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.
Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate)
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Product Details
Description
Breztri Aerosphere is a three-drug combination inhaler used to treat patients with chronic obstructive pulmonary disease (COPD).
Breztri Aerosphere contains budesonide (inhaled corticosteroid), glycopyrrolate (anticholinergic), and formoterol fumarate (long-acting beta2-adrenergic agonist).
Fact Table
Formula
C25H34O6
License
US DailyMed, EU EMA
Bioavailability
10-20% (first pass effect)
Legal status
RX-only
Chemical Name
budesonide, glycopyrrolate, and formoterol fumarate
Elimination half-life
2.0-3.6 hours
Dosage (Strength)
160mcg / 7.2mcg / 5mcg (120 doses / Inhaler), 160mcg / 9mcg / 4.8mcg (120 doses / inhaler)
Pregnancy
Consult Doctor
Brands
Breztri Aerosphere
Protein binding
85-90%
PubChem CID
40000
MedlinePlus
a608007
ChEBI
Not Assigned
ATC code
A07EA06
DrugBank
DB01222
KEGG
D00246
Routes of administration
inhalation
Directions
Breztri is available as a pressurized metered dose inhaler. The contents of Breztri are to be inhaled by mouth. Each puff provides 160 mcg of budesonide, 9 mcg of glycopyrrolate, and 4.8 mcg of formoterol fumarate.
Breztri dosing for maintenance COPD treatment is 2 puffs by mouth twice daily. Rinse your mouth with water and spit the water out after using Breztri to prevent an oral fungal infection called thrush.
Follow the instructions on your prescription label. If you have any questions about how to use your inhaler, ask your doctor or pharmacist.
Do not use Breztri to relieve sudden breathing problems.
Ingredients
The active ingredients contained in Breztri Aerosphere include micronized budesonide, micronized glycopyrrolate, and micronized formoterol fumarate.
Contraindications
Do not use Breztri if you are allergic to budesonide, glycopyrrolate, formoterol fumarate, or any of the other ingredients.
Cautions
- Before you start using Breztri Aerosphere, tell your doctor:
- About your allergies
- About the medications you take, including any inhalers, atropine, antifungal medications, and anti-HIV medications
- About your health problems
- If you are pregnant or plan to become pregnant
- If you are breastfeeding or plan to breastfeed
- Do not use Breztri with other medications that contain a long-acting beta2-adrenergic agonist due to the risk of overdose.
- Breztri can increase your risk for pneumonia. Call your doctor right away if you develop a fever, cough, chills, increased breathing problems, mucus production, or mucus color changes.
- Breztri can worsen infections.
- Adrenal function can be affected when being switched from systemic corticosteroids such as prednisone to a medication that contains an inhaled corticosteroid such as Breztri. You should be slowly tapered off systemic corticosteroids when switching to Breztri.
- Adrenal insufficiency and hypercorticism can occur with very high doses or normal doses in patients who are sensitive to these effects. Call your doctor right away if you experience tiredness, weakness, nausea, vomiting, no energy, or low blood pressure.
- Stop taking Breztri and call your doctor right away if you experience sudden breathing problems after using Breztri.
- Tell your doctor if you have heart problems.
- Tell your doctor if you have liver or kidney problems.
- Tell your doctor if you have weak or thin bones (osteoporosis).
- Tell your doctor if you have glaucoma, cataracts, or other vision problems.
- Tell your doctor if you have a convulsive disorder, thyroid problems, diabetes, or ketoacidosis.
- Breztri can worsen or cause urinary retention. Call your doctor right away if you have trouble urinating, painful urination, frequent urination, or urination in drips or a weak stream.
- Breztri can cause low potassium levels. Call your doctor right away if you experience muscle twitches, muscle weakness, or irregular heart rhythm.
- Breztri can increase blood sugar levels.
- Store Breztri Aerosphere at room temperature.
Side Effects
The most common side effects of Breztri Aerosphere include back pain, thrush, influenza, muscle spasm, diarrhea, urinary tract infection, upper respiratory tract infection, pneumonia, and sinusitis.
These are not all the possible side effects of Breztri Aerosphere. Contact your doctor if you experience side effects that bother you or won't go away.
References:
- Breztri Aerosphere. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021.
- Breztri Aerosphere. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021.
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 : 13564
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