Spiriva Respimat

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Spiriva Respimat: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. In case of impaired liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Spiriva Respimat

ATX code: R03BB04

Active ingredient: tiotropium bromide (tiotropium bromide)

Producer: Boehringer Ingelheim Pharma, GmbH & Co. KG (Germany)

Description and photo updated: 22.11.2018

Prices in pharmacies: from 2423 rubles.

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Solution for inhalation Spiriva Respimat

Spiriva Respimat is a bronchodilator drug, m-cholinergic receptor blocker.

Release form and composition

The dosage form of Spiriva Respimat is a solution for inhalation: colorless, transparent or almost transparent liquid (a cartridge with a solution, with a capacity of 4.5 ml, is placed in an aluminum cylinder; in a cardboard box there is 1 cylinder with a cartridge complete with a Respimat inhaler).

Composition of 1 dose:

active substance: tiotropium - 2.5 mcg (equivalent to tiotropium bromide monohydrate - 3.1235 mcg);
auxiliary components: benzalkonium chloride, disodium edetate, hydrochloric acid 1M.

Pharmacological properties

Pharmacodynamics

Tiotropium bromide is a long-acting antimuscarinic substance. It has an equal affinity for the M1 – M5 subtypes of muscarinic receptors. As a result of inhibition of M3 receptors, relaxation of smooth muscles occurs. The bronchodilating effect lasts at least a day and depends on the dose. The prolonged effect of the drug is explained, apparently, by the very slow dissociation of the substance from the M3 receptors, in comparison with ipratropium bromide, its half-dissociation period is much longer. When administered by inhalation, tiotropium bromide has a selective effect on the bronchi, without causing systemic side effects of m-anticholinergics. In comparison with M3 receptors, dissociation of M2 receptors is faster.

The effect of inhalation is primarily due to the local rather than systemic effect of the drug. Clinical studies have shown a significant improvement (in comparison with placebo) in lung function within 30 minutes after the first application of the solution, which lasts for a day at an equilibrium concentration.

Pharmacodynamic equilibrium develops within 7 days. No signs of addiction have been established, the effect of the drug persists for 48 weeks of its use.

Morning and evening peak volumetric expiratory flow rate is significantly improved during therapy with Spiriva Respimat.

Data from randomized, placebo-controlled, crossover clinical trials showed a greater bronchodilating effect of Spiriva Respimat (5 mcg) with 4 weeks of use than the effect of Spiriva (18 mcg).

Long-term studies conducted over 1 year in patients with chronic obstructive pulmonary disease (COPD) showed a significant decrease in shortness of breath, an improvement in the quality of life, an increase in activity and a decrease in the psychosocial impact of the disease. By the end of the study, the drug improved overall health compared to placebo, reduced the number of COPD exacerbations, and increased the period to the first exacerbation.

Spiriva Respimat reduces the risk of exacerbation of COPD by decreasing the frequency of hospitalizations.

A retrospective analysis of individual studies revealed a statistically insignificant increase in the number of deaths in patients with cardiac arrhythmias compared with placebo. These data are not confirmed and can be explained by heart disease.

Studies have shown that when Spiriva Respimat is added to therapy in patients with bronchial asthma who do not help to get rid of symptoms, treatment with inhaled corticosteroids and long-acting β2-adrenergic agonists improved lung function compared to placebo, significantly reduced the number of serious exacerbations and periods of worsening of symptoms diseases, the quality of life improved. The effect of the drug persisted throughout the year of its use without signs of addiction.

Pharmacokinetics

About 40% of the inhalation dose of tiotropium bromide is deposited in the lungs, the rest enters the gastrointestinal tract (GIT). About 33% of the dose enters the systemic circulation. Food intake does not affect the absorption of the drug.

The time to reach the maximum plasma concentration is 5-7 minutes. At the stage of dynamic equilibrium, the highest plasma concentration of tiotropium in patients with COPD is 10.5 pg / ml and rapidly decreases, which is explained by the multi-compartment type of its distribution. At the stage of dynamic equilibrium: the basal concentration of tiotropium in the blood plasma is 1.6 pg / ml; The peak plasma concentration of tiotropium in patients with bronchial asthma was 5.15 pg / ml, the time to reach it was 5 minutes. Communication with plasma proteins - 72%. The volume of distribution is 32 l / kg. Tiotropium bromide does not cross the blood-brain barrier.

The biotransformation of the drug is insignificant. The terminal elimination half-life in patients with COPD is 27–45 hours. In patients with bronchial asthma - 34 hours.

After inhalation of the drug, most of it is excreted by the intestines, and a smaller part (18.6% in patients with COPD, 11.9% in patients with bronchial asthma) - by the kidneys. Pharmacokinetic equilibrium with daily inhalation in patients with COPD is achieved on day 7.

The renal clearance of tiotropium is decreased in elderly patients with COPD. In bronchial asthma, the effect of tiotropium bromide does not depend on the age of the patients.

In patients with impaired liver function, the pharmacokinetics of the drug does not have significant differences.

In patients with COPD and mild renal impairment, there was a slight increase in AUC0–6, ss by 1.8–30% and Cmax, ss compared with patients with normal renal function. In case of bronchial asthma and a slight impairment of renal function, inhalation of tiotropium bromide did not cause a greater effect of the drug than in healthy people.

Indications for use

Inhalation with Spiriva Respimat solution is recommended for maintenance therapy in order to improve the quality of life and reduce the incidence of exacerbations in the following diseases and conditions:

COPD, chronic bronchitis, pulmonary emphysema (with persistent shortness of breath);
bronchial asthma with persistent symptoms of the disease on the background of therapy with at least inhaled glucocorticosteroids (GCS), to reduce its manifestation (as an additional supportive therapy).

Contraindications

Absolute:

children and adolescents under 18 years of age (there is no information on the effectiveness and safety of use);
increased sensitivity to the components of the drug, as well as to atropine and its derivatives (ipratropium bromide, oxitropium bromide, etc.).

According to the instructions, Spiriva Respimat 2.5 mcg / dose should be used with caution in case of prostatic hyperplasia, angle-closure glaucoma and bladder neck obstruction.

Instructions for use of Spiriva Respimat: method and dosage

The Spiriva inhaler Respimat is intended for use once a day at the same time. With each daily use, 2 inhalations should be done. The number of inhalation doses is 60, which corresponds to 30 therapeutic doses, subject to the conditions of use.

In bronchial asthma, the effect of the drug occurs after a few days of its use.

If the inhaler has not been used for more than 7 days, before the first use, it should be directed into the air and the dose delivery button should be pressed.

It is recommended to clean the mouthpiece, including its metal part, with a damp cloth at least once every 7 days.

The dose indicator shows how many doses are left, when it reaches the red area of the scale, this will mean that the remaining drug will last for about 7 days, provided that it is used according to the instructions. When the dose indicator reaches the end of the scale, the inhaler is blocked. This means that the drug has ended.

Preparation for the first use of the Spiriva Respimat inhaler:

Remove the transparent sleeve (keep the cap closed) by pressing the locking button and pulling firmly on the transparent sleeve with the other hand.
Insert the cartridge with the narrow end into the inhaler, place the bottom of the inhaler on a hard surface and press it firmly until it clicks, this will mean that the cartridge is in place.
Install the transparent sleeve until it clicks into place.
Keeping the cap closed, turn the transparent sleeve in the direction indicated on the label half a turn until it clicks.
Open the cap as far as it will go.
While pointing the inhaler down, press the dose button, then close the cap.

Repeat steps 4–6 until a cloud of aerosol appears, and then repeat them 3 more times (steps 4–6 must be performed both when the inhaler is used for the first time and when it has not been used for more than 3 weeks).

Daily use of the inhaler Spiriva Respimat:

Turn the transparent sleeve in the direction indicated on the label until it clicks, with the cap closed.
Open the cap as far as it will go.
Take a slow full exhalation, clasp the mouthpiece with your lips without blocking the air intakes, press the dose button while taking a deep breath, hold your breath for 10 seconds or as long as possible. Repeat these steps for a second dose.

Side effects

metabolism and nutrition: dehydration;
nervous system: dizziness, insomnia;
organ of vision: increased intraocular pressure, glaucoma, blurred vision;
cardiovascular system: atrial fibrillation, tachycardia (including supraventricular), palpitations;
respiratory, chest and mediastinal organs: cough, pharyngitis, dysphonia, sinusitis;
Gastrointestinal tract: dryness of the mucous membrane of the pharynx (minor, transient), oral candidiasis, constipation, dysphagia, gastroesophageal reflux, gingivitis, glossitis, stomatitis, intestinal obstruction (including paralytic);
skin and subcutaneous tissue: dry skin, skin infections and skin ulcers;
musculoskeletal and connective tissue: joint swelling;
kidneys and urinary system: dysuria, urinary retention, urinary tract infections;
allergic reactions: rash, itching, urticaria, angioedema, immediate hypersensitivity reactions.

Overdose

When using Spiriva Respimat in doses up to 40 mcg of tiotropium bromide in healthy people, no significant undesirable effects appeared, except for dryness of the nasal mucosa and oropharynx. From day 7, there was a decrease in salivation. With long-term use of the drug at a dose of 10 μg / day, no significant adverse events were observed.

special instructions

Spiriva Respimat is used as a supportive drug, it is not used at the beginning of therapy for acute attacks of bronchospasm, as well as to eliminate acute symptoms. With the development of an attack, fast-acting β2-agonists are used.

You should not interrupt therapy with anti-inflammatory drugs, for example, inhaled glucocorticosteroids due to the use of Spiriva Respimat, even if the symptoms are relieved, since it should not be used as a first-line drug.

Inhalation of the drug can lead to bronchospasm.

Avoid getting the aerosol or solution in the eyes. In case of development of pain and discomfort in the eyes, visual halos combined with redness of the eyes, blurred vision, edema of the conjunctiva and cornea, you should immediately consult a doctor due to the risk of developing acute angle-closure glaucoma.

Do not use Spiriva Respimat more than 1 time per day.

Influence on the ability to drive vehicles and complex mechanisms

Due to the risk of developing side effects such as dizziness and blurred vision, care should be taken when driving vehicles and other complex mechanisms that require the speed of psychomotor reactions.

Application during pregnancy and lactation

There are limited data on the effect of the drug on pregnancy, fetal development and labor. For safety reasons, it is preferable to refrain from using Spiriva Respimat during pregnancy, use is allowed only if the expected benefit to the mother outweighs the possible risk to the fetus.

There is no information on the release of the drug during lactation, therefore, if necessary, breastfeeding should be discontinued.

Pediatric use

The safety and efficacy of Spiriva Respimat in patients under 18 years of age have not been studied, therefore the drug is not used in pediatric practice.

With impaired renal function

Patients with mild to moderate renal impairment (creatinine clearance less than 50 ml / min) should be under medical supervision during the period of use of Spiriva Respimat.

If liver function is impaired

Patients with impaired liver function are allowed to use the drug in the usual dose.

Use in the elderly

Elderly patients do not need dose adjustment of Spiriva Respimat.

Drug interactions

Long-term combined use of tiotropium bromide and other m-anticholinergic drugs is not recommended, since it has not been studied.

Allowed to use Spiriva Respimat with other drugs for the treatment of COPD (symptomatic bronchodilators, methylxanthines, steroids for oral and inhalation use, antihistamines, mucolytics, leukotriene modifiers, cromones, anti-IgE drugs), with long-acting beta2-agonists HKS and inhalation combinations thereof.

Analogs

The analogues of Spiriva Respimat are Tiotropium-native, Atrovent, Ipravent, Truven, Troventol, Ipratropium, Sibri Breezhaler, etc.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children. Do not freeze.

Shelf life - 3 years, after first use - 3 months.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Spiriva Respimat

According to reviews, Spiriva Respimat effectively facilitates breathing, reduces shortness of breath in patients with COPD and has a long-lasting effect. Of the minuses, the high cost of the drug is mainly mentioned.

The price of Spiriva Respimat in pharmacies

The approximate price for Spiriva Respimat 2.5 mcg / dose for 1 cartridge of 4 ml with the Respimat inhaler is 2470–2720 rubles.