Index of drugs

COPD. Bronchodilator in maintenance therapy to relieve symptoms in patients with chronic obstructive pulmonary disease.Asthma. The drug is indicated as an additional bronchodilator in maintenance therapy in adult asthmatic patients who are currently treated with inhaled corticosteroids (≥800 μg Budesonide / day or equivalent dose of another inhaled corticosteroid) in combination with long-acting β₂- those who have had one or more severe exacerbations of the disease in the last year.

1 metered dose contains 2.5 μg of tiotropium (as the monohydrate tiotropium bromide); 1 spray dose consists of 2 sprays.

Anticholinergic drug - a long-acting, selective antagonist of muscarinic receptors in the airways, causing bronchospasm. By binding to the muscarinic receptors of the bronchial smooth muscle, it inhibits the cholinergic (bronchoconstrictor) effect of acetylcholine. The effect of the drug depends on the dose and persists for over 24 hours. The inhaler has a selective, local effect on the bronchi. After inhalation, approximately 40% of the dose is deposited in the target organ, i.e. in the lungs, the remainder of the dose in the gastrointestinal tract. Approx. 33% of the inhaled dose enters the circulatory system. The highest plasma concentration of tiotropium occurs 5-7 minutes after inhalation. C_max Steady-state plasma is 5 min after the same dose is administered to patients with asthma. The drug is 72% bound to plasma proteins. The degree of biotransformation is small. T_0,5 in the final phase of elimination in healthy volunteers and patients with COPD is 27-45 hours after inhalation. Effective T_0,5 in asthmatic patients is 34 h. After administration of the drug as a solution for inhalation to patients with COPD to a steady state 18.6% of the administered dose is excreted in the urine, the remainder of the dose, mainly unabsorbed in the gut, excreted in the faeces. In patients with asthma, 11.9% of the dose is excreted unchanged in the urine over a 24 h period after steady state dosing. After chronic inhalations administered once a day in patients with COPD, the pharmacokinetic steady state was reached after 7 days without further accumulation.

Hypersensitivity to tiotropium bromide, atropine or its derivatives (such as ipratropium or oxitropium) or to any of the excipients.

The preparation should not be used as an initial treatment for acute attacks of bronchial spasm or for the relief of acute symptoms of the disease. In the event of an acute bronchial spasm attack, a fast-acting β should be used₂-agonistę. It should not be used to treat asthma as a monotherapy (first-line treatment). Patients with asthma should be instructed not to discontinue the use of anti-inflammatory medications, i.e. inhaled corticosteroids, even after their health has improved. After applying the preparation, reflex bronchoconstriction and immediate hypersensitivity reactions may occur. Caution should be exercised in patients with narrow-angle glaucoma, prostatic hyperplasia or narrowing of the bladder neck. Tiotropium should be used with caution in patients with a recent myocardial infarction (<6 months); any unstable or life-threatening arrhythmia or arrhythmia requiring intervention, or a change in drug therapy over the last year; hospitalization for heart failure (NYHA class III or IV) during the last year. Such patients were excluded from clinical trials, because the anticholinergic mechanism of action of the drug may affect the above conditions. In patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml / min), tiotropium bromide should only be used if the expected benefit to the patient outweighs the potential risk. There is no long-term experience with the use of tiotropium bromide in patients with severe renal impairment. Do not allow the tiotropium bromide to get into your eyes when inhaled.This can cause or exacerbate the symptoms of narrow-angle glaucoma, eye pain or discomfort, transient blurred vision, seeing a rainbow rim around the light source, or altered color vision with eye redness induced by conjunctival congestion and corneal edema. In the event of any of these symptoms, the patient should discontinue the use of tiotropium bromide and immediately consult a specialist. Dryness of the oral mucosa observed during anticholinergic treatment may cause tooth decay after a long time. The preparation is not recommended for use in cystic fibrosis (cystic fibrosis may increase the symptoms and signs of cystic fibrosis).

In case of caution, avoid using the drug during pregnancy. It is not known whether tiotropium bromide is excreted in human milk. The use is not recommended during breastfeeding. The decision to continue or terminate breastfeeding or to continue or stop taking the medicine should be made taking into account the benefits for the child resulting from breastfeeding and the benefits for the mother from the use of the drug.

COPD. Common: dryness of the oral mucosa. Uncommon: dizziness, headache, cough, pharyngitis, dysphonia, constipation, candidiasis of the mouth and throat, rash, pruritus, urinary retention, painful or difficult urination. Rare: insomnia, glaucoma, increased intraocular pressure, blurred vision, atrial fibrillation, palpitations, supraventricular tachycardia, nosebleeds, bronchospasm, laryngitis, dysphagia, gastroesophageal reflux disease, tooth decay, gingivitis, inflammation of the tongue, edema vasomotor, urticaria, skin infection, skin ulcer, dry skin, urinary tract infection. Not known: dehydration, sinusitis, stomatitis, intestinal obstruction (including paralytic intestinal obstruction), nausea, hypersensitivity (including immediate reactions), anaphylactic reactions, swelling of the joints.Asthma. Common: dryness of the oral mucosa. Uncommon: dizziness, headache, insomnia, palpitations, cough, pharyngitis, dysphonia, bronchospasm, candidiasis of the mouth and throat. Rare: constipation, gingivitis, stomatitis, rash, pruritus, angioneurotic edema, urticaria, hypersensitivity (including immediate reactions). Not known: dehydration, glaucoma, increased intraocular pressure, blurred vision, atrial fibrillation, supraventricular tachycardia, nasal bleeding, laryngitis, sinusitis, dysphagia, gastroesophageal reflux disease, tooth decay, tongue inflammation, intestinal obstruction (including paralysis) intestinal obstruction), nausea, skin infection, skin ulcer, dry skin, anaphylactic reactions, swollen joints, urinary retention, painful or difficult urination, urinary tract infection. The anticholinergic effect of the drug may increase with age.

Inhalation. Adults: 2 sprays (5 μg) from the Respimat inhaler once a day, at the same time each day. In the treatment of asthma, full therapeutic benefits will be seen after taking several doses of the drug. Elderly patients, patients with impaired renal function and patients with hepatic impairment may use the product at the recommended dose.Special groups of patients. Elderly patients, patients with impaired liver function and patients with impaired renal function may use tiotropium bromide at the recommended dose. In patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml / min), tiotropium bromide should only be used if the expected benefit to the patient outweighs the potential risk. The drug should not be used in children and adolescents under 18 years of age.Method of administration. The drug cartridge can be placed and used only in the Respimat inhaler. In order to ensure proper use, a doctor or other qualified healthcare professional should instruct the patient on how to use the inhaler.