Kromospir^® (Aerosol) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Factory Of St. Petersburg, PJSC (Russia)

ATC Code

R03BC01 (Cromoglicic acid)

Active Substance

Cromoglicic acid (Rec.INN registered by WHO)

Dosage Form

Kromospir®

Inhalation aerosol, metered 5 mg/dose: canisters 112 doses

Dosage Form, Packaging, and Composition

Metered inhalation aerosol in an aluminum can with a metering valve; the contents of the can after the propellant evaporates is a white powder.

Excipients : povidone K30 – 0.0355 mg, macrogol 600 (polyethylene glycol) – 0.426 mg, hydrofluoroalkane (HFA-227) – up to 142 mg.

112 doses – aluminum aerosol cans (1) – cardboard packs.

Clinical-Pharmacological Group

Mast cell membrane stabilizer. Anti-allergic drug

Pharmacotherapeutic Group

Antiallergic agent – mast cell membrane stabilizer

Pharmacological Action

Anti-allergic agent, mast cell membrane stabilizer.

In studies conducted in animals, Cromoglicic acid caused inhibition of antigen-induced early and late phase airway obstruction and reduced the influx of inflammatory cells into the airways.

It suppresses the activation of many types of cells involved in the development and progression of bronchial asthma. Thus, Cromoglicic acid inhibits the release of inflammatory mediators (histamine, bradykinin, slow-reacting substance, leukotrienes, prostaglandins, and cytokines) from mast cells and reduces the chemotactic activity of eosinophils and neutrophils. Sodium cromoglicate also reduces the activation and release of mediators from macrophages and monocytes. This diverse spectrum of actions of sodium cromoglicate is associated with its ability to block chloride ion channels, which are important for cell activation, in various cell types.

The ability of cromoglicic acid to inhibit or reduce asthmatic reactions to antigen, physical exertion, and a number of non-specific trigger factors, including cold air, sulfur dioxide, hypertonic sodium chloride solution, and bradykinin, has been demonstrated in humans. After 4 weeks of treatment with cromoglicic acid in patients with bronchial asthma, antigen-induced increased bronchial hyperreactivity to histamine is prevented, and a reduction in the content of eosinophils and antigen-specific immunoglobulin E (IgE) in the bronchial mucosa is observed.

Due to these properties, Cromoglicic acid prevents bronchospasm caused by contact with an allergen or another provoking factor (cold air, physical exertion, stress). Furthermore, it allows for a reduction in the intake of other anti-asthmatic drugs (bronchodilators, corticosteroids). The drug’s action develops gradually. After 4-6 weeks of use, the frequency of bronchial asthma attacks decreases. Treatment should be long-term. Discontinuation of the drug may lead to the resumption of bronchial asthma attacks.

This agent is not intended for the relief of acute attacks of bronchial asthma.

Pharmacokinetics

In humans, after inhalation from a metered-dose inhaler, approximately 10% of the dose is absorbed from the respiratory tract. The remainder is either exhaled, deposited in the oropharynx, or swallowed and then excreted through the intestines, as only a small portion (about 1%) of the dose is absorbed from the gastrointestinal tract. The rate of absorption of cromoglicic acid from the respiratory tract is slower than its elimination rate (T_1/2 1.5-2 h). Thus, the active substance, entering the lungs and remaining there, exerts its therapeutic effect and is then rapidly eliminated from the body. During course treatment with sodium cromoglicate, no significant increase in its plasma concentration is observed.

Binding to plasma proteins is moderate and reversible (about 65%). It is not metabolized. It is excreted by the kidneys and with bile in approximately equal amounts in unchanged form.

Indications

Prevention and treatment of bronchial asthma (including exercise-induced asthma) in children and adults.

ICD codes

Dosage Regimen

Administer by inhalation using the metered-dose aerosol only. This product is for prophylactic use and is not intended to relieve an acute asthma attack.

For adults and children over 5 years of age, the usual starting dose is one inhalation (5 mg) four times daily. Inhale deeply and hold your breath for a few seconds after administration.

If control of symptoms is inadequate after 2-4 weeks, the frequency of administration may be increased. The maximum recommended dosage is six inhalations per day.

For the prevention of exercise-induced bronchospasm, use a single dose of one to two inhalations immediately before physical exertion, but not more than four times per day.

After achieving a stable therapeutic effect, a gradual reduction to a maintenance dose is possible. The maintenance dose is individually determined; it is typically two to three inhalations per day.

Do not discontinue therapy abruptly. A gradual reduction in dosage under medical supervision is required to prevent the recurrence of symptoms.

The duration of therapy is determined by the physician and is typically long-term. Regularly monitor liver and kidney function with prolonged use.

Adverse Reactions

From the respiratory system local reactions – mild irritation of the upper respiratory tract (dry mouth, unpleasant taste, hoarseness), cough and transient bronchospasm. In rare cases – eosinophilic pneumonia.

Allergic reactions hypersensitivity reactions, including difficulty swallowing, urticaria, skin itching, skin rash, angioedema, bronchospasm, decreased blood pressure and collapse.

Other headache, dizziness, nausea.

Contraindications

Hypersensitivity to cromoglicic acid, children under 5 years of age.

With caution

During pregnancy, especially in the first trimester of pregnancy; in patients with impaired renal and liver function

Use in Pregnancy and Lactation

Despite the lack of data on the negative effect of cromoglicic acid on the fetus, during pregnancy, especially in the first trimester, and during breastfeeding, it should be used only on the recommendation of a doctor with a careful assessment of the expected benefit of therapy for the mother and the possible risk to the fetus or infant.

Use in Hepatic Impairment

With long-term use, regular monitoring of liver function is necessary.

Use in Renal Impairment

With long-term use, regular monitoring of renal function is necessary.

Pediatric Use

Contraindicated for use in children under 5 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Cromoglicic acid preparations are not intended and should not be used to relieve acute bronchospasm.

If eosinophilic pneumonia occurs, use should be discontinued.

With long-term use, regular monitoring of liver and kidney function is necessary.

After discontinuation of sodium cromoglicate treatment, symptoms of bronchial asthma may resume.

Drug Interactions

Beta-adrenergic agonists, corticosteroids, antihistamines and theophylline enhance the effects of cromoglicic acid.

Concomitant administration of sodium cromoglicate and corticosteroids allows to reduce the dose of the latter, and in some cases to completely cancel them.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.