Symbicort Turbuhaler 160mcg/4.5mcg 60doses

Symbicort Turbuhaler instruction

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Composition

One dose of Symbicort Turbuhaler includes 320 μg of micronized budesonide and 9 μg of formoterol fumarate dihydrate, or 160 μg of micronized budesonide and 4.5 μg of formoterol fumarate dihydrate, or 80 μg of micronized budesonide and 4.5 μg of formoterol fumarate dihydrate.
Additional components: lactose monohydrate.

Form of issue

Powder intended for inhalation in the form of white granules of round shape.
60 doses (for all dosages) of such a powder in a plastic inhaler "turbuhaler", one such inhaler in a pack of cardboard.
120 doses (for doses of 80 / 4.5 mcg and 160 / 4.5 mcg) of such a powder in a plastic turbuhaler inhaler, one such inhaler in a pack of cardboard.

pharmachologic effect

Anti-inflammatory, bronchodilator.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

A two-component agent for the therapy of bronchial asthma. INN is not available. Includes budesonide and formoterol, which have a different effect and exhibit an interacting effect in reducing the incidence of asthma attacks.
Budesonide is a glucocorticosteroid that has a dose-dependent and rapid anti-inflammatory effect on the respiratory tract, decreasing the severity of symptoms and the frequency of attacks of bronchial asthma. When using inhalations of budesonide, there is a reduced incidence of serious adverse effects than with the use of systemic glucocorticosteroids. It reduces the swelling of the bronchial mucosa, the secretion of mucus, sputum.
Formoterol is the second component, the selective stimulator of β2-adrenergic receptors. Causes rapid and long-term relaxation of smooth muscles of the bronchi in patients with reversible narrowing of the airway lumen. This action is dose-dependent and occurs 2-3 minutes after inhalation and lasts a minimum of 12 hours.
When combined use of formoterol and budesonide, the signs of bronchial asthma decrease, the function of the lungs is stimulated and the frequency of attacks of the disease decreases. The drug is well tolerated by patients.

Pharmacokinetics

Studies have not revealed evidence of interaction between budesonide and formoterol. Inhaled budesonide is actively absorbed and reaches its maximum concentration after 30 minutes. Bioavailability is 49%. Pharmacokinetics in children 6-16 years old and in adult patients is not different.
Inhaled formoterol is also actively absorbed after inhalation and reaches its maximum concentration after 10 minutes. Systemic bioavailability - 61%. The binding with plasma proteins of formoterol is 50%, budesonide - about 90%.
Budesonide undergoes active biotransformation during the "first passage" through the liver with the synthesis of metabolites with weak hormonal activity.
Formoterol is metabolized in the liver by a conjugation method with the formation of active metabolites. Budesonide is excreted by the kidneys in the form of metabolites and only in a small amount - in its original form.
After applying up to 13% of the delivered amount of formoterol is excreted in its original form by the kidneys. The half-life is 17 hours.

Indications for use

    Chronic obstructive pulmonary disease (symptomatic therapy in persons with severe disease and with recurrences of exacerbations in the anamnesis and with severe symptoms, despite treatment with extended-action bronchodilators).
    Bronchial asthma (poorly controlled by the use of inhaled glucocorticosteroids and beta2-adrenomimetics of short-term action or well controlled by inhaled glucocorticosteroids and long-acting beta2-adrenomimetics).

Contraindications

    Age to 6 years (for all forms of release).
    Age to 12 years (for forms of release 320/9 mkg).
    Sensitization to formoterol, budesonide or inhaled lactose.
Caution should be used in patients with pulmonary tuberculosis; with viral, bacterial or fungal infections of the respiratory system; with thyrotoxicosis, diabetes mellitus, pheochromocytoma, hypokalemia, severe arterial hypertension, aneurysm or cardiovascular diseases of severe severity.

Side effects

    Reactions from the central nervous system: nausea, headache, anxiety, psychomotor agitation, depression, sleep disorders, taste disorders.
    Reactions from the circulatory system: atrial fibrillation, tachycardia, extrasystole, angina pectoris, pressure changes.
    Reactions from the musculoskeletal system: convulsions, tremor.
    Response from the respiratory system: mild irritation in the throat, candidiasis of the mucous membranes of the mouth and pharynx, hoarseness, cough, bronchospasm.
    Dermatological reactions: exanthema, itching, bruising, dermatitis.
    Allergic reactions: Quincke's edema, hives, anaphylactic reactions.
    Metabolic disorders: hyperglycemia, hypokalemia, symptoms of the generalized action of glucocorticosteroids.

Instructions for use Symbicort Turbuhaler (Method and dosage)

Instructions for use Symbicort Turbuhaler indicates that this drug does not serve for initial therapy of bronchial asthma of mild severity.
The dose is selected individually, given the severity of the disease.

Bronchial asthma

Patients taking the drug should be examined regularly by the doctor who prescribes the drug so that the dosage remains optimal.
Recommended doses. Adults (from 18 years old) can produce up to two inhalations twice a day. Some patients may need up to four inhalations twice a day. Children (12-17 years) should also use up to two inhalations twice a day.
After controlling the symptoms of asthma, the dose is selected to the lowest effective, up to the use of the medication once a day. Children (6-12 years old) use the dosage form with the lowest dosage to two inhalations twice a day.
Chronic obstructive pulmonary disease
The recommended adult dose is two inhalations twice a day.

Overdose

Symptoms: oppression of adrenal function, tremor, hypercortisy, heart palpitations, headache, hyperglycemia, hypokalemia, arrhythmia, nausea.
Treatment is symptomatic.

Interaction

Beta-adrenoblockers weaken the action of formoterol.
When combined with disopyramide, quinidine, procainamide, antihistamines, phenothiazines, MAO inhibitors and tricyclic antidepressants, the risk of ventricular arrhythmia increases.
L-thyroxine, L-dopa, oxytocin and ethyl alcohol can worsen the cardiovascular tolerance of beta-2-sympathomimetics.
The joint use of MAO inhibitors, furazolidone and procarbazine can cause allergic reactions.

Storage conditions

Observe the temperature regime up to 30 degrees. Keep away from children.
Shelf life - two years.

special instructions

Does not affect the ability to drive a car.

Children

It is forbidden to take the drug for children under 6 years, and the dosage form 320/9 μg for children under 12 years.

During pregnancy (and lactation)

It is possible to use it in the presence of strict indications and on the prescription of a doctor.

Reviews of Symbicort Turbuhaler

Reviews of Symbicort on forums on the Internet and doctors' reviews indicate that this drug helps many people cope with bouts of asthma and significantly improve the quality of life.