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Anoro ellipta® is a combination of an inhalation antagonist of long-acting muscarinic cholinergic receptors and inhaled long-acting beta2-adrenomimetic. After oral inhalation, both compounds have a local effect on the respiratory tract, causing bronchodilation due to different mechanisms of action.
Vilanterol belongs to the class of selective long-acting beta2-adrenergic receptor agonists (beta2-agonists). The pharmacological effects of beta2-adrenoreceptor agonists, including Vilanterol, are at least partially related to the stimulation of intracellular adenylate cyclase, an enzyme that catalyzes the conversion of ATP to cAMP. An increase in cAMP leads to relaxation of the smooth muscles of the bronchi and inhibition of the release from cells (primarily from mast cells) of mediators of immediate-type hypersensitivity reactions.
Umeclidine is a long-acting muscarinic receptor antagonist (also called an anticholinergic). It is a quinuclidine derivative, an antagonist of muscarinic receptors, which acts on muscarinic cholinergic receptors of various subtypes. Umeclidine has a bronchodilator effect by competitively inhibiting the binding of acetylcholine to muscarinic acetylcholine receptors in the smooth muscles of the respiratory tract. When conducting preclinical studies on in vitro models, this compound showed a slow reversibility of the action on the human muscarinic receptors of the M3 subtype, and on in vivo models, the duration of the effect of the drug after administration directly to the lungs was demonstrated.
In two placebo-controlled clinical trials of efficacy, an increase in forced expiratory volume was observed in the first second (FEV1) after the first dose of the combination of Vilanterol and Umeklidinium on the first day. This indicator increased by 0.11 and 0.13 l 15 minutes after the use of the drug at a dosage of 22 + 55 mcg / dose and 22 + 113 mcg / dose, respectively, compared with the same indicator for placebo (in both cases, p < 0,001). The difference between the baseline and peak FEV1, determined within 6 hours after the use of the drug, on the first day and on the 24th week of the experiment was 0.27 and 0.32 l, respectively, when using the drug in the dosage of 22 + 55 μg / dose , and 0.31 and 0.34 l, respectively, when using the drug at a dosage of 22 + 113 μg / dose. When using placebo, the corresponding figures were 0.11 and 0.09 l (day 1); and 0.1 and 0.06 liters (24th week).
The effect of the combination of Vilanterol and Humeralidinium on the duration of QT intervention was evaluated in a placebo and moxifloxacin-controlled study. 103 healthy volunteers used a combination of Vilanterol and umeclidine for 10 days 1 time per day at a dosage of 22 + 113 or 88 + 452 mcg / dose. After repeated use of this drug, there was no clinically significant effect on the duration of the QT interval (corrected by the Frederick method). In addition, no clinically significant effect of the combination of Vilanterol and Umeklidinium on heart rate was observed with 24-hour Holter ECG monitoring in 108 patients with COPD who received this drug for 6 months (of which 53 patients received the drug in a dosage of 22 + 55 mcg / dose and 55 - at a dosage of 22 + 113 mcg / dose 1 time per day), as well as in 226 patients receiving the drug at a dosage of 22 + 113 mcg / dose 1 time per day for 12 months.
Supportive bronchodilator therapy aimed at relieving the symptoms of chronic obstructive pulmonary disease.
1 dose / cell *:
Strip with Vilanterol:
- Vilanterol triphenate micronized 40 mcg (equivalent to 25 mcg ** Vilanterol)
excipients: magnesium stearate 125 mcg; lactose monohydrate to 12.5 mg
Strip with disguise:
- umeclidine bromide micronized 74.2 mcg (equivalent to 62.5 mcg ** umeclidine)
excipients: magnesium stearate 75 mcg; lactose monohydrate to 12.5 mg
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Dosage and Administration
Anoro Ellipt® should be used daily at the same time 1 time per day. The recommended dose of Anoro Ellipt®: one inhalation of 22 + 55 mcg / dose 1 time per day. In some patients, it was found that the use of Anoro Ellipt® at a dosage of 22 + 113 mcg / dose once a day has an additional advantage in terms of the effect on lung function and the frequency of use of emergency drugs. The maximum dose is one inhalation of Anoro Ellipt® at a dosage of 22 + 113 mcg / dose 1 time per day.
Special patient groups.
Children. This drug is not used to treat patients under 18 years old, taking into account the indications for its use.
Elderly patients. Patients over 65 years of age do not require dose adjustment (see Pharmacokinetics).
Impaired renal function. Patients with impaired renal function dose adjustment is not required (see "Pharmacokinetics").
Liver dysfunction. Patients with hepatic impairment do not require mild or moderate severity of dose adjustment. There have been no studies on the use of the combination of Vilanterol and Honemardinium in patients with severe liver dysfunction (see Pharmacokinetics).
Recommendations for use:
When using the Ellipt® inhaler for the first time, there is no need to check the correctness of its operation or special preparation of the inhaler for operation. Consistently follow the recommendations for use listed below.
The Ellipt® Inhaler is packaged in a container that contains a moisture-absorbing bag of silica gel, which is not intended for food or inhalation. This bag should be disposed of. After removing the inhaler from the container, its lid is in the closed position. Do not open it until ready to receive the drug.
Instructions for use of the inhaler Ellipt®:
When you open and close the lid of the Ellipt inhaler® without taking the drug, a single dose is lost. This dose remains closed inside the nebulizer, but will not be available for admission. It is impossible to accidentally get a large dose or a double dose for one inhalation.
One dose of the drug is ready for inhalation after each opening of the cap.
A dose counter shows how many doses of the drug are left in the inhaler. Before using the inhaler, the dose counter shows the number 30. Each time you open the lid, the number of doses decreases by 1. When less than 10 doses remain, half of the counter becomes red. After the last dose of the drug has been consumed, half of the counter is highlighted in red, the counter shows the number 0. This means that the inhaler is empty. When the cap is opened after this, the dose counter will turn completely red.
Do not open the lid until ready to receive the drug. Do not shake the inhaler.
1. Pull the cover down until it clicks.
2. The dose of the drug is ready for inhalation, and in confirmation of this, the counter reduces the number of doses per unit.
3. If the meter does not reduce the number of doses after clicking, then the inhaler is not ready to deliver a dose of the drug. In this case, you should contact by phone or the address specified in the subsection "For more information contact."
4. Do not shake the inhaler.
1. Hold the inhaler at a distance from the mouth to exhale the maximum depth. Do not exhale into the inhaler.
2. Place the mouthpiece between the lips and tightly clasp it with your lips. Do not cover the vent with your fingers.
The lips should exactly follow the shape of the inhaler mouthpiece.
3. Take one deep, long, even breath. Hold your breath as far as possible (at least 3-4 s).
4. Remove the inhaler from the mouth.
5. Slowly and quietly exhale.
With proper use of the inhaler, the patient may not feel the taste or not feel the intake of the drug.
Closure of the inhaler:
If necessary, clean the mouthpiece, before closing the lid, use a dry paper napkin.
Raise the lid until it stops, achieving complete closure of the mouthpiece.
The safety profile of a combination of Vilanterol and umeclidine is based on data from clinical studies that involved 2,454 patients with COPD who received at least one dose of Vilanterol and Umeclidinium during the study. All patients used the drug 1 time per day; of these, 1124 received the drug at a dosage of 22 + 55 μg / dose and 1330 - 22 + 113 μg / dose. The adverse reactions listed below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1 / 10); often (≥1 / 100 and <1/10); infrequently (≥1 / 1000 and <1/100); rarely (≥1 / 10,000 and <1/1000); very rarely (<1/10000, including isolated cases). Frequency categories were formed based on clinical studies of the drug.
Infectious and parasitic diseases: often pharyngitis.
From the side of the heart: infrequently - atrial fibrillation, tachycardia.
On the part of the respiratory system, organs of the chest and mediastinum: often - cough.
On the part of the digestive tract: often - constipation, dry mouth.
- severe allergic reactions to milk protein or hypersensitivity to the active substances or any other component that is part of the drug, in history;
- children under 18 years old.
With care: after the use of sympathomimetics and muscarinic receptor antagonists, incl. and Anoro Ellipt®, such adverse reactions as arrhythmia (for example, atrial fibrillation and tachycardia) can be observed on the part of the cardiovascular system. In this regard, anoro Ellipt® should be prescribed with caution in patients with severe cardiovascular disease. Given the antimuscarinic activity of this drug, it should be used with caution in patients with angle-closure glaucoma or urinary retention.
Beta-blockers can weaken the effects of beta2-agonists or act as antagonists of drugs of this group, including and Vilanterola. The simultaneous use of non-selective and selective beta-blockers should be avoided, unless there are compelling reasons for their combined use.
Vilanterol, a component of Anoro Ellipt®, is rapidly metabolized mainly in the gastrointestinal tract and liver using the cytochrome P450 CYP3A4 isoenzyme. With simultaneous administration of the drug with strong inhibitors of the isoenzyme CYP3A4 (for example, ketoconazole), caution should be exercised, since There is a possibility of increasing the systemic exposure of Vilanterol, which in turn may lead to an increased risk of unwanted reactions (see Pharmacokinetics).
Pregnancy and Lactation
Data on the use of a combination of Vilanterol and umeclidine in pregnant women are missing or limited. In preclinical studies, reproductive toxicity was revealed during inhalation use of Vilanterol. The use of the drug Anoro Ellipt® in pregnant women is permissible only if the potential benefit to the mother outweighs the possible risk to the fetus.
Data on the excretion of Vilanterol or Skillin in human breast milk are not available. However, other beta2-agonists are defined in breast milk. The risk of penetration of the drug with milk into the body of a newborn or child can not be excluded. Taking into account the ratio of the benefits of therapy for the mother and breastfeeding for the child, it is necessary to make a decision either to discontinue the drug or to discontinue breastfeeding.
Data on the effect of Anoro Ellipt® on human fertility are not available. In preclinical studies, the effect of Vilanterol or umeclidine on fertility was not found.
There were no studies on the use of Anoro Ellipt® in patients with bronchial asthma, therefore, it is not recommended to use the indicated drug for therapy in this group of patients.
Anoro Ellipta® is intended for use as a maintenance treatment for COPD. Do not use this drug for the relief of acute symptoms, i.e. as a treatment for emergency care in acute episodes of bronchospasm. For relief of acute symptoms, it is necessary to use a short-acting bronchodilator. An increase in the frequency of use of short-acting bronchodilators in order to relieve symptoms indicates a deterioration in the control of the disease, in which case the patient needs to consult a doctor.
As with other types of inhalation therapy, the use of Anoro Ellipt® can cause paradoxical bronchospasm, which can be life-threatening. With the development of paradoxical bronchospasm, it is necessary to stop treatment with the drug, and if necessary, alternative therapy can be prescribed.
Anoro Ellipt® 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.
Influence on ability to steer vehicles and work with mechanisms. Studies on the effect of Anoro Ellipt® on driving ability and working with machinery have not been conducted.
When conducting clinical trials were not obtained data on overdose combination of Vilanterol and umeclidine.
Symptoms: possible development of symptoms and signs caused by the action of individual components of the drug, including known adverse reactions that develop when exposed to muscarinic receptor antagonists (for example, dry mouth, accommodation disorders and tachycardia) and signs observed in overdose by other beta-2-agonists (for example, tremor, headache and tachycardia).
Treatment: in case of overdose, symptomatic therapy is required and, if necessary, appropriate supervision is provided to the patient. Further management of patients in case of overdose must be carried out in accordance with the clinical indications.
- Brand name: Anoro ellipta
- Active ingredient: Vilanterol, Umeclidinium bromide
- Dosage form: Powder Anoro ellipta for inhalation dosed.
- Manufacturer: GlaxoSmithKline
- Country of Origin: Great Britain