Ultibro Breezhaler (indacaterol / glycopyrronium bromide)

Prescription medicineOnly Available By Prescription
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50mcg/110mcg CAP+1 INHALATION DEVICE
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What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

Ultibro Breezhaler is a fixed-dose combination medication containing indacaterol and glycopyrronium bromide. It is classified as an ultra-long-acting beta-adrenoceptor agonist (ultra-LABA) and anticholinergic, working together to help those experiencing airway blockages. This medication is mainly used as a long-term maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), including conditions like chronic bronchitis and emphysema.

Fact Table

Formula

Indacaterol: C24H27N5O3 Glycopyrronium Bromide: C19H28BrNO3

License

US FDA, US DailyMed, EU EMA

Bioavailability

Indacaterol: 43-45% (inhalation) Glycopyrronium Bromide: Low systemic bioavailability when inhaled

Legal status

Rx-Only

Chemical Name

indacaterol / glycopyrronium bromide

Elimination half-life

Indacaterol: Approximately 45.5 hours Glycopyrronium Bromide: 52-58 hours

Dosage (Strength)

50mcg / 110mcg CAP+1 INHALATION DEVICE

Pregnancy

Consult a healthcare provider for advice

Brands

Ultibro Breezhaler

Protein binding

Indacaterol: 94.1-95.3% Glycopyrronium Bromide: Low protein binding

PubChem CID

11564052

MedlinePlus

Not listed specifically for Ultibro Breezhaler

ChEBI

Indacaterol: 68575 Glycopyrronium Bromide: 5959

ATC code

R03AL04

DrugBank

Indacaterol: DB05039 Glycopyrronium Bromide: DB01401

KEGG

D10505

Routes of administration

Inhalation

Directions

To properly use the Ultibro Breezhaler, follow the instructions provided by your healthcare professional and the guide included with the inhaler device. The standard dosage for this medication is one inhalation of the combined glycopyrrolate 15.6 mcg-indacaterol 27.5 mcg capsule, taken twice a day, once in the morning and once in the evening. Ensure you use the Ultibro Breezhaler consistently and avoid taking more than the prescribed dose. To get the most benefit from the medication, use it at the same time each day.

Ingredients

Ultibro Breezhaler is a medication containing two active substances: indacaterol (85 micrograms) and glycopyrronium (43 micrograms).

Contraindications

Avoid taking or using Ultibro Breezhaler if any of the following apply:

  • Allergy to indacaterol maleate or glycopyrronium bromide
  • Allergy to any other component of the Ultibro Breezhaler
  • Allergy to any ingredient in the formulation, including non-medicinal ingredients
  • Children under 18. This medication is only approved for use in adults.

Cautions

  • Before starting Ultibro Breezhaler, inform your doctor about:
    • Any medications you take.
    • Any medical conditions.
    • Pregnancy or plans to become pregnant.
    • Breastfeeding or plans to breastfeed.
  • Avoid using Ultibro Breezhaler with other long-acting beta-adrenergic agonists or muscarinic antagonists, as it may lead to adverse drug interactions.
  • Ultibro Breezhaler should not be used to treat asthma, as it could increase the risk of serious asthma-related events, including death.
  • Do not use Ultibro Breezhaler to treat sudden episodes of bronchospasm. Seek immediate medical attention if acute symptoms occur.
  • If you experience signs of an allergic reaction such as swelling or skin rash, discontinue use immediately and consult a healthcare provider for alternative treatments.
  • If using Ultibro Breezhaler leads to worsening of breathing problems, stop usage immediately and seek alternative therapy.
  • Patients with narrow-angle glaucoma should use Ultibro Breezhaler cautiously and remain alert to any worsening of symptoms.
  • Caution is advised for patients with a history of urinary retention.
  • Those with severe kidney problems should only use Ultibro Breezhaler if the benefit justifies the risk, and such patients should be monitored for adverse effects.
  • Patients with cardiovascular conditions should use Ultibro Breezhaler with caution due to the potential for increased heart rate, blood pressure, and ECG changes.
  • Monitor potassium levels as beta-adrenergic agonists can cause low potassium levels, potentially leading to cardiovascular issues.
  • If you have diabetes, you may need to monitor blood sugar levels more closely when starting Ultibro Breezhaler, as it may cause low blood sugar levels.
  • People with seizure disorders, thyroid issues, or heightened responsiveness to beta2-adrenergic agonists should use caution.
  • Ultibro Breezhaler contains lactose; those with lactose-related hereditary problems may need to avoid this medication.

Side Effects

Ultibro Breezhaler may cause side effects in some individuals. Common side effects may include cough, sore throat, headache, and runny nose. Additionally, some people may experience dizziness, trouble sleeping, and indigestion. More serious side effects of Ultibro Breezhaler may include cardiovascular effects like heart rhythm problems and fast heartbeat. If someone taking Ultibro Breezhaler experiences any of these serious side effects, it is important to seek medical advice immediately.

References:

  1. Ultibro Breezhaler (indacaterol / glycopyrronium bromide) Product Monograph. Nuremburg, Germany: Novartis Pharmaceuticals; 2018.
  2. Ultibro Breezhaler (indacaterol / glycopyrronium bromide) Full Prescribing Information. MIMS; 2023.



IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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