Anoro Ellipta

Anoro Ellipta – two-component drug with bronkhodilatiruyushchy action for daily use.

Form of release and structure

Dosage form of release of Anoro Ellipt – powder for inhalations dosed: white (in plastic inhalers on 30 doses, on 1 inhaler complete with two aluminum strips in containers, on 1 container from aluminum foil in a cardboard pack).

1 component
Structure of 1 dose:

• active agent: вилантерол (the delivered dose) – 0,022 mg (micronized трифенатат a vilanterola – 0,04 mg);
• auxiliary components: magnesium stearate – 125 mg, monohydrate of lactose – to 12,5 mg.

2 component
Structure of 1 dose:

• active agent: umeklidiniya (the delivered dose) – 0,055 or 0,113 mg (bromide an umeklidiniya – 0,0742 or 0,1483 mg);
• auxiliary components (irrespective of amount of active agent): magnesium stearate – 75 mg, monohydrate of lactose – to 12,5 mg.

Indications to use

Anoro Ellipt is appointed as the supporting bronchodilatory therapy directed to relief of symptoms of the chronic obstructive pulmonary disease (COPD).

Contraindications

Absolute:

• allergic reactions to protein of milk in a heavy current;
• age up to 18 years;
• hypersensitivity to drug components.

Relative (Anoro Ellipta is appointed with care at the following diseases / states):

• severe forms of cardiovascular diseases (probability of development of arrhythmia);
• closed-angle glaucoma;
• ischuria.

Pregnant women before purpose of therapy need to estimate an advantage ratio with risk (the safety profile for this category of patients is absent). In the period of a lactation in case of need Anoro Ellipt's uses chest feeding need to be cancelled (there is a probability of penetration of drug into the child's organism with milk).

Route of administration and dosage

Anoro Ellipta is intended only for inhalation use.

Frequency rate of use – once a day it is, daily, desirable – at the same time.

The recommended single/daily dose – 1 inhalation of 0,022 mg +0,055 mg. At some patients the dose of 0,022 mg +0,113 mg renders additional benefit concerning impact on function of lungs and frequency of use of drugs of acute management. This dose is maximum.

It is not necessary to open an inhaler cover in cases if performing inhalation is not planned (there is a loss of a dose). It is not necessary to stir up a bottle.

On a bottle the counter is installed if in a bottle there were less than 10 doses, a half of the counter becomes red.

For holding a procedure it is necessary to make the maximum exhalation then it is necessary to place a mouthpiece between lips, to densely clasp it with lips, without closing fingers an air vent to make a long deep breath and to hold the breath (at least for 3-4 seconds).

Side effects

Possible side reactions (it is very frequent (≥1/10), it is frequent (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), it is rare (≥ 1/10 000 and <1/1000), it is very rare (<1/10 000, including separate cases)):

• respiratory system: often – cough;
• cardiovascular system: infrequently – fibrillation of auricles, tachycardia;
• alimentary system: often – a lock, dryness in a mouth;
• parasitic and infectious diseases: often – pharyngitis.

Special instructions

It is not necessary to apply Anoro Ellipt at bronchial asthma (due to the lack of a safety profile to this category of patients).

Drug is not intended for stopping of acute symptoms (as acute management at acute episodes of a bronchospasm). For stopping of acute symptoms bronchodilators of short action have to be used. Increase in frequency of their use can demonstrate deterioration in control over a disease (consultation with the specialist is required).

Anoro Ellipt's use can lead to development of a life-threatening paradoxical bronchospasm. In these cases therapy is cancelled.

To patients 40 years before Anoro Ellipt's appointment aged are younger it is necessary to confirm the diagnosis spirometric.

Medicinal interaction

At the combined use of Anoro Ellipt with some medicinal means / substances development of the following effects is possible:

• beta adrenoblockers: easing/antagonism of action of Anoro Ellipt (without strong reasons the combined use is not recommended);
• strong inhibitors of an isoenzyme CYP3A4 (for example, кетоконазол): increase in system exposure of a vilanterol and probability of emergence of undesirable reactions (the combination demands care).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 2 years.

After opening of an aluminum container drug can be used for 6 weeks.