Spiriva - instructions for use, analogs, reviews and release forms (capsules with powder for inhalation 18 μg, inhalation solution with inhaler Respimat) medications for the treatment of asthma, obstructive bronchitis in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Spiriva. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Spiriva in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Spiriva in the presence of existing structural analogues.Use for the treatment of bronchial asthma, obstructive bronchitis in adults, children, as well as during pregnancy and lactation.

Spiriva - a bronchodilator.

Tiotropium bromide (active ingredient of the drug Spiriva) is a long-acting m-cholinoblocker. The drug has the same affinity for M1-M5 subtypes of muscarinic receptors. The result of the inhibition of M3 receptors in the airway is the relaxation of smooth muscles. The bronchodilator effect is dose dependent and persists for at least 24 hours. A significant duration of action is probably associated with a very slow dissociation of the drug from the M3 receptors; the half-dissociation period is much longer than in ipratropium bromide.

In the inhalation mode of administration, tiotropium bromide, as an N-quaternary ammonium derivative, exerts a local selective effect (on the bronchi), while at therapeutic doses it does not cause systemic m-cholinoblocking side effects. Dissociation from the M2 receptors occurs faster than from the M3 receptors, which indicates that the selectivity to the M3 receptor subtype predominates over the M2 receptors.High affinity for receptors and slow dissociation of the drug from receptor binding cause a pronounced and prolonged bronchodilator effect in patients with chronic obstructive pulmonary disease (COPD).

Bronchodilation after inhalation of tiotropium bromide is a consequence of local rather than systemic action.

In clinical studies, it was shown that 30 minutes after a single dose of Spiriva over 24 hours significantly improves lung function (increased FEV1 and FVC). Pharmacodynamic equilibrium was achieved during the 1 st week, and pronounced bronchodilator effect was observed on the 3rd day. Spiriva significantly increases the morning and evening peak flow rate of exhalation, measured by patients. The bronchodilator effect of Spiriva, evaluated during the year, did not reveal any manifestations of tolerance.

Spiriva significantly reduces the frequency of exacerbations of COPD and prolongs the period until the moment of the first exacerbation compared with placebo. Significantly improves the quality of life, which is observed throughout the treatment period. Spiriva significantly reduces the number of hospitalizations associated with exacerbation of COPD, and increases the time until the first hospitalization.

In a retrospective analysis of individual clinical studies, there was a statistically inaccurate increase in the number of deaths in patients with cardiac rhythm disturbances, compared with placebo. However, these data are not statistically confirmed and may be associated with heart disease.

In clinical studies in patients with bronchial asthma and continuing to experience the symptoms of the disease, despite maintenance therapy with an inhaled glucocorticosteroid (GCS), incl. in combination with a long acting beta2-adrenoreceptor agonist, it was found that the addition of Spiriva Respimat to maintenance therapy led to a significant improvement in lung function compared to placebo, significantly reduced the number of serious exacerbations and periods of worsening of symptoms of bronchial asthma, increased the period before their first onset , led to a significant improvement in the quality of life and an increase in the number of patients with a positive response to maintenance therapy.

The bronchodilating effect of the drug persisted for 1 year of use, there were no signs of addiction.

Composition

Tiotropium bromide monohydrate + auxiliary substances.

Pharmacokinetics

With inhalation, the absolute bioavailability of tiotropium bromide is 19.5%, which indicates a high bioavailability of the fraction of the drug reaching the lungs. Tiotropium bromide is poorly absorbed from the digestive tract. For the same reason, eating does not affect the absorption of tiotropium. When ingested tiotropium bromide in the form of a solution, the absolute bioavailability was 2-3%. Does not penetrate the blood-brain barrier (BBB). The degree of biotransformation is insignificant. Tiotropium bromide is cleaved non-enzymatically to alcohol N-methylscopic and dithienylglycolic acid, which do not bind to muscarinic receptors. A metabolic disorder is possible with the use of inhibitors of isoenzymes CYP2D6 and 3A4 (quinidine, ketoconazole, gestodene). Thus, the isozymes CYP2D6 and 3A4 are included in the metabolism of the drug. Tiotropium bromide does not inhibit cytochrome P450 isoenzymes 1A1, 1A2, 2B6, 2C9, 2C19, 2D6, 2E1 or 3A4 in human liver microsomes even in super therapeutic concentrations. Tiotropium bromide after intravenous administration is excreted, mainly with urine in unchanged form - 74%.After inhalation of the powder, renal excretion is 14%, the rest, not absorbed in the intestine, is excreted with feces. After long-term use of the drug once a day in patients with COPD, the equilibrium state of pharmacokinetic parameters is achieved after 2-3 weeks, with no further cumulation observed.

Indications

• for maintenance treatment of patients with COPD, chronic bronchitis, pulmonary emphysema, maintenance therapy with persistent dyspnea, to improve the quality of life impaired due to COPD, to reduce the frequency of exacerbations;
• for additional maintenance therapy in patients with bronchial asthma with persisting symptoms of the disease on the background of taking inhaled GCS, to reduce the symptoms of bronchial asthma, improve the quality of life and reduce the frequency of exacerbations.

Forms of release

Capsules with powder for inhalation 18 mcg.

Solution for inhalation with inhaler Spiriva Respimat.

Instructions for use and how to use them

Capsules with powder

Assign 1 capsule per day at the same time in the form of inhalations with the aid of the HandiHaler inhaler.

The drug should not be swallowed. Spiriva should not be used more than once a day.Capsules Spiriva should be used only with the inhaler HandiHaler.

Older patients should take the drug at recommended doses.

Patients can apply Spiriva in recommended doses for disorders of renal function. However, in the appointment of Spiriva in combination with other drugs, which are excreted mainly by the kidneys, it is necessary to monitor the condition of the patients. Patients with moderate or severe renal insufficiency (SC less than 50 mL / min) should be closely monitored.

Patients with hepatic impairment may take the drug at recommended doses.

How to use the inhaler HandiHaler

Inhaler HandiHaler is designed specifically for the use of Spiriva and is not designed to receive other drugs.

The inhaler includes: a dust cap, a mouthpiece, a base, a puncturing button, a central camera.

Using the HandiHaler

1. Open the dust cap by pressing the piercing button fully and then letting go.
2. Fully open the dust cap by lifting it upwards; then open the mouthpiece by lifting it up.
3. Immediately before use, get the Spiriva capsule from the blister and put it in the central chamber (it does not matter which side of the capsule is placed in the chamber).
4. Close the mouthpiece firmly until it clicks, and leave the dust cap open.
5. Hold the HandiHaler mouthpiece up, press the piercing button once to the end and then release; thus, an opening is formed through which the drug is released from the capsule during inspiration.
6. Completely exhale; never exhale into the mouthpiece.
7. Take HandiHaler in the mouth and tightly squeeze the lips around the mouthpiece; keeping your head straight, you should inhale slowly and deeply, but at the same time with enough force to hear the vibration of the capsule; inhale until the lungs are completely filled; then hold your breath as long as possible and take the HandiHaler out of your mouth; continue to breathe calmly; repeat procedures 6 and 7 for complete emptying of the capsule.
8. Next, open the mouthpiece again, remove and discard the used capsule. Close the mouthpiece and dust cap.

Cleaning the HandiHaler

The HandiHaler should be cleaned once a month. To do this, open the mouthpiece and dust cap, then open the base of the appliance by lifting the piercing button. Rinse the inhaler thoroughly in warm water until the powder is completely removed. HandiHaler should be wiped with a paper towel and leave to dry in the air for 24 hours with an open mouthpiece, base and a dust cap.After cleaning, the device is ready for subsequent use. If necessary, the outer surface of the mouthpiece can be cleaned with a damp but not wet cloth.

Opening the blister

Separate the strip of the blister along the perforated line. Open the blister strip immediately before use so that one capsule is completely visible. The capsule contains a small amount of powder, so it is not completely filled.

In case the capsule was accidentally opened and exposed to air, it should not be used. Neither in the device, nor in the blister, capsules should not be exposed to high temperatures, to sunlight.

Solution for inhalation

The recommended therapeutic dose is 2 inhalation doses of the Respipat inhaler spray (5 μg / dose) once a day, at the same time of day.

When treating bronchial asthma, the full therapeutic effect comes in a few days.

In elderly patients, patients with impaired liver function and patients with minor renal dysfunction (KK 50-80 ml / min), Spiriva Respimat preparation can be used at the recommended dose.

However, the use of the drug in patients with moderate or significant impairment of kidney function (QC less than 50 ml / min) should be carefully monitored.

COPD usually does not occur in children. Safety and effectiveness of the drug Spiriva Respimat in children have not been studied.

Rules of application of the inhaler Spiriva Respimat

Inserting a cartridge and preparing for use

Before using the inhaler for the first time, you must follow the steps below:

1. With the green cap closed, press the lock button and simultaneously remove the transparent sleeve by pulling it down.
2. Remove the cartridge from the package. Insert it with a narrow end into the inhaler until fixation. To ensure that the cartridge is fully inserted, press the cartridge hard on the hard surface. In this case, the bottom of the cartridge should not be flush with the lower edge of the inhaler, the lower part of the silver cartridge should be visible. After the cartridge is inserted into the inhaler, do not remove it.
3. Dress up the transparent sleeve again. After that, the cartridge should not be removed any more.

Preparation for the first use of the inhaler Spiriva Respimat

1. It is necessary to keep the inhaler Spiriva Respimat vertically with a green cap. It is necessary to turn the transparent sleeve in the direction of the red arrows indicated on the label, until it clicks (half-turn).
2. Remove the green cap.
3. To send the inhaler Spiriva Respimat down. Press the dose button. Close the green cap.

Steps a, b and c should be repeated until the appearance of an aerosol cloud.

Then repeat steps a, b and c 3 more times to ensure preparation of the inhaler for use.

Now the Spiriva Respimat inhaler is ready for use.

The implementation of these steps does not reduce the number of doses of the drug. After preparation, the Spiriva Respimat inhaler can release 30 doses (60 inhalations).

Use of the inhaler Spiriva Respimat

Use this inhaler only once a day. Each time you need to do 2 inhalations.

1. Keep the Spiriva inhaler upright vertically with a clothed green cap to prevent accidental release of the medication. Turn the transparent sleeve in the direction of the red arrows indicated on the label until it clicks (half-turn).

2. Remove the green cap. Exhale slowly and deeply. Cover tightly with the mouth end of the mouthpiece.The air opening of the inhaler should be free. Direct the inhaler to the back of the pharynx.

During a slow and deep inspiration through the mouth, you should press the dose button and continue inhaling as long as possible. Hold your breath for 10 seconds or as long as comfortable.

3. Repeat steps 1-2 to get the full dose. Use this inhaler only once a day. Each time you need to do 2 inhalations.

Close the green cap of the inhaler before using it again.

If the Spiriva Respimat inhaler has not been used for more than 7 days, you should direct it before use down and press the dose button once. If the inhaler has not been used for more than 21 days, repeat steps 4-6 until an aerosol cloud is obtained. Then repeat steps 4-6 three more times.

Determining the time when you need to start using a new inhaler

The inhaler Spiriva Respimat contains 30 doses (60 inhalations). The dose indicator shows how much the drug still remains. When the indicator of the inhaler shows on the red area of ​​the scale, it means that the medication remains for about 7 days (14 inhalations).In this period of time, you need to get a prescription for a new inhaler Spiriva Respimat.

When the indicator of the inhaler reaches the end of the red area of ​​the scale (ie when 30 doses are used), this means that the Spiriva Respimat inhaler is empty. The automatic blocking of the inhaler will occur. From now on, the turn of the transparent sleeve will not be possible.

After the first use, the Respirat Respirat inhaler should be disposed of no later than 3 months, even if not all of the medication has been applied.

Care of the inhaler

The mouthpiece and the metal part of the spray gun must be cleaned with a damp soft cloth at least once a week.

A slight discoloration of the mouthpiece does not affect the functioning of the inhaler. If necessary, wipe the inhaler also outside with a damp cloth.

Side effect

• dehydration;
• dizziness;
• insomnia;
• increased intraocular pressure, glaucoma;
• blurred vision;
• atrial fibrillation;
• tachycardia (including supraventricular tachycardia);
• a feeling of palpitations;
• cough;
• nose bleed;
• pharyngitis;
• dysphonia;
• paradoxical bronchospasm;
• laryngitis;
• sinusitis;
• slight transitory dryness of the pharyngeal mucosa;
• constipation;
• Candidiasis of the oral cavity;
• dysphagia;
• gastroesophageal reflux;
• gingivitis;
• glossitis;
• stomatitis;
• intestinal obstruction, including paralytic intestinal obstruction;
• skin infections and ulcers on the skin;
• dry skin;
• rash;
• itching;
• angioedema;
• hives;
• hypersensitivity, including immediate-type reactions;
• swelling of the joints;
• dysuria;
• retention of urine (more often in men with predisposing factors);
• urinary tract infection.

Contraindications

• 1 trimester of pregnancy;
• children and adolescents under 18 years of age (due to lack of data on effectiveness and safety);
• hypersensitivity to atropine or its derivatives, for example, ipratropium bromide, oxytropium bromide or to any component of the drug.

With caution, the drug should be used with closed angle glaucoma, prostatic hyperplasia, obstruction of the neck of the bladder.

Application in pregnancy and lactation

The drug is contraindicated for use in the first trimester of pregnancy.

In the second and third trimester of pregnancy and during lactation, the drug should be administered only in cases when,when the expected benefit of therapy for the mother exceeds the potential risk to the fetus or infant.

Data on the effect of the drug Spiriva on pregnancy are limited. In the study of reproductive toxicity in animals no indication of direct or indirect adverse effects of the drug has been obtained. As a precaution, it is preferable to refrain from using Spiriva during pregnancy.

There are no clinical data on the effect of tiotropium bromide during breastfeeding.

Use in children

Contraindicated in children and adolescents under the age of 18 years.

Application in elderly patients

Older patients should take the drug at recommended doses.

special instructions

The drug Spiriva is not intended for relief of acute attacks of bronchospasm.

After inhalation of Spiriva powder, the development of immediate-type hypersensitivity reactions is possible.

The process of inhalation Spiriva (as well as other inhaled drugs) can cause bronchospasm.

Patients with renal insufficiency (CC less than 50 ml / min) should be carefully monitored when Spiriva is prescribed.

Patients should be familiarized with the rules for using the inhaler.Do not let the powder get into the eyes. Pain in the eyes or discomfort, blurred vision, visual aureoles combined with red eyes, conjunctival stasis and corneal edema may indicate an acute attack of angle-closure glaucoma. If any combination of these symptoms develops, the patient should immediately consult a doctor. The use of only drugs that cause miosis, is not an effective method of treatment in this case.

One capsule contains 5.5 mg of lactose monohydrate.

The drug Spiriva Respimat, as a bronchodilator, applied once a day for maintenance treatment, should not be used as an initial therapy for acute attacks of bronchospasm or to eliminate acute symptoms. In the case of development of an acute attack, fast-acting beta2-agonists are used.

The drug Spiriva Respimat should not be used to treat bronchial asthma as first-line therapy. Patients should be advised against continued use of Spiriva Respimat to continue anti-inflammatory therapy (eg, inhaled glucocorticosteroids), even if symptoms decrease.

After application of the drug, immediate reactions of increased sensitivity can develop.

Spiriva Respimat should not be used more than once a day.

Cartridges Spiriva should be used only with the inhaler Respimat.

Impact on the ability to drive vehicles and manage mechanisms

Studies to study the effect of the drug on the ability to drive vehicles and control mechanisms have not been conducted. Causes of dizziness and blurred vision while using the drug may have a negative effect on the above ability.

Drug Interactions

Although no special studies of drug interaction have been conducted, tiotropium bromide has been used in conjunction with other drugs used to treat COPD, including sympathomimetic bronchodilators, methylxanthines, GCS for ingestion and inhalation, antihistamines, mucolytics, leukotriene modifiers, cromones, anti-IgE drugs; while there were no clinical signs of drug interaction.

Long-term combined use of tiotropium bromide with other m-cholin-blocking drugs has not been studied.Therefore, long-term joint use of the drug Spiriva Respimat with other m-holinoblokiruyuschimi drugs is not recommended.

Analogues of the drug Spiriva

Structural analogs for the active substance:

• Spiriva Respimat;
• Tiotropium bromide monohydrate.

Analogues on the curative effect (agents for the treatment of chronic obstructive pulmonary disease):

• Ambroxol;
• Amoxiclav;
• Amoxicillin;
• Asthmopent;
• ATSTS;
• ATSTS Long;
• Beclomethasone;
• Benacorte;
• Brilid;
• Budesonide;
• Witsef;
• Daxas;
• Doxycycline;
• Imunofan;
• Iprimol;
• Ipratropium;
• Clenbuterol;
• Kodelak Broncho;
• Lendacin;
• Lycopid;
• Nacef;
• Oriprim;
• Perti;
• Pefloxacin;
• Picillin;
• Pulmicort Turbuhaler;
• Pulmonizing;
• Salamol Eco Light Breathing;
• Salbutamol;
• Symbicort Turbuhaler;
• Spiriva Respimat;
• Super;
• Tazocine;
• Tarcephandol;
• Tarcephoxime;
• Tevakomb;
• Theophylline;
• Tertsef;
• Flavamed;
• Flukloxacillin;
• Ofomyl uno;
• Haliksol;
• Cefabol;
• Ceftriabal;
• Cibutaps Cyclocaps;
• Ciprofloxacin;
• Erdomed.

Similar medicines:

Other medicines: