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Aclidinium bromide is a competitive, selective muscarinic receptor antagonist (also called anticholinergic), with a longer binding time to Mz receptors than to M2 receptors. Mo - receptors serve as mediators in the reduction of smooth muscles of the respiratory tract. Inhaled aclidinium bromide acts locally in the lungs, as an antagonist of the M3 - receptors of the smooth muscles of the respiratory tract and causes expansion of the bronchi. In vitro and in vivo preclinical studies have demonstrated rapid, dose-dependent and long-term inhibition of aclidinium by bronchospasm bromide caused by acetylcholine. Aclidinium bromide is rapidly destroyed in plasma, so the number of systemic anticholinergic side effects is low.
Clinical efficacy studies have shown that Bretaris Jenweir 'provides a clinically significant improvement in lung function (measured by forced expiratory volume in one second [FEV1]) for more than 12 hours after morning and evening dosing, which occurred 30 minutes after taking the first dose (increase FEV1 compared with the initial level of 124-133 ml). Maximum bronchodilation was achieved within 1-3 hours after administration of the dose with an average peak of FEV1 improvements in relation to the initial level of 227-268 ml in equilibrium.
Electrophysiology of the heart
When prescribing aclidinium bromide (200 mcg or 800 mcg), healthy volunteers once a day for 3 days had no effect on the QT interval (corrected by the method of Friederitia or Bazetta or individually).
There was also no clinically significant effect of Bretaris 'Dzhenueyr' on heart rate during 24-hour Holter monitoring in 336 patients (164 of whom received Bretaris Dzhenueyri® twice a day at a dose of 322 μg) after 3 months of use.
The phase III clinical research program of Bretaris® Dzhenueyr® included 269 patients treated with Bretaris® Dzhenueyr® at a dose of 322 mcg twice a day during one 6-month randomized study with placebo control, and 190 patients treated with Betharis® Dzhenueyr ® at a dose of 322 mcg twice a day during another 3-month, randomized, placebo-controlled trial. Efficacy was assessed by the dynamics of lung function and clinical symptoms, such as shortness of breath, the health status determined by the diagnosis, the use of emergency drugs and the presence of exacerbations. In conducting long-term safety studies, Bretaris® Dzhenueyri® demonstrated bronchodilation efficacy with a duration of use of more than 1 year.
When conducting a 6-month study, patients who received Bretaris® Dzhenueir® at a dose of 322 mcg twice a day had a clinically significant improvement in lung function (measured with FEV]). The maximum bronchodilation effect was manifested from the first day and persisted for a 6-month period of application therapy. After 6 months of therapy, the average improvement before taking the morning dose (minimum) of FEV] compared with placebo was 128 ml (95% CI = 85-170; p
Similar observations were made for Bretaris® Dzhenueyri® during the 3-month study.
Disease-specific health and symptomatic improvement
Bretaris® Dzhenueyri® provided a clinically significant improvement in dyspnea (assessed using the transient dyspnea index [TDI]) and health condition associated with the disease (assessed using the St. George Respiratory Survey [SGRQ]). The table below shows the reduction of symptoms after 6 months of use of Bretaris® Jenewair®.
Improvement compared with placebo
Bretaris * „_
„„ ® Placebo Jenwair
Transient dyspnea index
Percentage of patients with minimal clinically important difference3
Mean change from baseline
Respiratory Questionnaire at St. George's Hospital
Percentage of patients with minimal clinically important difference
Mean change from baseline
- 4.6 units
a) The minimum clinically important difference (MCID) is at least 1 unit of change in the Transient Dyspnea Index.
b) The minimum clinically important difference (MCID) is at least 4 units of change according to the Respiratory Questionnaire of St. George's Hospital.
c) The odds ratio, the increased likelihood of achieving the Minimum clinically important difference compared to placebo.
Patients who received Bretaris® Dzhenueyr® required fewer emergency treatment drugs than patients who received placebo (a decrease of 0.95 administrations per day for 6 months [p = 0.005]). Bretaris® Dzhenueyr® also improved the daytime symptoms of COPD (shortness of breath, cough and sputum formation), as well as night and early morning clinical symptoms.
A pool analysis of the effectiveness of 6-month and 3-month placebo-controlled studies demonstrated a significant decrease in the incidence of moderate and severe exacerbations (requiring antibiotic therapy or glucocorticosteroid therapy or leading to hospitalization) with 322 mcg of aclidinium twice a day compared with placebo (patient frequency per year: 0.31 versus 0.44, respectively; p = 0.0149).
A 3-week, randomized, cross-sectional clinical trial with placebo-controlled treatment with Bretaris® Dzhenueyr® showed a statistically significant increase in exercise duration by 58 seconds compared to placebo (95% CI = 9-108; p = 0.021; values before therapy: 486 seconds).
When Bretaris® Dzhenueir® was used, there was a statistically significant decrease in excessive overstretching of the lungs at rest (functional residual capacity [IEF] = 0.197 l [95% CI = 0.321, 0.072; p = 0.002]; residual volume [RV] = 0.238 l [95 % CI = 0.396, 0.079; p =: 0.004]), and an improvement in the minimum inhalation capacity was observed (by 0.078 l; 95% CI = 0.01, 0.145; p = 0.025) and a decrease in shortness of breath when performing exercises (Borg scale) (by 0.63 Borg units; 95% CI = 1.11, 0.14; p = 0.012).
Aclidinium bromide is rapidly absorbed from the lungs, reaching a maximum plasma concentration within 5 minutes after inhalation in healthy volunteers, and usually during the first 15 minutes in patients with COPD. The fraction of the inhaled dose that reached the systemic circulation as unchanged aclidinium is very low, less than 5%.
The maximum plasma concentration achieved after inhalation of a dry powder in patients with COPD with a single dose of 400 μg of aclidinium bromide was approximately 80 pg / ml. Equilibrium plasma concentration was reached within 7 days when taken twice a day and, given the short half-life, the equilibrium concentration can be reached soon after taking the first dose. Accumulation when re-taking at the equilibrium level of concentrations was not observed.
The total amount of bromide delivered to the lungs via the Bretaris Jenewair Aclidinium inhaler was approximately 30% of the metered dose.
The binding of aclidinium bromide to plasma proteins in vitro most likely corresponds to the binding of metabolites to proteins, due to the rapid hydrolysis of plasma aclidinium bromide, the binding to plasma proteins was 87% for carboxylic acid metabolite and 15% for alcohol metabolite. The main plasma protein that binds aclidinium bromide is albumin.
Aclidinium bromide is rapidly and actively hydrolyzed to its pharmacologically inactive alcohol derivatives and carboxylic acid derivatives. There is a chemical hydrolysis (non-enzymatic), and enzymatic, with the participation of esterases. The major esterase involved in human hydrolysis is butyrylcholinesterase. The level of the acid metabolite in the blood plasma after inhalation is about 100 times higher than the level of the alcohol metabolite and the unchanged active substance.
Low absolute bioavailability of aclidinium bromide with inhalation (
Biotransformation with the participation of cytochrome P450 isoenzymes (CYP450) plays a minor role in the overall metabolic clearance of aclidinium bromide.
In vitro tests showed that aclidinium bromide at a therapeutic dose or its metabolites do not inhibit or induce any isoenzymes of cytochrome P450 (CYP450) and do not inhibit the activity of esterases (carboxylesterase, acetylcholinesterase and butyrylcholinesterase). In vitro tests have shown that aclidinium bromide or its metabolites are not substrates or inhibitors of P-glycoprotein.
The final period and the absorption of aclidinium bromide is about 2-3 hours.
After intravenous administration to healthy volunteers, 400 mcg of radiolabeled aclidinium bromide, about 1% of the dose was excreted unchanged in the urine.
Up to 65% of the dose was excreted in the form of metabolites in the urine and up to 33% in the form of metabolites with feces.
After inhalation administration to healthy volunteers and patients with COPD 200 mcg and 400 mcg of aclidinium bromide, a very small amount, about 0.1% of the dose taken, was excreted unchanged in the urine, which indicates that renal clearance plays a minor role in the overall clearance of aclidinium from blood plasma.
Linearity / nonlinearity
Aclidinium bromide in the therapeutic range has a linear and time-independent pharmacokinetics.
Pharmacokinetic / pharmacodynamic ratio
Given that aclidinium bromide has a local effect in the lungs and is rapidly destroyed in plasma, there is no direct correlation between pharmacokinetics and pharmacodynamics.
Special patient groups
The pharmacokinetic properties of aclidinium bromide in patients with moderate to severe COPD are similar in patients aged 40–59 years and in patients aged 70 and older. Therefore, in elderly patients with COPD, dose adjustment is not required.
Patients with impaired liver function
In patients with impaired liver function tests were not conducted. Since aclidinium bromide is metabolized mainly by chemical and enzymatic cleavage in plasma, it is very unlikely that an abnormal liver function changes its systemic effect. In patients with COPD and abnormal liver function, dose adjustment is not required.
Patients with impaired renal function
In patients with normal renal function and with its violation, no significant differences in pharmacokinetics were found. Therefore, in patients with COPD and renal dysfunction, dose adjustment and additional monitoring is not required.
Supportive bronchodilatory therapy to alleviate the symptoms of COPD in adults.
|aclidine bromide||375 mcg|
|which corresponds to the content of aclidinium||322 mcg|
Excipients: lactose monohydrate - 12.6 mg.
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Dosage and Administration
Acquaintance with the inhaler Bretaris genuair:
Remove the Jenwayer inhaler from the bag and familiarize yourself with its components.
To use Bretaris Jeneway inhaler after removing the cap, you need to do 2 steps:
Step 1. Press and release the green button and exhale completely, but not into the inhaler.
Step 2. Tightly clasp the mouthpiece with your lips and inhale strongly and deeply through the inhaler.
After inhalation, be sure to wear a protective cap.
Before the first use, open the closed package along the label and remove the Jenwayir inhaler
When you are about to take a dose of the drug, remove the protective cap, for which lightly squeeze the arrows on each side and pull out.
Make sure the mouthpiece does not block anything.
Hold the Jenwayer inhaler horizontally with the mouthpiece towards you, with the green button facing straight up.
Step 1. Press and release the green button.
Do not hold the green button down.
Stop and check; make sure the dose is ready for inhalation.
Make sure the color control box turns green.
The green color of the control window confirms that the drug is ready for inhalation.
If the color control window remains red, press and lower the green button again (see Step 1).
Step 2. Close your lips tightly around the mouthpiece of the Jenewair inhaler and inhale deeply and deeply through the mouthpiece.
Such a strong, deep breath delivers the drug through an inhaler into the lungs.
Attention: during inhalation it is impossible to hold the device with the green button pressed down.
During inhalation, you will hear a “click” meaning the proper use of the Jenwayer inhaler.
In order to make sure that you have taken the entire dose, keep breathing, even after you have heard the “click” of the inhaler.
Remove the Jenwayer inhaler from the mouth and hold the breath for as long as it is comfortable, then slowly exhale through the nose.
Note: Some patients, depending on their individual characteristics, may have a slight sweet or bitter taste when inhaling this drug. Do not take an extra dose if you do not feel any taste after inhalation.
Stop and check: Make sure you have properly inhaled.
Make sure the control window turns red. This confirms that you performed the full dose inhalation correctly.
If the color control box stays green, you must re-inhale strongly and deeply through the mouthpiece (see Step 2).
If the window still does not change its color to red, then it is possible that you could forget to let go of the green button before inhalation or could inhale the wrong way. If so, try again.
Make sure you let go of the green button and take a strong deep breath through the mouthpiece.
Note: if after several attempts you have not managed to perform the inhalation correctly, consult your doctor.
As soon as the window turns red, put the protective cap on the mouthpiece.
When you need a new inhaler, Jenway
The inhaler Jenweir is equipped with a dose indicator, showing how many doses are left in the inhaler. The dose indicator slowly lowers, showing intervals up to 10 (60, 50, 40, 30, 20, 10, 0). Each Jenwayer inhaler contains at least 30 or 60 doses, depending on the type of package.
When a tape with red stripes appears on the dose indicator, it means that you are approaching the last dose and you need to purchase a new inhaler, Jenwayir.
Note: if your Jenwayir inhaler is damaged or if you lose the cap, you need to replace the inhaler. Inhaler Dzhenueyri not need to be cleaned. However, if necessary, this should be done with a dry cloth or tissue paper outside the mouthpiece. Never use water to clean the Jenwayer inhaler, asit may damage the drug.
How to know that your inhaler Jenwayir is empty?
When 0 (zero) appears in the middle of the dose indicator, it is necessary to continue using all the remaining doses in the Jenwayer inhaler.
When the last dose is fully prepared for inhalation in its highest position, and will remain blocked in the middle position. Even when the green button is locked, you can still take the last dose. After this, the inhaler Jenway will not be used again, and you will need to start using the new inhaler Jenway.
The most common side effects with the use of the drug Bretaris Jenewair are headache (6.6%) and nasopharyngitis (5.5%).
The frequency of side effects is based on an assessment of the overall rates of side effects (i.e., events related to the use of Bretaris Jenwair) observed with the use of Bretharis Jenweir at a dose of 322 μg (636 patients) in a pool analysis of one 6-month and two monthly randomized clinical trials with placebo control.
The frequency of side effects is defined as follows: very often (≥1 / 10), often (≥1 / 100 to
Infectious and parasitic diseases: often - sinusitis, nasopharyngitis.
On the part of the immune system: rarely - hypersensitivity reactions; frequency is unknown - angioedema.
On the part of the nervous system: often - headache; infrequently - dizziness.
On the part of the organ of vision: infrequently - blurred vision.
Since the cardiovascular system: infrequently - tachycardia, palpitations.
On the part of the respiratory system, organs of the chest and mediastinum: often - cough; infrequently - dysphonia.
On the part of the digestive tract: often - diarrhea; infrequently - dryness of the oral mucosa, stomatitis.
On the part of the skin and subcutaneous tissues: infrequently - rash, pruritus.
On the part of the kidneys and urinary tract: infrequently - urinary retention.
Hypersensitivity to aclidinium bromide, atropine and its derivatives (ipratropium, oxitropium, or tiotropium) or to lactose; Age up to 18 years (efficacy and safety not established); Galactose intolerance, lactase deficiency or glucose-galactose malabsorption (the product contains lactose).
The simultaneous use of aclidinium bromide with other m-anticholinegic not studied and is not recommended.
Despite the lack of in vivo studies, the use of aclidinium bromide for inhalation is possible in combination with other drugs for the treatment of COPD, including sympathomimetics, bronchodilators, methylxanthines and inhaled or oral GCS.
In vitro studies have demonstrated that aclidinium bromide at a therapeutic dose or its metabolites do not interact with drugs that are P-glycoprotein substrates or drugs that are metabolized by cytochrome P450 isoenzymes (CYP450) and esterases.
Pregnancy and Lactation
There are no clinical data on the use of aclidinium bromide in pregnant women. Preclinical studies have demonstrated toxic effects on the fetus only in doses many times higher than the maximum therapeutic dose in humans. Aclidinium bromide can be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
It is not known whether aclidinium bromide and / or its metabolites penetrate into breast milk in women. Since Preclinical studies have shown that small amounts of aclidinium bromide and / or its metabolites pass into milk, it is necessary to decide whether to stop breastfeeding, or to discontinue therapy with aclidinium bromide, comparing the benefits of breastfeeding for a child and the benefits of long-term aclidinium bromide therapy for women.
Preclinical studies have shown a slight decrease in fertility only in doses many times higher than the maximum therapeutic dose of aclidinium bromide in humans. It is considered unlikely that aclidinium bromide, given at the recommended dose, affects fertility in humans.
Bretaris Jenwayer should not be used for asthma; No clinical studies on the use of aclidinium bromide for the treatment of asthma have been conducted.
As with other inhalation therapy, the use of the drug Bretaris Jenweir may cause paradoxical bronchospasm. If this happens, then treatment with Bretaris Jenwair should be stopped and other therapy should be considered.
Strengthening the symptoms of the disease
Aclidinium bromide is intended for the maintenance treatment of patients with COPD and should not be used as an emergency therapy drug. If during the treatment of aclidinium with bromide, the patient experienced a change in the severity of symptoms of COPD, which required additional emergency treatment, the patient’s condition should be re-evaluated and the treatment tactics should be revised.
Effect on the cardiovascular system
The safety profile in relation to the cardiovascular system is characterized by the presence of anticholinergic action.
Like other m-holinoblokatory drug, Bretaris Jenweir should be prescribed with caution to patients who have had a myocardial infarction in the preceding 6 months, with unstable angina, first diagnosed with arrhythmia in the preceding 3 months, or patients in the preceding 12 months hospitalized for heart failure III and IV functional classes according to the classification of the New York Heart Association, because such patients were excluded from clinical studies, and anticholinergic effects may affect the course of these diseases.
Dryness of the oral mucosa, observed with the use of anticholinergic drugs, over time may be associated with the development of dental caries.
Due to the presence of anticholinergic effects, aclidine bromide should be prescribed with caution in patients with angle-closure glaucoma (despite the fact that direct contact of the drug with the eyes is very unlikely), prostatic hyperplasia and bladder neck obstruction. Patients should be informed about the signs and symptoms of an acute attack of angle-closure glaucoma and the need to discontinue use of the drug and consult a doctor if they develop.
The drug Bretaris genuair is intended for the maintenance treatment of patients with COPD. Due to the fact that in the general population of COPD, patients over the age of 40 years predominate significantly, when prescribing the drug to patients under 40 years of age, a spirometric confirmation of the diagnosis of COPD is required.
Impact on ability to drive vehicles and other mechanisms
Aclidinium bromide may affect the ability to drive vehicles and other mechanisms. Given the possibility of the development of such side effects as headache, dizziness, blurred vision, caution should be exercised when driving vehicles, other mechanisms, as well as when engaging in potentially hazardous activities that require increased concentration and psychomotor reactions.
High doses of aclidinium bromide can lead to symptoms associated with anticholinergic effects.
However, a single inhalation dose of aclidinium bromide up to 6000 mcg in healthy volunteers did not lead to systemic anticholinergic side effects. There were no clinically significant side effects after 7 days of treatment with aclidinium bromide in doses up to 800 µg 2 times / day in healthy volunteers.
The development of acute intoxication in case of accidental overdose of aclidinium with bromide is unlikely due to the low bioavailability during ingestion and inhalation dosing of the drug Bretaris Jenewair.
- Brand name: Britaris Jenweir powder for inhalation
- Active ingredient: Aclidine bromide
- Dosage form: Powder for inhalation dosed white or almost white, fine, free-flowing, not containing visible conglomerates or foreign particles.
- Manufacturer: Almiral S.A.
- Country of Origin: Spain