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Instructions

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Instruction for use: Spiriva

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Active substance: Tiotropium bromide

ATX Code

R03BB04 Tiotropium bromide

Pharmacological group

M Cholinolytics

The nosological classification (ICD-10)

J22 Acute respiratory infection of lower respiratory tract, unspecified

Bacterial respiratory disease, Bacterial infections of the lower respiratory tract, Bacterial infections of the respiratory system, Viral respiratory disease, Viral respiratory tract infections, Inflammatory respiratory diseases, Difficult sputum separation in acute and chronic respiratory diseases, Respiratory tract infections, Respiratory and lung infections, Lower respiratory tract infections, Infections of the lower respiratory tract, Infectious inflammation of the respiratory tract, Infectious diseases of the respiratory tract, Infectious diseases of the lungs, Infectious diseases of the respiratory system, Respiratory tract infection, Cough for colds, Pulmonary infection, Acute respiratory tract infection, Acute respiratory viral infection, Acute inflammatory airway disease, Acute respiratory disease, Respiratory infection, Respiratory and viral infections, Respiratory syncytial viral infection in young children, Respiratory diseases, Respiratory infections

J42 Chronic bronchitis, unspecified

recurrent bronchitis, Bronchitis asthma, wheeze bronchitis, chronic Bronchitis, Inflammatory airways disease, bronchi disease, Qatar smoker, Cough in inflammatory diseases of the lung and bronchus, Exacerbation of Chronic Bronchitis, Chronic bronchitis, Chronic obstructive pulmonary disease, Chronical bronchitis, Chronic bronchitis smokers, Chronic spastic bronchitis, allergic Bronchitis

J44.9 Chronic obstructive pulmonary disease, unspecified

Obstructive pulmonary diseases, Bronchial obstruction, bronchial obstruction, Exacerbation of chronic obstructive pulmonary disease, reversible airflow obstruction, Reversible airway obstruction, panbronchiolitis, Panbronhit, COPD, Chronic pulmonary infection, Chronic infection of the lower respiratory tract, Chronic obstructive pulmonary disease, Chronic obstructive pneumonia, Chronic lung disease, Chronic obstructive pulmonary disease, Chronic bronchopulmonary disease, Chronic broncho-pulmonary diseases, Airway obstruction

Structure and Composition

Capsules with powder for inhalation 1 caps.

Tiotropium bromide 18 μg

(Corresponding to 22.5 μg of tiotropium bromide monohydrate)

Excipients: lactose monohydrate

In a planar cell pack of 10; In a pack of cardboard 1, 3 or 6 packs complete with a HandyHaler inhaler or without an inhaler.

Description of dosage form

Hard gelatin capsules are light greenish-blue, opaque.

The contents of the capsules are a white powder.

pharmachologic effect

The pharmacological action is bronchodilating, anticholinergic.

The result of inhibition of M3 receptors in the respiratory tract is the relaxation of the smooth muscles of the bronchi. High affinity for M3 receptors and slow dissociation from them cause a pronounced and prolonged bronchodilator effect when inhaled in patients with chronic obstructive pulmonary disease (COPD).

Pharmacodynamics

The bronchodilator effect is a consequence of local rather than systemic action, depends on the dose and is maintained for at least 24 hours. The studies showed that the drug significantly increases lung function (volume of forced expiration in 1 s) and vital capacity of the lungs 30 minutes after a single dose For 24 hours. Pharmacodynamic equilibrium was achieved during the first week, and pronounced bronchodilator effect was observed on the third day. Assessment of bronchodilator effect throughout the year did not reveal the manifestation of tolerance. The drug reduces the number of exacerbations of COPD, prolongs the period until the first exacerbation compared with placebo, improves quality of life throughout the treatment period, reduces the number of hospitalizations associated with exacerbation of COPD and prolongs the time until the first hospitalization.

Pharmacokinetics

In the inhalation mode of administration, the absolute bioavailability of tiotropium bromide is 19.5%, which provides high concentrations in the lungs and a negligible effect on the body as a whole. Based on the chemical structure (quaternary ammonium compound), tiotropium bromide is poorly absorbed from the digestive tract. For the same reason, eating does not affect the absorption of tiotropium bromide. Cmax after inhalation of the powder in a dose of 18 mcg is achieved after 5 minutes and is in patients with COPD 17-19 pg / ml, the equilibrium concentration in the plasma is 3-4 pg / ml. Binding to plasma proteins is 72%, the volume of distribution is 32 l / kg. Does not penetrate the BBB.

Biotransformation is insignificant, which is confirmed by the fact that after intravenous administration of the drug to young healthy volunteers in urine 74% of unchanged tiotropium is detected. Tiotropium is cleaved by a non-enzymatic method to alcohol N-methylscopin and dithienylglycolic acid, which do not bind to muscarinic receptors. Even at ultra-high doses, tiotropium does not inhibit cytochrome P450, 1A1, 1A2, 2B6, 2C9, 2C19, 2D6, 2E1 or 3A in human liver microsomes.

After inhalation, the terminal T1 / 2 is 5-6 days, excreted by the kidneys (14% of the dose), the remaining (unabsorbed in the intestine) part - with feces.

Indications As maintenance therapy in patients with COPD, including chronic bronchitis and emphysema (with persistent dyspnea and to prevent exacerbations).

Contraindications

Hypersensitivity (including to atropine or its derivatives, for example, ipratropium or oxotropy), I trimester of pregnancy, age to 18 years.

pregnancy and lactation

Contraindicated in the first trimester of pregnancy. In the remaining periods of pregnancy and breastfeeding - only if the expected benefit exceeds any possible risk to the fetus or baby.

Side effects

On the part of the intestine: dry mouth (usually mild, often disappears when continuing treatment), constipation.

On the part of the respiratory system: cough, local irritation, it is possible to develop bronchospasm, as well as when taking other inhalants.

Other: tachycardia, difficulty or delay in urination (in men with predisposing factors), angioedema, fuzzy vision, acute glaucoma (associated with anticholinergic action).

Interaction

It is not recommended simultaneous use with other anticholinergics.

It is possible to use tiotropium bromide in combination with other drugs commonly used to treat COPD, such as sympathomimetics, methylxanthines, oral and inhaled steroids.

Dosing and Administration

Inhalation with a HandiHaler device, 1 caps. Per day at the same time. Capsules should not be swallowed.

Elderly people, patients with impaired renal or hepatic function, may apply the drug at recommended doses.

Instructions for the use of HandiHaler

The HandyHaler was specially developed for Spiriva, it is used for 1 year. Do not use it to take other medications.

The HandyHaller device includes:

1) a dustproof cap;

2) the mouthpiece;

3) the base;

4) the puncturing button;

5) the central chamber.

Using the HandiHalleer

Open the dust cap by lifting it upwards.

Then open the mouthpiece.

Get the Spiriva capsule from the blister (just before use) and put it in the central chamber. It does not matter which side of the capsule is placed in the camera.

Close the mouthpiece firmly until it clicks, and leave the dust cap open.

Holding HandyHaler with the mouthpiece up, press the piercing button 1 time to the end and then release. Thus, an opening is formed through which the drug is released from the capsule during inspiration.

It is necessary to make a full exhalation without exhaling into the mouthpiece, then take HandyHaler in his mouth and tightly compress his lips around the mouthpiece. Holding your head straight, inhale slowly and deeply, but at the same time with enough force to hear the vibration of the capsule. Take a deep breath; Then hold your breath until you feel discomfort, while taking out HandyHaler from your mouth. Continue breathing peacefully.

Repeat procedure for complete emptying of the capsule.

Open the mouthpiece again. Remove and discard the used capsule.

Close the mouthpiece and the dust cap.

Purge KhandiHalera spend 1 time per month.

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 wipe with a paper towel and leave the mouthpiece, base and dust cap left to dry in air for 24 hours. After cleaning the device according to the instructions, it is ready for the next 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.

Open the strip of blister immediately before use so that one capsule is completely visible.

Get the capsule.

Neither in the device nor in the blister the capsules should be exposed to high temperatures, i.e. The action of solar rays, etc.

Overdose

Symptoms: dry mouth, disruption of accommodation, increased heart rate.

Treatment: symptomatic therapy.

Precautionary measures

Careful observation of patients with moderate or severe renal failure receiving the drug in combination with other drugs excreted, mainly by the kidneys, is necessary.

Be wary appoint patients with narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder.

special instructions

The drug can not be used as a means of initial therapy for acute attacks of bronchospasm (that is, in urgent cases).

As with other inhaled medications, immediate reactions of hypersensitivity may develop after inhalation.

Do not let the powder get into your eyes.

The drug should only be used with a HandyHaler device.

Storage conditions

At a temperature not higher than 25 C (do not freeze). Do not expose to freezing.

Keep out of the reach of children.

Shelf life

24 months

Do not use after the expiry date printed on the package.

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