Description
Release form
Metered-dose inhalation solution
Pharmacological action
Combined bronchodilator ((beta two – long-acting adrenergic agonist + m-anticholinergic drug)
Indications
The drug Spiolto Respimat taken 1 time / day, is indicated for
– long-term maintenance therapy for patients with COPD, chronic bronchitis, pulmonary emphysema,
– reduce airway obstruction and concomitant shortness of breath
– reduce the frequency of exacerbations improve exercise tolerance and quality of life.
Contraindications
– for patients with hypersensitivity to olodaterol, tiotropium bromide or to any component of the
drug – to patients who have previously been hypersensitive to atropine or its derivatives, for example ipratropium and
oxytropy – not recommended for use in children 18 years of age (not recommended in children performance and safety data).
Caution
In patients with acute-angle glaucoma, prostatic hyperplasia, and obstruction of the bladder neck.
In patients with cardiovascular disease, including coronary insufficiency, cardiac arrhythmias, prolongation of the QT interval, hypertrophic obstructive cardiomyopathy, arterial hypertension, thyrotoxicosis, seizures. Patients with a history of diseases such as myocardial infarction or hospitalization for heart failure (during the previous year), life-threatening arrhythmia, paroxysmal tachycardia with a heart rate> 100.
In patients with unusual reactions to sympathomimetic amines.
Pregnancy and lactation
There is no clinical data on the effects of olodaterol / tiotropium bromide on pregnancy. In preclinical studies using high doses of olodaterol, several times higher than therapeutic doses, the effects typical of beta2-adrenergic agonists have been established. The inhibitory effect of olodaterol on uterine contractility should be considered. Spiolto Respimat should not be used in pregnant women, unless the potential benefit to the mother does not exceed the potential risk to the fetus.
Clinical data on the use of olodaterol / tiotropium bromide in women who are breast-feeding is not. Spiolto Respimat should not be used in breast-feeding women, unless the potential benefit to the mother does not exceed the potential risk to the baby.
For the period of use of the drug, it is necessary to stop breast-feeding a child
Special instructions
The drug Spiolto Respimate should not be used for bronchial asthma. The efficacy and safety of the drug Spiolto Respimate in bronchial asthma have not been studied.
Acute bronchospasm
The drug Spiolto Respimat is not indicated for the treatment of acute episodes of bronchospasm, i.e. as an ambulance.
Hypersensitivity
After the use of Spiolto Respimat, immediate hypersensitivity reactions may develop.
Paradoxical bronchospasm
Use of the drug Spiolto Respimat, like other inhaled drugs, it can lead to paradoxical bronchospasm, sometimes life-threatening. In the case of the development of paradoxical bronchospasm, the use of the drug Spiolto Respimat should be immediately discontinued and alternative therapy prescribed.
Patients with impaired renal function
tiotropium bromide is excreted mainly by the kidneys, patients with moderate to severe renal insufficiency (CC
Visual disorders
Patients should be aware of the correct use of the drug Spiolto Respimat. Do not allow the solution or aerosol to get into the eyes. Pain or discomfort in the eyes fuzzy vision, visual halos around light sources in combination with redness of the eyes, conjunctival and corneal edema can be symptoms of acute angle-closure glaucoma. If any combination of these symptoms develops, you should immediately contact a specialist. Eye drops with a myotic effect are not considered an effective treatment.
Cardiovascular effects
Olodaterol, like other beta-adrenergic agonists, can have a clinically significant effect on the cardiovascular system in some patients (increased heart rate, increased blood pressure and / or the appearance of the corresponding symptoms). If such symptoms occur, discontinuation of treatment may be required. In addition, it was reported that beta2-adrenergic agonists led to ECG changes such as flattening of the T wave and ST segment depression, although the clinical significance of these changes is unknown.
Hypokalemia
Beta2-adrenergic agonists in some patients can lead to the development of hypokalemia, which creates the prerequisites for undesirable effects on the cardiovascular system. Decreased serum potassium concentrationovia is usually short-lived and does not require replenishment. In patients with severe COPD, hypokalemia may increase due to hypoxia and concomitant treatment and increase the risk of arrhythmias.
Hyperglycemia
Inhalation of high doses of beta2-adrenergic agonists can increase plasma glucose concentration.
Spiolto Respimate should not be used in combination with any other medication containing long-acting beta2-adrenergic agonists.
Patients often using short-acting inhaled beta2-adrenergic agonists (for example, 4 times / day) should be instructed that these drugs are used only to alleviate acute symptoms of bronchospasm.
Spiolto Respimat is intended for the supportive treatment of patients with COPD. Due to the fact that in the general population of COPD, patients older than 40 years predominate significantly. when prescribing the drug to patients younger than 40 years of age, spirometric confirmation of the diagnosis of COPD is required.
Influence of the drug on the ability to drive vehicles and mechanisms
No studies have been conducted to study the effect on the ability to drive vehicles and mechanisms. Caution should be exercised when performing these types of activities, as possible development of dizziness or blurred vision.
Dosage and administration
Recommended therapeutic dose is 2 inhalations of the spray from the Respimat inhaler (5 ?g / therapeutic dose of tiotropium bromide and 5 ?g / therapeutic dose of olodaterol) 1 time / day, at the same time of the day (see Instructions but application).
In elderly patients, you can use the drug Spiolto Respimat in the recommended dose.
In patients with mild to moderate hepatic insufficiency, you can use Spiolto Respimate in the recommended dose.
Data on the use of olodaterol in patients with severe hepatic insufficiency is not available.
In patients with impaired renal function, you can use the drug Spiolto Respimat in the recommended dose.
Patients with moderate to severe renal failure using Spiolto Respimat should be closely monitored by a physician.
Side effects
Infections and infestations: nasopharyngitis.
On the part of metabolism and nutrition: dehydration.
From the nervous system: dizziness, insomnia.
From the side of the organ of vision: increased intraocular pressure, glaucoma blurred vision.
From the cardiovascular system: atrial fibrillation, palpitations, tachycardia, supraventricular tachycardia, increased blood pressure.
On the part of the respiratory organ, chest and mediastinal organs: cough, nosebleeds, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis.
From the gastrointestinal tract: slight dry mouth, constipation, candidiasis of the oral cavity, dysphagia, gastroesophageal reflux, gingivitis, glossitis, stomatitis, intestinal obstruction, including paralytic intestinal obstruction.
From the skin: skin infections and ulcers on the skin, dry skin.
Allergic reactions: rash, itching, angioedema, urticaria, hypersensitivity, including immediate reactions.
Musculoskeletal system and related connective tissue diseases: arthralgia, swelling in the joints, back pain *.
From the kidneys and urinary system: dysuria, urinary retention (more often in men with predisposing factors), urinary tract infection.
Drug Interactions
Although no special studies of drug interactions have been conducted, tiotropium bromide has been used in conjunction with other drugs to treat COPD, including methylxanthines, steroids for oral administration and inhalation, with no clinical signs of drug interactions.
Long-term concomitant use of tiotropium bromide with other m-anticholinergic drugs has not been studied. Therefore, the long-term combined use of the drug Spiolto Respimate with other m-anticholinergic drugs is not recommended.
The simultaneous use of other adrenergic drugs may enhance the undesirable effects of the drug Spiolto Respimat.
The simultaneous use of xanthine derivatives, steroids or diuretics (not belonging to the group of potassium-sparing) can enhance the hypokalemic effect of adrenergic agonists.
Beta-blockers can weaken or counteract the effect of olodaterol. In this case, it is preferable to use run 1-blockers, although they should be used with caution.
MAO inhibitors, tricyclic antidepressants, or other drugs that can lengthen the QTc interval can enhance the effect of the drug Spiolto Respimat on the cardiovascular system.
The combined use of olodaterol with ketoconazole led to a 1.7-fold increase in systemic exposure to olodaterol. However, this did not affect safety. No dose changes are required.
An overdose of
An overdose of olodaterol can lead to pronounced effects typical of beta2-adrenergic agonists, for example, myocardial ischemia, increased or decreased blood pressure, tachycardia, arrhythmias, palpitations, dizziness, nervousness, sleepiness, insomnia, insomnia, and insomnia. in the mouth, muscle spasm, nausea, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.
When using high doses of tiotropium bromide, m-anticholinergic effects are possible. After a 14-day inhalation administration of tiotropium bromide in doses reaching 40 mcg, in healthy individuals there were no significant adverse events, in addition to a feeling of dryness of the mucous membranes of the nose and oropharynx, the frequency of which depended on the size of the dose (10-40 μg / day). The exception was a clear decrease in salivation, starting from the 7th day of drug administration.
Treatment
Taking Spiolto Respimate should be discontinued. Supportive and symptomatic treatment is indicated. In severe cases, hospitalization is necessary. The use of beta1-blockers may be recommended, but only with extreme caution, because the use of these drugs can cause bronchospasm.
Storage conditions
The product should be stored out of the reach of children at a temperature not exceeding 25 ° C. Expiration – 3 years. Use within 3 months after first inhalation.
Deystvuyuschee substances
Olodaterol, Tyotropyya bromide
Form of Treatment
simply entails dlya ingalyatsiy
Appointment of
Adult on prescription
Possible product names
Spiolto Respimat 2.5mkg + 2.5mkg / dose 4ml cartridges. 1 pc., With ing. Respimat No. 1
Beringer Ingelyhaym, Austria
