Description overdue on 17/11/2014
- Latin name: Spiriva
- ATC code: R03BB04
- Active substance: Tiotropium bromide (Tiotropium bromide)
- Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Flomax, instructions for use
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Babies
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
Active ingredient:
INN - tiotropium bromide 22.5 mcg (18 mcg, respectively tiotropium ) Per capsule and 3.1235 g tiotropium bromide (respectively, 2.5 g tiotropium ) In a single dose of the inhalation solution.
Capsules, besides the active ingredient, is included lactose monohydrate.
The inhalation solution, besides the active ingredient include: benzalkonium chloride, hydrochloric acid, disodium edetate and water.
Product form
Spiriva (Spiriva) - capsules comprising powder for inhalation for 10, 30 or 60 pieces. The scope of the package may include an inhaler.
Spiriva Respimat (Spiriva Respimat) - inhalable solution enclosed in cartridges 4, 5 ml (60 doses per 4 ml).
Pharmacological action
Bronchodilator, holinoliticheskoe.
Pharmacodynamics and pharmacokinetics
Tiotropium It is antimuscarinic a long-acting drug ( anticholinergic preparation ) And exhibits similar affinities for different receptors muscarinic types M1 to M5. Because of the oppression of the airway M3 receptors relaxes them smooth muscle , Which in turn leads to bronhodilatiruyuschimu effect drug, which, depending on the dose maintained for 24 hours or even longer. When inhaled method of administration action tiotropium a selective local, does not, at therapeutic doses, to system anticholinergic negative effects. In this way, bronchodilation It manifested not systemic and local effect of the drug.
After 30 minutes inhalation 1 there is a significant increase in the dose of lung function, which continues throughout the day. Pharmacodynamic balance was observed within 7 days of receipt, and expressed bronchodilatory effect was achieved on day 3. There were no manifestations of intolerance Flomax, when evaluating its bronchodilatory effect at 12 months. The drug reduces the number of exacerbations COPD compared with placebo, lengthens the time to first exacerbation, a positive effect on the quality of life throughout the period of application, reduces the number of internally displaced hospitalizations Associated with aggravation COPD And delays the first hospitalization .
Absolute bioavailability of tiotropium when taking inhaled - 19, 5% to guarantee a high content of light at a negligible impact on the patient as a whole. From GI rather poorly absorbed, and therefore, its absorption is independent of food intake. Patients COPD Cmax is reached after 5 minutes and after inhalation of 17-19 pg / ml, at equilibrium plasma concentration of 3-4 pg / ml. The plasma protein is bound by 72%, while the volume of distribution - 32 l / kg. It does not have the ability to pass BBB .
It is small biotransformation . Way non-enzymatic cleavage leads to the formation ditienilglikolevoy acid and alcohol N-metilskopina Not binding muscarinic receptors .
The terminal T1 / 2 after inhalation - 5-6 days.
14% of the dose excreted in the urine by the kidneys, the remainder in the faeces.
Indications
- holding support treatment of patients with COPD , Including those shown at emphysema Persisting shortness of breath . chronic bronchitis e, and in order to prevent relapse;
- conduct additional treatment patients asthma To reduce the frequency of exacerbations and symptoms as well as improving quality of life.
Contraindications
- age 18 years;
- first trimester pregnancy ;
- hypersensitivity one or amount of the ingredients of the preparation.
Carefully:
- angle-closure glaucoma ;
- obstruction bladder neck;
- prostatic hyperplasia .
Side effects
Inhalation drug Spiriva Spiriva Respimat, and may be accompanied by:
- rash ;
- dry mouth;
- candidiasis oral mucosa;
- bronchospasm ;
- dysphonia ;
- tachycardia ;
- dizziness ;
- itching ;
- hives ;
- dysphagia ;
- constipation ;
- gastroesophageal reflux ;
- cough ;
- supraventricular tachycardia ;
- throat irritation;
- increase intracranial pressure ;
- ileus ;
- difficulty urinating;
- anaphylaxis ;
- epistaxis;
- infections of the urinary tract;
- Atrial Fibrillation ;
- blurred vision;
- glaucoma ;
- angioedema .
Flomax, instructions for use
Instructions for use in the form of capsules Flomax suggests their use by inhalation using the device (inhaler) HandiHaler. The recommended daily dose is equal to one capsule. Application of Flomax capsules orally (internal) is not allowed.
Medication Spiriva Respimat in the form of a solution is also designed to receive inhaled via Respimat inhaler. The recommended daily dose of 5 mg (2 inhalations) one-off at the same time of the day.
Elderly patients and patients with liver abnormalities take drugs without dose adjustment.
At kidney disease dose adjustment is not required, but it is desirable to pass the regular examination of renal function.
For the product inhaled drug Spiriva in capsule form, a special inhaler HandiHaler, which must not be used for other drugs. The service life of the inhaler 12 months.
Set inhaler includes: a mouthpiece, dust cap, the base, the central chamber and the piercing button.
When using it should be:
- pressing the button piercing open dust cap;
- raised, completely open the cap, and then in the same manner mouthpiece;
- place the capsule in the center chamber (any side) previously took it out of the package;
- thoroughly close the mouthpiece (you will hear a click) without closing dust cap;
- position in the inhaler mouthpiece up to make one complete pressing the piercing button and release (to create a hole in the capsule);
- to make the fullest possible exhale (not into the mouthpiece of the inhaler);
- place the inhaler in the mouth, lips tightly covering the mouthpiece;
- at the position of the head right to hold a deep, slow but strong enough breath (with hearing or feeling the vibrations of the capsule) to complete saturation of the lungs;
- hold your breath to feelings of discomfort while taking the inhaler out of his mouth;
- repeat these breaths to release the full contents of the capsule;
- open mouthpiece and remove the capsule, and then close the mouthpiece and dust cap.
Clean the inhaler HandiHaler should be carried out every 30 days.
For this purpose, pre-lifting the piercing button, open the dust cap and mouthpiece, as well as the base of the unit. Using warm water wash inhaler to remove residual powder. Wipe with paper towel and allowed to dry for 24 hours in air. If necessary, clean the outer surface of the mouthpiece with a damp cloth.
When removing the capsule from the blister strip should separate it along the perforations. Open the box and pull it out of the capsule before the actual application. Avoid long stay retrieved capsule outdoors.
For the product inhaled drug Spiriva Respimat inhaler is used Respimat:
- the first opening is performed by displacing a transparent substrate by pressing the fuse with a closed cap green;
- remove the cartridge from its packaging and insert the narrow end into the inhaler, and the 'click' (do not remove the cartridge once it is installed);
- establish a clear framework in its place;
- hold the inhaler in the right hand, turn it until it clicks basis, following the instructions of the red arrows (half a turn);
- fully open green cap;
- directing the inhaler down by pressing a button to release the drug, and then close the cap.
Then the inhaler charged and ready for further use.
For inhalations should:
- with closed green cap holding inhaler in his right hand, rotating its base until it clicks by following the red arrows (half a turn);
- fully open the green cap;
- produce a slow full breath, then tightly cover the mouthpiece mouth without closing the ventilation openings;
- directing the mouthpiece in the direction of the posterior pharyngeal wall, to make a deep slow breath while pressing the inhaler (inhalation continue as long as possible);
- hold your breath not less than 10 seconds;
- repeat the procedure until receiving a dose.
Inhalation is performed 1 time per 24 hours, after which the cap is closed.
When not using the inhaler for a week, you need to make preventive spraying, the mouthpiece pointing downward.
Respimat inhaler is designed for 60 breaths, and is equipped with a dose indicator. The indicator LED on the beginning of the red zone, suggests a 7-day supply of the drug (14 breaths). This is the reason for the acquisition of the new inhaler.
The inhaler can be used for 3 months, after which, even partial use, it must be discarded.
Clean the mouthpiece once a week with a damp cloth.
Overdose
When inhalation use tiotropium at higher doses was observed anticholinergics manifestations: dryness in the oral cavity, increase in heart rate . accommodation disturbances .
Displaying holding symptomatic treatment.
Cooperation
Perhaps inhalation tiotropium the parallel use of other medications commonly used for treatment COPD ( methylxanthines . sympathomimetic , Inhaled or oral steroids ).
Co-administration with other anticholinergic not recommended.
Terms of sale
Spiriva Respimat Drugs and Flomax are released from pharmacies by prescription.
Storage conditions
The storage temperature of both drugs should not exceed 25 ° C.
Shelf life
Flomax - 24 months.
Spiriva Respimat - 36 months.
Cautions
Preparations Spiriva Respimat and Spiriva is not used to treat bronchospasm Particularly during acute attacks.
You may experience bronchospasm and Immediate reactions hypersensitivity Immediately after inhalation.
The patient must provide full information on the use of an inhaler.
Should avoid contact with drugs in the organs of vision. Discomfort in the eyes, pain . blurred vision . redness . swelling corneal . conjunctival stagnation may indicate an acute attack angle-closure glaucoma . When observing any of these symptoms should report it to your doctor.
Analogs of Spiriva Respimat and Spiriva
- Atrovent
The most applicable analogues of these drugs are:
- Atrovent ;
- Ipravent ;
- Truvent ;
- Troventola ;
- Ipratropium ;
- ARIS Brizhaler .
Price analogs of the active substance depends on the drug manufacturer, the number of doses and many other factors. For example, the inhalable Atrovent can be bought for 350 rubles, while the cost ARIS Brizhalera It varies from 2,000 rubles.
Babies
Due to the lack of information is not administered to children under 18 years.
During pregnancy (and lactation)
Tiotropium bromide contraindicated for use in the first trimester of pregnancy.
During the rest period pregnancy And between Lactation Perhaps his appointment only in extreme cases and under constant medical supervision.
Reviews
Reviews of Flomax as of Spiriva Respimat reviews almost 100% of the positive. According to many doctors, these drugs are the "golden mean" during maintenance therapy COPD . It confirms the high effectiveness and duration of action of drugs and from applying its patients.
Not bad results showed the use of drugs in asthma But only as an aid to facilitate general condition.
Several problems arise when using the inhaler. To ensure proper use should be exactly the same as the procedure described in the instructions for use of inhalers, as well as to spend a few inhalations in the presence of an experienced doctor who can fix errors that occur.
Price Flomax Where To Buy
In Russia, the price of Spiriva 18 mcg capsules №30 about 2500 - 2800 rubles.
Buy Spiriva Respimat is possible for 3000 - 3600 rubles.
The price in Ukraine is about 800 hryvnia per 30 capsules and about 1,000 hryvnia for the solution.
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