Ultibro Brizchailer (glycopyrronium, indacaterol) capsules 110 mcg/50 mcg. №30 with inhaler

Description

Ultibro Brizchailer (glycopyrronium, indacaterol) capsules 110 mcg/50 mcg. №30 with inhaler

Composition

active substance: glycopyrronium bromide, indacaterol maleate;

1 capsule contains 110 mcg of indacaterol, corresponding to 143 mcg of indacaterol maleate, equivalent to 85 mcg of the target dose released, and 50 mcg of glycopyrronium, corresponding to 63 mcg of glycopyrronium bromide, equivalent to 43 mcg of the target dose;

Excipients: lactose monohydrate, magnesium stearate.

Dosage form

Powder for inhalation, hard capsules.

Basic physical and chemical properties:

Capsules with a transparent yellow cap with a black mark “” and a naturally transparent body with a blue inscription “IPG110.50” under two blue stripes, size 3, containing powder from white to almost white.

Pharmacotherapeutic group

Means used in obstructive airways diseases. A combination of adrenergic and anticholinergic drugs. ATX code R03AL04.

Pharmacological properties

This drug Ultibro Brizchailer is included in the group of drugs used for obstructive respiratory diseases.
It is a combination of adrenergic and anticholinergic substances.
Indacaterol is a long-acting beta 2-adrenergic receptor agonist once a day. It stimulates intracellular adenylate cyclase, an enzyme that catalyzes the conversion of adenosine triphosphate to cyclic 3 ‘, 5’-adenosine monophosphate. An increase in the concentration of the latter leads to relaxation of the muscles of the bronchi.
When inhaled into the bronchi, the substance has a local effect as a bronchodilator.
Glycopyronium is an inhaled muscarinic receptor antagonist (anticholinergic agent) with a prolonged action for once a day. Its goal is to support bronchodilator therapy for chronic obstructive pulmonary disease. Its mechanism of action is to block the bronchoconstrictive action of acetylcholine in the muscle cells of the airways, which contributes to the expansion of the airways.

Indications

Ultibro Brizchailer is used as a supportive bronchodilator therapy to relieve symptoms and reduce flare-ups in people with chronic obstructive pulmonary disease.

Contraindications

The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
Not used in pediatrics.

Application during pregnancy and lactation

Ultibro Brizchailer is not recommended for pregnant women – only under strict indications determined by the attending physician.
If it is necessary to take the drug during breastfeeding, lactation is suspended.

Method of application and dosage

The recommended dose is to inhale the contents of one capsule with an Ultibro Brizchailer inhaler once a day.

Ultibro Brizchailer is recommended to be used once a day at the same time every day. If a dose is missed, the next dose should be taken as soon as possible. Patients should be aware that they should not take more than one dose per day.

How to use the inhaler:

1. Remove the cap.

2. Open the inhaler: hold the base of the inhaler firmly and tilt the mouthpiece. The inhaler is open.

3. Prepare the capsule: separate one blister from the blister pack, tearing it along the perforation line.
Take one blister and remove the protective liner to open the capsule. Do not squeeze the capsule through the foil.

4. Remove the capsule:
The capsules should always be stored in the blister and removed only before use.
Remove the capsule from the blister with dry hands. Do not swallow the capsule.

5. Insert the capsule:
place the capsule in the capsule chamber.
Never place the capsule directly in the mouthpiece.

6. Close the inhaler:
close the inhaler until it “clicks”.

7. Pierce the capsule:
keep the inhaler upright so that the mouthpiece is pointing upwards.
Pierce the capsule by pressing both side buttons hard at the same time. Do it only once.
The moment the capsule is punctured, you should hear a click.

8. Completely release the side buttons.

9. Exhale: before placing the mouthpiece in your mouth, exhale completely.

Do not blow into the mouthpiece.

10. Inhale the drug:
In order for the medicine to get deep into your airways, you need to hold the inhaler as shown. The side buttons should be in front of you on the left and right. Do not squeeze the side buttons.
Put the mouthpiece in your mouth and press your lips tightly around it.
Take a quick but steady breath as deep as you can.
Do not press the side buttons.

Note: When you inhale through the inhaler, the capsule rotates in the chamber and you should hear a buzzing sound. You will feel the sweet aroma as soon as the medicine starts to reach your lungs.

If you do not hear buzzing:
the capsule may jam in the chamber. If this happens:
open the inhaler and gently release the capsule by tapping on the base of the inhaler. Do not press the side buttons.
Inhale the medicine again, repeating steps 9 and 10.

Hold your breath: after you have inhaled the medicine:
hold your breath for at least 5-10 seconds or as long as you can without feeling uncomfortable, while removing the inhaler from your mouth.
Then exhale.
Open the inhaler and check the capsule for powder residue.

If powder remains in the capsule: close the inhaler.
Repeat steps 9 through 12.

Most people can empty the capsule with one or two breaths.

Additional Information

Some people may sometimes cough for a short time immediately after inhaling the medicine. If this happens to you, don’t worry. If the capsule is empty, you have received enough medicine.

After taking your daily dose of Ultibro Brizchailer:
open the mouthpiece again and remove the empty capsule, tilting the camera to drop the capsule. Discard the empty capsule in the household waste.
Close the inhaler and replace the cap.

Do not store capsules in the Ultibro Brizchailer inhaler.

Overdose

There may be a slight increase in heart rate, blood pressure and an increase in the QTc interval.

Side effects

The drug is usually well tolerated when used in the recommended doses.
As side effects can be observed:

• upper respiratory tract infections;
• nasopharyngitis;
• urinary tract infections;
• sinusitis;
• rhinitis;
• hypersensitivity;
• angioneurotic edema;
• hyperglycemia and diabetes mellitus;
• mental disorders;
• insomnia;
• dizziness;
• headache;
• glaucoma;
• cardiac ischemia;
• atrial fibrillation;
• tachycardia;
• palpitations;
• cough;
• oropharyngeal pain, including throat irritation,
• paradoxical bronchospasm;
• dysphonia;
• nose bleed;
• stomach upset;
• caries;
• gastroenteritis,
• dry mouth;
• itching or rash;
• musculoskeletal pain,
• muscle spasm
• myalgia;
• pain in the limbs;
• obstruction of the bladder neck and urinary retention;
• general disorders and reactions at the injection site;
• peripheral edema;
• fatigue.

If side effects appear, you should interrupt treatment and contact your doctor for help and changes in the treatment process.