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.
Ultibro Breezhaler (indacaterol / glycopyrronium bromide)
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Product Details
Description
Ultibro Breezhaler is a combination of indacaterol and glycopyrronium bromide, used to provide long-term relief for adults with chronic obstructive pulmonary disease (COPD). It works by acting as an ultra-long-acting beta-adrenoceptor agonist and a long-acting muscarinic antagonist, which help expand the airways and make it easier to breathe. It is used as a maintenance treatment to help improve the quality of life for individuals living with COPD.
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
One inhalation of Ultibro (glycopyrrolate 15.6 mcg-indacaterol 27.5 mcg) is typically taken orally once per day. The medication is administered using an inhaler device, which requires you to inhale the content of one capsule per dose. Do not take more than the recommended dosage or use more frequently, as it may lead to adverse effects. Keep in mind that this medication is intended for treating COPD and should not be used to treat asthma, as doing so may increase the risk of asthma-related death.
Ingredients
Ultibro Breezhaler is a combination medication composed of two active substances: indacaterol (85 micrograms) and glycopyrronium (43 micrograms). Indacaterol maleate is an ultra long-acting beta-adrenoceptor agonist (ultra-LABA), while glycopyrronium bromide aids in further lung function improvement and symptom relief.
Contraindications
The following list details some conditions and situations in which the use of Ultibro Breezhaler is not recommended:
- Hypersensitivity to indacaterol maleate or glycopyrronium bromide
- Allergy to any other component of the medication
- Children, as the safety and effectiveness of this drug have not been established in individuals under 18 years of age
Cautions
- Before starting Ultibro Breezhaler, inform your doctor about:
- Any medications you currently take, as some may interact with the active substances in Ultibro Breezhaler.
- Any existing medical conditions, particularly if they involve the respiratory system or if you have a history of allergies.
- Pregnancy or plans to become pregnant, as the safety of Ultibro Breezhaler during pregnancy has not been established.
- Breastfeeding or plans to breastfeed since it is unknown whether the active substances in Ultibro Breezhaler pass into breast milk and could affect the baby.
- Do not use Ultibro Breezhaler alongside other medicines containing long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, as it already contains these ingredients.
- Ultibro Breezhaler is not approved for asthma treatment. Long-acting beta-adrenergic agonists may pose a risk of serious asthma-related events, including death.
- This medication is not for the treatment of acute bronchospasm. Immediate alternative treatments should be sought if such an episode occurs.
- Discontinue immediately if signs of allergic reactions, such as difficulty breathing, swelling of the tongue, lips, or face, urticaria, or skin rash occur.
- If paradoxical bronchospasm occurs, stop using Ultibro Breezhaler immediately and seek alternative treatments.
- Use with caution if you have narrow-angle glaucoma, and be vigilant for symptoms. Discontinue use and seek medical attention if symptoms develop.
- Exercise caution if you have a history of urinary retention.
- Those with severe kidney problems or end-stage renal disease should use Ultibro Breezhaler only if the benefits outweigh the risks and should be closely monitored for adverse reactions.
- Use with caution if you have cardiovascular disorders such as heart disease, heart rhythm problems, or high blood pressure. Discontinue use if cardiovascular effects occur.
- Be aware of the potential for low potassium levels and high blood sugar levels, especially if you have severe COPD, are diabetic, or are on other treatments that may affect potassium and glucose levels.
- Use Ultibro Breezhaler cautiously if you have seizure disorders, thyrotoxicosis, or are sensitive to beta2-adrenergic agonists.
- This medication contains lactose. Do not use if you have conditions like galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
Side Effects
Ultibro Breezhaler may cause side effects. Common side effects may include cough, sore throat, runny or stuffy nose, and headache. Additionally, some people may experience frequent urination, dizziness, and indigestion. It is important to use the medication as prescribed and consult your health care professional if these side effects persist or worsen.
More serious side effects of Ultibro Breezhaler may require immediate medical attention. These can include an allergic reaction, which may present as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. Additionally, severe eye problems or worsening of lung symptoms may occur. If you or a loved one is taking Ultibro Breezhaler and experiences any serious side effects, seek medical advice immediately.
References:
- Ultibro Breezhaler (indacaterol / glycopyrronium bromide) Product Monograph. Nuremburg, Germany: Novartis Pharmaceuticals; 2018.
- 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.Product Code : 13790
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