Intal - instructions for use, dose, side effects, contraindications

Each dose of Intal contains active substance: sodium cromoglycate - 5 mg. Excipients: povidone K30, macrogol (polyethylene glycol) 600, hydrofluoroalkane (HFA-227).

Description:

Aluminum balloon with dosing outlet valve.The contents of the balloon after evaporation of the propellant is a white powder.

Pharmacotherapeutic group:antiallergic agent - stabilizer of mast cell membranes

ATX: & nbsp

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

Pharmacodynamics:

Intal refers to anti-allergic anti-inflammatory anti-asthmatic drugs. The active substance of this drug is sodium cromoglycate. When systematically applied, it reduces the symptoms of allergic inflammation in the respiratory system. Cromoglycate sodium inhibits both early and late stages of the allergic reaction, preventing degranulation of mast cells and the release of inflammatory mediators (histamine, bradykinin, slowly reacting substance, leukotrienes, prostaglandins) from them. Due 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 anti-asthmatic agents (bronchodilators, glucocorticosteroids). The effect of the drug develops gradually.After 4-6 weeks of Intal, the frequency of asthma attacks decreases. Treatment should be long. When the drug is withdrawn, resumption of asthma attacks is possible. For the relief of acute attacks of bronchial asthma, the drug is not used.

Pharmacokinetics:

After administration by inhalation, the maximum concentration of sodium cromoglycate is reached after approximately 15 minutes. Cromolyn sodium is poorly absorbed from the gastrointestinal tract. Only 8% of the administered dose is subject to systemic absorption. The half-life is 46-99 minutes (an average of about 80 minutes). Cromolyn sodium is not metabolized. It is excreted by the kidneys and with bile approximately in equal amounts in unchanged form. The rest of the drug is removed 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 is excreted from the body through the digestive tract.

Indications:Prevention and treatment of bronchial asthma (including asthma of physical effort) in children and adults.

Contraindications:

Hypersensitivity to any components of the drug.

The drug should not be administered to children under 5 years of age.

Carefully:

Carefully a drug should be used to treat patients with impaired renal and hepatic function. Treatment should be under constant medical supervision (it is advisable to reduce the dose).

Pregnancy and lactation:

The drug should not be given to women during the first 3 months of pregnancy.

Sodium cromolyn can be prescribed by a doctor only when the expected benefit for a pregnant or lactating woman exceeds the possible risk to the fetus or baby.

Dosing and Administration:

Adults (including the elderly) and children

2 inhalations 4 times a day.

When the optimal therapeutic effect is achieved, it is possible to 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, do not suddenly stop using Intal. If necessary, the drug is withdrawn gradually within a week.When the dose is reduced, it is possible to resume the symptoms of the disease.

Additional intake of the drug can be made immediately before exercise to prevent asthma physical effort or before contact with suspected allergens.

With concomitant therapy with bronchodilators, they must be taken before inhalation of Intala.

In patients receiving corticosteroids, the addition of Intal may significantly reduce the dose or completely abandon them.

The basis for effective treatment is the proper use of the inhaler. Use of the inhaler by children is recommended only under the supervision of adults.

Application of the inhaler.
At first use, shake the inhaler and press once or twice on the dosing valve.

When inhaling, follow the instructions below:

Remove the dust cap. Inspect the inner and outer surfaces of the mouthpiece (tip) to make sure they are clean.

Vigorously shake the inhaler.

Hold the inhaler vertically, placing your thumb on the base of the can.Make the fullest exhalation, then insert the mouthpiece in the mouth between the teeth (but do not bite it) and tightly grasp your lips.

Starting to inhale air through the mouth, press the base of the canister so as to spray the dose of Intal; simultaneously continue a calm and deep breath. Hold your breath, take the inhaler out of your mouth. Continue to hold your breath as far as possible.

If you need to immediately enter a second dose of Intala, repeat the procedure.

After inhalation, always cover the mouthpiece with a dust cap.

Side effects:

The drug can cause irritation of the upper respiratory tract, dryness in the oral cavity, unpleasant taste sensations, hoarseness, cough, short-term bronchospasm. In the case of recurrent bronchospasm, the bronchodilator is pre-inhaled, and the cough is soothed by the intake of water immediately after inhalation.

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

The above undesirable phenomena can be reduced by the simultaneous use of IntaL with a spacer.

To rare undesirable phenomena are: anaphylaxis (difficulty swallowing, hives, itching of the skin, swelling of the face, lips and eyelids, pronounced stridorose or shortness of breath, lowering blood pressure), headaches and dizziness, painful or difficult urination, frequent urination, nausea and rash .

After drug cancellation, exacerbation of bronchial asthma, eosinophilic lung infiltrate is possible.

Very rarely there were cases of eosinophilic pneumonia.

Overdose:Cromolyn sodium has a low toxicity, so the risk of overdose and the development of any toxic phenomena is small.

Interaction:

Beta-adrenostimulants, glucocorticosteroids (GCS), antihistamines and theophylline enhance the effect.

The combined use of sodium cromoglycate and GCS can reduce the dose of the latter, and in some cases completely eliminate them.

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

Special instructions:

To stop bronchospasm, the drug is not used.

With concomitant therapy with bronchodilators, they must be taken before inhalation of Intala.

The maintenance dose of glucocorticosteroids can usually be reduced, and in some cases completely eliminated. During the reduction of the dose of glucocorticosteroids, the patient should be under close supervision doctor: the rate of dose reduction should not exceed 10% per week. If eosinophilic pneumonia occurs, the drug should be discontinued.

Effect on the ability to drive transp. cf. and fur:not described

Form release / dosage:

Aerosol for inhalation dose of 5 mg / dose.

The amount of the preparation is 112 doses in an aerosol aluminum canister placed in a dispensing plastic device with a dust cap. 1 bottle with instructions for use or 1 bottle with an additional dispenser and instructions for use in a cardboard box.

Packaging:

Storage conditions:

At a temperature of no higher than 30 ° C. Protect from direct sunlight. Do not store in the refrigerator and do not freeze.

Keep out of the reach of children.

Shelf life:

2 years and 6 months.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013684 / 01

Date of registration:17.03.2008

The owner of the registration certificate:Aventis LaboratoriesAventis Laboratories France

Manufacturer: & nbsp

AVENTIS PHARMA HOLMES CHAPEL United Kingdom

Representation: & nbspAventis Pharma Co., Ltd.Aventis Pharma Co., Ltd.India

Information update date: & nbsp19.07.2012

Illustrated instructions

Instructions

Intal® (Intal®)