Pharmacodynamics and pharmacokinetics
The mechanism of action is based on the stabilization of mast cell . The main active ingredient is cromoglycic acid . Intal prevents the process of degranulation of mast cells, blocks the flow of calcium into them, inhibits the release of leukotrienes, bradykinin, histamine and other bioactive components from mast cells.
The drug prevents the formation of bronchospasm. Most often used to prevent an allergic response.
With long-term use, there is a decrease in the frequency of asthma in bronchial asthma, the course of the disease is alleviated, and the need for the use of glucocorticosteroids and bronchodilators is reduced.
A stable effect is registered after ½-1 month of use. With a single use, the effect lasts up to five hours.
Intal aerosol d/ing doses 5 mg/dose 112 DOZES
Compound
dosed aerosol for inhalation
Pharmacokinetics
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. When the drug is discontinued, attacks of bronchial asthma may recur. The drug is not used to relieve acute attacks of bronchial asthma.
Indications for use
After administration by inhalation, the maximum concentration of sodium cromoglycate is reached after approximately 15 minutes. Sodium cromoglicate is poorly absorbed from the gastrointestinal tract. Only 8% of the administered dose undergoes systemic absorption. The half-life is 46-99 minutes (average about 80 minutes). Sodium cromoglycate is not metabolized. It is excreted by the kidneys and bile in approximately equal amounts unchanged. 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.
Contraindications
Prevention and treatment of bronchial asthma (including exercise-induced asthma) in children and adults.
Directions for use and doses
Beta-agonists, glucocorticosteroids (GCS), antihistamines and theophylline enhance the effect.
The combined administration of sodium cromoglycate and corticosteroids allows you to reduce the dose of the latter, and in some cases completely cancel them.
Bronchodilators must be taken (inhaled) before inhalation of the drug.
Storage conditions
On prescription
Best before date
At a temperature not higher than 30C. Protect from direct sunlight. Do not refrigerate or freeze.
Keep out of the reach of children.
special instructions
not described
Description
Each dose of the drug Intal contains the active substance: sodium cromoglycate - 5 mg. Excipients: povidone K30, macrogol (polyethylene glycol) 600, hydrofluoroalkane (HFA-227).
Dosage form
Cromoglicic acid
Pharmacodynamics
Aluminum cylinder with metering release valve. The contents of the cylinder after the propellant evaporates is a white powder.
Side effects
The drug should not be prescribed to women in the first 3 months 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.
Use during pregnancy and breastfeeding
Hypersensitivity to any components of the drug.
The drug should not be prescribed to children under 5 years of age.
Interaction
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 adverse events include: anaphylaxis (difficulty swallowing, hives, itchy skin, swelling of the face, lips and eyelids, severe wheezing or difficulty breathing, decreased blood pressure), 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.
Overdose
Prevention and treatment of bronchial asthma (including exercise-induced asthma) in children and adults.
Release form
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. If eosinophilic pneumonia occurs, the drug should be discontinued.
Impact on the ability to drive vehicles and operate machinery
Adults (including the elderly) and children
2 inhalations 4 times a day.
Once 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 two 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 on 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.
Side effects
Digestive system: dry mouth, use of the aerosol causes an unpleasant taste in the mouth.
Respiratory system: cough, hoarseness, irritation of the respiratory tract.
Nervous system: periodic headaches, dizziness, weakness.
Urinary system: disruption of the renal system, urinary retention.
Allergic reactions may develop in the form of swelling of the eyelids, face, lips, lacrimation, anaphylaxis , and skin rash.
The use of the drug Intal may be accompanied by difficulty, stridor breathing, and instability of blood pressure.
Contraindications
The use of Intal is contraindicated in cases of hypersensitivity to the active component or to other substances included in the composition.
Capsules should not be taken by children under 2 years of age or in the first trimester of pregnancy. The aerosol is contraindicated in children under 5 years of age.
Capsules should be used with caution during pregnancy in the second and third trimesters, as well as during breastfeeding.
Intal should be used in the treatment of patients with impaired liver and kidney function only under the supervision of a physician.
Instructions for use of Intal (Method and dosage)
Capsules with Intal powder for inhalation
To prevent attacks of bronchial asthma, swallowing capsules is ineffective. Using a spinhaler, the powder is inhaled. 20 mg of the drug (1 capsule) is used 4 times a day: during the day at intervals of 3-6 hours, in the morning and in the evening. If necessary, the dosage can be increased to 160 mg per day.
Metered aerosol Intal for inhalation
1 dose contains 1 mg of active substance, apply 4 times a day, 2-10 mg. The dosage may be increased to 2 mg, administered up to 8 times daily. After achieving the required therapeutic effect, they switch to a maintenance dosage, which allows optimal control of the course of the disease. In case of severe pathology, the amount of the drug is increased to 20 mg, 4 times a day. The drug is withdrawn gradually over the course of a week.
Solution for inhalation Intal, instructions for use
Using an inhaler, apply 20 mg 4 times a day. Before use, the contents of the container must be shaken thoroughly. During inhalation, the metering valve should be located at the bottom, and the container itself should be in a vertical position.
Intal 5 mg/dose 112 doses aerosol for inhalation dosed
Latin name
Intal
Release form
Aerosol dosed for inhalation.
Package
The cans contain 112 doses. There is 1 cylinder in a cardboard box.
112 doses
pharmachologic effect
Mast cell membrane stabilizer. Intal prevents bronchospasm by preventing the degranulation of mast cells and the release of histamine and other biologically active substances (leukotrienes, the slow-reacting substance of anaphylaxis) from them.
In the lungs, inhibition of the mediator response prevents the development of both the early and late stages of the asthmatic reaction in response to immunological and other stimuli.
Indications
Prevention and treatment of bronchial asthma (including exercise-induced asthma) in children and adults.
Contraindications
- Hypersensitivity to any components of the drug.
- Children under 5 years of age.
Carefully:
- When treating patients with impaired renal and liver function.
Use during pregnancy and breastfeeding
The drug should not be prescribed to women in the first 3 months 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.
special instructions
Intal is not a drug for relieving attacks of bronchial asthma. The patient should be instructed regarding the need for regular use of Intal, as opposed to taking medications used occasionally to reduce bronchospasm. Bromhexine and ambroxol should not be used simultaneously in the inhalation solution of cromoglycic acid. The contents of the canister are under pressure and should not be punctured or exposed to fire, even if empty.
Compound
Active ingredient: Sodium cromoglycate 5 mg.
Excipients: Povidone KZO, macrogol (polyethylene glycol) 600, hydrofluoroalkane (HFA-227).
Directions for use and doses
Treatment and prevention of bronchial asthma
2 inhalations 4 times a day. Once 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 two 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.
Exercise asthma
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.
Side effects
- Upper respiratory tract irritation.
- Dry mouth.
- Unpleasant taste sensations.
- Hoarseness.
- Cough.
- Short-term bronchospasm.
- Anaphylaxis:
- Difficulty swallowing.
- Hives.
- Itchy skin.
- Swelling of the face, lips and eyelids.
- Severe wheezing or difficulty breathing.
- Reduced blood pressure.
- Headache.
- Dizziness.
- Painful or difficult urination.
- Frequent urination.
- Nausea.
- Rash.
- Eosinophilic infiltrate of the lung.
- Eosinophilic pneumonia.
Drug interactions
When cromoglycic acid is used with oral and inhaled forms of beta-agonists, oral and inhaled forms of glucocorticoids, theophylline and other methylxanthine derivatives, and antihistamines, a potentiation effect is possible.
Overdose
Symptoms: increased side effects.
Treatment: symptomatic.
Storage conditions
Store at a temperature not exceeding 30°C, but not in the refrigerator; Avoid exposure to direct sunlight.
Best before date
4 years.
Conditions for dispensing from pharmacies
Dispensed with a doctor's prescription.
special instructions
Cromoglicic acid can provoke an attack of bronchospasm, dysuria , cough, swelling of the parotid glands.
During the period of reducing the dosage of the drug, the patient should be under the supervision of the attending physician; the rate of reduction is calculated using the formula: 10% per 1 week.
A gradual reduction in the dosage of the drug helps prevent exacerbation of the disease.
In a long-term study on animals, no teratogenic or carcinogenic effects of the drug were observed.
Release form and composition
Intal is available in the form of capsules with powder for inhalation and a metered aerosol for inhalation.
The capsules are transparent, hard, gelatinous, consisting of a yellow cap and a colorless body. The contents of the capsules are a homogeneous, almost white powder. Available in blister packs of 10 pieces. 1 sachet contains 1 blister. A cardboard pack contains 3 sachets.
The aerosol after spraying and evaporation is a white powder. Available in 112 doses in aluminum aerosol cans. A cardboard box contains 1 cylinder.
The active ingredient of Intal is sodium cromoglycate.
The auxiliary components in the aerosol are the following substances:
- Hydrofluoroalkane;
- Povidone K30;
- Macrogol 600.
Directions for use and dosage
Intal capsules are used by inhalation only with the Spinhaler inhaler.
Capsules are used for systemic preventive therapy, so regular use of the drug is necessary.
The capsule dosage regimen is the same for adults and children over 2 years of age. The dose is 1 capsule 4 times a day at intervals of 3-6 hours. In severe cases or with increased antigen content in the external environment, the frequency of administration is increased to 6-8 times a day.
For prophylaxis before physical activity that causes asthma attacks, additional dosage is prescribed.
After achieving a stable therapeutic effect, it is possible to switch to a minimum maintenance dose to control the symptoms of bronchial asthma.
According to the instructions, Intal in the form of an aerosol is prescribed to adult patients and children over 5 years of age, 2 inhalations 4 times a day. With a high concentration of allergens, as well as in severe cases, the dose is increased to 2 inhalations 6-8 times a day.
After achieving the optimal therapeutic effect, switch to a maintenance dose. One inhalation 4 times a day provides optimal control of the condition.
Treatment should not be stopped suddenly; withdrawal should be carried out gradually over a week.
Additionally, the drug is prescribed before contact with suspected allergens or for the prevention of physical exertion asthma.
When using Intal in the form of an aerosol, an important factor is the correct use of the inhaler. The spray can must be used to treat children under adult supervision.
Before using the inhaler, remove the dust cap and then inspect the outer and inner surfaces of the tip to ensure they are clean. The inhaler is then shaken vigorously. The thumb is placed on the base of the canister and the inhaler is held in an upright position. Exhale as completely as possible and insert the tip into the mouth between the teeth, without biting and clasping it tightly with your lips.
They begin to inhale air through their mouth and press the base of the can so as to spray a dose of aerosol. At the same time, continue to take a deep and calm breath. Holding your breath as long as possible, the inhaler is removed from your mouth.
To administer the second dose of the aerosol, the procedure is repeated. After finishing inhalation, it is necessary to close the tip with a dust cap.
