INTAL

Active material: Cromoglicic acid
When ATH: R03BC01
CCF: Stabilizers fat cell membranes. Allergy medication
When CSF: 13.02.02
Manufacturer: AVENTIS Laboratories (France)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Aerosol for inhalation dose (after spraying and evaporation of the propellant is a white powder).

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

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

Capsules with powder for inhalation hard gelatin, clear, size №2, consisting of a body and a colorless transparent yellow transparent lid, with an inscription “SODIUM CROMOGLYCATE 20 mg”; contents of capsules – homogeneous powder white or nearly white.

Ingredients of the capsule shell: gelatin 100%.

10 PC. – blisters (1) – sachet (3) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Antiallergic agent, Stabilizers fat cell membranes. It inhibits the release of histamine, leukotrienes and other biologically active substances from mast cells. It is believed, delay release of mediators is the result of indirect blockade penetration of calcium ions into cells. Established, cromoglicic acid that inhibits the migration of neutrophils, eozinofilov, monotsitov.

Warns of immediate asthmatic reactions and delayed-type after inhalation of allergens and non-antigenic stimuli.

Pharmacokinetics

The degree of absorption of the active ingredient depends on the route of administration.

Plasma protein binding is 65%. Do not metabolized. T_1/2 is about 1.5 no. Excreted unchanged in the urine and bile in approximately equal proportions.

Testimony

Bronchial asthma (atopic form, astmatičeskaâ triad, asthma physical effort), chronic bronchitis with a broncho-obstructive syndrome. Prevention and treatment of allergic conjunctivitis and keratoconjunctivitis. Prevention of seasonal and / or year-round rhinitis allergic genesis. Alimentary allergy (if to prove the presence of antigen). As part of combination therapy for ulcerative colitis, proctitis or proctocolitis.

Dosage regimen

Individual. Inhalation – by 1-10 mg (depending upon the dosage form) 4 times / day.

Inside adults – by 200 mg 4 times / day, children aged 2 to 14 years – by 100 mg 4 times / day.

When used in ophthalmology and ENT practice dose set depending on the indication and dosage form.

Rectal used as microclysters.

Side effect

When inhaled: possible irritation of the upper respiratory tract, cough, short-term phenomenon of bronchospasm; in some cases – marked by bronchoconstriction decline in respiratory function.

When administered intranasally: at the beginning of treatment may result in irritation of the nasal mucosa; in a few cases – nosebleeds, allergic reactions.

The local application in ophthalmology: possible violation of a temporary definition of visual perception, heat sensation in the eye.

Allergic reactions: in a few cases – skin rash, joint pain.

Other: in a few cases – nausea.

Contraindications

Hypersensitivity to cromoglicic acid, I trimester of pregnancy, Children up to age 5 years (for administration by inhalation as an aerosol), to 2 years (in the form of capsules and powder for inhalation solution for inhalation application).

Pregnancy and lactation

Cromoglicic acid is contraindicated for use in the I trimester of pregnancy.

Application in II and III trimester of pregnancy is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus.

In small amounts excreted in breast milk. Use during lactation is possible only if, when the intended benefits to the mother outweighs the potential risk to the baby.

Cautions

Not used for the relief of acute asthma attacks.

To use caution during concomitant liver and kidney diseases.

In exceptional cases,, When inhalation kromoglitsievoy acid develops bronchospasm with the decline in respiratory function, repeated use is not recommended.

In lechenii NYAK, proctitis or proktokolita cromoglicic acid is the drug of choice in patients with hypersensitivity to sulfasalazine.

The inhalation solution kromoglitsievoy acid should not be used simultaneously bromhexine and ambroxol.

If a food allergy should be used in conjunction with diet, limiting the supply of the antigen.

Children under the age of 2 It s not defined cromoglicic acid dose for administration by inhalation in a powder form and a solution of.

Children under the age of 5 s not defined dose kromoglitsievoy acid for administration by inhalation in aerosol form for intranasal use.

Effects on ability to drive vehicles and management mechanisms

For some time after instillation into the eyes should refrain from performing any work, requiring greater attention.

Drug Interactions

When using kromoglitsievoy acid with oral and inhaled forms of beta-agonists, oral corticosteroids and inhaled forms, theophylline and other methylxanthine derivatives, antihistamines possible potentiating effect. Combined designation kromoglitsievoy acid and corticosteroids to reduce the dose of the latter, and in some cases – abolish. While reducing the dose of GCS patient should be under close medical supervision, the rate of reduction of the dose should not exceed 10% in Week.

The inhalation solution is pharmaceutically incompatible with bromhexine or ambroxol. Bronchodilators should be taken (ingalirovat) before inhalation kromoglitsievoy acid.

When applied topically in ophthalmic practice cromoglicic acid reduces the need for use of ophthalmic drugs, containing corticosteroids.