Spiolto Respimat inhaler: instructions for use

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Spiolto Respimat inhaler (Spiolto® Respimat®) is manufactured in Germany. It is a mobile device for inhalation in emergency situations when bronchial or pulmonary spasm occurs. It consists of a can with a spray, a replaceable cartridge, inside of which there is a medicine. The Spiolto inhaler is used to eliminate spasms and prevent them when exposed to provocateurs.

Release form and composition

Dosage form - dosed solution for inhalation: almost colorless or colorless, transparent (in a cardboard box there is 1 cartridge of 4.5 ml, containing 60 inhalation doses, which corresponds to 30 therapeutic doses, the kit includes a Respimat inhaler and instructions for use of Spiolto Respimat).

Active substances in 1 dose:

• olodaterol – 2.5 mcg (olodaterol hydrochloride – 2.736 mcg);
• tiotropium bromide – 2.5 mcg (tiotropium bromide monohydrate – 3.124 mcg).

Auxiliary components: disodium edetate, benzalkonium chloride solution, hydrochloric acid 1M (up to pH 2.9), purified water.

What does it consist of?

This medication is a combination medication. The main active ingredients of the inhaler are olodapterol hydrochloride and tiotropium bromide. Both belong to the class of bronchodilators and serve to expand the lumen of the lungs and increase the amount of air entering them. In most cases, they are used together and complement each other's action.

In their pure form they are a white powder, but for use in an inhaler they are diluted to obtain a colorless liquid using the following components:

• an aqueous solution of non-concentrated hydrochloric acid;
• benzalkonium chloride – antiseptic
• distilled water to reduce concentration
• disodium edetate is an anticoagulant to improve drug absorption.

The composition does not contain hazardous substances or antibiotics, which greatly expands the range of applications.

Pharmacological properties

Pharmacodynamics

Spiolto Respimat is a combination bronchodilator. Olodaterol is a long-acting β2-adrenergic agonist, tiotropium bromide is an m-anticholinergic blocker. When used in combination, the active components of Spiolto Respimat provide complementary bronchodilation, which occurs due to their different mechanism of action and different localization of target receptors in the lungs.

Olodaterol has high affinity and selectivity for β2-adrenergic receptors. Due to the activation of β2-adrenergic receptors in the respiratory tract, intracellular adenylate cyclase is stimulated, which takes part in the biosynthesis of cAMP (cyclic 3,5-adenosine monophosphate). With an increase in cAMP levels, bronchodilation is observed and, as a consequence, relaxation of the smooth muscle cells of the respiratory tract. Olodaterol is a selective long-acting β2-adrenergic receptor agonist, which is characterized by a rapid onset of action and long-term (at least 24 hours) retention of the effect. β2-adrenergic receptors are not only found in smooth muscle cells, but are also present in many other cells, including endothelial and epithelial cells of the heart and lungs. The exact function of β2 receptors in the heart is still not fully understood, but their presence indicates that even highly selective beta2-adrenergic agonists can affect the heart.

Tiotropium bromide is a long-acting m-anticholinergic blocker that has equal affinity for the M1–M5 subtypes of muscarinic receptors. As a result of inhibition of M3-cholinergic receptors in the airways, smooth muscles relax. The bronchodilator effect is determined by the dose and lasts for at least 24 hours. It is assumed that the significant duration of exposure to the substance is based on the very slow dissociation of the drug from M3-cholinergic receptors: the half-life of tiotropium bromide significantly exceeds the value of this indicator for ipratropium bromide. As an N-quaternary ammonium derivative, tiotropium bromide, when administered by inhalation, has a local selective effect (on the bronchi), while when used in therapeutic doses, the development of systemic m-anticholinergic adverse reactions does not occur. Dissociation from M2 cholinergic receptors occurs more quickly than from M3 cholinergic receptors, which suggests a predominance of selectivity for the M3 cholinergic receptor subtype over M2 cholinergic receptors. The long-lasting and pronounced bronchodilator effect in patients with COPD (chronic obstructive pulmonary disease) is due to the slow dissociation of the substance from the receptors and high affinity for the receptors. The bronchodilation that develops after inhalation of tiotropium bromide is based primarily on local (on the respiratory tract) rather than systemic action.

During clinical studies, it was found that the use of Spiolto Respimat once a day in the morning leads to a rapid (within 5 minutes after the first dose) improvement in lung function. The effect of therapy exceeded the effect of using 5 mcg of tiotropium bromide and 5 mcg of olodaterol, used as monotherapy, the FEV1 value (forced expiratory volume in the first second of the forced expiratory maneuver): Spiolto Respimat - by 0.137 l; tiotropium bromide – by 0.058 l; olodaterol – by 0.125 l.

During therapy with Spiolto Respimat, in comparison with the use of tiotropium bromide and olodaterol in the form of monotherapy, a more significant bronchodilator effect is achieved, and the peak volumetric expiratory flow rate increases both in the morning and evening hours.

Compared with placebo, the use of Spiolto Respimat leads to a reduced risk of exacerbations of COPD.

Spiolto Respimat significantly improves inspiratory capacity compared with tiotropium bromide, olodaterol or placebo alone. The drug also significantly improves exercise tolerance time compared to placebo.

Pharmacokinetics

The pharmacokinetic parameters of Spiolto Respimat are equivalent to those of olodaterol and tiotropium bromide used separately.

The active components of the drug are characterized by linear pharmacokinetics.

Steady state pharmacokinetics of olodaterol is achieved within 8 days when administered once a day, and the degree of exposure increases compared to a single dose by 1.8 times. When administered once daily, steady state pharmacokinetics of tiotropium bromide is achieved within 7 days.

Olodaterol

The substance is rapidly absorbed, Cmax (maximum concentration of the substance) in plasma after inhalation is usually reached within 10–20 minutes. Absolute bioavailability in healthy volunteers after inhalation is approximately 30%, while when taken orally as a solution, it is less than 1%. Thus, after inhaled administration, the systemic exposure of olodaterol is primarily through pulmonary absorption, and the ingested portion of the dose does not significantly influence the systemic exposure.

The level of binding of olodaterol to plasma proteins is about 60%, Vd (volume of distribution) is 1110 l.

The substance is metabolized to a large extent by direct glucuronidation and O-demethylation followed by conjugation. 6 metabolites have been identified, of which only one unconjugated demethylated derivative binds to β2-adrenergic receptors (SOM 1522). This metabolite is not detected in plasma after prolonged inhaled use of olodaterol at the recommended therapeutic dose or at doses 4 times higher than the therapeutic dose. Cytochrome P450 takes part in O-demethylation of the substance (isoenzymes CYP2C9, CYP2C8, and also to a small extent CYP3A4), in the process of formation of olodaterol glucuronides - isoforms of uridine diphosphate glycosyl transferase, UGT1A1, UGT2B7, 1A7 and 1A9.

In healthy volunteers, the renal clearance of olodaterol is 173 ml/min, and the total clearance is 872 ml/min. The final T1/2 (half-life) after intravenous administration of the substance is 22 hours, while the value of this indicator after inhalation use is about 45 hours. Thus, excretion in the latter case depends more on absorption.

The total isotopically labeled dose of olodaterol that is excreted by the kidneys (including all metabolites of the parent compound) is: intravenous administration - 38%, oral administration - 9%. The total isotope-labeled dose of unchanged substance excreted by the kidneys after intravenous administration is 19%. The total isotope-labeled dose released through the intestines is: intravenous administration - 53%, oral administration - 84%.

More than 90% of the dose of olodaterol after intravenous administration is eliminated in 5 days, after oral administration - in 6 days. After inhalation administration, renal excretion of unchanged substance during the dosing interval in healthy volunteers during the period of steady-state pharmacokinetics is 5-7% of the dose.

Tiotropium bromide

After inhalation, approximately 33% of the inhalation dose enters the systemic circulation. Absolute bioavailability after oral administration is 2–3%. The time to reach Cmax in plasma after inhalation is 5–7 minutes.

The level of binding of the substance to plasma proteins is 72%, Vd is 32 l/kg. Preclinical studies have shown that tiotropium bromide does not penetrate the blood-brain barrier.

Tiotropium bromide is biotransformed to an insignificant extent. This is confirmed by the fact that the substance, after intravenous administration, is excreted unchanged by the kidneys. Tiotropium bromide is an ester that splits into dithienylglycolic acid and ethanol-N-methylscopine; these compounds do not bind to muscarinic receptors.

Studies have shown that some part of the dose (after intravenous administration - less than 20% of the dose) is metabolized by oxidation by cytochrome P450 (CYP3A4 and CYP2D6), after which conjugation with glutathione occurs and the formation of various metabolites.

After intravenous administration, the substance is excreted mainly by the kidneys unchanged (74%), the total clearance in young healthy volunteers is 880 ml/min. In patients with COPD, after inhalation of the solution, renal excretion is 0.93 mcg (18.6%), excretion of the remaining unabsorbed portion occurs through the intestine. The renal clearance of tiotropium bromide is higher than CC (creatinine clearance), which is evidence of its tubular secretion. Terminal T1/2 of the substance after inhalation ranges from 27 to 45 hours.

Pharmacokinetics in special clinical situations

In clinical studies, it was found that, despite the influence of weight, age and gender on the systemic exposure of olodaterol, no dose adjustment is required.

In elderly patients with COPD, a decrease in the renal clearance of tiotropium is observed: up to 65 years - 347 ml/min, from 65 years - 275 ml/min. At the same time, this does not lead to an increase in the values ​​of the concentration of the substance (Cmax, ss) and the area under the concentration-time curve (AUC0-6, ss).

In severe renal failure (in patients with creatinine clearance <30 ml/min), the systemic exposure of olodaterol increases by an average of 1.4 times. Given the experience gained with olodaterol in clinical trials, this increased exposure does not raise safety concerns.

During the period of steady state after inhaled administration of tiotropium once a day in patients with COPD and mild renal failure (with CC 50–80 ml/min), an increase in AUC0-6,ss values ​​by 1.8–30% and Cmax,ss is noted compared with patients with no impairment of renal function (with CC > 80 ml/min). In patients with COPD and moderate to severe renal failure (with creatinine clearance <50 ml/min), intravenous use of tiotropium bromide results in a twofold increase in the total exposure of the substance (the AUC0-4 value increases by 82%, and the Cmax value increases by 52%) in compared with patients without impaired renal function. A similar increase in plasma concentration is observed after inhalation of dry powder.

In mild to moderate liver failure, the systemic effect of olodaterol does not change; in severe liver failure, it has not been studied. Liver failure presumably does not have a significant effect on the pharmacokinetics of tiotropium bromide, since tiotropium bromide is excreted primarily by the kidneys and by non-enzymatic cleavage of the ester bond to form derivatives that do not have pharmacological activity.

Efficiency

Spiolto Respimat is an inhaler (the price of the drug is justified by its effectiveness in combating diseases of the lower respiratory tract, characterized by inflammation of the mucous membrane of the bronchi running from the trachea to the pulmonary alveoli), which within 5 minutes. after 1 dose, significantly improves lung function.

The drug helps to achieve a positive bronchodilator effect, as well as increase the peak volumetric expiratory flow rate in the morning and evening hours. With regular use, the inhaler significantly reduces the risk of exacerbations in patients with chronic obstructive pulmonary disease.

Spiolto Respimat improves inspiratory capacity, allowing the body to cope much better with grueling physical activity. The active components of the drug are characterized by linear pharmacokinetics.

A positive therapeutic effect can only be achieved if you strictly adhere to the recommendations of the pulmonologist, without deviating from the prescribed dosage and number of inhalations.

Making independent changes to the therapeutic course leads to irreversible consequences, which can lead to a severe allergic reaction and suffocation.

Contraindications

Absolute:

• age under 18 years;
• lactation period;
• individual intolerance to the components of the drug, as well as the presence of hypersensitivity to atropine/its derivatives, including ipratropium and oxitropium.

Relative (Spiolto Respimat is prescribed under medical supervision):

• cardiovascular diseases, including coronary insufficiency, heart rhythm disturbances, prolongation of the QT interval, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, arterial hypertension, seizures;
• aggravated history of myocardial infarction or hospitalization for heart failure (over the previous 12 months), life-threatening arrhythmia, paroxysmal tachycardia with a heart rate > 100 beats/min;
• angle-closure glaucoma;
• unusual reactions to sympathomimetic amines;
• prostatic hyperplasia and bladder neck obstruction;
• pregnancy.

Conditions for dispensing from pharmacies

By doctor's prescription.

Name and address of the legal entity in whose name the registration certificate was issued

Boehringer Ingelhanm International GmbH

Binger Strasse 173, 55216 Ingelheim am Rhein. Germany

Name and address of the place of production of the medicinal product

Boehringer Ingelhanm Pharma GmbH & Co.KG

Binger Strasse 173. 55216 Ingelheim am Rhein. Germany

You can obtain additional information about the drug, as well as send your complaints and information about adverse events to the following address in Russia

Berppger Ingelhanm LLC

125171, Moscow, Leningradskoe shosse, 16A building 3

Spiolto Respimat, instructions for use: method and dosage

Spiolto Respimat is intended for inhalation use, preferably at the same time of day.

The recommended therapeutic dose is 2 inhalations of the Respimat inhaler spray once a day.

Rules for using the inhaler

The inhaler is intended for use once a day. Each time you use it, you should take 2 inhalations.

To prepare for first use, please complete the following steps:

1. Remove the transparent sleeve by pressing the locking button and pulling firmly on the transparent sleeve with your other hand.
2. Insert the cartridge into the inhaler with the narrow end; to do this, you need to place the inhaler with the bottom of the cartridge on a hard surface and press it firmly, the cartridge is put into place with a click.
3. Place the transparent sleeve in place (until it clicks).
4. Turn the clear sleeve in the direction indicated by the arrows on the label until you hear a click (half a turn is required).
5. Open the cap all the way.
6. Press the dose button while pointing the inhaler down.
7. Close the cap and repeat steps 4–6 until a cloud of aerosol appears. After this, repeat steps 4–6 three more times.

If used daily, follow steps 4-5. Then a full, slow exhalation is performed, the lips are wrapped around the mouthpiece, and care must be taken to ensure that the air intakes do not overlap. Simultaneously with a slow, deep breath through the mouth, press the dose button without interrupting the inhalation. After this, hold your breath for about 10 seconds or as long as possible. The second inhalation is performed in the same way.

Daily checking of the inhaler after preparing it for use is not required.

The inhaler should be kept out of the reach of children and not frozen.

If the inhaler has not been used for more than 7 days, before use, you must point it down and press the dose button once. If the break exceeds 21 days, you need to repeat steps 4–6 until a cloud of aerosol appears, and then repeat them three more times.

Do not touch the piercing element located inside the transparent sleeve.

The mouthpiece, including the metal part inside it, is cleaned with a damp cloth or cloth at least once every 7 days.

Any slight change in the color of the mouthpiece does not affect the operation of the inhaler.

The inhaler contains 60 inhalation doses (i.e., if used in accordance with the dosage regimen, 30 therapeutic doses).

The dose indicator shows the approximate number of doses remaining in the inhaler. If the indicator points to the red area of ​​the scale, this means that there is approximately 7 days of use left of the drug. After reaching the end of the red area of ​​the scale, the inhaler is automatically locked (it will be impossible to turn the transparent sleeve), therefore, no more inhalation doses can be received.

The inhaler can be used for no longer than three months, even if there is medication left in it. At the end of this period it should be thrown away.

If you accidentally turn the transparent sleeve before installing the cartridge, you must open the cap and press the dose button, then install the cartridge with the narrow end.

If you cannot press the dose button, you should check whether the transparent sleeve has been turned or whether the inhaler has run out of drug.

It must be taken into account that the dose indicator counts each turn of the transparent sleeve, regardless of whether the cartridge has been installed.

Do not remove the transparent sleeve or remove the cartridge after preparing the inhaler for use.

For what diseases is it prescribed?

Doctors prescribe Spiolto Respimat to patients if they require long-term maintenance therapy for the development of COPD, chronic bronchitis and emphysema - all this allows them to achieve the following therapeutic effect on the body:

• decreased frequency of exacerbations;
• quick relief of spasms;
• reduction of respiratory obstruction;
• prevention of frequently developing shortness of breath;
• improving the tolerance of stress on the body, which requires changing the breathing rhythm;
• normalization of quality of life and respiratory health.

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Doctors say that this effect of the drug can be achieved only if, when using it, you strictly follow the instructions and observe the dosage. Otherwise, the use of the inhaler will not be able to provide a comprehensive therapeutic effect and restore the patient’s health.

Side effects

Adverse reactions identified during clinical trials of Spiolto Respimat (> 10% - very often; > 1% and < 10% - often; > 0.1% and < 1% - uncommon; > 0.01% and < 0.1 % – rare; <0.01% – very rare; with unknown frequency – it is not possible to establish the frequency of occurrence of undesirable effects):

• nervous system: infrequently – insomnia, dizziness;
• respiratory system: infrequently – dysphonia, cough; rarely – pharyngitis, laryngitis, nosebleeds; with an unknown frequency – sinusitis, bronchospasm;
• cardiovascular system: uncommon – palpitations, atrial fibrillation, tachycardia, increased blood pressure; rarely - supraventricular tachycardia;
• digestive system: often – xerostomia (usually minor); infrequently – constipation; rarely – gingivitis, oral candidiasis; with an unknown frequency - intestinal obstruction, including paralytic intestinal obstruction, gastroesophageal reflux, stomatitis, glossitis, dysphagia;
• musculoskeletal system: rarely – back pain, arthralgia; with an unknown frequency - swelling in the joints;
• kidneys and urinary system: rarely - urinary retention (more common in men with predisposing factors), urinary tract infection, dysuria;
• skin and subcutaneous tissues: with unknown frequency - dry skin, skin infections and skin ulcers;
• organ of vision: rarely – blurred vision; with an unknown frequency - glaucoma, increased intraocular pressure;
• infectious and parasitic diseases: rarely – nasopharyngitis;
• allergic reactions: rarely - hypersensitivity (including immediate reactions), urticaria, angioedema, itching; with an unknown frequency - rash;
• metabolism: with unknown frequency - dehydration.

Many of these disorders are related to the anticholinergic properties of tiotropium bromide or the β-adrenomimetic properties of olodaterol. Therefore, it is necessary to take into account the likelihood of developing undesirable effects that are characteristic of the entire class of β-agonists, including arrhythmia, angina pectoris, myocardial ischemia, hypotension, tremor, nervousness, headache, nausea, muscle cramps, malaise, fatigue, metabolic acidosis, hypokalemia and hyperglycemia .

Possible harm and side effects

The drug Spiolto Respimat is well tolerated by patients in 98% of cases.

Only in isolated situations does the drug provoke the following adverse reactions:

• Central nervous system: dizziness, migraine, sleep disturbance.
• Musculoskeletal system: body aches, swelling of the limbs, joint pain.
• Respiratory system: coughing fits, change in voice, inflammation of the larynx, pharynx or sinuses.
• Visual apparatus: temporary decrease in visual acuity, dry cornea.
• Cardiovascular system: increased blood pressure, arrhythmia, coronary heart disease.
• Skin: increased dryness of the epithelium, rashes, itching and burning of the skin.
• Genitourinary system: impaired urine outflow, development of bladder infections.
• Gastrointestinal tract: dry mouth, dyspepsia, aching pain in the epigastric region, increased stomach acidity, oral candidiasis, dehydration.

Spiolto Respimat
An independent increase in the number of inhalations can provoke the occurrence of adverse reactions that can worsen not only the well-being, but also the quality of life of the patient. If the patient misuses the inhaler or regularly exceeds the recommended dosage, then the following symptoms of overdose may occur:

• Attacks of acute pain in the heart, which is associated with deterioration of blood flow in the myocardium.
• Confusion of consciousness.
• Discoordination.
• Sudden increase or decrease in blood pressure readings.
• Tachycardia.
• General malaise.
• Hand tremors.
• Increased irritability.
• Insomnia.
• Vomit.
• Abnormal stool.
• Increased body temperature.

To normalize the condition, the patient must stop using the inhaler. In severe cases, the patient may be prescribed beta blockers, which can be taken exclusively in an inpatient setting, so that the pulmonologist can monitor respiratory functions.

Overdose

Main symptoms:

• olodaterol: pronounced effects typical of β2-agonists, including myocardial ischemia, increased/decreased blood pressure, tachycardia, arrhythmias, palpitations, dizziness, nervousness, nausea, malaise, fatigue, insomnia, anxiety, headache, tremor, xerostomia, spasms muscle, metabolic acidosis, hypokalemia and hyperglycemia;
• Tiotropium bromide: manifestations of m-anticholinergic effects. After inhalation use for 14 days in doses reaching 40 mcg, no significant adverse events were observed in healthy individuals, except for the feeling of dryness of the mucous membranes of the oropharynx and nose; the incidence of these disorders varied depending on the daily dose (10–40 mcg). The exception is a clear decrease in salivation starting from the seventh day of using tiotropium bromide.

Therapy: discontinuation of Spiolto Respimat, maintenance and symptomatic treatment. In severe cases, hospitalization is indicated. It is possible to prescribe β1-blockers, but their use requires special caution, as this can lead to bronchospasm.

Exceeding the dose of the drug

If the patient takes the dose of the inhaler incorrectly, he may experience the following symptoms indicating an overdose of Spiolto Respimat:

• arrhythmia;
• nausea;
• causeless nervousness;
• fatigue;
• muscle spasms;
• hyperglycemia;
• xerostomia;
• insomnia;
• causeless anxiety;
• headaches;
• tachycardia;
• dizziness;
• general malaise;
• hypokalemia;
• increase or decrease in blood pressure level.

If the dosage of the medication has not been exceeded greatly, the patient may experience dryness of the mucous membrane of the nose, pharynx and mouth. You can get rid of this side effect only by completely removing the drug from the body.

In case of an overdose of Spiolto Respimat, the doctor discontinues the use of the drug in the patient, and also carries out symptomatic and supportive treatment. If the patient's condition is serious, hospitalization cannot be ruled out, since the patient's health requires constant medical monitoring.

When the body’s functioning is restored, the doctor prescribes adrenergic blockers to the patient, but they must be taken with caution, as they often lead to the development of bronchospasm or severe cough.

special instructions

Spiolto Respimat should not be used for bronchial asthma; the safety profile of the drug in this group of patients has not been studied.

The drug is not intended for the treatment of acute episodes of bronchospasm, i.e. as an emergency medicine.

It must be taken into account that immediate hypersensitivity reactions may occur during the use of Spiolto Respimat.

As with therapy with other inhaled drugs, during the use of Spiolto Respimat, the development of paradoxical bronchospasm is possible, which in some cases is life-threatening, which requires immediate discontinuation of the drug and transfer of the patient to alternative therapy.

The condition of patients with moderate to severe renal failure (with creatinine clearance <50 ml/min) should be monitored by physicians, since tiotropium bromide is excreted primarily by the kidneys.

Contact of the drug with the eyes should be avoided. Blurred vision, discomfort and/or pain in the eyes, visual halos around light sources, accompanied by redness of the eyes associated with swelling of the cornea and conjunctiva can be symptoms of acute angle-closure glaucoma. If these symptoms appear in any combination, you should immediately consult a doctor. Eye drops with a miotic effect are not considered an effective treatment.

Like other β2-agonists, olodaterol may have clinically significant effects on the cardiovascular system (manifested as increased heart rate, increased blood pressure and/or symptoms) in some patients. Patients who develop these signs should avoid further use of Spiolto Respimat. In addition, there is evidence that therapy with β2-agonists may lead to ECG changes, including ST segment depression and T wave flattening (the clinical significance of these changes is unknown).

In some patients, β2-agonists can cause hypokalemia, which creates the preconditions for the development of undesirable effects on the cardiovascular system. The decrease in serum potassium concentration in the blood is usually short-term and does not require replenishment. Hypokalemia in the setting of severe COPD due to hypoxia and concomitant therapy may increase, which increases the risk of developing arrhythmias.

With inhaled use of β2-adrenergic agonists in large doses, an increase in the plasma concentration of glucose in the blood is possible.

Spiolto Respimat should not be used in combination with any other drug that contains a long-acting β2-adrenergic agonist.

Patients frequently using short-acting inhaled β2-agonists (eg, 4 times daily) should be aware that these medications are used only to relieve acute symptoms of bronchospasm.

Before prescribing Spiolto Respimat to patients under 40 years of age, spirometric confirmation of the diagnosis of COPD is required.

Impact on the ability to drive vehicles and complex mechanisms

During the period of treatment with Spiolto Respimat, care must be taken when driving vehicles, which is associated with the likelihood of developing blurred vision and dizziness.

In what form is it produced?

Spiolto Respimat is available as a solution for inhalation. 1 cardboard package contains a 4.5 ml medication cartridge and an inhaler. The drug contains 60 doses, which is enough to complete a standard course of therapy.

The inflated price of the drug is justified not only by its high efficiency, but also by the presence of a high-quality inhaler in the kit, which is disposable and can only be used to spray the supplied solution.

The use of such cartridges has a number of significant advantages:

• There is no need to waste time preparing the medicinal solution yourself.
• It is impossible to make a mistake when calculating a safe dosage, due to which the risk of deterioration in the patient’s well-being is minimized.

If 30 days have passed after opening the cartridge with the solution, then the drug must be disposed of, since after this period of time the medication loses its properties.

Use during pregnancy and lactation

• pregnancy: Spiolto Respimat can only be used in cases where the expected benefit to the mother is higher than the existing harm to the fetus. Clinical studies of the use of the active components of the drug in this group of patients have not been conducted. Preclinical studies using high doses of olodaterol (several times higher than therapeutic doses) revealed an effect typical of β2-adrenergic agonists. The inhibitory effect of olodaterol on uterine contractility must be taken into account;
• lactation period: breastfeeding should be stopped while using the drug. Clinical studies of the use of the active components of the drug in this group of patients have not been conducted. Spiolto Respimat can be prescribed only in cases where the expected benefit to the mother is higher than the existing harm to the child.

Indications

As maintenance therapy, inhalations are prescribed to people suffering from the following pathologies:

1. Chronic obstructive pulmonary disease (difficulty breathing).
2. Bronchitis in a protracted form.
3. Emphysema (pathological expansion of the alveoli).
4. Bronchial asthma.

Regular inhalations using Spiolto Respimat improve pulmonary ventilation, reduce shortness of breath and help improve quality of life.

Drug interactions

Specific drug interaction studies of Spiolto Respimat have not been conducted, however, there is experience in using tiotropium bromide concomitantly with other drugs for the treatment of COPD, including methylxanthines, steroids for oral administration and inhalation, and there are no signs of drug interaction that are clinically significant. not noted.

Long-term simultaneous use of tiotropium bromide with other m-anticholinergic drugs has not been studied. In this regard, long-term combined use of Spiolto Respimat with other m-anticholinergic drugs is not recommended.

When used simultaneously with other adrenergic drugs, the undesirable effects of Spiolto Respimat may be enhanced.

The hypokalemic effect of adrenergic agonists is enhanced by combination therapy with xanthine derivatives, steroids or diuretics (not classified as potassium-sparing).

Weakening the effect of olodaterol or counteracting the development of this effect is possible when used simultaneously with beta-blockers. In such cases, it is preferable to use β1-blockers (with caution).

Combination therapy with monoamine oxidase inhibitors, tricyclic antidepressants or other drugs that can prolong the QTc interval may increase the effect of Spiolto Respimat on the cardiovascular system.

When ketoconazole and olodaterol are used together, the systemic exposure of the latter increases by 1.7 times, which does not affect the safety of therapy and does not require dose changes.

Analogs

It happens that “Spiolto Respimat” is not available in the pharmacy or for some medical reasons it is impossible to take it. Substitutes are intended for such situations and are divided into several groups:

• by active ingredients;
• according to indications.

Taking analogues will not be an equal replacement.

Preparations containing identical active ingredients include solutions for inhalation "Striverdi" and "Spiriva", and the drug "Spiriva" in capsule form. It is advisable to select analogs with substances that are derivatives of olodapterol and tiotropium or are similar in action to them.

Spiolto respimat solution d/ing. dosage 2.5 µg+2.5 µg/dose (cartridge) 4 ml

Combined bronchodilator ((beta two - long-acting adrenomimetic + m-anticholinergic)

Indications for use of the drug

• long-term maintenance therapy for patients with COPD, chronic bronchitis, pulmonary emphysema,
• reducing airway obstruction and accompanying shortness of breath;
• reducing the frequency of exacerbations; improving exercise tolerance and quality of life.

Recommendations for use

The recommended therapeutic dose is 2 inhalations of a spray from the Respimat inhaler (5 mcg/therapeutic dose of tiotropium bromide and 5 mcg/therapeutic dose of olodaterol) 1 time per day, at the same time of day (see instructions for use).

In elderly patients, Spiolto Respimat can be used at the recommended dose.

In patients with mild to moderate hepatic impairment, Spiolto Respimat can be used at the recommended dose.

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In patients with impaired renal function, Spiolto Respimat can be used at the recommended dose.

Patients with moderate to severe renal impairment using Spiolto Respimat should be closely monitored by a physician.

Instructions for use

Inserting a cartridge

Before using the inhaler for the first time, you must carry out the steps listed below under numbers 1-6.

1. With the light green cap closed, press the locking button and remove the clear sleeve.

2. Remove the cartridge from its packaging. Insert the thin end into the inhaler until it clicks.

To make sure. To ensure that the cartridge is in place, press the cartridge firmly onto a hard surface. The cartridge should not be completely submerged in the inhaler; the silver ring at its lower end should protrude from the inhaler. Once the cartridge is inserted into the inhaler, do not remove it.

3. Put on a transparent sleeve.

https://www.youtube.com/watch?v=pWiMUvXs8W0

After this, the sleeve should no longer be removed.

Preparing for the first use of the Spiolto Respimat inhaler

4. Keep the Spiolto Respimat inhaler upright with the light green cap closed.

Turn the transparent sleeve in the direction of the black arrow indicated on the label until it clicks (half a turn).

5. Open the light green cap completely.

6. Point the Spiolto Respimat inhaler downwards. Press the dose button. Close the light green cap.

Repeat steps 4, 5 and 6 until an aerosol cloud appears.

The Spiolto Respimat inhaler is now ready for use.

The implementation of these steps does not reduce the number of doses of the drug. Once prepared, your Spiolto Respimat inhaler allows you to release 60 inhalations of medication (30 therapeutic doses).

Side effect

Infections and infestations: nasopharyngitis.

Metabolism and nutrition: dehydration.

From the nervous system: dizziness, insomnia.

From the organ of vision: increased intraocular pressure, glaucoma; blurred vision.

From the cardiovascular system: atrial fibrillation, palpitations, tachycardia, supraventricular tachycardia, increased blood pressure.

From the respiratory organs, chest and mediastinum: cough, nosebleeds, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis.

From the skin: skin infections and skin ulcers, 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.

Contraindications

• patients with hypersensitivity to olodaterol, tiotropium bromide or any component of the drug;
• patients who have previously had hypersensitivity to atropine or its derivatives, for example ipratropium and oxitropium;
• not recommended for use in children under 18 years of age (due to lack of data on effectiveness and safety).

Carefully

In patients with acute-angle glaucoma, prostatic hyperplasia and bladder neck obstruction.

In patients with cardiovascular diseases, incl.

coronary insufficiency, heart rhythm disturbances, prolongation of the QT interval, hypertrophic obstructive cardiomyopathy, arterial hypertension, thyrotoxicosis, convulsions.

Patients with a history of such diseases as: myocardial infarction or hospitalization for heart failure (within the previous year), life-threatening arrhythmia, paroxysmal tachycardia with heart rate >100.

In patients with unusual reactions to sympathomimetic amines.

special instructions

The drug Spiolto Respimat should not be used for bronchial asthma. The effectiveness and safety of Spiolto Respimat in bronchial asthma have not been studied.

Acute bronchospasm

Spiolto Respimat is not indicated for the treatment of acute episodes of bronchospasm, i.e. as an ambulance.

Hypersensitivity

After using the drug Spiolto Respimat, immediate hypersensitivity reactions may develop.

The use of Spiolto Respimat, like other inhaled drugs, can lead to paradoxical bronchospasm, sometimes life-threatening. If paradoxical bronchospasm develops, the use of Spiolto Respimat should be immediately discontinued and alternative therapy should be prescribed.

https://www.youtube.com/watch?v=mlBqCWN8cBo

Patients with impaired renal function

Because Tiotropium bromide is excreted primarily by the kidneys; patients with moderate to severe renal failure (CK

Source: https://www.aptekamega.ru/lekarstva_i_bad/dyhatelnaya_sistema/tsb000028431/

Advantages and disadvantages

Each inhaler has not only positive, but also negative characteristics.

Among the main advantages of the drug Spiolto Respimat are:

• The low toxicity of the drug components for the cardiovascular system has been proven in laboratory conditions.
• Selective principle of action on the patient’s body (to a greater extent, the inhaler only affects the bronchi).
• In just 5 minutes. after inhalation, the quality of breathing improves significantly.
• The likelihood of adverse reactions is minimized.
• Physical exercise tolerance improves.
• The incidence of shortness of breath is reduced.
• The patient is less likely to need to use additional medications to eliminate asthma attacks.

After a year of regular use of the Spiolto Respimat inhaler, the frequency of exacerbations decreases. The first stable results from drug treatment of diseases of the bronchi and lungs can be noticed only after 7-10 days of therapy.

The disadvantages of the drug include:

• Overcharge.
• The need to coordinate inhalation.
• Difficult preparation of the inhaler for use.

With the development of a drug allergy, instead of the expected dilation of the bronchi, a paradoxical spasm occurs, which causes an attack of suffocation and a hacking cough. In this case, an urgent call to a doctor is necessary for subsequent hospitalization. It is forbidden to try to overcome a spasm on your own using an inhaler.