Symbicort Rapihaler, aerosol 80 mcg+4, 5 mcg/dose 120 doses

Indications

80/4.5 mcg/dose
Bronchial asthma, to achieve overall disease control, including prevention and relief of symptoms, and reducing the risk of exacerbations.
160/4.5 mcg/dose

Pharmacological effect

Pharmacotherapeutic group: combined bronchodilator (selective beta2-adrenergic agonist + local glucocorticosteroid)

ATX code: R03AK07

Pharmacological properties

Pharmacodynamics

Special instructions

Dosage Directions

If the symptoms of bronchial asthma are controllable, the dose of Symbicort® Turbuhaler® can be gradually reduced, and it is important to constantly monitor the patient’s condition. The lowest effective dose of Symbicort® Turbuhaler® should be prescribed (see section “Dosage and Administration”).

Patients are recommended to always carry emergency medications or Symbicort® Turbuhaler® (for patients with bronchial asthma using Symbicort® Turbuhaler® for the relief of attacks/symptoms with anti-inflammatory effects – therapy A or B), or short-acting beta2-agonists (for all patients using Symbicort® Turbuhaler® only for maintenance therapy – therapy C).

When using Symbicort® as maintenance therapy, the patient’s attention should be drawn to the need for regular use of a maintenance dose of the drug in accordance with the selected therapy, even in cases where there are no symptoms of the disease.

It is recommended to instruct the patient to rinse the mouth with water after inhaling maintenance doses in order to prevent the risk of developing candidiasis of the oral and pharyngeal mucosa. It is also necessary to rinse your mouth with water after inhalation on demand in case of development of candidiasis of the oral mucosa and pharynx.

It is recommended to gradually reduce the maintenance dose of the drug before stopping treatment and it is not recommended to abruptly discontinue treatment. Inhaled glucocorticosteroids should not be completely discontinued, except in cases where temporary withdrawal is necessary to confirm the diagnosis of bronchial asthma.

Symbicort® Turbuhaler® 80/4.5 mcg/dose is not intended for patients with mild to severe bronchial asthma.

Increased symptoms of the disease

During therapy with Symbicort® Turbuhaler®, exacerbations and the development of serious adverse events associated with bronchial asthma may occur. Patients should continue treatment but seek medical attention if asthma symptoms are not controlled or if symptoms worsen after starting therapy.

If therapy is insufficiently effective or the maximum recommended doses of Symbicort® are exceeded, it is necessary to reconsider treatment tactics. Sudden and progressive deterioration in control of symptoms of asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, you should consider increasing the dose of glucocorticosteroids, for example, prescribing a course of oral glucocorticosteroids, or treatment with antibiotics in case of infection. In case of severe exacerbation, monotherapy with a combination of an inhaled glucocorticosteroid and a long-acting beta2-adrenergic agonist is not enough.

Transfer from oral therapy

If there is reason to believe that adrenal function has been impaired due to previous systemic glucocorticosteroid therapy, precautions should be taken when transferring patients to treatment with Symbicort®.

The benefits of inhaled budesonide therapy generally minimize the need for oral corticosteroids, but patients who discontinue oral corticosteroid therapy may experience long-term adrenal insufficiency. Patients who have previously required acute high-dose corticosteroids or have received long-term treatment with high-dose inhaled corticosteroids may also be at risk. It is necessary to provide additional administration of glucocorticosteroids during periods of stress or surgery. Excipients

Symbicort® Turbuhaler® contains lactose (< 1 mg/inhalation). Typically this amount does not cause problems in patients with lactose intolerance.

Precautions for specific diseases

Precautions should be taken when treating patients with a prolonged QTc interval. Taking formoterol may cause a prolongation of the QTc interval.

When beta2-agonists are used together with drugs that can cause or enhance the hypokalemic effect, for example, xanthine derivatives, steroids or diuretics, the hypokalemic effect of beta2-agonists may be enhanced. Special precautions should be taken in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve attacks during exacerbation of severe bronchial asthma, since the risk of developing hypokalemia increases against the background of hypoxia and in other conditions when the likelihood of developing a hypokalemic effect increases. In such cases, it is recommended to monitor serum potassium levels.

During treatment, blood glucose concentrations should be monitored in patients with diabetes mellitus.

The need for the use and dose of inhaled glucocorticosteroids should be reconsidered in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system.

Systemic action

Systemic effects may occur when using any inhaled glucocorticosteroids, especially when using high doses of drugs over a long period of time. Systemic effects are less likely to occur with inhaled therapy than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma.

Due to the potential effect of inhaled corticosteroids on bone mineral density, special attention should be paid to patients taking high doses of the drug for a long period with risk factors for osteoporosis. Studies of long-term use of inhaled budesonide in children at an average daily dose of 400 mcg (metered dose) or adults at a daily dose of 800 mcg (metered dose) did not show a significant effect on bone mineral density. There is no data on the effect of high doses of Symbicort® Turbuhaler® on bone mineral density.

Paradoxical bronchospasm

As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. In this regard, therapy with Symbicort® should be discontinued, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed.

Pediatric patient population

It is recommended to regularly monitor the growth of children receiving long-term inhaled glucocorticosteroid therapy. In case of established growth retardation, therapy should be reconsidered in order to reduce the dose of inhaled glucocorticosteroid. It is necessary to carefully evaluate the ratio of the benefits of glucocorticosteroid therapy to the possible risk of growth retardation. When choosing therapy, it is recommended to consult a pediatric pulmonologist.

Based on limited data from studies of long-term corticosteroid use, it can be assumed that most children and adolescents treated with inhaled budesonide will eventually achieve normal adult height. However, minor short-term growth retardation has been reported, mainly in the first year of treatment.

Population of patients with COPD

Data from clinical studies of the drug Symbicort® Turbuhaler® in patients with COPD with pre-bronchodilator FEV1 > 50% of predicted and with post-bronchodilator FEV1 < 70% of predicted are not available (see section “Pharmacodynamics”).

Clinical studies and meta-analyses have shown that the use of inhaled corticosteroids during maintenance treatment of COPD may lead to an increased risk of pneumonia. Clinicians should be aware of the possibility of pneumonia in patients with COPD, since the clinical signs of pneumonia and exacerbation of the disease often overlap.

Effect on the ability to drive vehicles and machines Symbicort® Turbuhaler® does not affect the ability to drive vehicles and machines. May affect the ability to drive vehicles and machinery if side effects develop.

Active ingredient

Budesonide, Formoterol

Composition

Each dose delivered contains:

80/4.5 mcg/dose

Pregnancy

There are no clinical data on the use of Symbicort® or the combined use of formoterol and budesonide during pregnancy.
During pregnancy, Symbicort® should be used only in cases where the benefit of the drug outweighs the potential risk to the fetus. The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used.
Inhaled budesonide is excreted in breast milk, however, when used in therapeutic doses, no effects on the child were noted. It is not known whether formoterol passes into women’s breast milk. Symbicort® should only be prescribed to breastfeeding women if the expected benefit to the mother is greater than any possible risk to the baby.

Contraindications

• Hypersensitivity to budesonide, formoterol or inhaled lactose.
• Children under 6 years of age.
• Lactose intolerance, lactase deficiency or glucose-galactose malabsorption (see section “Special instructions”).

With caution: pulmonary tuberculosis (active or inactive form); fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, decreased function of the adrenal cortex, uncontrolled hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any location or other severe cardiovascular diseases (coronary heart disease, tachyarrhythmia or severe heart failure), prolongation of the QT interval (taking formoterol may cause prolongation of the QTc interval).

Side Effects

With the combined use of budesonide and formoterol, there was no increase in the incidence of adverse reactions. The most common adverse reactions associated with the use of the drug are such pharmacologically expected adverse events for b2-adrenergic agonists, such as tremor and palpitations; symptoms are usually of moderate severity and resolve on their own within a few days after starting treatment.

Adverse reactions associated with the use of budesonide or formoterol are listed below by organ system class and incidence. The frequency of reactions is presented in the following gradation: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (<1/10000).

Infections and infestations: often – candidiasis of the oral mucosa and pharynx, pneumonia (in patients with COPD)

Immune system disorders: rarely – immediate and delayed hypersensitivity reactions (for example, dermatitis, exanthema, urticaria, pruritus, angioedema, anaphylactic reaction)

Metabolic and nutritional disorders: rarely – hypokalemia; very rarely – hyperglycemia, signs or symptoms of systemic effects of glucocorticosteroids (including adrenal hypofunction)

Mental disorders: infrequently – psychomotor agitation, anxiety, sleep disturbances; very rarely – depression, behavioral disorders (mainly in children)

Nervous system disorders: often – headache, tremor; infrequently – dizziness; very rarely – taste disturbances

Disorders of the heart and blood vessels: often – palpitations; infrequently – tachycardia; rarely – arrhythmia (for example, atrial fibrillation, supraventricular tachycardia, extrasystole); very rarely – angina pectoris, blood pressure fluctuations

Disorders of the respiratory system, chest and mediastinal organs: often – cough, hoarseness, mild irritation of the pharyngeal mucosa; rarely – bronchospasm

Gastrointestinal disorders: uncommon – nausea

Skin and subcutaneous tissue disorders: uncommon – bruising

Musculoskeletal and connective tissue disorders: uncommon – muscle cramps

Systemic effects of inhaled corticosteroids may occur when high doses are used over a long period of time.

The use of b2-adrenergic agonists can lead to an increase in the blood levels of insulin, free fatty acids, glycerol and ketone bodies.

Interaction

Taking ketoconazole 200 mg once daily increased the plasma concentration of budesonide (single oral dose of 3 mg) when administered together by an average of 6-fold. When using ketoconazole 12 hours after taking budesonide, the plasma concentration of the latter increased, on average, 3 times. There is no information about such an interaction with inhaled budesonide, however, a noticeable increase in the concentration of the drug in the blood plasma should be expected. Since there are no data for dosage recommendations, the combination of drugs described above should be avoided. If this is not possible, the time interval between the use of ketoconazole and budesonide should be increased as much as possible. A dose reduction of budesonide should also be considered. Other strong CYP3A4 inhibitors are also likely to significantly increase budesonide plasma concentrations. Symbicort® for the relief of attacks/symptoms with anti-inflammatory effects is not recommended in patients receiving strong CYP3A4 inhibitors.

β-adrenergic receptor blockers may weaken the effect of formoterol. Symbicort® should not be prescribed simultaneously with beta-blockers (including eye drops), except in cases of emergency.

Concomitant use of Symbicort® Turbuhaler® and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants may prolong the QTc interval and increase the risk of ventricular arrhythmias.

In addition, levodopa, levothyroxine, oxytocin and alcohol can reduce the tolerance of the heart muscle to b2-agonists.

The combined use of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, may cause an increase in blood pressure. There is an increased risk of developing arrhythmias in patients undergoing general anesthesia with halogenated hydrocarbon preparations.

When taking Symbicort® Turbuhaler® and other b-adrenergic drugs together, the side effects of formoterol may be increased.

As a result of the use of beta2-agonists, hypokalemia may occur, which may be exacerbated by concomitant treatment with xanthine derivatives, mineral derivatives of glucocorticosteroids or diuretics. Hypokalemia may increase the susceptibility to the development of arrhythmias in patients taking cardiac glycosides.

There were no interactions of budesonide and formoterol with other drugs used to treat bronchial asthma.

Overdose

Symptoms of formoterol overdose: tremor, headache, rapid heartbeat. In isolated cases, the development of tachycardia, hyperglycemia, hypokalemia, prolongation of the QTc interval, arrhythmia, nausea and vomiting was reported. Can be assigned
supportive and symptomatic treatment. The use of formoterol at a dose of 90 mcg for 3 hours in patients with acute bronchial obstruction was safe.
If it is necessary to discontinue the drug Symbicort® Turbuhaler® due to an overdose of formoterol, which is part of the combination drug, you should consider prescribing an appropriate glucocorticosteroid.
In case of acute overdose of budesonide, even in significant doses, no clinically significant effects are expected. With chronic use of excessive doses, systemic effects of glucocorticosteroids, such as hypercortisolism and suppression of adrenal function, may occur.

Storage conditions

At temperatures below 30 C, in places inaccessible to children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

AstraZeneca Dunkirk Production, France