Intal^® (Capsules, Aerosol) Instructions for Use

ATC Code

R03BC01 (Cromoglicic acid)

Active Substance

Cromoglicic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Mast cell membrane stabilizer. Anti-allergic drug

Pharmacotherapeutic Group

Antiallergic agent – mast cell membrane stabilizer

Pharmacological Action

Intal^® is an anti-allergic, anti-inflammatory, anti-asthmatic agent. The active substance of this drug is sodium cromoglicate. With systematic use, it leads to a reduction in the symptoms of allergic inflammation in the respiratory system.

Sodium cromoglicate inhibits both the early and late stages of the allergic reaction, preventing mast cell degranulation and the release of inflammatory mediators (histamine, bradykinin, slow-reacting substance, leukotrienes, prostaglandins) from them. Due to these properties, Intal^® 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, glucocorticosteroids).

The drug’s action develops gradually. After 4-6 weeks of using Intal^®, the frequency of bronchial asthma attacks decreases. Treatment should be long-term. Discontinuation of the drug may lead to a recurrence of bronchial asthma attacks. The drug is not used for relieving acute attacks of bronchial asthma.

Pharmacokinetics

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

T_1/2 is 46-99 minutes (on average about 80 minutes). Sodium cromoglicate is not metabolized. It is excreted from the body unchanged in urine and bile in approximately equal amounts. The remainder of the drug is expelled from the lungs with the exhaled air stream or deposits on the oropharyngeal walls, is then swallowed (without significant absorption – less than 2%), and is excreted from the body through the digestive tract.

Indications

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

ICD codes

Dosage Regimen

Capsules

The drug is used by inhalation.

Intal^® capsules are intended for use only with the “Spinhhaler” inhaler. They must not be taken orally.

Since Intal^® therapy is essentially prophylactic, it is important that the patient is instructed on the need for regular administration of the drug, unlike other drugs whose inhalations are used to relieve attacks.

Adults and children from 2 years of age

The dosage regimen is the same for adults and children.

Usual dose: 1 capsule 4 times/day with 3-6 hour intervals between them. In more severe cases or with a high antigen content in the environment, the frequency of administration can be increased to 6-8 times/day (120-160 mg/day).

Additional dosing may also be used for prophylaxis before physical exertion that causes asthma attacks.

Upon achieving a stable therapeutic effect, it is possible to switch to the minimum maintenance dose that provides sufficient control over the symptoms of bronchial asthma.

Aerosol

Adults (including the elderly) and children – 2 inhalations 4 times/day.

Upon achieving the optimal therapeutic effect, it is possible to switch to a maintenance dose (1 inhalation 4 times/day) that provides optimal disease control. In severe cases, as well as with a high concentration of allergens, the drug dose can be increased to 2 inhalations 6-8 times/day.

After achieving a therapeutic effect, Intal^® should not be abruptly discontinued. If necessary, the drug should be withdrawn gradually over one week. During dose reduction, a recurrence of disease symptoms is possible.

An additional dose of the drug may be taken immediately before physical exertion to prevent exercise-induced asthma or before contact with expected allergens.

With concomitant bronchodilator therapy, they must be taken before the inhalation of Intal^®.

In patients receiving corticosteroids, the addition of Intal^® may allow for a significant reduction in their dose or complete discontinuation.

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

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

Using the inhaler

Before first use, shake the inhaler and press the dosing valve once or twice.

When inhaling, follow these instructions:

Remove the dust cap. Inspect the inner and outer surfaces of the mouthpiece (tip) to ensure they are clean. Shake the inhaler vigorously. Hold the inhaler upright, placing your thumb on the base of the canister. Exhale as fully as possible, then place the mouthpiece in your mouth between your teeth (but do not bite it) and close your lips tightly around it.

As you begin to inhale air through your mouth, press down on the base of the canister to release a dose of Intal^®; simultaneously continue a calm and deep inhalation. Hold your breath, remove the inhaler from your mouth. Continue to hold your breath for as long as possible.

If a second dose of Intal^® is needed immediately, repeat the procedure. After inhalation, always replace the mouthpiece dust cap.

Adverse Reactions

The drug may cause irritation of the upper respiratory tract, dry mouth, unpleasant taste sensations, hoarseness, cough, and transient bronchospasm. In case of recurrent bronchospasm, a preliminary inhalation of a bronchodilator is administered, and cough is soothed by drinking water immediately after inhalation.

As with any inhalation therapy, bronchospasm may develop unexpectedly immediately after inhalation. In this case, the drug should be discontinued and the patient should be prescribed another treatment.

The aforementioned adverse events can be reduced by using Intal^® with a spacer.

Rare adverse events include anaphylaxis, headaches and dizziness, painful or difficult urination, frequent urination, nausea, and rash.

After discontinuation of the drug, exacerbation of bronchial asthma and pulmonary eosinophilic infiltrate are possible.

Very rarely, cases of eosinophilic pneumonia have been reported.

Contraindications

• Children under 5 years of age;
• Hypersensitivity to any components of the drug.

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

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

With caution, the drug should be used to treat patients with impaired liver function.

Use in Renal Impairment

With caution, the drug should be used to treat patients with impaired renal function.

Pediatric Use

Contraindication: children under 5 years of age.

Children – 2 inhalations 4 times/day.

Geriatric Use

Adults (including the elderly)– 2 inhalations 4 times/day.

Special Precautions

The drug is not used for relieving bronchospasm.

With concomitant bronchodilator therapy, they must be taken before the inhalation of Intal^®.

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

During the reduction of the glucocorticosteroid dose, the patient should be under careful medical supervision: the rate of dose reduction should not exceed 10% per week.

Overdose

Sodium cromoglicate 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.

Storage Conditions

Store at a temperature below 30°C (86°F). Do not store in the refrigerator and do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

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.