Spiriva capsules. porosh.dlya with ING. with an inhaler 18mkg 30 pcs handihaler

$60.34

Spiriva capsules. porosh.dlya with ING. with an inhaler 18mkg 30 pcs handihaler

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SKU: 01269496063 Categories: , Tags: ,

Description

Composition
Active substance:
1 capsule contains: tiotropium bromide monohydrate equivalent of 0.0225 mg 0.0180 mg tiotropium.
Excipients:
Lactose monohydrate, 200 mg of 5.2025 M; micronised lactose monohydrate 0.2750 mg. Composition Capsules (mg / capsule): 2.4000 mg macrogol, indigo carmine (E132) 0.0120 mg, titanium dioxide (E171) 1.0240 mg yellow iron oxide (E172) 0.0120 mg Gelatin 44.5160 mg.
Description:
Hard gelatin capsule size 3, a light greenish-blue color, opaque, with an overprint of a symbol and TI 01 black ink contents of the capsules – White powder.
Product form:
Capsules for powder inhalation with 18 ug. 10 capsules in blister PVC / aluminum foil. 1,3 or 6 blister complete inhaler HandiHaler (HandiHaler), or without an inhaler with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to atropine or its derivative (e.g., ipratropium or oxitropium) or to the components of the drug (in particular to lactose monohydrate, which comprises a milk protein, resulting lactase deficiency, lactose intolerance, glucose-galactose malabsorption); I trimester of pregnancy; children under 18 years.
Carefully
Angle-closure glaucoma, prostatic hyperplasia, bladder neck obstruction.
Indications
Spiriva is shown as a maintenance therapy in patients with COPD, including chronic bronchitis and emphysema (maintenance therapy for persistent breathlessness and exacerbations of warning).
Interaction with other drugs
Perhaps the use of tiotropium in a combination with other drugs commonly used to treat COPD sympathomimetics, methylxanthines, oral and inhaled glucocorticosteroids. The combined use of long-acting beta2-agonists, inhaled corticosteroids, and combinations thereof does not affect the action of tiotropium. Limited information on the joint application with anticholinergic drugs derived from 2 clinical trials: a one-time appointment of a single dose of ipratropium bromide on a background of continuous use of Spiriva in patients with COPD (64 patients) and healthy volunteers (20 people) did not lead to a reduction in adverse reactions, changes in vital parameters and electrocardiogram. However, a permanent joint application of anticholinergics and Spiriva not been studied and hence is not recommended.
Overdose
At high doses are possible manifestations anticholinergic action. However, systemic anticholinergic side effects were not detected after a single inhalation dose to 282 ug of tiotropium when receiving healthy volunteers. Bilateral conjunctivitis in combination with dry mouth were observed in healthy volunteers after repeated administration in a single daily dose of 141 ug, which disappeared with continued treatment. In the study, which examined the effects of multiple doses of tiotropium in COPD patients receiving 36 micrograms of the drug as possible for more than 4 weeks, dry mouth was the only side effect. Acute toxicity associated with the random reception of capsules inside unlikely due to low bioavailability of the drug.
pharmachologic effect
Pharmacological group:
M-holinoblokator.
Pharmacodynamics:
Tiotropium bromide – long-acting antimuscarinic drug m- holinoblokator in clinical practice often called an anticholinergic. It has the same affinity for the different subtypes of muscarinic receptors M1 to M5. The result of the inhibition of M3 receptors in the airways is the relaxation of smooth muscles. Bronchodilatory effect depends on the dose and maintained for at least 24 hours. A significant duration of action is probably due to the very slow dissociation from the M3 receptor, as compared to ipratropium bromide. Inhalation administration method, tiotropium bromide as an N-quaternary anticholinergic agent exerts a local selective effect, wherein the therapeutic dose does not cause systemic m-anticholinergic side effects. Dissociation from M2-receptors is faster than from M3. High receptor affinity and slow dissociation cause a pronounced and long-lasting bronchodilator effect in patients with chronic obstructive pulmonary disease. Bronchodilation following inhalation of tiotropium bromide is a consequence of local rather than a systemic effect. It was shown that Spiriva significantly increases pulmonary function (forced expiratory volume in 1 second FEV1, forced vital capacity FVC) 30 minutes after a single dose over 24 hours. Pharmacodynamic balance achieved during the first week, and expressed bronhodilyatiruyuschy effect was observed on Day 3. Spiriva significantly increases the morning and evening peak expiratory stream rate as measured by patients. Bronhodilyatiruyuschy effect Spiriva, estimated during the year, has not revealed the manifestations of tolerance. Spiriva significantly reduces shortness of breath during the entire treatment period. In two randomized, double-blind, placebo-controlled studies have shown that Spiriva significantly improved exercise tolerance compared with placebo. Spiriva significantly reduces the number of exacerbations of COPD, and increases the period before the first exacerbation compared to placebo. Spiriva significantly improves quality of life. This improvement is observed throughout the treatment period. It was shown that Spiriva significantly reduces the number of hospitalizations associated with COPD exacerbations and increases the time until the first admission. It was also shown that the Spiriva induces a sustained improvement in FEV1 after administration for 4 years without changing the rate of annual decline in FEV1. During treatment, there is a decrease in risk of death by 16%. As compared with the reception salmeterol, application Spiriva increases the time to first exacerbation (187 versus 145 days), with reduced risk of relapse in 17% (hazard ratio, 0.83; 95% confidence interval [CI] 0.77 to 0, 90; P
Pharmacokinetics:
Tiotropiy- quaternary ammonium compound is sparingly soluble in water.
Absorption: inhalation administration method tiotropium absolute bioavailability of 19.5%, indicating that the fraction of drug that reaches the lungs, high bioavailability. Tiotropium in solution when administered has an absolute bioavailability equal to 2-3%. Eating does not affect the absorption of tiotropium. The maximum concentration of tiotropium in the plasma (Cmax) after inhalation is achieved after 5-7 minutes. In step dynamic equilibrium peak concentration of tiotropium in the blood plasma of patients with COPD is 12.9 pg / ml, and rapidly declines. This indicates multikompartmentny type of distribution of the drug. At dynamic equilibrium stage basal concentration of tiotropium in the blood plasma of 1.71 pg / ml
Distribution. 72% of the dose of the drug is bound to plasma proteins and volume of distribution is 32 l / kg. Studies have shown that tiotropium does not penetrate the blood-brain barrier.
Biotransformation: degree of biotransformation is small. This is confirmed by the fact that after intravenous administration to healthy young volunteers, found in the urine 74% of unchanged substance. Tiotropium cleaved by non-enzymatic method to alcohol and N-metilskopina ditienilglikolivoy acids which do not bind to muscarinic receptors. In studies indicated that the formulation (
Excretion: tiotropium half-life after inhalation ranges from 27 to 45 hours. Total clearance after intravenous administration to healthy young volunteers is 880 ml / min. Tiotropium after intravenous administration is mainly excreted by the kidneys unchanged (74%). After inhalation of the dry powder in the step of dynamic equilibrium renal excretion is 7% of the dose per day, the remaining portion not grown deep is outputted through the intestine. The renal clearance of tiotropium exceeds the creatinine clearance, indicating that tubular secretion of the drug. After prolonged administration of the drug once a day by patients with COPD, pharmacokinetic equilibrium is reached at day 7, the accumulation is not observed in the future. Tiotropium has a linear pharmacokinetics in the therapeutic range, regardless of dosage form preparation.
Elderly patients: elderly patients a decrease of tiotropium renal clearance (365 mL / min in COPD patients younger than 65 years, up to 271 ml / min in COPD patients over 65 years). These changes do not result in a corresponding increase in values ​​of area under the curve “concentration / time» (AUC0-6) or Cmax.
Patients with impaired renal function: in patients with COPD and mild renal impairment (creatinine clearance of 50-80 ml / min) inhalation use of tiotropium once daily in the step of dynamic equilibrium resulted in an increase AUC0-6 values ​​of 1.8 – 30% . The value of Cmax was kept the same as in patients with normal renal function (creatinine clearance of> 80 ml / min). Patients with COPD and moderate or severe renal impairment (creatinine clearance
Patients with impaired liver function: it is assumed that the liver failure would not have a significant effect on the pharmacokinetics of tiotropium as tiotropium is mainly excreted by the kidneys, and through non-enzymatic cleavage of ether bonds, with the formation of metabolites that are not associated with muscarinic receptors.
Pregnancy and breast-feeding
Data on the use of tiotropium in pregnancy in humans is limited. In animal studies, received indications of direct or indirect adverse effects on pregnancy, embryo / fetal development, birth or postnatal development process. As a precaution, preferable to refrain from using the drug Spiriva during pregnancy. Clinical data on the use of tiotropium in women, breast-feeding is not available. In preclinical studies, the data that a small amount of tiotropium is excreted in breast milk were obtained. Flomax should not be used in pregnant or breast-feeding women, unless the expected benefit is less than the potential risk to the fetus or child.
Conditions of supply of pharmacies
By prescription.
side effects
Adverse drug reactions were identified on the basis of the data obtained in clinical studies and anecdotal post-registration messages during use of the drug.
Violations by the metabolism and nutrition, dehydration *
Disorders of the gastrointestinal tract often (> 1% and 0.1% and 0.01%, and
Disorders of the respiratory system, chest and mediastinum infrequently (> 0.1% and 0.01%, and
Violations of the cardiovascular system infrequently (> 0.1% and 0.01%, and
Violations of the kidneys and urinary tract infrequently (> 0.1% and 0.01%, and
Allergic reactions infrequently (> 0.1% and 0.01%, and
* Angioedema.
Violations by the skin skin infections and sores on the skin, dry skin *.
Musculo-skeletal system and associated connective tissue disease * swelling of the joints.
Disorders of the nervous system infrequently (> 0.1% and 0.01%, and
Violations of the organ of vision infrequently (> 0.1% and 0.01%, and
special instructions
Spiriva – as a bronchodilator used once a day for maintenance therapy, should not be used as initial therapy for acute attacks of bronchospasm, i.e. in urgent cases. After inhalation Spiriva powder can develop immediate hypersensitivity reaction. Inhalation of the drug can lead to bronchospasm. Patients with moderate or severe renal failure (creatinine clearance
Effects on ability to drive a car or operate machinery.
Not conducted research on such influence. Cases of dizziness and blurred vision while taking the drug can exert such influence.
Storage conditions
At a temperature not exceeding 25 C not subjected to freezing. Keep out of the reach of children!.
Dosing and Administration
Inhalation. When using Spiriva by inhalation via the device HandiHaler recommended one capsule a day at the same time. The drug does not need to swallow. Elderly patients should take Spiriva at the recommended doses. Patients with impaired renal function may be used at the recommended doses of Spiriva. However, careful observation of patients with moderate or severe renal impairment receiving Spiriva (as is the case with other drugs eskretiruyuschimisya in the kidneys). Patients with hepatic insufficiency may take Spiriva at the recommended doses.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Behringer

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