Cromoglycic acid prescription. Medicinal reference book geotar

Cromoglycic acid is an antiallergic agent, has a membrane-stabilizing effect, prevents degranulation of mast cells and the release of histamine, leukotrienes (including SRSA, bradykinin), prostaglandins and other biologically active substances from them. active substances. When inhaled, it prevents the development of bronchospasm caused by various factors, but does not stop the developed bronchospasm in the husband. Long-term use reduces the frequency of asthma attacks and facilitates their course, reduces the need for bronchodilators and corticosteroids. A stable effect is achieved after 24 weeks of use, after a single injection, the effect lasts up to 5 hours.

Absorption from respiratory tract into the systemic circulation during inhalation in the form of a powder 515%, after inhalation in the form of a solution 8%. Absorption from the mucous membranes of the respiratory tract decreases with an increase in the amount of bronchial secretions. The maximum plasma concentration is reached after 15 minutes. Not metabolized in the body. Elimination half-life 4699 min (average about 80 min). It is excreted by the kidneys and through the intestines unchanged in approximately equal proportions; the rest is excreted through the lungs with exhaled air or settles on the walls of the oropharynx, then swallowed (absorption less than 2%) and excreted through the intestines. With intranasal administration, less than 7% is absorbed into the systemic circulation. Approximately 65% ​​of cromoglycic acid binds to plasma proteins. The half-life is 1.5 hours. Part of the active substance is swallowed (about 1%), practically not absorbed, excreted in the feces.

Indications

In the form of an aerosol for dosed inhalation, it is used to prevent asthma attacks, bronchospasm caused by allergens, irritants, cold or physical activity in chronic obstructive bronchitis.

Dosed nasal aerosol and nasal drops are used for the prevention and treatment of seasonal and year-round allergic rhinitis.

Eye drops are used for acute and chronic allergic conjunctivitis.

Application

Inhalation powder for inhalation contained in the capsule, is carried out using a special device (spinhaler) the contents of 1 capsule (20 mg) 4 times a day: at night, in the morning, 2 times in the afternoon, with an interval of 36 hours. If necessary, the dose is increased to 120 160 mg/day

Aerosol dosed for inhalation. A metered dose aerosol for inhalation for adults and children aged 5 years and older is prescribed 210 mg 4 times a day. It is possible to increase the dose to 2 mg 6-8 times a day. Upon reaching the optimum therapeutic effect you can switch to a maintenance dose. In severe cases, as well as with a high concentration of allergens, the dose can be increased to 15-20 mg 4 times a day. After achieving a therapeutic effect, treatment should not be abruptly stopped; cancellation is made gradually, within 1 week. During a dose reduction, the symptoms of the disease may recur. To prevent bronchospasm in asthma caused by exercise or cold air, 10-15 minutes before exposure to a provocative factor, inhaled at a dose of 10 mg.

Aerosol for intranasal use 1 dose in each nasal passage 4-6 times a day. Course of treatment 4 weeks. Cancel gradually, within 1 week.

Eye drops adults and children: 12 drops in the conjunctival sac 4 times a day. Treatment must be continued until contact with the allergen that caused the disease is terminated.

Contraindications

Hypersensitivity to cromoglycic acid, pregnancy (I trimester), age up to 5 years (for inhalation use in the form of an aerosol), up to 2 years (in the form of capsules with powder for inhalation).

Side effects

When inhaled, irritation of the mucous membrane of the respiratory tract, dysphonia, cough are possible; change in taste sensations, dry mouth; dizziness, headache; urinary retention, impaired renal function; rarely - allergic reactions (skin rash, lacrimation, dysphagia, urticaria, pruritus, angioedema of the face, lips and eyelids, stridor breathing, decreased blood pressure).

When using a nasal spray, rarely - irritation of the mucous membrane of the nasal cavity and pharynx, reflex cough, a feeling of dryness in the throat.

When applied eye drops possible burning sensation foreign body, swelling and hyperemia of the conjunctiva.

special instructions

Use with caution in renal or liver failure, during pregnancy (IIIII trimester) and breastfeeding.

If it is necessary to stop treatment, the dose is reduced gradually (for at least 1 week) to reduce the risk of exacerbation of the disease. It is not used for the relief of bronchospasm.

It is not recommended to use soft contact lenses during treatment. eye drops. If the patient uses hard contact lenses during treatment, it is recommended to remove the eye drops before instillation. contact lenses and put them back on no earlier than 15 minutes after instillation.

Interactions

β-Adrenergic agonists, corticosteroids, antihistamines and theophylline enhance the effect of cromoglycic acid. The combined appointment of cromoglycic acid and GCS allows you to reduce the dose of the latter, and in some cases completely cancel them. While reducing the dose of corticosteroids, the patient should be under the close supervision of a physician, the rate of reduction should not exceed 10% per week. In the inhalation solution, cromoglycic acid is pharmaceutically incompatible with bromhexine or ambroxol. Bronchodilators should be used before inhalation of cromoglycic acid.

1. International non-proprietary name

Cromoglycic acid.

2. Basic synonyms

Kromoglin, Kromolin, Kromoheksal, Lomuzol, Kromosol.

3. Pharmacotherapeutic group

Means for treatment allergic reactions.

4. Main pharmacotherapeutic action and effects

Antiallergic. It stabilizes the membranes of sensitized mast cells, inhibits the entry of calcium ions, degranulation and the release of histamine, bradykinin, leukotrienes, prostaglandins and other biologically active substances from them. Prevents the development of allergic and inflammatory reactions, bronchospasm, inhibits eosinophil chemotaxis. It has the ability to block receptors specific for inflammatory mediators. With perennial allergic rhinitis, the effect appears within 1 week and reaches a maximum after 1-4 weeks.

5. Summary of Evidence of Effectiveness

Evidence Level A. Efficacy has been confirmed in multicenter placebo-controlled studies.

6. Brief results of pharmacoeconomic studies

Estimated price per capsule 100 mg - 14.00 rubles.

7. Pharmacodynamics, pharmacokinetics, bioequivalence for analogues

After oral administration, no more than 1% is absorbed (0.45% is excreted in the urine within 24 hours), the rest is in the faeces. When instilled into the eye, it is poorly absorbed into the systemic circulation (0.03%), trace amounts (less than 0.01%) penetrate into the aqueous humor and are completely eliminated within a day. After intranasal use, less than 7% is absorbed into the systemic circulation. When inhaled into the bloodstream, up to 90% of the drug settles in the trachea and large bronchi. 5-15% of the dose is absorbed from the lungs (C_max in the blood is created in 15-20 minutes), a small part enters the gastrointestinal tract, the rest is exhaled. Absorbed from mucous membranes; absorption decreases with an increase in the amount of secretion. Binding to plasma proteins - 65-75%. It is not metabolized and excreted from the body in equal amounts with urine and bile for 24 hours. T_1/2 is 1-1.5 hours. breast milk. Action of a single dose # continues until 5 o'clock.

8. Indications

Nasal spray: perennial and seasonal allergic rhinitis.

Aerosol for inhalation: prevention - bronchial asthma, bronchospasm, chronic obstructive pulmonary disease.

Capsules: food allergy (if the allergen is proven, alone or in combination with an allergen-restricting diet). Nonspecific ulcerative colitis, proctitis, coloproctitis. Mastocytosis (urticaria pigmentosa).

9. Contraindications

Hypersensitivity (including to benzalkonium hydrochloride), pregnancy, breastfeeding, children under 2 years of age (in the form of capsules with powder for inhalation and solution for inhalation), for metered aerosol - up to 5 years. Premature babies.

10. Performance criteria

Reducing the severity of the symptoms of the disease.

11. Principles of selection, dose modification and withdrawal

Intranasally - 2 aerosol doses in each nasal passage 4-6 times a day. The course of treatment is 4 weeks. Cancellation should be carried out gradually over 1 week.

Drops in the nose - adults are recommended to instill 3-4 drops of the solution in each nasal passage after 4-6 hours, children over 6 years old - 1-2 drops every 6 hours. After achieving the effect, a gradual lengthening of the intervals between doses of drugs is possible.

Inhalation.

1. Capsules with powder for inhalation. If the capsule is swallowed, the drug is ineffective for the prevention of bronchial asthma. Inhalation of the contents of the capsule (powder for inhalation) is carried out using a spinhaler - 1 capsule (20 mg) 4 times a day: at night, in the morning, 2 times in the afternoon, with an interval of 3-6 hours. If necessary, the dose is increased to 120-160 mg / day

2. Solution for inhalation: 20 mg 4 times a day using an inhaler. The contents of the can are thoroughly shaken before use. During inhalation, it should be kept in vertical position with the metering valve at the bottom.

3. Metered aerosol for inhalation. In 1 dose - 1 mg: adults (including the elderly) and children from 5 years old - 2-10 mg 4 times a day. It is possible to increase the dose to 2 mg 6-8 times a day. In 1 dose - 5 mg: 5-10 mg (1-2 inhalations) 4 times a day. Upon reaching the optimal therapeutic effect, you can switch to a maintenance dose that provides optimal control of the disease. In severe cases, as well as with a high concentration of allergens, the dose can be increased to 15-20 mg 4 times a day. After achieving a therapeutic effect, treatment should not be abruptly stopped; cancellation is made gradually, within 1 week. During a dose reduction, the symptoms of the disease may recur. To prevent suffocation bronchial asthma caused by physical stress or cold air, 10-15 minutes before the provoking factor, you need to take 10 mg.

Inside, at food allergies, 15 minutes before meals, adults and children over 14 years old - 200 mg 4 times a day; children aged 2 to 14 years - 100 mg 4 times a day, from 2 months to 2 years - 20-40 mg / kg / day in several doses. Upon reaching a stable therapeutic effect, the dosage can be reduced to a minimum. Patients who for some reason cannot avoid eating food containing allergens can take 1 dose 15 minutes before meals. The optimal dose is 100-500 mg. Capsules are swallowed whole, or the contents are dissolved in a small volume of very hot water, diluted with cold water and taken orally. In the treatment of proctitis and coloproctitis, it can be administered as microclysters by dissolving the capsules in water.

12. Overdose

Cases of overdose are not described.

13. Warnings and information for medical personnel

Not intended for the relief of an attack of bronchial asthma.

Patients with a history of anaphylactic shock or other life-threatening conditions that occur when taking food products, cromoglycic acid should not be used as a prophylactic drug.

If irritation or burning of the nasal mucosa does not go away or increases, treatment should be discontinued.

14. Features of use and restrictions in the elderly, with insufficiency of the liver, kidneys, etc.

Be wary appoint patients with renal or hepatic insufficiency, nasal polyps, pregnancy, lactation.

15. Side effects and complications

When administered intranasally:

From the respiratory system: short-term irritation of the mucous membrane and increased secretion from the nose, frequent sneezing; very rarely - bleeding from the nose, ulceration of the mucous membrane of the nasal cavity, cough, suffocation.

Other: headache, arthralgia, anaphylactic reaction (cough, swallowing disorder, itching of the skin, swelling of the face, lips, eyelids, shortness of breath), exanthema, urticaria, unpleasant taste sensations, headache.

When taking a metered-dose aerosol:

From the respiratory system: irritation of the mucous membrane of the respiratory tract (hoarseness, cough), rarely - pulmonary infiltrates with eosinophilia;

From the side digestive tract: dry mouth;

From the side nervous system: dizziness, headache;

From the urinary system: urinary retention, impaired renal function.

Allergic reactions: skin rash, anaphylaxis (difficulty swallowing, urticaria, itching of the skin, swelling of the face, lips and eyelids, pronounced stridor or shortness of breath, decreased blood pressure) - are observed in less than 1 out of 100 thousand patients.

When taking capsules - arthralgia, a feeling of fullness in the stomach, nausea, vomiting, diarrhea, skin rash.

In addition to the above adverse reactions, when prescribing cromoglycic acid for inhalation use, the following are described (a causal relationship has not been proven): in 1 out of 10 thousand patients - angioedema, bronchospasm, cough, dizziness, dysuria (including increased urination), headache, arthralgia , swelling of the joints, swelling of the larynx, lacrimation, nausea, nasal congestion, rash, swelling of the parotid salivary glands, urticaria. Anemia, exfoliative dermatitis, hemoptysis, hoarseness, myalgia, nephropathy, periarteritis, pericarditis, peripheral neuritis, photodermatitis, polymyositis, pulmonary infiltrates with eosinophilia are noted in 1 out of 100 thousand patients.

There have been no reports of similar effects with intranasal formulations.

16. Interaction with other drugs

beta-agonists, glucocorticoids, antihistamines and theophylline potentiate the effect. Bromhexal, ambrohexal mixed with a solution of cromoglycic acid should not be inhaled. Cromoglycic acid can increase the effectiveness of H_1-histamine blockers.

In an inhalation solution, it is pharmaceutically incompatible with bromhexine or ambroxol. Bronchodilators must be taken (inhaled) before inhalation of the drug.

The combined appointment of cromoglycic acid and glucocorticosteroids allows you to reduce the dose of the latter, and in some cases completely cancel. While reducing the dose of glucocorticosteroids, the patient should be under close medical supervision, the rate of dose reduction should not exceed 10% per week.

17. The use of drugs in the composition of complex medicines

Not applicable.

18. Warnings and information for the patient

The patient is informed about the need to take the drug, warned about the possibility of side effects.

19. Additional requirements for informed consent of the patient

The patient must consent to the treatment of possible complications.

20. Forms of release, dosage.

Capsules 100 mg; nasal spray, 28 ml, 1 dose contains 2.6 mg of the active substance; nasal spray, 15 ml, 1 dose contains 2.8 mg of the active ingredient; nasal spray 2% in vials of 15 and 30 ml.

Firms: Orion, Finland, ICN Polfa Rzeszow, Poland; Merck KGAA, Germany; Rhone-Poulenc Rorer, France; Hexal, Germany.

21. Storage Features

In a place inaccessible to children.

What is cromoglycic acid? You will learn about this from the materials of the presented article. We will also tell you about which drugs contain the mentioned substance and what it is.

Release forms, description

Cromoglycic acid is available as an inhalation aerosol, nasal spray, eye drops, and nasal spray. Also, this tool can be purchased in the form of a clear solution and powder capsules intended for inhalation.

The principle of action of the drug

Cromoglycic acid, the price of which is indicated below, stabilizes the membranes of mast cells, as well as their granules. This happens due to the blockade of calcium entry into cells.

It should also be noted that this agent inhibits the release of allergy mediators such as leukotrienes, histamine, PG2 and others from various cells that are in the bronchial mucosa and in the lumen. In addition, this substance helps to suppress the migration of monocytes and neutrophils.

Properties

Cromoglycic acid exhibits the following properties:

• It is very effective for the prevention of immediate type allergies in young people who have not yet developed irreversible chronic changes in the lungs. It should be noted that the mentioned substance does not eliminate the already developed bronchospasm.
• Shows a membrane-stabilizing effect. In the lungs, the process of mediator response inhibition helps prevent the development of early and late stage asthmatic response (including in response to immune and other stimuli).
• A stable effect from the use of the drug is achieved after 2-4 weeks. The effect of the drug after a single injection is observed for 5 hours.
• A noticeable result of treatment for allergic diseases of the visual organs occurs after a few days or weeks.

• Long-term use of the drug reduces the frequency of bronchial asthma attacks, and also greatly facilitates their course, reduces the need for taking corticosteroids and bronchodilators.

Kinetics

Cromoglycic acid is absorbed from the respiratory tract in an amount of 10%, and after inhalation of the medicinal powder and solution - 5-15% and 8%, respectively.

Absorption from the mucous membrane of the respiratory system decreases with an increase in the amount of secretion. The maximum concentration of this substance is reached after ¼ hour.

This drug is not metabolized. Its half-life is 45-90 minutes. It is excreted through the intestines and kidneys in approximately equal proportions, as well as through the lungs.

With intranasal administration, about 7% of the drug enters the bloodstream. It binds to plasma proteins by 65%. In this case, the drug is not metabolized and is excreted unchanged in the bile and kidneys within an hour and a half. Part of the active substance is swallowed and excreted through the gastrointestinal tract without absorption.

Indications

Antiallergic eye drops are prescribed for allergic conjunctivitis, allergic keratitis, keratoconjunctivitis, dry eye syndrome, overstrain, eye fatigue, irritation of the mucous membrane of the visual organs due to allergic reactions.

It should also be noted that this remedy is used for bronchospasm and chronic bronchitis With

The drug in the form of an intranasal agent is recommended for use in hay fever and allergic rhinitis.

Contraindications

The drug in question is not prescribed for:

• hypersensitivity;
• pregnancy (first trimester for inhalation);
• V childhood(up to two years - in the form of capsules with powder and solution for inhalation, up to 5 years - in the form of an aerosol for inhalation and intranasal use);
• breastfeeding (for intranasal administration).

Cromoglycic acid: instruction

Inhalation of the contents of capsules for inhalation should be carried out with the help of a spinhaler 4 times a day with an interval of 3-6 hours (20 mg each).

The dosed inhalation aerosol is prescribed 1 dose (1 mg) four times a day.

Used by inhaler (20 mg) four times a day. Before use, the balloon is thoroughly shaken and kept upright.

Nose drops are prescribed for adults in each nasal passage, 3-4 drops every 4-6 hours, and for children from 6 years old - every 6 hours, 1-2 drops. After the appearance of a therapeutic effect, the interval between doses of the drug can be gradually increased.

Nasal spray is used 1 dose in each course of the nose 4-6 times a day. The course of treatment is 4 weeks. Cancellation of the drug should be carried out gradually over one week.

Eye drops (for example, "Sodium Cromoglycate") use 1-2 drops in each visual organ four times a day with an interval of 4-6 hours. If necessary, the number of instillations is increased to 6-8 drops.

Side effects

The remedy in question may cause:

• dizziness, nausea, nosebleeds;
• irritation and dryness in the throat, headache, dry mouth, urinary retention;
• irritation of the respiratory mucosa, nasal congestion, cough, burning sensation in the eyes, impaired renal function, increased secretion of nasal secretions;
• skin rash, conjunctival edema, unpleasant taste sensations, foreign body sensation, barley, lacrimation;
• anaphylaxis (including difficulty swallowing, skin itching, severe stridor, urticaria, swelling of the lips, face and eyelids, lowering blood pressure, shortness of breath).

Synonyms and price of the drug

Under what trade name Selling cromoglycic acid? These are Ditek, Sodium Kromoglikat, Ifiral, Intal, Kromoheksal, Kromogen Easy Breathing, Nalkrom, Kromogen, Kromoglin, Kromosol, Kromolin, Kropoz ”, “Lekrolin”, “Kuzikrom”, “Stadaglycine”, “Hi-krom”.

The price of this remedy may be different, depending on the manufacturer, the form of the drug and the pharmacy chain. However, the average cost of cromoglycic acid is 100-250 rubles.

Cromoglycic acid INN (metered-dose inhalation aerosol)

INN
Cromoglycic acid
Dosage form
dosed aerosol for inhalation
chemical name
5, 5 "- [(2 - hydroxy - 1, 3 - propandiyl) bis (hydroxy)] bis (as disodium salt)
pharmachologic effect
Pharmacokinetics
Indications for use
Contraindications
Carefully
Dosing regimen
Side effect
Interaction
special instructions

pharmachologic effect

An antiallergic agent that has a membrane-stabilizing effect, prevents the degranulation of mast cells and the release of histamine, leukotrienes (including bradykinin), Pg, and other biologically active substances from them, and prevents the development of bronchospasm.

In the lungs, inhibition of the mediator response prevents the development of both early and late stages of the asthmatic response (in response to immune and other stimuli). The drug is most effective for the prevention of immediate-type allergic reactions in patients with relatively young age who have not yet developed chronic irreversible changes in the lungs. Does not eliminate the developed bronchospasm.

Long-term use reduces the frequency of asthma attacks and facilitates their course, reduces the need for bronchodilators and corticosteroids.

A stable effect is achieved after 2-4 weeks. Action single dose continues until 5 o'clock.
Pharmacokinetics

Absorption from the respiratory tract into the systemic circulation - 10%; after inhalation of the powder - 5-15%, after inhalation of the solution - 8%. Absorption from the mucous membranes of the respiratory tract decreases with an increase in the amount of secretion. TCmax - 15 min.

Does not undergo metabolism. T1 / 2 - 46-99 minutes (average about 80 minutes). It is excreted by the kidneys and through the intestines unchanged in approximately equal proportions; the rest is excreted through the lungs with exhaled air or settles on the walls of the oropharynx, then swallowed (without significant absorption - less than 2%) and excreted through the intestines.
Indications for use

Prevention: bronchial asthma, bronchospasm (including those caused by allergens, cold or dry air, environmental pollution), COPD.
Contraindications

Hypersensitivity, pregnancy (I trimester), children's age (up to 5 years - for inhalation use in the form of an aerosol, up to 2 years - in the form of capsules with powder for inhalation and a solution for inhalation use).
Carefully

Renal / liver failure, pregnancy (II-III trimesters), lactation.
Dosing regimen

Inhalation. 1. Capsules with powder for inhalation. If the capsule is swallowed, the drug is ineffective for the prevention of bronchial asthma. Inhalation of the contents of the capsule (powder for inhalation) is carried out using a spinhaler - 1 capsule (20 mg) 4 times a day: at night, in the morning, 2 times in the afternoon, with an interval of 3-6 hours. If necessary, the dose is increased to 120-160 mg / day

2. Solution for inhalation: 20 mg 4 times a day using an inhaler. The contents of the can are thoroughly shaken before use. During inhalation, it should be kept in an upright position, while the metering valve should be at the bottom.

3. Metered aerosol for inhalation. In 1 dose - 1 mg: adults (including the elderly) and children from 5 years old - 2-10 mg 4 times a day. It is possible to increase the dose to 2 mg 6-8 times a day. In 1 dose - 5 mg: 5-10 mg (1-2 inhalations) 4 times a day. Upon reaching the optimal therapeutic effect, you can switch to a maintenance dose that provides optimal control of the disease.

In severe cases, as well as with a high concentration of allergens, the dose can be increased to 15-20 mg 4 times a day. After achieving a therapeutic effect, treatment should not be abruptly stopped; cancellation is made gradually, within 1 week. During a dose reduction, the symptoms of the disease may recur.

To prevent an asthma attack in bronchial asthma caused by physical exertion or cold air, 10 mg should be taken 10-15 minutes before the provoking factor.
Side effect

From the respiratory system: irritation of the mucous membrane of the respiratory tract (hoarseness, cough), rarely - pulmonary infiltrates with eosinophilia.

From the digestive tract: dryness of the oral mucosa.

From the nervous system: dizziness, headache.

From the urinary system: urinary retention, impaired renal function.

Allergic reactions: skin rash, anaphylaxis (difficulty swallowing, urticaria, skin itching, swelling of the face, lips and eyelids, severe stridor or shortness of breath, decreased blood pressure) are observed in less than 1 out of 100 thousand patients.
Interaction

Beta-agonists, corticosteroids, antihistamines and theophylline enhance the effect.

The combined appointment of cromoglycic acid and GCS allows you to reduce the dose of the latter, and in some cases completely cancel.

In an inhalation solution, it is pharmaceutically incompatible with bromhexine or ambroxol.

Bronchodilators must be taken (inhaled) before inhalation of the drug.
special instructions

In addition to the above adverse reactions, when prescribing cromoglycic acid, the following are described (a causal relationship has not been proven): in 1 out of 10 thousand patients - angioedema, bronchospasm, cough, dizziness, dysuria, increased urination, headache, arthralgia, swelling of the joints, edema larynx, lacrimation, nausea, nasal congestion, rash, swelling of the parotid salivary glands, urticaria.

While reducing the dose of corticosteroids, the patient should be under close medical supervision, the rate of reduction should not exceed 10% in 1 week.

Anemia, exfoliative dermatitis, hemoptysis, hoarseness, myalgia, nephropathy, periarteritis, pericarditis, peripheral neuritis, photodermatitis, polymyositis, pulmonary infiltrates with eosinophilia are noted in 1 out of 100 thousand patients.

If it is necessary to stop treatment, the dose is reduced gradually (for at least 1 week) to reduce the risk of exacerbation of the disease.

It is not used for the relief of bronchospasm.

Treatment of patients with renal / hepatic insufficiency should take place under the constant supervision of a physician (the advisability of dose reduction should be considered).

Long-term studies conducted on mice, hamsters, rabbits and rats did not reveal carcinogenic and teratogenic effects. When administered parenterally to mice, rats and rabbits at doses up to 338 times therapeutic dose for humans, does not affect fertility. In higher doses, it has a toxic effect on the body of females, increases the frequency of resorption of fetuses and reduces their body weight.

The price of cromoglycic acid and the availability in the pharmacies of the city

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Active substance

Sodium cromoglycate (cromoglycic acid)

Release form, composition and packaging

Capsules hard gelatin, №2, body and cap white color; contents of capsules - powder of white or almost white color; the presence of seals of the capsular mass in the form of a column or tablet is allowed, which crumble when pressed with a glass rod.

The composition of the capsule body: titanium dioxide (E171) - 2%, gelatin - up to 100%.
The composition of the capsule cap: titanium dioxide (E171) - 2%, gelatin - up to 100%.

10 pieces. - blister packs (1) - cardboard packs.
10 pieces. - blister packs (2) - cardboard packs.
10 pieces. - blister packs (3) - cardboard packs.
10 pieces. - blister packs (4) - cardboard packs.
10 pieces. - blister packs (5) - cardboard packs.
10 pieces. - blister packs (10) - cardboard packs.
100 pieces. - polymer cans (1) - packs of cardboard.

pharmachologic effect

Antiallergic agent, has a membrane-stabilizing effect, prevents the degranulation of mast cells and the release of histamine, bradykinin, leukotrienes and other biologically active substances from them. Prevents the development, but does not eliminate the symptoms of allergic reactions of the immediate type.

When taken orally in patients with mastocytosis, relief of symptoms from the gastrointestinal tract (diarrhea) and skin (urticaria, itching) is observed at 2-6 weeks of treatment and lasts 2-3 weeks.

Pharmacokinetics

Suction and distribution

After oral administration, the absorption of sodium cromoglycate from the gastrointestinal tract is low (less than 1% of the dose), but its systemic clearance is high (plasma clearance is 7.9 ± 0.9 ml / min / kg), so the drug does not accumulate.

Protein binding is approximately 65%.

Metabolism and excretion

Not metabolized.

It is excreted unchanged through the intestines and by the kidneys in approximately equal proportions.

Indications

- food allergy (if proven) as monotherapy or in combination with a diet that limits the intake of the allergen;

- non-specific ulcerative colitis(as an adjuvant in combination with glucocorticosteroids (GCS) or, as well as the drug of choice in patients with hypersensitivity to sulfasalazine).

Contraindications

- children's age up to 2 years;

— hypersensitivity to sodium cromoglycate or any other component of the drug.

Dosage

The drug is taken orally in the form of capsules or a solution prepared from the contents of the capsules (open the capsule, pour the contents into a glass, pour 1 teaspoon of hot boiled water into a glass, dilute the resulting solution with 2 teaspoons of cold water).

At food allergies take 15-20 minutes before meals. Adults and children over 14 years old appoint an initial dose of 200 mg 4 times / day; children aged 2 to 14 years- 100 mg 4 times / day. Maximum daily dose should not exceed 40 mg/kg.

When a stable therapeutic effect is achieved, the dose can be reduced to a minimum, ensuring the absence of symptoms of the disease.

Patients who for some reason cannot avoid eating food containing allergens should take 1 capsule 15 minutes before meals. The optimal dose is selected individually, but in the range from 100 to 500 mg.

If a dose is missed, it should be taken as soon as possible. If this coincides with the next dose, the missed dose is not taken.

Side effects

Possible: nausea, vomiting, diarrhea, abdominal discomfort, joint pain.

Rarely: allergic reactions.

Overdose

Because the drug is absorbed very little, overdose is unlikely.

Treatment: in case of overdose, medical supervision is indicated and, if necessary, symptomatic treatment.

drug interaction

The combined appointment of sodium cromoglycate and GCS allows you to reduce the dose of the latter, and in some cases completely cancel them. While reducing the dose of corticosteroids, the patient should be under close medical supervision. The rate of reduction in the dose of GCS should not exceed 10% per week.

special instructions

Patients with a history of anaphylactic shock or other life-threatening food-related conditions should not use cromoglycic acid as an adjuvant.

The patient should be warned about the need for regular use of the drug.

Influence on the ability to drive vehicles and control mechanisms

Not studied.

Pregnancy and lactation

During pregnancy (especially in the first trimester), when prescribing the drug, as well as when prescribing other drugs, care should be taken. The accumulated experience in the use of the drug during pregnancy confirms the absence of adverse effects of the drug on the development of the fetus. During pregnancy, the drug should be prescribed only in cases where the need for its administration is obvious.

It has not been established whether sodium cromoglycate passes into breast milk, however, based on its physical and chemical properties may be considered unlikely. There were no reports confirming that the use of sodium cromoglycate by nursing mothers had any adverse effect on the child.

Application in childhood

Contraindicated in children under 2 years of age.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 30°C. Shelf life - 3 years. Do not use after the expiration date indicated on the package.