Pulmikort

Pulmikort – an inhalation glucocorticosteroid (GKS) with antiinflammatory activity in bronchial tubes, reduces the frequency of aggravations and expressiveness of symptoms of bronchial asthma.

Form of release and structure

Dosage form – suspension for inhalations dosed: almost white or white color liquid, easily gives in to resuspending (on 2 ml in one-dose polyethylene containers, on 5 containers in an envelope from the laminated foil, in a cardboard pack 4 envelopes).

Pulmikort contains in 1 ml of suspension:

• Active ingredient: будесонид (micronized) – 0,25 mg or 0,5 mg;
• Auxiliary components: sodium citrate, citric acid (anhydrous), sodium chloride, polysorbate 80, dinatrium эдетат (disubstituted sodium salt of ethylene diamine tetraacetic acid), the water purified.

Indications to use

• Bronchial asthma (as a maintenance therapy);
• Chronic Obstructive Pulmonary Disease (COPD).

Contraindications

• Age up to 6 months;
• Hypersensitivity to a budesonid and excipients.

With care and under more careful observation accept Pulmikort at an active form of a pulmonary tuberculosis, cirrhosis, and also at fungal, bacterial and viral infections of a respiratory organs.

In the course of therapy it is necessary to consider a possibility of manifestation of systemic action of GKS.

Route of administration and dosage

Pulmikort is applied with use of the special device to inhalations – the nebulizer turning suspension into an aerosol. At a quiet and equal breath through a mouthpiece drug in the form of an aerosol gets into the patient's lungs. At small children the procedure is made through a special mask.

In the form of suspension ultrasonic nebulizers are not suitable for Pulmikort's use!

Start use of the nebulizer after attentive studying of the instruction, strictly observing all recommendations.

After each inhalation it is required to rinse carefully a mouth water, it will allow to reduce risk of development of candidiasis of a stomatopharynx, it is also necessary to wash out water a face to prevent irritation of skin. The diluted suspension use in the next half an hour.

After each procedure it is necessary to clear the nebulizer camera.

By means of the compressor the speed of an air flow (5-8 l a minute) necessary for filling of the nebulizer with a capacity of 2-4 ml is created. The device is equipped with a special mask and a mouthpiece.

The doctor establishes Pulmikort's dose individually.

At purpose of a daily dose of 1 mg it is entered for once if a dose higher – divide into 2 receptions.

For mixing of suspension use 0,9% solution of sodium of chloride or solutions of Acetylcysteinum, salbutamol, a terbutalin, Fenoterolum, sodium of a kromoglikat, a bromide ipratropiya.

The recommended daily dosing:

• Adults, including patients of advanced age: an initial dose – 1-2 mg, a maintenance dose – 0,5-4 mg. For achievement of desirable effect at a heavy exacerbation of a disease the dose can be increased;
• Children aged after 6 months: the initial dose – 0,25-0,5 mg, is in case of need allowed increase up to 1 mg. A maintenance dose – 0,25-2 mg.

To each patient define the minimum effective maintenance dose providing clinical effect.

Because of lower risk of development of undesirable system effects increase in a daily dose of drug to 1 mg in the form of monotherapy, instead of a combination with GKS for intake is in certain cases recommended.

The patients who is on treatment of GKS for intake need to begin therapy cancellation in the period of a stable state. Against the background of a usual dose of GKS for oral administration within 10 days the patient receives high doses of Pulmikort. Then within a month the dose of peroral GKS gradually decreases, to the minimum effective. Very often it is possible to cancel completely reception of GKS inside.

At the expressed cirrhosis duration of effect of drug increases.

Side effects

• Respiratory system: often – dryness in a mouth, cough, stomatopharynx candidiasis, hoarseness of a voice, irritation of a mucous membrane of a throat; seldom – a bronchospasm;
• Nervous system: seldom – a headache; perhaps – a depression, nervousness, behavior disorders; excitability;
• Dermatological reactions: seldom – skin rash, a small tortoiseshell, contact dermatitis;
• Allergic reactions: seldom – a Quincke's disease;
• Other reactions: seldom – irritation of face skin (from use of the nebulizer with a mask), bruises on skin; in some cases – a hypoadrenalism and symptoms of other pathologies caused by systemic action of GKS.

Special instructions

It is recommended to avoid purpose of a budesonid at simultaneous use of a ketokonazol, itrakonazol or other potential CYP3A4 inhibitors. In need of this combination, the period between administrations of drugs should be increased to greatest possible.

Control over a condition of patients upon transition to Pulmikort's reception from system GKS as the risk of weakening of function of adrenal glands increases is required. It is necessary to pay special attention to patients at oral administration of high doses of GKS or long receiving the highest recommended doses of inhalation GKS. As stressful situations can cause symptoms of adrenal insufficiency in this category of patients, at surgical intervention and other stresses performing additional therapy is recommended by system GKS.

With care transition from system GKS on Pulmikort is carried out.

At risk of disturbance of pituitary and adrenal function it is necessary to reduce a dose of system GKS with special attention to a condition of the patient and control of indicators of function гипоталамо - pituitary and adrenal system. At an injury, surgical intervention and other stresses of this category of patients additional reception of GKS inside can be required.

At emergence of a joint pain or muscles in case of transition from peroral GKS on inhalation perhaps temporary increase in a dose of GKS for intake. Development during transition of feeling of fatigue, a headache, nausea, vomiting is the testimony of system insufficiency of GKS.

Because of cancellation of system drugs during transition the risk of an exacerbation of the available eczema, allergic pathologies, rhinitis increases.

For prevention of asthma of physical effort 1-2 times a day are effective Pulmikort's use.

During pregnancy it is recommended to use a drug minimal effective dose.

Use of therapeutic doses of Pulmikort during breastfeeding does not make impact on the child.

GKS in pediatrics use after careful assessment of comparison of the expected therapeutic effect and potential threat in delay of growth of the child. At prolonged use of any GKS forms at children and teenagers it is necessary to carry out regular control of an indicator of growth.

Results of observations showed that use of a budesonid within 11 years at children and teenagers did not affect achievement of normative indicators of growth by them.

Biochemical symptoms of systemic action of drug can arise at use of a daily dose of 0,4-0,8 mg, system effects often occur at the children accepting doses 0,8 mg a day are higher.

After each use the nebulizer camera, a mouthpiece or a mask is required to be washed up warm water with soft detergent, the nebulizer – to rinse and dry up, connect the camera to the entrance air valve or the compressor.

Pulmikort does not influence ability of the patient to driving and other mechanisms.

Medicinal interaction

Interaction of a budesonid with other drugs used for therapy of bronchial asthma was not observed.

In need of simultaneous use of a ketokonazol it is necessary to lower a dose of a budesonid and as much as possible to increase an interval between their receptions.

Level of concentration of a budesonid in a blood plasma considerably raises итраконазол, potential CYP3A4 inhibitor.

Use beta адреностимуляторов for performing preliminary inhalation promotes a bronchiectasia, improvement of receipt of a budesonid in respiratory tracts, to strengthening of its therapeutic effect.

At a combination to Phenytoinum, phenobarbital, rifampicin Pulmikort's action decreases, and in a combination with estrogen, methandrostenolone – increases.

Terms and storage conditions

To store at a temperature up to 30 °C in the place, unavailable to children.

Period of validity – 2 years.

After disturbance of tightness of an envelope containers are suitable for use 3 months, to protect from light influence. The opened container needs to be used within 12 hours.