Cromolyn sodium in the treatment of children with severe, perennial asthma

Frequently Asked Questions (FAQ)

Common questions about Кромоген (FAQ)


Q: What is the main difference between a mast cell stabilizer like Кромоген and an anti-leukotriene drug?

Official documents describe Кромоген as a mast cell stabilizer that works earlier in the allergic process than anti-leukotriene medicines. It functions by stabilizing mast cells, which prevents the rapid release of various inflammatory chemicals like histamine and also suppresses the subsequent formation of leukotrienes. This means Кромоген interrupts the allergic cascade at its starting point.


Q: How quickly do people typically feel the effects of Кромоген after starting therapy?

The time it takes to notice an effect varies depending on the product form. For eye drops, symptomatic response is often seen within a few days, but up to six weeks of regular use may be needed to reach full benefit. The oral solution typically has a delayed onset, with effects usually becoming apparent within two to six weeks.


Q: Can I take herbal supplements at the same time as Кромоген?

Official regulatory product information states that there are no known clinically significant interactions with other systemic medicines. However, specific interactions with herbal supplements are not explicitly covered in the drug labels. Official documents do not contain information regarding the combination of this medicine with specific herbal supplements.


Q: Is it safe to use Кромоген every day for an extended period?

Official information indicates that, for authorized uses like ocular allergies, the therapy is described as a maintenance treatment that may be continued to sustain improvement. Some clinical studies have explored the long-term use of the medicine for periods up to one year.


Q: Can using Кромоген make symptoms feel worse initially?

Certain localized dosage forms of the medicine, such as the eye drops or inhalation powder, may cause transient (temporary) sensations immediately after administration, such as stinging, burning, or a cough. These effects are transient and are localized to the area of administration.


Q: Is tiredness or fatigue a known side effect of Кромоген?

Official reports mention that drowsiness has been reported in some clinical trials with the medicine. However, the regulatory information notes that a clear link showing that the medicine caused this effect was not always established.


Q: What level of symptom improvement should generally be expected from Кромоген?

Studies and official clinical data indicate that use is associated with positive changes in reported symptoms. For instance, the oral form has been linked to improvement in abdominal pain and flushing, and for the eye drops, improvement has been observed in symptoms such as itching, tearing, and redness.


Q: Is there a generic version of Кромоген available?

The active ingredient in Кромоген is called Sodium Cromoglycate, which is the generic name for this medicine. This active ingredient is widely available and is marketed under various brand names, in addition to being sold as a generic product.


Q: Is dry mouth or a change in taste a frequently reported side effect?

Official adverse event lists do not include dry mouth or changes in taste as common side effects. However, rare reports of mouth or tongue inflammation (stomatitis and glossitis) have been noted with the oral formulation.


Q: What is the proper procedure if I experience an unusual reaction after taking Кромоген?

In the event of signs of a serious adverse reaction, such as difficulty breathing or severe swelling (a sign of a hypersensitivity reaction), official patient information advises contacting a medical professional immediately.


Q: How long does the active ingredient in Кромоген stay in the body?

Regulatory and pharmacokinetic reviews state that the medicine is poorly absorbed into the bloodstream and is not metabolized by the body. This means it has a short elimination half-life, which is approximately 80 to 90 minutes.


Q: Do I need a doctor's prescription to obtain Кромоген?

The regulatory status of the medicine can vary by its specific formulation. For example, the nasal spray is often available Over-the-Counter (OTC) in the US, while the ophthalmic (eye) and inhalation solutions are typically regulated as Prescription Only (Rx) medicines.


Q: Does taking Кромоген affect my ability to drive or operate machinery?

Official product information for the eye drops formulation advises caution regarding activities requiring clear vision. The instillation of eye drops may cause transient blurring of vision, and patients are advised not to drive or operate machinery until their vision returns to normal.


Q: What types of allergens is Кромоген most effective against?

Official indications show that the medicine is used for a variety of allergic conditions based on its formulation. This includes use for food allergy with the oral form, and for seasonal and perennial allergic conjunctivitis (eye drops) or allergic asthma (inhalation).


Q: Does taking Кромоген increase sensitivity to the sun?

Postmarketing experience, as noted in official regulatory documents, has included rare or isolated reports of photosensitivity. Photosensitivity is an increased sensitivity or reaction when the skin is exposed to the sun.


Q: What does it mean that Кромоген is a chromone derivative?

Кромоген is a synthetic compound derived from a chemical structure known as a chromone. A chromone is a basic organic molecule featuring a specific type of chemical ring called a benzo-annelated gamma-pyrone ring.

How should Кромоген be stored and disposed of?

Кромоген (Sodium Cromoglycate) requires specific storage conditions documented in regulatory prescribing information to ensure product stability.

Required Storage and Handling

Condition Requirement (Official Labeling)
Temperature Store at 15 C to 30 C (59 F to 86 F) (Controlled Room Temperature).
Protection Must be protected from light and should not be frozen.
Packaging Unit-dose vials must remain in the original foil pouch until use. Ophthalmic containers must be kept tightly closed.
Integrity Check Do not use the solution if it is discolored or contains a precipitate.

Child Safety and Disposal

The medicine must be stored out of the sight and reach of children.

For stability, opened ophthalmic solutions have a mandatory 4-week discard period. Any unused or expired product must be discarded in accordance with local regulatory requirements.

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

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