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Кромолин

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Кромолин

Kromolin_RU

Treatment option: Allergic Conjunctivitis, Allergy, Asthma, Fever, Food Allergy, Rhinitis, Pink Eye, Seasonal Allergic Conjunctivitis, Hay Fever

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 Кромолин

Quick Facts

Property Description
Active ingredient Sodium Cromoglycate (Disodium Cromoglycate)
Form Solution (inhalation, nasal, ophthalmic, oral)
Pharmacological class Mast cell stabilizer, Antiallergic agent
Common purpose Prophylaxis (prevention) of allergic symptoms
Origin Synthetic, derived from a chromone complex

What Type of Drug is Кромолин (Sodium Cromoglycate)?

Кромолин, scientifically identified as Sodium Cromoglycate (INN), is a synthetic compound primarily categorized as a mast cell stabilizer and an antiallergic agent. This classification means the medication works by reinforcing the specific immune cells responsible for initiating allergic responses. Its primary action is the prevention of inflammatory mediator release from mast cells. Unlike many allergy treatments, Sodium Cromoglycate is often available over-the-counter (OTC) in certain low-concentration ophthalmic and nasal forms, making it readily accessible for common allergic scenarios.

Composition and Available Forms of Кромолин

The medication is a single-active-ingredient product containing only Sodium Cromoglycate as its therapeutic component, which is a derivative of the chromone chemical class. The unique feature of Sodium Cromoglycate is its administration flexibility across multiple physiological systems. Common dosage forms include an inhalation solution or aerosol for the respiratory system, a nasal spray solution for topical application in the nose, an ophthalmic solution (eye drops) for the eyes, and an oral solution targeting the gastrointestinal tract. This extensive range of forms ensures that the medication can provide localized protection against allergic triggers at the precise site of exposure.

General Purpose: How Кромолин Provides Prophylactic Protection

The general purpose of Кромолин is to offer prophylactic protection against allergic symptoms before they manifest. This is achieved by stabilizing the mast cells, which inhibits their degranulation and stops the release of inflammatory mediators like histamine. This preventative action helps individuals manage persistent allergy issues; for instance, using the nasal spray consistently before the start of the pollen season. Because this stabilization effect must be built up over time, the drug is used consistently to maintain protective capacity, establishing its role as a key preventative agent against chronic or seasonal allergic responses.

Regulatory References

  1. Cromolyn Sodium - StatPearls - NCBI Bookshelf
  2. NASALCROM - cromolyn sodium spray label - DailyMed (NIH/FDA)
  3. Cromolyn Sodium Ophthalmic Solution Label - DailyMed (NIH/FDA)

What side effects are possible with Кромолин?

Possible Side Effects and Safety Information

The information regarding the side effects and safety profile of Cromolyn Sodium Oral Solution is based strictly on data found in official governmental regulatory documents.

Adverse Reactions Scope

Adverse events are often classified by frequency and the body system affected:

Most Frequently Reported Side Effects

Side effects that occurred most frequently in clinical studies include:

  • Headache
  • Diarrhea
  • Pruritus (Itching)
  • Nausea
  • Myalgia (Muscle Aches)

System-Organ Classes (SOCs) Affected

The label lists effects across several body systems, including:

  • Gastrointestinal: Diarrhea, Nausea, Abdominal Pain
  • Neurologic: Headache, Dizziness
  • Musculoskeletal: Myalgia, Arthralgia
  • Skin: Pruritus, Rash

Serious Adverse Reactions and Safety Constraints

Serious Adverse Reactions (RARs)

The label notes that Severe Allergic Reactions, including Anaphylaxis and Angioedema (swelling of the face, lips, or throat), are rare but clinically significant adverse reactions that have been reported.

Safety Restrictions and Limitations

  • Contraindication: The medication is contraindicated in patients with a known hypersensitivity to cromolyn sodium.
  • Acute Symptoms: Cromolyn has no role in the treatment of acute symptoms or status asthmaticus.
  • Route of Administration: The Oral Solution, Concentrate, must not be used for inhalation or injection.

Population-Specific Safety Considerations

Regulatory documents include specific cautions for certain patient populations:

  • Pregnancy (Category B): Use should occur only if clearly needed.
  • Renal/Hepatic Impairment: Caution and potential dose decrease are advised for patients with reduced kidney or liver function due to the drug's excretion pathways.

This information is intended to convey the drug’s risk profile as documented by regulatory authorities, detailing potential side effects and required limitations for use.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Кромолин (Sodium Cromoglycate)

Overdose Scope

Domain Regulatory Statement
Documented overdose presentations No clinical syndrome is associated with an overdosage of Sodium Cromoglycate. Overdosage is widely stated to be unlikely due to poor systemic absorption.
Physiological systems affected (as stated in label) None explicitly detailed as affected by acute toxicity in human overdose scenarios.
Dose-related or exposure-related factors (if applicable) Acute toxicity has been documented in non-human studies only at very high exposure levels significantly exceeding typical human exposure.
Population-specific overdose notes (if applicable) None explicitly documented in the official overdose sections regarding specific management differences for human populations.
Emergency-response statements (as written in official documents) In case of accidental ingestion/overdose, seek professional assistance or contact a Poison Control Center immediately.
When immediate medical help is required (label-derived phrasing only) Immediate medical help is required upon suspected drug overdose or accidental ingestion.

Overdose Classifications (High-Level)

Classification Regulatory Statement
Severity classification (as defined in official documents) Overdosage is generally classified as posing a minimal systemic toxicity risk.
Regulatory basis (EMA / FDA / etc.) The overdose management strategy is primarily based on the drug's pharmacokinetic profile (poor systemic absorption).
Overdose-context constraints (as defined in official documents) The recommended action is primarily medical observation and supportive treatment.

Resulting Overdose Structure

Official overdose statements:

  • No specific clinical syndrome is associated with an overdosage of Sodium Cromoglycate as documented in regulatory prescribing information.
  • In the event of accidental ingestion or suspected overdose, regulatory labeling mandates that individuals seek professional assistance or contact a Poison Control Center immediately.
  • Management of overdosage is classified as symptomatic and supportive, and medical observation or supervision is the most commonly recommended action in official documentation.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the overdose profile by stating that systemic overexposure is highly unlikely due to the drug’s consistently poor absorption across all formulations. Although the risk of toxicity is classified as minimal, immediate professional contact is required for any suspected overdose event. The officially described management protocol is limited to medical observation and supportive treatment because no specific antidote is available.

Therapeutic Uses of Кромолин

What Кромолин Treats: Main Uses and Benefits

Кромолин (Sodium Cromoglycate) is generally utilized to provide prophylactic support across various conditions involving inflammatory or irritative states driven by allergic processes. Its application is centered on establishing a protective barrier against known triggers to help manage the overall burden and frequency of symptoms. The medication is commonly used to help with the wheezing, shortness of breath, and coughing associated with asthma, affirming its preventative role.

The primary use of this medication is for the controller management of mild to moderate persistent asthma and the prevention of allergen-induced bronchospasm. It is also applied across domains involving certain distressing symptoms affecting the mucous membranes of the eyes and nose, relevant for managing allergic rhinitis and allergic conjunctivitis. Additionally, it may be part of symptomatic management in cases of systemic mast cell disease (Mastocytosis).

Quick Fact: Supportive Relief for Allergic Symptoms This medication may assist with easing the symptom clusters of persistent sneezing, runny nose, itchiness, redness, and tearing, which contributes to easing the overall symptom load, supporting day-to-day comfort. This use plays a role in managing the frequency of asthma episodes and is relevant for managing symptoms that interfere with daily comfort.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Cromolyn Sodium

The eligibility profile for Cromolyn Sodium is strictly defined by regulatory bodies, focusing on patient status and age. Use is determined by the official classifications of contraindication and conditional use.

Eligibility Status Official Regulatory Stance
Contraindicated Prohibited for patients with known hypersensitivity to the drug or any component. The inhalation solution must not be used for acute symptoms or Status Asthmaticus.
Age-Related Rules Eligibility is product-specific: Inhalation and Oral solutions are generally approved for patients 2 years and older. Ophthalmic solution use is often restricted to ages 4 years and older. Use in older adults (ge 65 years) requires cautious dose selection.
Conditional Use Caution is mandatory for patients with impaired renal (kidney) or hepatic (liver) function; a dose reduction must be considered. Pregnant women (FDA Category B) should use the medicine only if clearly needed. Caution is advised during lactation as drug excretion into human milk is unknown.

These official statements define who can and cannot use the medicine by first enforcing absolute exclusions for hypersensitivity and acute respiratory distress. Eligibility is then constrained by minimum age thresholds and the functional health of the patient's elimination organs.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Кромолин (Sodium Cromoglycate) indicates a generally low risk for drug-drug interactions, particularly for non-oral forms due to minimal systemic absorption. The few documented interactions relate primarily to specific administration constraints and effects on drug clearance.

Category Documented Regulatory Statement
Drug-Drug Interference The drug may decrease the effectiveness of Methacholine when used as a diagnostic agent, and substances like Oxymetazoline are associated with reduced absorption of cromoglycic acid.
Metabolic/Transporter No interactions mediated by Cytochrome P450 enzymes (CYP) or major drug transporters (P-gp, OATP) are explicitly documented in regulatory labeling.
Food/Timing Restriction The oral solution must be taken on an empty stomach, generally 30 minutes before meals, to ensure proper absorption. Furthermore, the oral medicine must not be mixed with liquids like fruit juice or milk, as these interfere with its intended function.
Population-Specific Note Due to the drug's elimination via both biliary and renal routes, regulatory guidance recommends that a dosage reduction be considered in patients with impaired renal or hepatic function to account for potentially altered clearance and increased exposure.

These constraints define the official interaction structure: minimal interaction risk for topical/inhaled forms, mandatory timing rules for the oral solution, and a formal caution regarding clearance in specific patient populations.

Mechanism of Action

How Кромолин Works

Mast Cell Stabilization and Ca^2+ Inhibition

The core mechanism of Sodium Cromoglycate involves the functional stabilization of the mast cell membrane at the site of potential allergen exposure. The drug acts to suppress the transmembrane influx of calcium ions ( Ca^2+) that serves as the critical internal trigger for cellular activation following IgE cross-linking. This suppression of the activation signal maintains the stable, non-responsive state of the mast cell upon allergen encounter, which characterizes the prophylactic nature of the molecular action.

Suppression of Inflammatory Mediator Release

By suppressing mast cell activation, the drug functionally halts the rapid release of potent inflammatory mediators, including histamine, leukotrienes, and prostaglandins, into the surrounding tissue. This inhibition of mediator release limits the subsequent physiological changes, specifically modulating vascular permeability and inhibiting acute smooth muscle contraction, characteristic of the local IgE-mediated response.

Prophylactic Mechanism Constraint

The mechanism is intrinsically prophylactic; the molecule must be present at the target site and stabilized on the cell membrane before the allergen encounter occurs. This constraint means the drug is unable to reverse or halt an allergic reaction that has already begun, differentiating its action from mechanisms that reverse established physiological dysfunction.

Dosage and Administration Information

How to use Кромолин

Cromolyn sodium is administered according to specific procedural requirements associated with its dosage form. It is available for four distinct administration routes: Oral (as a concentrate solution), Oral Inhalation (via nebulizer solution), Intranasal (as a metered spray), and Topical Ophthalmic (as eye drops).

Dosing Schedule and Consistency

The fundamental principle of use is consistent and prophylactic. For maintenance, the inhalation and oral forms are typically administered four times daily (QID) at regular intervals, a frequency necessary to establish and sustain the required protective capacity. Topical forms (nasal and ophthalmic) are often scheduled for administration three to six times daily. Because the effect is based on prevention, the full protective benefit may take several weeks of continuous and regular use to develop, and treatment must be maintained throughout the period of anticipated exposure.

Contextual Timing and Preparation

Specific conditions apply to administration, particularly for the oral concentrate used for systemic mastocytosis. This form is administered 30 minutes before meals and at bedtime (AC and HS). The concentrate must be diluted with a glass of plain water before ingestion, and is not to be mixed with other fluids. Additionally, the inhalation solution is specifically required to be administered via a power-driven nebulizer.

Administration Constraints

Solutions designated for oral consumption and oral inhalation are not for injection. For pediatric use, lower starting doses (e.g., 100 mg QID) for the oral solution are specified for children aged 2 to 12 years. If a dose is missed, it is taken when remembered, unless the next scheduled dose is nearly due; in that case, the missed dose is skipped to avoid a doubled dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Кромолин (Sodium Cromoglycate)

This overview summarizes the available research on Sodium Cromoglycate, focusing on the types of studies conducted, the outcomes researchers measured, and where the evidence remains incomplete. The text describes the research record and is not intended as medical advice or instruction.

Evidence for Use in Asthma and Allergen-Induced Bronchospasm

Research has examined Sodium Cromoglycate in short-term Randomized Controlled Trials (RCTs) and comparative studies to assess its potential role in prophylaxis for mild to moderate persistent asthma and for episodes caused by allergens. Studies monitored how symptoms evolved in the observed populations, focusing on outcomes related to physiological strain or stress, such as objective lung function measurements and the frequency of bronchodilator rescue inhaler use. The evidence contributes to understanding symptom patterns, with studies including children and adults.

Findings were mixed, and certainty remains low regarding its current role in clinical practice. Long-term effects are not fully established; most trials tracked outcomes only for relatively short-term follow-up durations.

Evidence for Use in Allergic Rhinitis (Nose Symptoms) and Conjunctivitis (Eye Symptoms)

Sodium Cromoglycate was evaluated in Randomized, Double-Blind, Placebo-Controlled Trials (RCTs) to assess the outcomes when applied topically via nasal spray for allergic rhinitis and eye drops for allergic conjunctivitis. This research explored short-term symptom changes, focusing on patient-reported outcomes describing perceived discomfort. For allergic rhinitis, studies evaluated outcomes related to physical discomfort, such as sneezing and congestion. For the eyes, research examined changes in subjective symptoms like itching and tearing, alongside objective clinical signs.

Follow-up durations were limited, with many studies assessing outcomes only in the short-term. Certain systematic reviews have noted that evidence quality varies across studies, and some reports described inconsistent findings.

What is Still Uncertain About Кромолин Research

A review of the available evidence highlights several areas where certainty remains low or research is incomplete. The main research limitation frames include: Long-term effects are not fully established; evidence quality varies across studies; and sample sizes were modest in certain key areas, such as the specialized research for systemic mast cell disease. Research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.

Key Studies & References

  1. NIH MedlinePlus Drug Information: Cromolyn Sodium (Systemic and Topical Use Overview)

Frequently Asked Questions (FAQ)

Common questions about Кромолин (FAQ)

Q: Is it safe for me to use this drug if I am two years old?

Official product information indicates that safety and effectiveness have generally been studied and established in children aged 10 to 17 years for certain inherited cholesterol conditions. Information on the safety and efficacy of the drug in children younger than 10 years old is not available for most conditions listed on the label. Eligibility depends highly on the specific condition being managed.

Q: Does atorvastatin make you tired or sleepy?

According to official regulatory documents, fatigue or general tiredness has been reported as an uncommon side effect, meaning it was not frequently observed in clinical trials. Drowsiness or sleepiness is not typically listed among the common or frequent adverse reactions in the authorized product information.

Q: Can I take atorvastatin during pregnancy or while breastfeeding?

Use during pregnancy is generally not recommended and is often listed as a contraindication in the official label. Official information also advises that breastfeeding is not recommended while undergoing treatment, as the medicine may pass into breast milk.

Q: Can I continue to take this long-term, over many years?

Regulatory documents indicate that this medicine is intended as an adjunct to diet for the long-term management of elevated cholesterol. Its official indication is to help reduce the risk of certain cardiovascular events in specific patient populations. The medicine is sometimes used as part of a long-term treatment plan, based on specific medical needs and clinician guidance.

Q: What are the contraindications for atorvastatin?

Official product information states that this medicine is contraindicated in patients who have active liver disease, which includes unexplained persistent elevations in liver enzymes. It is also contraindicated in patients who have a known hypersensitivity (allergic reaction) to the active substance or any other ingredients in the medication.

How should Кромолин be stored and disposed of?

How to Store and Dispose of Cromolyn

Cromolyn sodium must be stored according to regulatory requirements to ensure product stability and safety.

Storage Conditions

The medication should be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), and must be protected from light and kept from freezing.

  • Container Rules: Keep the container tightly closed. Unit-dose vials for inhalation or oral solutions must remain in the original foil pouch until use.
  • Integrity Check: The solution must not be used if it is discolored, cloudy, or contains a precipitate.

Child Safety and Disposal

All forms of Cromolyn must be stored out of the sight and reach of children and pets. Outdated or unused medication should not be flushed down the toilet or poured into drains. Disposal should follow official guidelines, preferably through a medicine take-back program or as directed by local waste regulations.

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

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