Intal

Intal – antiallergic drug, the stabilizer of membranes of mast cells.

Form of release and structure

Dosage forms:

• Capsules with powder for inhalations: the size No. 2, gelatinous, consisting of the firm transparent colourless case and a transparent yellow lid, with a text of "SODIUM CROMOGLYCATE 20 mg", in capsules – powder of white or almost white color of homogeneous structure (on 10 pieces in blisters or in a sachet, in a cardboard pack 1 blister or 3 sachets);
• Aerosol for inhalations dosed: after evaporation in the place of spraying there is a powder of white color (on 112 doses in aluminum aerosol cans, in a cardboard pack 1 cylinder).

Active agent – кромогликат sodium:

• 1 capsule – 20 mg;
• 1 dose of an aerosol – 5 mg.

Auxiliary components:

• Capsules: structure of a cover – gelatin of 100%;
• Spray: macrogoal (polyethyleneglycol) 600, K30 povidone, гидрофторалкан (HFA-227).

Indications to use

Use of Intal is shown for preventive treatment of bronchial asthma, including asthma of physical tension.

Contraindications

• I trimester of pregnancy;
• Hypersensitivity to drug components.

Appointment in II and III trimesters of pregnancy and during breastfeeding is possible only in case the estimated advantage of treatment for mother exceeds possible harm for a fruit or the child.

It is impossible to use capsules at treatment of children aged up to 2 years.

With care of the capsule appoint the patient with a liver and/or renal failure.

It is contraindicated to apply an aerosol to children up to 5 years.

With care it is recommended to use an aerosol at an impaired renal function and/or a liver.

Route of administration and dosage

• Capsules with powder for inhalations: are intended only for inhalation use with an inhaler Spinkhaler, it is impossible to accept capsules inside. Preventive therapy assumes regular use of capsules by adults and children from 2-year age. The dosing mode for adults and children identical: on 1 capsule 4 times a day every 3-6 hours. At the increased contents in the environment of antigen or a severe form of an allergy it is possible to increase frequency rate of reception to 6-8 times a day (120-160 mg of a kromoglikat of sodium a day). For prevention of attacks of suffocation from the forthcoming exercise stress it is previously possible to carry out additional inhalation. Transition to the supporting minimum dose capable to provide control of symptoms of bronchial asthma is possible only after achievement of steady therapeutic effect;
• Aerosol for inhalations dosed: for children 5 years are more senior, than adult and elderly patients – on 2 inhalations 4 times a day. After achievement of the therapeutic effect providing optimum control of a disease transition to a maintenance dose – on 1 inhalation 4 times a day is possible. Increase in a dose of drug up to 2 inhalations of 6-8 times a day at the increased concentration of allergens is allowed or in case of heavy attacks. Sudden phase-out of drug after stabilization of a state is not recommended, cancellation is made within a week, gradually. At a dose decline symptoms of a disease can recur. The additional dose of Intal can be accepted for prevention of asthma just before an exercise stress or alleged contact with allergens. At simultaneous treatment by bronchodilators, inhalations need to be carried out after their reception. The patients receiving corticosteroids against the background of use of Intal can lower considerably a dose or completely cancel their reception. Spray use by children is recommended to be carried out only under observation of adults. Efficiency of treatment depends on the correct use of an inhaler. Before the first use the inhaler should be stirred up and pressed several times the dosing valve. At each use of an inhaler after removal of a dust-protection cap it is necessary to be convinced of purity of an internal and external surface of a tip and several times to stir up inhaler contents. Having made a full exhalation, keeping an inhaler in vertical position, to place a tip between teeth (not to bite) and to clasp densely with lips. At inhalation of air through a mouth, having pressed against the stop the barrel basis, to spray a drug dose, quietly continuing a deep breath. With the held breath to pull out a tip from a mouth and not to breathe some time (as far as there will be enough forces). Then it is possible to enter the second dose (if it is required). After use to close a tip a dust-protection cap.

Side effects

Use of capsules of Intal can cause side effects:

• From respiratory system: irritation of upper respiratory tracts in the form of hoarseness and cough; extremely seldom – pulmonary infiltrates with increase in maintenance of eosinophils in blood;
• Allergic reactions: bronchospasm, Quincke's disease, throat hypostasis, skin rash; seldom – an anaphylaxis;
• From a digestive tract: nausea, dryness in a mouth;
• From an urinary system: ischuria, renal failure;
• From a nervous system: headache, dizziness.

The aerosol can cause unpleasant flavoring feelings, dryness in oral cavities, irritation of a mucous surface, a short-term bronchospasm, a hoarseness and cough.

At the repeating bronchospasms previously do bronchial spasmolytic inhalation, and reception of water after inhalation calm cough.

At unexpected development of bronchospasms right after inhalation of an aerosol use of Intal is recommended to cancel and appoint other treatment.

Emergence of the listed undesirable effects can be reduced, applying an aerosol with a spacer.

The unusual undesirable occurrences can become: a headache and dizziness, an anaphylaxis, disturbances of an urination (painful, speeded up or complicated), nausea, skin rash.

Against the background of cancellation of an aerosol there is a risk of an exacerbation of bronchial asthma, eosinophilic infiltrate of a lung, seldom or never – development of eosinophilic pneumonia.

Special instructions

Capsules and aerosol are not intended for stopping of attacks of a bronchospasm.

Broncholitic drugs of the accompanying therapy should be accepted before Intal inhalation.

Usually it is possible to lower, and sometimes and completely to cancel reception of a maintenance dose of glucocorticosteroids against the background of Intal use. Process of a dose decline of glucocorticosteroids has to take place under careful observation of the attending physician, within a week it should not exceed 10%. At a dose decline of glucocorticosteroids reception of Intal should be continued before purpose of new dosing of glucocorticosteroids.

Need of increase in a dose of glucocorticosteroids can arise at an infection, an aggravation of a course of asthma or increase in content of antigen in the environment.

Patients on whom preventive therapy by Intal makes positive impact are recommended not to interrupt drug use.

Drug withdrawal is made within 1 week, the gradual dose decline can promote resuming of symptoms of asthma.

Patients with a renal and/or liver failure have to use capsules under constant control of the doctor.

Medicinal interaction

The combined use кромогликат sodium with glucocorticosteroids and bronchial spasmolytics is shown.

Simultaneous use beta адреностимуляторов, antihistamines, glucocorticosteroids, theophylline strengthens action of a kromoglikat of sodium.

At a combination to kromoglitsiyevy acid and glucocorticosteroids Intal allows to lower their dose, and sometimes completely to cancel.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C, not to freeze.

It is impossible to keep a barrel with an aerosol in the refrigerator.

Period of validity: capsules – 5 years, an aerosol – 2 years.