Compound
Active ingredient:
INN - tiotropium bromide 22.5 mcg (respectively 18 mcg tiotropium ) in one capsule and 3.1235 mcg tiotropium bromide (respectively 2.5 mcg tiotropium ) in one dose of inhalation solution.
In addition to the active ingredient, the capsules contain lactose monohydrate.
In addition to the active ingredient, the inhalation solution includes: benzalkonium chloride, hydrochloric acid, disodium edetate, water.
Pharmacodynamics and pharmacokinetics
Tiotropium is a long-acting antimuscarinic drug ( anticholinergic drug ) and exhibits equal affinity for different muscarinic type receptors from M1 to M5. smooth muscles relax , which in turn leads to the bronchodilator effect of the drug, which, depending on the dose taken, lasts for 24 hours or even longer. With the inhalation method of administration, the effect of tiotropium is selective local in nature, without leading, in therapeutic doses, to systemic anticholinergic negative effects. Thus, bronchodilation is manifested not by a systemic, but by a local effect of the drug.
30 minutes after inhalation of 1 dose, a significant increase in lung function occurs, which continues throughout the day. Pharmacodynamic equilibrium was observed within 7 days of administration, and a pronounced bronchodilator effect was achieved on the 3rd day. There were no manifestations of tolerance to Spiriva when assessing its bronchodilator effect over a 12-month period. Taking the drug reduces the number of exacerbations of COPD compared to placebo, lengthens the time to the first exacerbation, has a positive effect on the quality of life throughout the entire period of use, reduces the number of forced hospitalizations associated with exacerbation of COPD , and also delays the time of first hospitalization .
The absolute bioavailability of tiotropium when taken in the form of inhalations is 19.5%, which guarantees its high content in the lungs with an insignificant effect on the patient’s body as a whole. from the gastrointestinal tract , and therefore its absorption does not depend on food intake. In patients with COPD, Cmax is reached 5 minutes after inhalation and is 17–19 pg/ml, with a steady-state plasma concentration of 3–4 pg/ml. It is 72% bound to plasma proteins, with a volume of distribution of 32 l/kg. Does not have the ability to pass the BBB .
Subject to minor biotransformation . The degradation pathway is non-enzymatic and results in the formation of dithienylglycolic acid and the alcohol N-methylscopine , which do not bind to muscarinic receptors .
Terminal T1/2 after inhalation - 5–6 days.
14% of the dose is excreted in the urine by the kidneys, the remaining in feces.
Drug interactions
It is possible to prescribe Spiriva® in combination with other drugs commonly used to treat COPD: sympathomimetics, methylxanthine derivatives, oral and inhaled corticosteroids.
Limited information on combined use with anticholinergic drugs comes from two clinical studies: a single dose of ipratropium bromide with continuous use of Spiriva in patients with COPD (64 people) and healthy volunteers (20 people) did not lead to a decrease in adverse reactions, changes in vital parameters and ECG. However, chronic combined use of anticholinergic drugs and Spiriva has not been studied and is therefore not recommended.
Side effects
Inhalation of Spiriva and Spiriva Respimat may be accompanied by:
- rash;
- dry mouth;
- candidiasis of the oral mucosa;
- bronchospasm;
- dysphonia;
- tachycardia;
- dizzy;
- itching;
- hives;
- dysphagia;
- constipation;
- gastroesophageal reflux ;
- cough;
- supraventricular tachycardia ;
- throat irritation;
- increased intracranial pressure ;
- intestinal obstruction;
- difficulty urinating;
- anaphylaxis;
- nosebleeds;
- urinary tract infections;
- atrial fibrillation;
- blurred vision;
- glaucoma;
- angioedema.
Overdose
Symptoms:
When using high doses, manifestations of anticholinergic effects are possible - dry mouth, accommodation disturbances, increased heart rate.
After inhalation of a single dose of up to 282 mcg in healthy volunteers, no systemic anticholinergic effects were detected. After repeated administration of a single daily dose of 141 mcg, bilateral conjunctivitis in combination with dry mouth was observed in healthy volunteers, which disappeared with continued treatment. In a study examining the effects of multiple-dose tiotropium in COPD patients receiving a maximum of 36 mcg of the drug for more than 4 weeks, dry mouth was the only adverse effect.
Acute intoxication associated with accidental ingestion of capsules is unlikely due to the low bioavailability of the drug.
Spiriva, instructions for use
Instructions for use of Spiriva in capsule form suggest their use in the form of inhalation using the HandiHaler device (inhaler). The recommended daily dose is one capsule. The use of Spiriva capsules orally (internally) is not allowed.
The medicine Spiriva Respimat in the form of a solution is also intended for inhalation using the Respimat inhaler. The recommended daily dose is 5 mcg (2 inhalations) once at one time of the day.
Elderly patients and patients with liver pathologies take drugs without dose adjustment.
For kidney disease, dosage adjustment is also not required, but regular testing of kidney function is advisable.
For inhalation of the drug Spiriva in the form of capsules, a special inhaler HandiHaler has been developed, which should not be used for other drugs. The service life of this inhaler is 12 months.
The inhaler kit includes: mouthpiece, dust cap, base, central chamber and lancing button.
When using it you should:
- open the dust cap by pressing the piercing button;
- lifting up, open the cap completely, and then the mouthpiece in the same way;
- place the capsule in the central chamber (either side), after removing it from the package;
- Close the mouthpiece thoroughly (you will hear a characteristic click) without closing the dust cap;
- with the inhaler positioned with the mouthpiece up, press the piercing button one full time and release (to create a hole in the capsule);
- exhale as completely as possible (not into the mouthpiece of the inhaler);
- place the inhaler in the oral cavity, tightly covering the mouthpiece with your lips;
- With the head positioned straight, take a deep, slow, but quite strong breath (while hearing or feeling the vibration of the capsule) until the lungs are completely saturated;
- hold your breath until you feel discomfort, while removing the inhaler from your mouth;
- repeat similar breaths until the contents of the capsule are completely released;
- open the mouthpiece and remove the capsule, then close the mouthpiece and dust cap.
The HandiHaler inhaler should be cleaned once every 30 days.
To do this, after first lifting the piercing button, you need to open the dust cap and mouthpiece, as well as the base of the device. Using warm water, rinse the inhaler until any remaining powder is removed. Wipe with a paper towel and let air dry for 24 hours. If necessary, you can clean the outer surface of the mouthpiece using a damp cloth.
When removing a capsule from a blister, separate its strip along the perforation line. Open the capsule bed and remove it before use. Do not allow the removed capsule to remain in the open air for a long time.
To inhale the drug Spiriva Respimat, use the Respimat inhaler:
- the first opening is carried out by displacing the transparent base by pressing the safety lock, with the green cap closed;
- remove the cartridge from the packaging and insert the narrow end into the inhaler, a click should be heard (do not remove the cartridge after installing it);
- install the transparent base in its original place;
- holding the inhaler in your right hand, turn its base until it clicks, following the direction of the red arrows (half a turn);
- open the green cap completely;
- pointing the inhaler down, press the button until the drug is released, then close the cap.
After this, the inhaler is charged and ready for further use.
To carry out inhalations you should:
- with the green cap closed, holding the inhaler in your right hand, turn its base until it clicks, following the direction of the red arrows (half a turn);
- open the green cap completely;
- exhale slowly and completely, then tightly cover the mouthpiece with your lips without closing the ventilation holes;
- pointing the mouthpiece towards the back wall of the throat, take a deep, slow breath, while pressing the inhaler button (continue inhalation as long as possible);
- hold your breath for at least 10 seconds;
- repeat the procedure until the full dose is received.
Inhalations are carried out once every 24 hours, after which the cap is closed.
If the inhaler is not used for a week, it is necessary to perform a preventive spray with the mouthpiece pointing down.
The Respimat inhaler is designed for 60 breaths and is equipped with a dose indicator. The indicator reading at the beginning of the red zone indicates a 7-day supply of the drug (14 breaths). This is a reason to purchase a new inhaler.
The inhaler can be used for 3 months, after which, even if not fully used, it must be thrown away.
Clean the mouthpiece once a week using a damp cloth.
special instructions
The drugs Spiriva and Spiriva Respimat are not used to treat bronchospasm , especially during acute attacks.
Bronchospasm and immediate hypersensitivity may occur immediately after inhalation.
The patient must be provided with complete information on the use of a particular inhaler. Drugs should not be allowed to come into contact with the eyes. Eye discomfort, pain , blurred vision , redness , corneal swelling , conjunctival congestion may indicate an acute attack of angle-closure glaucoma . If you observe any of these symptoms, you should inform your doctor.
Release form
The drug Spiriva is produced in the form of powder capsules for inhalation. The shell of each of them is matte, made in green and blue tones. It contains white powder filler. The blister consists of 10 doses. The medication is available in cardboard packaging with 1, 3 or 6 blisters.
The medicine may be sold together with the inhaler Spiriva Respimat.
Analogues of Spiriva and Spiriva Respimat
Level 4 ATX code matches:
Atrovent
The most used analogues of these drugs are:
- Atrovent;
- Ipravent;
- Truvent;
- Troventol;
- Ipratropium;
- Sibri Breezhaler.
The price of analogues depends on the active substance of the drug, the manufacturer, the number of doses and many other factors. For example, inhalation Atrovent can be purchased for 350 rubles, while the cost of Sibri Breezhaler varies within 2000 rubles.
Reviews
Reviews about Spiriva, as well as reviews about Spiriva Respimat, are almost 100% positive. According to many doctors, these medications are the “golden mean” when conducting maintenance therapy for COPD . The high effectiveness and duration of action of the drugs is also confirmed by the patients using them.
bronchial asthma showed good results , but only as an additional means to alleviate the general condition.
Some problems arise when using inhalers. For proper use, you should exactly repeat the procedure described in the instructions for use of the inhalers, and also carry out several inhalations in the presence of an experienced doctor who can correct errors that occur.
Contraindications
According to the instructions, the medication is not used in the following cases:
- individual intolerance to components;
- first trimester of pregnancy;
- age up to 18 years.
Under special medical supervision, inhalations are done when:
- angle-closure glaucoma;
- prostatic hyperplasia;
- pathology of the bladder neck;
- renal failure;
- lactation.
During pregnancy, Spiriva can be used under the supervision of specialists, starting from the second trimester.
Spiriva price, where to buy
In Russia, the price of Spiriva 18 mcg capsule No. 30 is approximately 2500 - 2800 rubles.
You can buy Spiriva Respimat for 3000 – 3600 rubles.
The price in Ukraine is about 800 hryvnia for 30 capsules and about 1000 hryvnia for a solution.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
LuxPharma* special offer
- Spiriva (analogue of Braltus, Tiotropium, Braltus) caps.
10mcg No. 30 (inhaler set + capsules) RUB 2180 order
ZdravCity
- Spiriva capsules for inhalation. 18mcg 30 pcs. Boehringer Ingelheim
2505 rub. order
Pharmacy Dialogue
- Spiriva respimat (d/ing solution 2.5 mcg/dose 4.5 ml cartridges 60 doses) Boehringer Ingelheim
RUB 2,571 order
- Spiriva (caps. d/ing. 18 µg No. 30 with HandiHaler inhaler) Boehringer Ingelheim
RUB 2,509 order
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Pharmacy24
- Spiriva 18 mcg No. 30 capsules + Handy Highler device 60% discount Boehringer Ingelheim Pharma GmbH i Co.
KG, Nimechchina 618 UAH. order - Spiriva Respimat 2.5 mcg 4 ml No. 1 solution + Respimat inhaler
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- Spiriva 18 mcg No. 30 + Handy Highler device capsules Boehringer Ingelheim Pharma GmbH & Co. KG, Nimechchina
1476 UAH order
- Spiriva Respimat 2.5 mcg 4 ml solution + Respimat inhaler 67% discount
743 UAH order
PaniPharmacy
- Spiriva Respimat liquid Spiriva Respimat solution for inhalation 2.5 µg 4 ml 60 doses Germany, Boehringer Ingelheim Pharma
1285 UAH. order
- Spiriva capsules 18mkg No. 30 Australia, Boehringer Ingelheim
1727 UAH. order
- Spiriva capsule Spiriva capsules 18 µg with Handy Hayler device No. 30 Germany, Boehringer Ingelheim Pharma
1594 UAH. order
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