Sodium cromoglycate – description of the drug, instructions for use, reviews

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Manufacturers: SIFAVITOR SRL

Active ingredients

• Cromoglicic acid

Disease class

• Other diseases of the lacrimal gland
• Acute atopic conjunctivitis
• Keratitis
• Keratoconjunctivitis
• Vasomotor and allergic rhinitis
• Chronic rhinitis, nasopharyngitis and pharyngitis
• Asthma
• Allergy unspecified

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Membrane stabilizing
• Antiallergic

Pharmacological group

• Mast cell membrane stabilizers

Release form and composition

Dosage form of Cromoglycic acid - capsules: gelatin hard, size No. 2, with a white cap and body, filled inside with white or almost white powder; it is possible that there are compactions of the capsule mass in the form of a tablet or a column, which crumble when pressed with a glass rod (in a cardboard pack there is 1 polymer or polypropylene jar with first opening control, containing 100 capsules, or 1, 2, 3, 4, 5 or 10 packages of cellular contour , containing 10 capsules) and instructions for use of Cromoglycic acid.

Composition of 1 capsule:

• active substance: sodium cromoglycate – 100 mg;
• auxiliary components: titanium dioxide (E 171) – 2%, gelatin – up to 100%.

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Pharmacological properties

Pharmacodynamics

Cromoglicic acid is an antiallergic agent that has a membrane-stabilizing effect. The drug prevents the degranulation of mast cells and the release of leukotrienes, bradykinin, histamine and other biologically active substances from them. Its intake prevents the development, but does not eliminate the manifestations of immediate allergic reactions.

When administered orally in patients with mastocytosis, relief from skin symptoms (itching and urticaria) and gastrointestinal tract (abdominal pain, diarrhea) is observed after 14–42 days from the start of therapy and persists for 14–21 days.

Pharmacokinetics

Absorption of sodium cromoglycate from the gastrointestinal tract after oral administration is low (<1% of the dose), but its systemic clearance is high (plasma clearance is 7.9 ± 0.9 ml per 1 min per 1 kg). Thanks to this, the drug does not accumulate. Plasma protein binding is approximately 65%. Sodium cromoglycate is not metabolized. It is excreted unchanged through the kidneys and intestines in approximately equal proportions.

Powder substance Sodium cromoglicate

Instructions for medical use of the drug

Description of pharmacological action

Stabilizes the membranes of sensitized mast cells, inhibits the entry of calcium ions, degranulation and the release of histamine, bradykinin, leukotrienes (including the slow-reacting substance of anaphylaxis), prostaglandins and other biologically active substances.

Indications for use

Inhalation forms: bronchial asthma, incl. atopic, physical exertion and asthmatic triad, chronic bronchitis with broncho-obstructive syndrome. Capsules: food allergy (with proven presence of antigen, separately or in combination with a diet that limits the intake of allergen), as an aid: ulcerative colitis, proctitis, coloproctitis; mastocytosis. Nasal spray: year-round and seasonal allergic rhinitis, hay fever. Eye drops: acute and chronic allergic conjunctivitis, allergic keratitis, keratoconjunctivitis, dry eye syndrome, eye strain and fatigue, irritation of the mucous membrane of the eyes caused by allergic reactions (environmental factors, occupational hazards, household chemicals, cosmetics, ophthalmic drugs shapes, plants and pets).

Release form

powder substance;

Pharmacodynamics

Stabilizes the membranes of sensitized mast cells, inhibits the entry of calcium ions, degranulation and the release of histamine, bradykinin, leukotrienes (including the slow-reacting substance of anaphylaxis), prostaglandins and other biologically active substances. Prevents the development of allergic and inflammatory reactions, bronchospasm, inhibits the chemotaxis of eosinophils. It has the ability to block receptors specific for inflammatory mediators. Long-term use reduces the frequency of bronchial asthma attacks and facilitates their course, reduces the need for bronchodilators and glucocorticoids. In patients with mastocytosis, after 2–6 weeks from the start of treatment, a decrease in symptoms from the gastrointestinal tract (diarrhea, abdominal pain, nausea, vomiting) and skin (hyperemia, urticaria, itching) is observed, which persists for 2–3 weeks after its discontinuation. Reduction of symptoms in allergic eye diseases manifests itself in a period of several days to several weeks. With year-round allergic rhinitis, the effect appears within 1 week and reaches a maximum after 1–4 weeks.

Pharmacokinetics

After oral administration, no more than 1% is absorbed (0.45% is excreted in the urine within 24 hours), the rest is excreted in feces. 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 1 day. After intranasal administration, less than 7% is absorbed into the systemic circulation. When administered by inhalation, up to 90% of the drug settles in the trachea and large bronchi. 5–15% of the dose is absorbed from the lungs (Cmax in the blood is created in 15–20 minutes), a small part enters the gastrointestinal tract, and the rest is exhaled. Absorption from the mucous membranes decreases as the amount of secretion increases. Binding to blood plasma proteins is 65–75%. It is not metabolized and is excreted from the body in equal quantities with urine and bile within 24 hours. T1/2 is 1–1.5 hours. It passes into breast milk in small quantities. The effect of a single dose lasts up to 5 hours.

Use during pregnancy

Contraindicated (especially in the first trimester of pregnancy). Breastfeeding should be stopped during treatment.

Contraindications for use

Hypersensitivity (including to benzalkonium hydrochloride), pregnancy, breastfeeding, children under 2 years of age (for a dosed aerosol - up to 5 years).

Side effects

For inhalation use: For the skin: exanthema, dermatitis; rarely - urticaria; in some cases - vascular edema, photodermatitis, exfoliative dermatitis. From the nervous system and sensory organs: in some cases - malaise, dizziness, irritability, insomnia, hallucinations, tremor, peripheral neuritis, tinnitus. From the gastrointestinal tract: nausea, gastroenteritis; in some cases - unpleasant taste in the mouth, stomatitis, glossitis, swelling of the parotid salivary gland, esophagospasm, dyspepsia, flatulence, abdominal pain, diarrhea, constipation, impaired liver function. From the genitourinary system: frequent urination, nephropathy. From the respiratory system: bronchial irritation during inhalation (cough, retching, short-term spasm; rarely - expressed with a decrease in external respiration, requiring discontinuation of the drug), pharyngitis; very rarely - hemoptysis, laryngeal edema, eosinophilic pneumonia. From the cardiovascular system: in some cases - chest pain, periarterial vasculitis, heart failure, pericarditis, hypotension, cardiac arrhythmia. From the musculoskeletal system: myositis, in some cases - muscle and joint pain, polymyositis, joint swelling. Other: rarely - serum sickness. When taken orally: From the gastrointestinal tract: nausea, vomiting, abdominal discomfort, diarrhea. Other: skin rash, joint pain. With intranasal administration: From the gastrointestinal tract: unpleasant taste in the mouth, swelling of the tongue. From the respiratory system: short-term irritation of the mucous membrane and increased secretion from the nose; very rarely - nosebleeds, ulceration of the nasal mucosa, cough, suffocation. Other: headache, arthralgia, anaphylactic reaction (cough, difficulty swallowing, itchy skin, swelling of the face, lips or eyelids, difficulty breathing), exanthema, urticaria. For eye drops - short-term burning and blurred vision, conjunctival hyperemia, lacrimation, conjunctival swelling, sensation of a foreign body in the eye, dryness around the eyes, stye.

Directions for use and doses

Inhalation: for bronchial asthma - adults and children over 5 years of age (metered-dose aerosol) at the beginning of treatment - 1-2 doses 4-6 (up to once a day. To prevent asthma from physical exertion, an additional dose of the drug can be taken immediately before physical work. In severe cases, 2 doses 6–8 times a day, with clinical improvement - 1 dose 4 times a day. Orally, adults and children (over 12 years old) 2 capsules (200 mg) 4 times a day half an hour before food and sleep. Children from 2 to 12 years old - 1 capsule (100 mg) 4 times a day (up to 40 mg/kg/day). Intranasal - 1 aerosol dose in each nasal passage 3-4 times a day. Eye drops: conjunctivally, adults and children - 1-2 drops 4 times a day (up to 6-8 times) at equal intervals (when the effect is achieved, the intervals between uses are gradually lengthened).

Interactions with other drugs

Beta-agonists, glucocorticoids, antihistamines and theophylline potentiate the effect. You should not inhale bromhexine, ambroxol mixed with a solution of cromoglycic acid.

Special instructions for use

Not intended for relief of acute attacks of bronchial asthma and status asthmaticus. The patient should be warned about the need for regular use of the drug. Inhalation of the solution should be carried out using a compression, ultrasonic or piezoelectric inhaler through a face mask or mouthpiece. The aerosol can must be shaken before use and kept in an upright position during inhalation (the dosing valve must be at the bottom). Inhalation of the contents of the capsule is carried out using a special pocket turbo inhaler (“Spinhaler”), into which a capsule with the drug is placed. By pressing the cap of the inhaler, the capsule is pierced and with the patient’s active respiratory effort during inhalation, the powder enters the respiratory tract.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C.

Best before date

60 months

ATX classification:

R Respiratory system

R03 Drugs for the treatment of bronchial asthma

R03B Other drugs for inhalation use for the treatment of bronchial asthma

R03BC Antiallergic drugs (excluding glucocorticoids)

R03BC01 Cromoglic acid

Cromoglicic acid, instructions for use: method and dosage

Capsules or a solution prepared from their contents are taken orally. To prepare the solution, pour the powder into a glass, pour 1 teaspoon of hot boiled water, and then dilute with 2 teaspoons of cold water.

In cases of food allergies, cromoglycic acid is taken 15–20 minutes before meals. The initial dose for children aged 2 to 14 years is 1 capsule (100 mg) 4 times a day; for children over 14 years of age and adults – 2 capsules 4 times a day. The maximum dose should not exceed 40 mg per 1 kg of body weight per day.

The dosage of the drug can be reduced to a minimum when a stable therapeutic effect is achieved, ensuring the absence of manifestations of pathology.

In cases where for some reason it is not possible to avoid eating food containing allergens, it is recommended to take 1 dose of the drug 15 minutes before meals. The optimal dose is selected by the doctor individually, but it should be no less than 1 and no more than 5 capsules.

If you accidentally miss the next dose of the drug, you should take it as soon as possible. If this coincides with the next dose, the missed dose is not taken.

Cromoglycic acid capsules 100 mg No. 20

Compound

Active substance: sodium cromoglycate - 100 mg.

Pharmacokinetics

After oral administration, 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. Plasma protein binding is approximately 65%. Not metabolized. It is excreted unchanged through the intestines and kidneys in approximately equal proportions.

Indications for use

• Food allergy (if the presence of an allergen is proven) as monotherapy or in combination with a diet that limits the intake of the allergen.

• Nonspecific ulcerative colitis (as an adjuvant in combination with glucocorticosteroids (GCS) or sulfasalazine, and also as a drug of choice in patients with hypersensitivity to sulfasalazine).

Contraindications

• Hypersensitivity to sodium cromoglycate or any other component of the drug.

• Children under 2 years of age.

Directions for use and doses

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 the glass, dilute the resulting solution with 2 teaspoons of cold water).
For food allergies, 15–20 minutes before meals, adults and children over 14 years old are prescribed an initial dose of 200 mg 4 times a day; children aged 2 to 14 years - 100 mg 4 times a day. The maximum daily dose should not exceed 40 mg/kg.

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

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

If you accidentally miss taking the drug, it should be taken as soon as possible. If this time coincides with taking the next dose, then the missed dose is not taken.

Storage conditions

In a place protected from light at a temperature not exceeding 30°C.
Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date indicated on the package.

special instructions

Patients with a history of anaphylactic shock or other life-threatening conditions that occur when ingesting foods should not use cromoglycic acid as an adjuvant drug.
The patient should be warned about the need for regular use of the drug.

Dosage form

Hard gelatin capsules No. 2, white body and cap. The contents of the capsules are white or almost white powder. It is allowed to have compactions of the capsule mass in the form of a column or tablet, which crumble when pressed with a glass rod.

Pharmacodynamics

An antiallergic agent that 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 immediate allergic reactions. When taken orally in patients with mastocytosis, relief of symptoms from the gastrointestinal tract (diarrhea, abdominal pain) and skin (urticaria, itching) is observed at 2–6 weeks of treatment and lasts 2–3 weeks.

Side effects

Nausea, vomiting, diarrhea, abdominal discomfort, skin rash, joint pain.
Allergic reactions are extremely rare.

Use during pregnancy and breastfeeding

During pregnancy (especially in the first trimester), caution should be exercised when prescribing the drug, just as when prescribing other medications.
The accumulated experience in using 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 use is obvious. It has not been established whether sodium cromoglycate enters breast milk, however, based on its physicochemical properties, this can be considered unlikely. There have been no reports that the use of sodium cromoglycate by nursing mothers had any adverse effects on the child.

Interaction

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

Overdose

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

Impact on the ability to drive vehicles and operate machinery

Not studied.

special instructions

If there is a history of indications of anaphylactic shock or other life-threatening conditions that develop as a result of ingestion of food products, Cromoglycic acid is not used as an adjuvant.

The patient should be informed that the drug must be used regularly.

Impact on the ability to drive vehicles and complex mechanisms

No studies have been conducted on the effect of the drug on the ability to drive vehicles or operate complex machinery.

Use during pregnancy and lactation

During pregnancy, especially in the first trimester, the use of the drug is possible only under medical supervision. As with the prescription of other drugs, caution must be exercised.

The existing experience with the use of cromoglycic acid during pregnancy confirms the absence of adverse effects on fetal development. It is recommended to prescribe capsules only in cases where the need for their use is obvious.

There is no data confirming the entry of sodium cromoglycate into breast milk. Based on the physicochemical properties of the active substance, it can be considered unlikely that it will be excreted into breast milk. There have been no reports from nursing mothers who took the drug that would confirm any adverse effects of the drug on the child.

Instructions:

Clinical and pharmacological group

13.006 (Mast cell membrane stabilizer. Antiallergic drug)

Release form, composition and packaging

Dosed aerosol for inhalation (after spraying and evaporation of the propellant it is a white powder).

Excipients: povidone K30, macrogol (polyethylene glycol) 600, hydrofluoroalkane (HFA-227).

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

pharmachologic effect

Intal is an anti-allergic, anti-inflammatory, anti-asthmatic drug. The active substance of this drug is sodium cromoglycate. When used systematically, it leads to a reduction in the symptoms of allergic inflammation in the respiratory system.

Sodium cromoglycate inhibits both the early and late stages of the allergic reaction, preventing the degranulation of mast cells and the release of inflammatory mediators from them (histamine, bradykinin, slow-reacting substance, leukotrienes, prostaglandins). Thanks to these properties, Intal prevents bronchospasm caused by contact with an allergen or other provoking factor (cold air, physical stress, stress). In addition, it allows you to reduce the intake of other antiasthmatic drugs (bronchodilators, glucocorticosteroids).

The effect of the drug develops gradually. After 4-6 weeks of using Intal, the frequency of bronchial asthma attacks decreases. Treatment should be long-term. If the drug is discontinued, bronchial asthma attacks may recur. The drug is not used to relieve acute attacks of bronchial asthma.

Pharmacokinetics

After administration by inhalation, the maximum concentration of sodium cromoglycate is reached after approximately 15 minutes. Sodium cromoglycate is poorly absorbed from the gastrointestinal tract. Only 8% of the administered dose undergoes systemic absorption.

T1/2 is 46-99 minutes (on average about 80 minutes). Sodium cromoglycate is not metabolized. It is excreted unchanged from the body with urine and bile in approximately equal quantities. The rest of the drug is excreted from the lungs with a current of exhaled air or settles on the walls of the oropharynx, then swallowed (without significant absorption - less than 2%) and excreted from the body through the digestive tract.

Dosage

Adults (including elderly people) and children - 2 inhalations 4 times a day.

When the optimal therapeutic effect is achieved, you can switch to a maintenance dose (1 inhalation 4 times a day), which ensures optimal control of the disease. In severe cases, as well as with a high concentration of allergens, the dose of the drug can be increased to 2 inhalations 6-8 times a day.

After achieving a therapeutic effect, you should not suddenly stop using Intal. If necessary, the drug is discontinued gradually over a week. During dose reduction, symptoms of the disease may recur.

An additional dose of the drug can be taken immediately before physical activity to prevent exercise-induced asthma or before contact with suspected allergens.

When concomitant therapy with bronchodilators is used, they must be taken before inhalation of Intal.

In patients receiving corticosteroids, the addition of Intal may allow the dose to be significantly reduced or eliminated entirely.

The basis of effective treatment is the correct use of the inhaler.

The use of the inhaler by children is recommended only under adult supervision.

Using an inhaler

When using for the first time, shake the inhaler and press the metering valve once or twice.

When inhaling, you should adhere to the following instructions:

Remove the dust cap. Inspect the inside and outside of the mouthpiece (tip) to ensure they are clean. Shake the inhaler vigorously. Hold the inhaler upright with your thumb on the base of the canister. Exhale as completely as possible, then insert the mouthpiece into your mouth between your teeth (but without biting it) and close your lips tightly.

Starting to inhale air through your mouth, press the base of the canister so as to spray a dose of Intal; At the same time, continue to breathe calmly and deeply. Hold your breath and remove the inhaler from your mouth. Continue to hold your breath as much as possible.

If you need to immediately administer a second dose of Intal, repeat the procedure. After inhalation, always close the mouthpiece with a dust cap.

Overdose

Sodium cromoglycate has low toxicity, so the risk of overdose and the development of any toxic phenomena is small.

Drug interactions

Sodium cromoglicate can be used in combination with bronchodilators and glucocorticosteroids.

Use during pregnancy and lactation

The drug should not be prescribed to women in the first trimester of pregnancy. Sodium cromoglicate can be prescribed by a doctor only when the expected benefit to a pregnant or lactating woman outweighs the possible risk to the fetus or infant.

Side effects

The drug may cause irritation of the upper respiratory tract, dry mouth, unpleasant taste, hoarseness, cough, and short-term bronchospasm. In case of recurring bronchospasm, a bronchodilator is first inhaled, and the cough is calmed by drinking water immediately after inhalation.

As with any inhalation therapy, bronchospasm may unexpectedly develop immediately after inhalation. In this case, you should stop taking the drug and prescribe the patient another treatment.

The above-mentioned adverse events can be reduced by combining Intal with a spacer.

Rare side effects include anaphylaxis, headaches and dizziness, painful or difficult urination, frequent urination, nausea and rash.

After discontinuation of the drug, exacerbation of bronchial asthma and eosinophilic infiltration of the lung are possible.

Very rarely, cases of eosinophilic pneumonia have been reported.

Storage conditions and periods

Store at temperatures below 30°C. Do not refrigerate or freeze. Keep out of the reach of children. Shelf life: 2 years. Do not use after the expiration date indicated on the package.

Indications

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

Contraindications

- children under 5 years of age;

- hypersensitivity to any components of the drug.

The drug should be used with caution to treat patients with impaired renal and liver function. It should be under constant medical supervision (it is advisable to reduce the dose). If eosinophilic pneumonia occurs, the drug should be discontinued.

special instructions

The drug is not used to relieve bronchospasm.

When concomitantly treated with bronchodilators, they must be taken before inhalation of Intal.

The maintenance dose of glucocorticosteroids can usually be reduced, and in some cases completely canceled.

When reducing the dose of glucocorticosteroids, the patient should be under close medical supervision: the rate of dose reduction should not exceed 10% per week.

Use for renal impairment

The drug should be used with caution to treat patients with impaired renal function.

Use for liver dysfunction

The drug should be used with caution to treat patients with impaired liver function.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Reviews of Cromoglycic acid

According to reviews, Cromoglicic acid is a safe and effective drug used for food allergies. Among the advantages are the development of resistance to allergens, the ability to eat foods to which you were previously allergic, as well as the absence of side effects such as drowsiness or lethargy, which usually appear when taking similar medications.

Among the disadvantages, the most often mentioned is the need for long-term administration of capsules on a strict schedule, the high cost of the drug, and the impossibility of its use in children under 2 years of age.