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Spiriva® respimat®

The recommended therapeutic dose is 2 inhalation doses of Respimat® inhaler spray (5 mcg/dose) 1 time/day, at the same time of day.

In elderly patients, patients with impaired liver function and patients with minor impaired renal function (creatinine clearance 50-80 ml/min)

you can use the drug Spiriva® Respimat® at the recommended dose.

However, the use of the drug in patients with moderate or significant renal impairment (creatinine clearance less than 50 ml/min)

should be carefully monitored.

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

have not been studied.

Rules for using the Spiriva® Respimat® inhaler

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

Inserting a cartridge

1. With the green cap closed, press the locking button and remove the transparent sleeve down.

2. Remove the cartridge from the packaging. Insert the thin end into the inhaler until it locks into place. To ensure that the cartridge is fully inserted, gently press the cartridge onto a hard surface. Once the cartridge is inserted into the inhaler, there is no need to remove it.

3. Put the transparent sleeve back on. After this, the sleeve should no longer be removed.

Preparing to use your inhaler for the first time

4. The inhaler should be held vertically with the green cap on. You need to turn the transparent sleeve in the direction of the red arrows indicated on the label until it clicks (half a turn).

5. Remove the green cap.

6. Point the inhaler down. Press the dose button. Close the green cap.

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

Then repeat steps 4, 5 and 6 three more times to ensure the inhaler is ready for use.

The Spiriva® Respimat® inhaler is now ready for use.

The implementation of these steps does not reduce the number of doses of the drug. Once prepared, the Spiriva® Respimat® inhaler delivers 30 doses (60 inhalations).

Using an inhaler

I. Hold the inhaler upright with the green cap on 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 a turn).

II. Remove the green cap. Exhale slowly and deeply. Cover the end of the mouthpiece tightly with your lips. The air hole of the inhaler must be free. Point the inhaler towards the back of the throat.

While inhaling slowly and deeply through your mouth, press the dose button and continue inhaling as long as possible. Hold your breath for 10 seconds or as long as comfortable.

III. Repeat steps I-II to obtain the full dose. This inhaler should only be used once a day.

Close the green cap of the inhaler until you use it again.

If the Spiriva® Respimat® inhaler has not been used for more than 7 days, you should point it down before use 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 when to start using a new inhaler

The Spiriva® Respimat® inhaler contains 30 doses (60 inhalations). The dose indicator shows approximately how much of the drug is left. When the inhaler pointer points to the red area of the scale, this means there is approximately 7 days of medication left (14 inhalations). During this time, you must obtain a prescription for a new Spiriva® Respimat® inhaler.

When the inhaler pointer reaches the end of the red area of the scale (i.e. when 30 doses have been used), this means that the inhaler is empty. The inhaler will be automatically blocked. From this point on, turning the transparent sleeve will not be possible.

After the first use, the Spiriva® Respimat® inhaler must be discarded no later than after 3 months, even if not the entire amount of the medicine has been used.

Caring for your inhaler

The mouthpiece and metal part of the atomizer must be cleaned with a damp, soft cloth at least once a week. Slight discoloration of the mouthpiece does not affect the functioning of the inhaler. If necessary, wipe the outside of the inhaler with a damp cloth.

SPIRIVA RESPIMAT

Pharmacokinetics

Tiotropium bromide is a quaternary ammonium derivative, sparingly soluble in water.
Tiotropium bromide is available as an inhalation solution, which is used with the RESPIMAT inhaler. Approximately 40% of the inhalation dose is deposited in the lungs, the rest enters the gastrointestinal tract. Some pharmacokinetic data described below were obtained using doses higher than those recommended for treatment.

Suction

After inhalation of the solution by young healthy volunteers, it was found that about 33% of the inhalation dose enters the systemic circulation. Taking pitti does not affect the absorption of tiotropium bromide, due to this. that it is poorly absorbed from the gastrointestinal tract.

Absolute bioavailability when taken orally is 2 - 3%. The maximum concentration in plasma is observed 5-7 minutes after inhalation. At the dynamic equilibrium stage, the peak plasma concentration of tiotropium in patients with COPD is 10.5 pg/ml and decreases rapidly. This indicates a multicompartmental type of drug distribution. At the stage of dynamic equilibrium, the basal concentration of tiotropium in the blood plasma is 1.6 pg/ml. At the stage of dynamic equilibrium, the peak concentration of tiotropium in blood plasma in patients with bronchial asthma was 5.15 pg/ml and was achieved after 5 minutes. Distribution

The binding of the drug to plasma proteins is 72%; volume of distribution 32 l/kg. Studies have shown that tiotropium bromide does not penetrate

blood-brain barrier. Biotransformation

The degree of biotransformation is insignificant. This is confirmed by the fact that after intravenous administration of the drug to young healthy volunteers, 74% of the substance tiotropium bromide in unchanged form is found in the urine. Tiotropium bromide is an ester that is cleaved into ethanol-M-methylscopine. and dithienylglycolic acid; these compounds do not bind to muscarinic receptors.

in vitro studies

it has been shown that some part of the drug (<20% of the dose after intravenous administration) is metabolized by oxidation by cytochrome P450, followed by conjugation with glutathione and the formation of various metabolites. This mechanism can be inhibited by inhibitors of the CYP450 isoenzymes 2D6 and 3A4, quinidine, ketoconazole and gestodene. Thus, CYP450 2D6 and 3A4 are involved in metabolism. Tiotropium bromide, even at supratherapeutic concentrations, does not inhibit cytochrome P450 1A1, 1A2, 2B6, 2C9, 2C19, 2D6, 2E1 or 3A in human liver microsomes.

Removal

The terminal half-life of tiotropium bromide after inhalation is 27 to 45 hours in patients with COPD. In patients with asthma, the effective half-life after inhalation is 34 hours.

The total clearance after intravenous administration of the drug to young healthy volunteers was 880 ml/min. Tiotropium bromide after intravenous administration is mainly excreted unchanged by the kidneys (74%). After inhalation of the solution in patients with COPD, renal excretion is 18.6% (0.93 mcg), the remaining unabsorbed portion is excreted through the intestine. At the pharmacokinetic equilibrium stage in patients with asthma, 11.9% (0.595 mcg) of the dose is excreted unchanged in the urine 24 hours after taking the drug. The renal clearance of tiotropium bromide exceeds the clearance of creatinine, indicating its tubular secretion. After long-term inhalation administration of the drug once a day by patients with COPD, pharmacokinetic equilibrium is achieved on day 7; however, no further accumulation is observed.

Tiotropium bromide has linear pharmacokinetics within therapeutic limits after intravenous administration, dry powder inhalation and solution inhalation. Pharmacokinetics in elderly patients

In old age, there is a decrease in renal clearance of tiotropium

(347 ml/min in patients with COPD under the age of 65 years and 275 ml/min in patients with COPD and asthma over 65 years of age), It has been established that in patients with bronchial asthma, the effect of tiotropium bromide does not depend on the age of the patients.

Patients with impaired renal function

After inhaled once-daily administration of tiotropium during steady-state pharmacokinetics in patients with COPD and mild renal impairment (creatinine clearance 50-80 ml/min), there was a slight increase in AUC0-6.ss by 1.8-30% and Cmax ,Ss compared with patients with normal renal function (creatinine clearance >80 ml/min). In patients with COPD and moderate to severe renal impairment (creatinine clearance <50 mL/min), intravenous tiotropium bromide resulted in a twofold increase in total exposure (AUC0-44 increased by 82% and Cmax increased by 52%) compared with patients with COPD and normal renal function. A similar increase in plasma concentration was noted after inhalation of the dry powder.

In patients with bronchial asthma and mild renal impairment (creatinine clearance 50-80 ml/min), inhaled tiotropium bromide did not lead to a significant increase in exposure compared to patients with normal renal function.

Patients with liver dysfunction

It is assumed that liver failure does not have a significant effect on the pharmacokinetics of tiotropium bromide, since tiotropium bromide is primarily excreted by the kidneys and by non-enzymatic cleavage of the ester bond to form derivatives that do not have pharmacological activity.

Spiriva (with inhal Handihaler) por d/inhal caps 18 µg N30

Registration Certificate Holder

BOEHRINGER INGELHEIM INTERNATIONAL (Germany)

Dosage form

Medicine - Spiriva®

Description

Capsules with powder for inhalation

hard gelatin, size No. 3, light greenish-blue color, opaque; with the symbol printed in black ink; the contents of the capsules are white powder.

1 caps.

tiotropium bromide monohydrate 22.5 mcg, which corresponds to a tiotropium content of 18 mcg

Excipients

: lactose monohydrate, 200 M - 5.2025 mg, micronized lactose monohydrate - 0.2750 mg.

Capsule composition (mg/capsule):

macrogol - 2.4000 mg, indigo carmine (E132) - 0.0120 mg, titanium dioxide (E171) - 1.0240 mg, yellow iron oxide (E172) - 0.0120 mg, gelatin - 44.5160 mg.

10 pieces. - blisters (1) - cardboard packs. 10 pieces. - blisters (3) - cardboard packs. 10 pieces. - blisters (6) - cardboard packs. 10 pieces. — blisters (1) complete with the HandiHaler® inhaler — cardboard packs. 10 pieces. - blisters (3) complete with the HandiHaler® inhaler - cardboard packs. 10 pieces. - blisters (6) complete with the HandiHaler® inhaler - cardboard packs.

Indications

as maintenance therapy in patients with COPD, including chronic bronchitis and emphysema (maintenance therapy for persistent shortness of breath and to prevent exacerbations).

Contraindications for use

I trimester of pregnancy;
children and adolescents up to 18 years of age;
hypersensitivity to atropine or its derivatives (including ipratropium and oxitropium);
hypersensitivity to the components of the drug.

Carefully

The drug should be used for angle-closure glaucoma, prostatic hyperplasia, and bladder neck obstruction.

pharmachologic effect

Long-acting m-cholinergic receptor blocker.

It has equal affinity for various muscarinic receptor subtypes from M1 to M5. As a result of inhibition of M3 receptors in the airways, smooth muscles relax. The bronchodilator effect is dose dependent and lasts for at least 24 hours. The significant duration of action is probably due to a very slow release from M3 receptors compared to ipratropium bromide. When administered by inhalation, tiotropium bromide, as an anticholinergic agent of N-quaternary structure, has a local selective effect, while in therapeutic doses it does not cause systemic anticholinergic side effects. The release of tiotropium bromide from the connection with the M2 receptors occurs faster than from the connection with the M3 receptors. High affinity for receptors and slow release from binding to them determine an intense and long-lasting bronchodilator effect in patients with COPD.

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

Clinical studies have shown that 30 minutes after a single dose of Spiriva® for 24 hours significantly improves lung function (increased FEV1 and FVC). Pharmacodynamic equilibrium was achieved within the 1st week, and a pronounced bronchodilator effect was observed on the 3rd day. Spiriva® significantly increases morning and evening peak expiratory flow rates measured by patients. The bronchodilator effect of Spiriva, assessed over a year, did not reveal any manifestations of tolerance.

Spiriva® significantly reduces shortness of breath throughout the treatment period. In two randomized, double-blind, placebo-controlled studies, Spiriva® was shown to significantly improve exercise capacity compared with placebo.

Significantly improves the quality of life, which is observed throughout the entire treatment period. Spiriva® significantly reduces the number of hospitalizations associated with exacerbation of COPD and increases the time to first hospitalization.

Spiriva® has also been shown to result in sustained improvements in FEV1 after 4 years of use, with no change in the rate of annual decline in FEV1.

During treatment, there was a 16% reduction in the risk of death.

Compared with salmeterol, Spiriva increased the time to first exacerbation (187 versus 145 days), with a 17% reduction in the risk of exacerbations (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P < 0.001). Also, taking Spiriva® increases the time of onset of the first severe (requiring hospitalization) exacerbation (risk ratio 0.72; 95% CI 0.61 to 0.85; P <0.001) and reduces the annual number of moderate or severe (requiring hospitalization) exacerbations (0.64 versus 0.72; risk ratio 0.89; 95% CI 0.83 to 0.96; P=0.002), reduces the annual number of severe (requiring hospitalization) exacerbations (0.09 vs. 0.13; risk ratio 0.73; 95% CI 0.66 to 0.82; P<0.001).

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. Combined use with long-acting beta2-agonists, inhaled corticosteroids and their combinations does not affect the effect of tiotropium.

Limited information on combined use with anticholinergic drugs comes from two clinical studies: a single dose of ipratropium bromide during chronic administration of Spiriva in patients with COPD (64 people) and healthy volunteers (20 people) did not reduce adverse reactions, changes in vital parameters and ECG. However, the chronic combined use of anticholinergic drugs and Spiriva® has not been studied and is therefore not recommended.

Dosage regimen

Prescribed 1 capsule/day at the same time in the form of inhalations using the HandiHaler® inhaler.

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

Elderly patients

The drug should be taken in recommended doses.

For impaired renal function

patients can use Spiriva® in recommended doses.
However, careful monitoring is required in patients with moderate or severe renal impairment
receiving Spiriva (as with other drugs excreted primarily by the kidneys).

Patients with liver failure

can take the drug in recommended doses.

How to use the HandiHaler® inhaler

The HandiHaler® inhaler is designed specifically for the use of Spiriva and is not intended for use with other medications. The patient can use their HandiHaler® for one year.

The inhaler includes: dust cap, mouthpiece, base, piercing button, central chamber.

Using the HandiHaler® inhaler:

1. Open the dust cap by pressing the piercing button fully and then releasing it.

2. Open the dust cap completely by lifting it up; then open the mouthpiece by lifting it up.

3. Immediately before use, remove the Spiriva capsule from the blister and place it in the central chamber (it does not matter which side the capsule is placed in the chamber).

4. Close the mouthpiece tightly until it clicks, leaving the dust cap open.

5. Holding the HandiHaler® with the mouthpiece facing up, press the piercing button all the way once and then release; This creates an opening through which the drug is released from the capsule during inhalation.

6. Exhale completely; never exhale into the mouthpiece.

7. Place HandiHaler® in your mouth and press your lips tightly around the mouthpiece; keeping your head straight, you should inhale slowly and deeply, but at the same time with enough force to hear or feel the vibration of the capsule; inhale until your lungs are completely filled; then hold your breath as long as possible and remove the HandiHaler® from your mouth; continue to breathe calmly; repeat procedures 6 and 7 to completely empty the capsule.

8. Next, you should open the mouthpiece again, remove and discard the used capsule. Close the mouthpiece and dust cap.

Cleaning the HandiHaler® inhaler

HandiHaler® should be cleaned once a month. To do this, open the mouthpiece and dust cap, then open the base of the device 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 with the mouthpiece, base and dust cap open, left to air dry for 24 hours. Once cleaned in this manner, the device is ready for subsequent use. If necessary, the outer surface of the mouthpiece can be cleaned using a damp, but not wet, cloth.

Opening the blister

Separate the blister strip 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.

If the capsule is accidentally opened and exposed to air, it should not be used. Neither in the device nor in the blister, capsules should be exposed to high temperatures or exposure to sunlight.

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.

Side effect

From the side of metabolism:

dehydration*.

From the digestive system:

often (≥1% and <10%) – dry mouth, usually mild; uncommon (≥0.1% and <1%) – stomatitis, constipation, gastroesophageal reflux; rarely (≥0.01% and <0.1%) – oropharyngeal candidiasis, gingivitis, glossitis; intestinal obstruction, including paralytic ileus, dysphagia.

From the respiratory system:

infrequently (≥0.1% and <1%) - dysphonia, cough, pharyngitis; rarely (≥0.01% and <0.1%) – paradoxical bronchospasm, laryngitis, sinusitis, nosebleeds.

From the cardiovascular system:

uncommon (≥0.1% and <1%) - atrial fibrillation; rarely (≥0.01% and <0.1%) – tachycardia (including supraventricular tachycardia), palpitations.

From the urinary system:

uncommon (≥0.1% and <1%) - difficulty urinating and urinary retention (in men with predisposing factors), dysuria; rarely (≥0.01% and <0.1%) - urinary tract infections.

Allergic reactions:

uncommon (≥0.1% and <1%) - rash; rarely (≥0.01% and <0.1%) - urticaria, itching, hypersensitivity reactions, including immediate reactions, angioedema*.

From the skin:

skin infections and skin ulcers, dry skin*.

From the musculoskeletal system:

swelling of the joints*.

From the nervous system:

uncommon (≥0.1% and <1%) - dizziness;
rarely - (≥0.01% and <0.1%) - insomnia. From the organ of vision:
infrequently (≥0.1% and <1%) - blurred vision; rarely - (≥0.01% and <0.1%) - increased intraocular pressure, glaucoma.

* these adverse reactions were not identified in the combined database of clinical studies; There have been only isolated reports of these adverse reactions with widespread use of the drug, but the connection with the m-anticholinergic effect of the drug Spiriva® has not been proven; the frequency of these rare events is difficult to estimate.

special instructions

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

After inhalation of Spiriva powder, immediate hypersensitivity reactions may develop.

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

Patients with renal insufficiency (creatinine clearance ≤50 ml/min) should be carefully monitored when prescribing Spiriva.

Patients should be familiarized with the rules for using the inhaler. Do not allow the powder to get into your eyes. Eye pain or discomfort, blurred vision, visual halos in combination with eye redness, conjunctival congestion and corneal edema may indicate an acute attack of angle-closure glaucoma. If any combination of these symptoms develops, the patient should consult a doctor immediately. The use of only drugs that cause miosis is not an effective treatment in this case.

One capsule contains 5.5 mg of lactose monohydrate.
Effect on the ability to drive vehicles and operate machines.
No studies have been conducted to study the effect of the drug on the ability to drive vehicles and operate machines. Cases of dizziness and blurred vision while using the drug may have a negative impact on the above-mentioned ability.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C; do not freeze.

Best before date

Shelf life: 2 years.

Once opened, the blister should be used within 9 days.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

Data on the use of tiotropium in human pregnancy are limited. Animal studies provide no indication of direct or indirect adverse effects on pregnancy, embryo/fetal development, childbirth or postnatal development.

As a precaution, it is preferable to avoid using Spiriva during pregnancy.

There are no clinical data on the use of tiotropium in breastfeeding women. Preclinical studies have shown that small amounts of tiotropium are excreted into breast milk.

Spiriva® should not be used in pregnant or breastfeeding women unless the expected benefit outweighs the possible risk to the fetus or child.

Use for renal impairment

Restrictions for impaired renal function - With caution.

For impaired renal function

patients can use Spiriva in recommended doses.
However, when prescribing Spiriva in combination with other drugs that are excreted primarily by the kidneys, monitoring the patient’s condition is necessary. Patients with moderate or severe renal insufficiency (creatinine clearance≤50 ml/min)
require careful monitoring.

Use for liver dysfunction

Restrictions for liver dysfunction - No restrictions. Patients with liver failure

can take the drug in recommended doses.

Use in elderly patients

Restrictions for elderly patients - No restrictions.

Elderly patients

The drug should be taken in recommended doses.

Use in children

Restrictions for children - Contraindicated.

Contraindicated for use in children and adolescents under 18 years of age.

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

BERINGER INGELHEIM INTERNATIONAL GmbH (Germany)

Boehringer Ingelheim LLC

125171 Moscow Leningradskoe highway 16A, building 3 Tel. Fax

Instructions for use of SPIRIVA

Tiotropium is a quaternary ammonium compound, sparingly soluble in water.

After inhalation in powder form over a therapeutic dose range, it exhibits linear pharmacokinetics.

Suction

When administered by inhalation, the absolute bioavailability of tiotropium is 19.5%, which indicates the high bioavailability of the drug fraction reaching the lungs. Cmax in blood plasma is achieved 5 minutes after inhalation. Tiotropium is poorly absorbed from the gastrointestinal tract. For the same reason, food intake does not affect the absorption of tiotropium. When taken orally, tiotropium in solution form had an absolute bioavailability of 2-3%.

Distribution

Plasma protein binding - 72%. Vd - 32 l/kg. At steady state, Cmax in blood plasma in patients with COPD is 17-19 pg/ml 5 minutes after inhalation of powder at a dose of 18 mcg and decreases rapidly. Css in blood plasma was 3-4 pg/ml.

Does not penetrate the BBB. After long-term administration 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.

Metabolism

The degree of biotransformation is insignificant. Tiotropium is broken down nonenzymatically to the alcohol N-methylscopine and dithienylglycolic acid, which do not bind to muscarinic receptors.

Metabolic disorders are possible with the use of inhibitors of the cytochrome P450 system isoenzymes 2D6 and 3A4 (quinidine, ketoconazole, gestodene). Tiotropium, even at supratherapeutic concentrations, does not inhibit cytochrome P450 isoenzymes 1A1, 1A2, 2B6, 2C9, 2C19, 2D6, 2E1 or 3A4 in human liver microsomes.

Removal

After inhalation administration, terminal T1/2 is 5-6 days.

After inhalation of the powder, renal excretion is 14%, the rest, not absorbed in the intestine, is excreted in the feces. The renal clearance of tiotropium exceeds CC, indicating tubular secretion of the drug.

Tiotropium is excreted mainly in the urine unchanged - 74%.

Pharmacokinetics in special clinical situations

In elderly patients, a decrease in the renal clearance of tiotropium is observed (326 ml/min in patients with COPD under 58 years of age, to 163 ml/min in patients with COPD over 70 years of age), which is apparently due to a decrease in renal function with age. After inhalation, urinary excretion of tiotropium is reduced from 14% (young healthy volunteers) to 7% (patients with COPD), but no significant changes in plasma concentrations were observed in elderly patients with COPD when inter- and intra-individual variability was taken into account (after inhalation powder increases AUC0-4 by 43%).

If renal function is impaired after inhalation use, the concentration of the drug in the blood plasma increases and renal clearance decreases. With mild renal impairment (creatinine clearance 50-80 ml/min), often observed in elderly patients, the increase in plasma tiotropium concentration is insignificant.

It is expected that hepatic impairment will not have a significant effect on the pharmacokinetics of tiotropium because the drug is mainly excreted in the urine and the formation of pharmacologically active metabolites is not associated with the participation of enzymes.