Spiriva respimat solution Inh. 2.5mkg / 4ml dose 1 piece cartridge inhaler respimat

$61.27

Spiriva respimat solution Inh. 2.5mkg / 4ml dose 1 piece cartridge inhaler respimat

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Description

Composition
Active substance:
1 dose contains: Tiotropium – 2.5 g (corresponding tiotropium bromide monohydrate, 3.1235 g.
Excipients:
Benzalkonium chloride 1.105 mg disodium edetate-1,105 micrograms, 1 M hydrochloric acid to pH 2.8-3.0, water-to 11,05 mg.
Description:
The clear colorless or nearly colorless solution in 4.5 ml capacity cartridge placed in the aluminum cylinder.
Product form:
A solution for inhalation of 2.5 ug / dose inhaler Respimat® complete with a capacity of 4.5 ml cartridge, placed in the aluminum cylinder. The inhaler and the cartridge cylinder with instructions for use in a cardboard box.
Contraindications
RESPIMAT Spiriva formulation is contraindicated in patients who have previously observed hypersensitivity to any component of the formulation to atropine or its derivatives, for example, ipratropium bromide, oxitropium bromide.
Carefully
Angle-closure glaucoma, prostatic hyperplasia, bladder neck obstruction.
Indications
Spiriva formulation RESPIMAT shown: for the maintenance treatment of patients with COPD, chronic bronchitis, pulmonary emphysema; maintenance therapy of persistent shortness of breath; improve the quality of life impaired due to COPD, and reducing the frequency of exacerbations; as adjunctive maintenance treatment in patients with 6 years with asthma with persistent symptoms of the disease in patients receiving at least inhaled glucocorticosteroids; to reduce the symptoms of asthma, improve the quality of life and reduce the frequency of exacerbations.
Interaction with other drugs
Although specific studies of drug interactions was conducted, tiotropium bromide used in conjunction with other medications for the treatment of COPD, including sympathomimetic bronchodilators, methylxanthines, steroids for oral administration and administration by inhalation, antihistamines, mucolytics, leukotriene modifiers, cromones, anti-IgE agents, wherein clinical signs of drug-drug interactions were noted. The combined use of long-acting beta2-agonists, inhaled corticosteroids, and combinations thereof does not affect the action of tiotropium. Long-term joint use of tiotropium bromide with other m-anticholinergic drugs has not been studied. Therefore, long-term drug combined use with other Spiriva RESPIMAT m-anticholinergic drugs are not recommended.
Overdose
When high doses of drug may manifestations m-anticholinergic action. After 14-day inhalation use tiotropium bromide at doses up to 40 mg, in healthy persons were no significant adverse events except feeling of dryness of mucous membranes of the nose and the oropharynx, which depended on the dose rate values ​​(10 – 40 micrograms per day). The only exception was a distinct decrease salivation starting 7 days of the drug. The six long-term studies in patients with COPD with inhaled tiotropium bromide solution was applied in a daily dose of 10 mg for 4 – 48 weeks, no significant adverse events.
pharmachologic effect
Pharmacological group:
M-holinoblokator.
Pharmacodynamics:
Tiotropium bromide – long-acting antimuscarinic drug in clinical practice often called m-anticholinergic agent. The preparation has the same affinity for M1 – M5 muscarinic receptor subtypes. The result of the inhibition of M3-receptors in the respiratory tract 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 of the drug from the M3-receptor; poludissotsiatsii period significantly longer than that of ipratropium bromide. Inhalation administration method, tiotropium bromide as N-quaternary ammonium derivative, exerts a local selective effect (on the bronchi), wherein at therapeutic doses do not cause systemic m-anticholinergic side effects. Dissociation from M2-receptors is faster than from M3-receptors, indicating that the prevalence of selectivity for M3 receptor subtype over the M2-receptors. High affinity for the receptors and slow dissociation of the drug from binding with receptors cause a pronounced and lasting bronchodilatory effect in patients with chronic obstructive pulmonary disease (COPD).
Bronchodilation, developing after inhalation of tiotropium bromide is due, primarily, local (the respiratory tract) and not systemic action. Clinical studies have shown that the use of the drug Spiriva RESPIMAT once daily leads to a significant improvement (compared to placebo), pulmonary function (forced expiratory volume in 1 second FEV1 and forced vital capacity FVC) within 30 minutes after the use of the first dose . Improvement in lung function is preserved when the equilibrium concentration within 24 hours. Pharmacodynamic equilibrium is achieved within one week. Spiriva RESPIMAT significantly improved morning and evening peak expiratory flow volume (WWTP) measured by patients. Application RESPIMAT Spiriva formulation resulted in a reduction (compared to placebo) use as bronchodilator agents ambulance. Bronchodilator effect of the drug lasts for 48 weeks of the drug; signs of addiction are not marked.
Analysis of combined data from two randomized, placebo-controlled, crossover clinical trial showed that the bronchodilatory effect of the drug Spiriva RESPIMAT (5 g) after 4-week treatment period was quantitatively higher than the effect of Spiriva formulation (18 ug). The long-term (12-month) studies have established that the Spiriva RESPIMAT significantly reduces breathlessness; improves quality of life; reduces the psychosocial impact of COPD and increase the activity. The drug Flomax RESPIMAT significantly improves overall health (total score) compared to placebo by the end of the two 12-month studies, this difference was maintained throughout the treatment period; RESPIMAT Spiriva formulation significantly reduced the number of exacerbations of COPD and increased until the first period of exacerbation compared to placebo.
It is proved that Spiriva RESPIMAT reduces the risk of COPD exacerbations and significantly reduces the number of hospitalizations. In a retrospective analysis of individual clinical studies it was observed statistically significant increase, compared with placebo, the number of deaths in patients with heart rhythm disorders. However, these findings were not statistically confirmed and may be associated with heart disease. In clinical trials in patients suffering from bronchial asthma and continue to experience symptoms of the disease, despite maintenance therapy with an inhaled corticosteroid, including in combination with long-acting agonist beta2-adrenoceptor it has been found that the addition of the drug Spiriva RESPIMAT to maintenance therapy resulted in significant improvement in lung function compared with placebo, significantly reduced the number of severe exacerbations and periods worsening asthma symptoms, and led ichivalo until the first of their occurrence, resulted in a significant improvement of quality of life and increase the number of patients with a positive response to maintenance therapy. Bronchodilator drug effect persisted for 1 year of use, signs of addiction were reported.
Pharmacokinetics:
Tiotropium bromide – a quaternary ammonium derivative, moderately soluble in water. Tiotropium bromide is produced as a solution for inhalation, which is applied via RESPIMAT inhaler. Approximately 40% of the inhaled dose is deposited in the lungs, the remainder enters the gastrointestinal tract. Some pharmacokinetic data described below were obtained using doses exceeding recommended for treatment.
Absorption: after inhalation solution young healthy volunteers found that enters into the systemic circulation of about 33% of the inhaled dose. Eating does not affect the absorption of tiotropium bromide, due to the fact that it is poorly absorbed from the gastrointestinal tract. Absolute oral bioavailability is 2-3%. The maximum plasma concentration observed after 5-7 minutes after inhalation. In step dynamic equilibrium peak concentration of tiotropium in the blood plasma of patients with COPD is 10.5 pg / ml, and rapidly declines. This indicates multikompartmentny type of distribution of the drug. At dynamic equilibrium stage tiotropium basal concentration in plasma of 1.6 pg / ml. In step dynamic equilibrium tiotropium peak concentration in the blood plasma of patients with bronchial asthma was 5.15 pg / mL and was reached after 5 min
Distribution: drug binding to plasma proteins is 72%; volume of distribution – 32 l / kg. Studies have shown that tiotropium bromide does not penetrate the blood-brain barrier.
Biotransformation: degree of biotransformation is small. This is confirmed by the fact that after intravenous administration to young healthy volunteers in the urine is detected substance 74% of tiotropium bromide in an unmodified form. Tiotropium bromide is an ester which is cleaved in ethanol-N-metilskopin and ditienilglikolievuyu acid; these compounds do not bind to muscarinic receptors. In in vitro studies have shown that some of the drug (
Excretion: terminal half-life after inhalation of tiotropium bromide is from 27 to 45 hours in patients with COPD. Patients with asthma effective half-life after inhalation is 34 hours. Total clearance after intravenous administration to young healthy volunteers was 880 ml / min. Tiotropium bromide following intravenous administration is mainly excreted by the kidneys in unchanged form (74%). After inhalation of a solution in patients with COPD, renal excretion is 18.6% (0.93 g), the remaining unabsorbed portion is output through the intestine. In step pharmacokinetic equilibrium in patients with asthma 11.9% (0.595 g) dose is excreted unchanged in the urine at 24 hours after ingestion. The renal clearance of tiotropium bromide exceeds the creatinine clearance, which indicates its tubular secretion. After prolonged inhalation dosing once daily to patients with COPD pharmacokinetic equilibrium is reached at day 7; while there is no further accumulation. Tiotropium bromide, has a linear pharmacokinetics in the therapeutic range after intravenous administration, inhalation of dry powder and inhalation of a solution.
Pharmacokinetics in elderly patients: in old age there is a decrease renal clearance of tiotropium (347 ml / min in COPD patients aged 65 years and 275 ml / min in patients with COPD and asthma than 65 years). It was found that patients with asthma effects of tiotropium bromide does not depend on the age of patients.
Patients with impaired renal function: after inhalative application of tiotropium once daily during the steady state pharmacokinetics in patients with COPD and minor renal impairment (creatinine clearance of 50-80 ml / min) indicated a slight increase in values ​​AUC0-6, ss-1, and 8-30% Cmax, ss compared with patients with normal renal function (creatinine clearance of> 80 ml / min). Patients with COPD and moderate or significant impairment of renal function (creatinine clearance of> 80 ml / min). Patients with COPD and moderate or severe renal impairment (creatinine clearance
Patients with impaired hepatic function: it is assumed that the hepatic failure has no significant effect on the pharmacokinetics of tiotropium bromide, tiotropium bromide, because mainly excreted by the kidneys and through enzymatic cleavage of the ester bond to form derivatives that do not possess pharmacological activity.
Pregnancy and breast-feeding
Data on the effect of the drug Spiriva RESPIMAT pregnancy are limited. In preclinical studies in studying the reproductive toxicity received instructions to direct or indirect adverse effect on the drug. As a precaution, preferable to refrain from using the drug Spiriva RESPIMAT during pregnancy. Clinical data on the effect of tiotropium bromide in women who are breastfeeding, no. The drug should not be used in pregnant or breast-feeding women unless the potential benefit to the mother outweighs the potential risk not to the fetus and child. The period of application of the drug to stop breast-feeding a baby.
Conditions of supply of pharmacies
By prescription.
side effects
Many of the following adverse reactions can be due m- anticholinergic properties of the drug. Adverse reactions were identified on the basis of the data obtained in clinical studies and anecdotal post-registration messages during use of the drug.
The frequency of adverse reactions that can occur during treatment is shown by the following grading: very often (> 1/10); common (> 1/100,
special instructions
Spiriva formulation RESPIMAT as bronchodilator used once a day for maintenance therapy, should not be used as initial therapy for acute attacks of bronchospasm, or to eliminate the acute symptoms arise. In the event of an acute attack of the speed of beta2-agonists. RESPIMAT Spiriva formulation should not be used for the treatment of asthma as a first line therapy. Patients should be advised in patients receiving the drug Spiriva RESPIMAT continue anti-inflammatory therapy (e.g., inhaled corticosteroids), even if the symptoms are reduced. After application of immediate hypersensitivity reactions may develop drug.
Inhalation of the drug can cause bronchospasm. At moderate or severe renal failure (creatinine clearance
The drug Flomax should not be used RESPIMAT more frequently than once a day. Spiriva cartridges should only be used with an inhaler RESPIMAT.
Effect of the drug on the ability to drive mechanisms and
Studies on the effects on the ability to drive and use machinery have not been conducted. Use caution when performing these activities, since it is possible the development of dizziness or blurred vision.
Storage conditions
At a temperature not exceeding 25 C. Do not freeze.
Use within 3 months after the first inhalation.
Keep out of the reach of children.
Dosing and Administration
The recommended therapeutic dose is two spray inhalation from the inhaler RESPIMAT (5 ug / therapeutic dose) once a day, at the same time (see. “Instructions for use”).
In the treatment of asthma full therapeutic effect occurs within a few days.
In older patients, patients with impaired liver function, and patients with small renal function (creatinine clearance 50 – 80 ml / min) can be used Spiriva RESPIMAT drug at the recommended dose. However, the use of the drug in patients with moderate or significant impairment of renal function (creatinine clearance less than 50 mL / min) must be carefully monitored. COPD usually does not occur in children. The safety and efficacy of the drug Spiriva RESPIMAT in children has not been studied up to one year.
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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