Budesonide / Formoterol fumarate / Glycopyrrolate

Breztri Aerosphere

Breztri Aerosphere is an FDA-approved prescription medication made for the long-term treatment of people suffering from chronic obstructive pulmonary disease (COPD). This inhalation aerosol is formulated to aid patients by improving their breathing and managing symptoms associated with COPD. As a maintenance treatment, Breztri Aerosphere combines three active ingredients (budesonide, formoterol fumarate, & glycopyrrolate) to help open airways, reduce inflammation, and prevent exacerbations, enhancing the quality of life for those affected by this progressive respiratory condition. So, if you want to buy Breztri Aerosphere to treat COPD, you need your doctor’s prescription.

Product Overview

Breztri Aerosphere is a prescription medication specifically designed for the long-term management of COPD (chronic obstructive pulmonary disease). It is not suitable for asthma treatment or as a rescue inhaler for breathing issues. This inhalation aerosol utilizes a combination of budesonide, formoterol fumarate, and glycopyrrolate, which work together to decrease inflammation, improve lung function, and reduce the frequency of COPD exacerbations. Patients prescribed Breztri Aerosphere should use it strictly according to their doctor’s instructions. 

Generally, the dosage involves taking two puffs in the morning and two in the evening, amounting to four puffs daily. The medicine should be inhaled using the Aerosphere device, which is a metered-dose inhaler that delivers the medication in aerosol form. Users need to follow several key steps when using Breztri Aerosphere: the device should be stored at room temperature and kept away from direct heat and moisture. Each dose should be followed by rinsing the mouth with water to avoid oral thrush—this rinse should not be swallowed. 

Regarding side effects, common reactions include nausea, headache, muscle spasms, and cough. More serious adverse effects could involve heart palpitations, urinary retention, and increased risk of infections due to the immunosuppressive properties of corticosteroids like budesonide. It’s crucial to discuss all risks & side effects with a healthcare provider. Patients should also be aware of specific health conditions that may interact with the medication, such as existing heart conditions or allergies to the medication’s components. Regular consultations and follow-ups with a healthcare provider are advisable to adjust dosages or treatment plans as needed. 

Uses of Breztri Aerosphere 

• Breztri Aerosphere is recommended as a long-term medication treatment for adults with COPD.

[Important Warning: Breztri Aerosphere is unsuitable for treating asthma and should not be used as a rescue inhaler.]

How to Use the Breztri Aerosphere?

Dosage

Breztri Aerosphere is a metered-dose inhaler called Aerosphere. It dispenses medication as an aerosol that you inhale in puffs. Each puff delivers:

• 160 micrograms (mcg) of budesonide
• 9 mcg of glycopyrrolate
• 4.8 mcg of formoterol fumarate

Recommended Dosage for Different Patients

Breztri Aerosphere Dosage for COPD

Breztri Aerosphere is for long-term chronic obstructive pulmonary disease (COPD) treatment. Generally, the dose is two puffs in the morning and two in the evening, totaling up to four puffs daily.

Important: Do not use the Breztri Aerosphere for sudden breathing problems. Use a rescue inhaler like albuterol for emergencies.

[Note: Remember these recommendations mentioned above may vary depending on person to person. Discuss it with your doctor or pharmacist, and they’ll customize your Breztri Aerosphere dosage accordingly.]

How to Take It?

• Follow your doctor’s instructions closely for using the Breztri Aerosphere.
• Breztri Aerosphere is administered as an inhalation aerosol using the Aerosphere device.
• Take two puffs orally, twice daily, using the inhaler.
• The medication comes in a foil pouch containing either 120 or 28 puffs. Wait to open the pouch until you are ready to use it.
• After inhaling your Breztri Aerosphere dose, rinse your mouth with water to prevent oral thrush; do not swallow the rinse water.
• Refer to the manufacturer’s guide for detailed instructions on using the Breztri Aerosphere inhaler, including videos if available.
• If you have received an inhaler with an updated design, check the manufacturer’s website for instructions specific to both the old and new versions of the inhaler.
• Consult your healthcare giver or pharmacist if you have questions about using the Breztri Aerosphere inhaler.
• Continue using your prescribed rescue inhaler alongside Breztri Aerosphere as directed by your doctor; Breztri is not a replacement for a rescue inhaler.
• Breztri Aerosphere can be taken with or without food as it does not affect the medication’s efficacy.

[Note: Your doctor will decide the right Breztri Aerosphere inhalation dose for you based on your condition, following guidelines & studies on the drug. They’ll adjust it as needed over time.]

How Does the Breztri Aerosphere Work?

Breztri Aerosphere integrates a trio of active pharmaceutical ingredients, each targeting a different aspect of airway management to facilitate easier breathing. The first component, Budesonide, is an inhaled corticosteroid that significantly reduces inflammation within the airways. This reduction in inflammation helps to alleviate breathing difficulties by preventing airway constriction. 

The second ingredient, Formoterol fumarate, functions as a long-acting beta-agonist. Its primary role is to relax the muscles surrounding the lungs, which aids in opening the airways for extended periods. This mechanism is crucial for providing sustained relief from breathing restrictions. 

Lastly, Glycopyrrolate, an anticholinergic agent, blocks the action of acetylcholine, a neurotransmitter in the body that contributes to the tightening of airway muscles. By inhibiting this chemical, Glycopyrrolate helps to relax further and open the airways, enhancing respiratory function.

Important Safety Information

Side Effects

Common side effects of Breztri Aerosphere include:

• Nausea
• Diarrhea
• Muscle spasms
• Cough
• Joint or back pain
• Swelling in your sinuses
• Headache
• Influenza (flu)
• Urinary tract infection (UTI)
• Heart palpitations (rapid or irregular heartbeat)
• Hoarseness

Serious side effects of Breztri Aerosphere include:

• Allergic reactions
• Problems with adrenal gland function
• Sudden breathing problems
• High blood sugar levels
• Oral thrush 
• Feeling anxious or nervous
• Increased risk of infection
• Heart problems
• Pneumonia
• Low blood potassium levels
• Eye problems (glaucoma & cataracts)
• Urinary retention (difficulty emptying your bladder)
• Osteoporosis
• Tremors (involuntary movements)

[Note: This above list may not cover all possible side effects of Breztri Aerosphere. Always consult with your healthcare giver or doctor for medical advice about side effects.]

Warnings

Before starting your treatment with Breztri Aerosphere, discussing your complete health history with your healthcare provider is crucial. The Breztri Aerosphere may not be suitable for individuals with specific health conditions or factors that influence their overall health. Important considerations include:

• Asthma: Breztri Aerosphere is not approved for the treatment of asthma. The safety and efficacy of this medication for individuals suffering from asthma have not been established. It is important to consult with your healthcare provider to explore alternative, appropriate, and effective treatments for managing asthma.
• Allergic Reactions: If you have a bad experience with an allergic reaction to using Breztri Aerosphere or any of its components, it is advised not to use this medication. Allergic reactions can be very serious. Discuss with your doctor to identify safer and more suitable medication alternatives that do not pose the same risk of an allergic response.
• Tuberculosis (TB): Breztri Aerosphere is a medication that includes budesonide, a type of corticosteroid. Corticosteroids can suppress your immune system, reducing its ability to combat infections effectively. This is particularly critical if you have tuberculosis. For those with an active TB infection, it is usually necessary to undergo a complete course of anti-tuberculosis treatment before initiating therapy with Breztri Aerosphere. If you have a history of TB, it’s essential to discuss this with your doctor before starting Breztri Aerosphere. TB bacteria can remain dormant in your body for many years and may reactivate if the medication weakens your immune system. Your doctor will evaluate your TB status and may recommend monitoring for TB reactivation or initiating treatment for TB alongside the use of Breztri Aerosphere.
• Bacterial, Viral, Fungal, or Parasitic Infections: The corticosteroid component in Breztri Aerosphere, budesonide, may decrease your immune system’s response to other types of infections, including bacterial, viral, fungal, and parasitic infections. If you are currently dealing with a significant infection, your doctor will likely suggest treating it fully before you start using Breztri Aerosphere. Furthermore, you must consult your doctor immediately if you acquire an infection during your treatment. They will generally prescribe appropriate medications to treat the infection while you are still using Breztri Aerosphere. This approach helps manage the infection effectively without interrupting your ongoing treatment with Breztri Aerosphere.
• Ocular Herpes: Breztri Aerosphere, a medication that includes budesonide, a type of corticosteroid, can potentially suppress the immune system, reducing its capability to combat infections. This suppression is particularly concerning for individuals with ocular herpes, a viral eye infection. Those currently experiencing an outbreak of ocular herpes must generally undergo antiviral treatment before commencing treatment with Breztri Aerosphere. Additionally, for those who have a history of ocular herpes, there is a risk that the use of Breztri Aerosphere could trigger a reactivation of the virus. It is crucial to consult with your healthcare professional to assess the safety of using Breztri Aerosphere under these conditions. They may prescribe an antiviral medication as a preventive measure against the resurgence of ocular herpes to safeguard your ocular health.
• Susceptibility to Measles and Chickenpox: The corticosteroid component, budesonide, in Breztri Aerosphere, also impacts the immune system’s ability to ward off infections, including those caused by the viruses responsible for measles and chickenpox. These infections can be particularly serious in individuals who are treated with Breztri Aerosphere. If you have not been vaccinated or have not previously contracted these illnesses, avoiding contact with infected individuals is advisable. Should exposure occur, it is imperative to inform your healthcare provider immediately. You might require prompt medical intervention with medication to prevent or manage these infections effectively.
• Reduced Adrenal Function: Chronic administration of high doses of corticosteroids, including budesonide found in Breztri Aerosphere, may lead to diminished adrenal gland function. The adrenal glands produce cortisol, a critical hormone that helps the body respond to stress. A deficiency in cortisol due to impaired adrenal function can compromise your ability to handle stress, especially during times of significant physical stress such as illness, injury, or surgery. If you are using Breztri Aerosphere and are concerned about reduced adrenal function, discussing these concerns with your doctor is important. They may advise adjusting your corticosteroid dosage to prepare your body for stressful situations adequately.
• Cardiovascular Risks: Breztri Aerosphere, a medication intended for specific health conditions, can pose risks to individuals with pre-existing heart issues. It has the potential to elevate blood pressure and cause rapid or irregular heart rhythms. If you suffer from cardiovascular conditions like heart failure, angina (characterized by chest pain), or irregular heartbeats, using Breztri Aerosphere may exacerbate these issues. It is crucial to consult with your doctor or pharmacist to determine if this medication aligns with your health needs and to discuss potential risks and benefits.
• Impact on Blood Pressure: Breztri Aerosphere may increase blood pressure. For those already diagnosed with hypertension, the medication may intensify the condition. Before starting treatment, a thorough discussion with your healthcare provider is advised to assess the suitability of Breztri Aerosphere in the context of your existing health conditions.
• Effects on Bone Mineral Density: With long-term use, Breztri Aerosphere has been observed to reduce bone mineral density, potentially leading to more fragile bones that are susceptible to fractures. If you are already predisposed to bone density issues, your doctor needs to monitor your bone health before and during treatment with Breztri Aerosphere. Factors that might increase your risk of reduced bone mineral density include:
  • A family history of osteoporosis, a condition that weakens bones and increases fracture risk.
  • Having undergone menopause which can accelerate bone density loss.
  • Leading a sedentary lifestyle or infrequent participation in physical activities.
  • Smoking tobacco can negatively affect bone health.
  • Consuming a diet low in essential nutrients required for bone strength.
  • Being aged 65 years or older.
  • Prolonged use of certain medications such as oral corticosteroids or anticonvulsants, that can diminish bone strength.

• Ophthalmic Concerns: Prolonged usage of Breztri Aerosphere has been associated with the exacerbation or onset of several eye conditions, including increased intraocular pressure, glaucoma, and cataracts. Individuals with pre-existing eye disorders may require more frequent ophthalmological evaluations while undergoing treatment with this medication. It is very crucial to alert your doctor immediately if you detect any alterations in your vision during the course of using Breztri Aerosphere.
• Urinary Retention: Individuals who experience difficulties with urination or bladder emptying, possibly due to prostate or bladder issues, may find that Breztri Aerosphere aggravates these symptoms. It is important to discuss the appropriateness of using Breztri Aerosphere with your healthcare provider if you have such urinary conditions.
• Overactive Thyroid: Breztri Aerosphere may intensify certain signs related to an overactive thyroid gland, like accelerated heart rate. If you have an overactive thyroid, consulting with your doctor to determine the suitability of this medication for your condition is advisable.
• Seizure Disorders: For people who suffer from seizure disorders, including epilepsy, Breztri Aerosphere could potentially worsen seizure activity. It is essential to discuss the safety and suitability of this medication with your doctor if you are prone to seizures.
• Diabetes: Treatment with Breztri Aerosphere may lead to an increase in blood sugar levels. If you are diabetic, it may be necessary for your doctor or healthcare giver to monitor your blood sugar more frequently than usual while you are on this medication to manage any potential changes effectively.
• Liver Function: Breztri Aerosphere contains budesonide and formoterol, two components metabolized by the liver. In patients with severe liver impairment, these substances could accumulate in the body, heightening the risk of adverse effects. Your doctor may recommend closer monitoring during your treatment with this medication if you have significant liver issues.
• Kidney Concerns: There is a lack of research on the effects of Breztri Aerosphere in individuals with kidney issues. If you have severe kidney problems, it is imperative to discuss with your healthcare provider whether this medication is appropriate for your use.

Precautions

• Breztri Aerosphere and Alcohol: While no specific interactions between alcohol and Breztri Aerosphere have been identified, research suggests that heavy alcohol consumption may deteriorate lung function over time. If you have COPD and decide to drink, it’s advisable to limit your alcohol intake. For guidance on safe alcohol consumption while using Breztri Aerosphere, please consult your healthcare provider.
• Use During Pregnancy: The safety of using Breztri Aerosphere during pregnancy remains unclear. If you are pregnant or planning to become pregnant, it’s important to discuss the potential risks & advantages of using this particular medication with your doctor. Your doctor can also suggest alternative treatments that might be safer during pregnancy.
• Breastfeeding Considerations: The safety of Breztri Aerosphere during breastfeeding is not established. While it is known that budesonide, one of the active ingredients in Breztri Aerosphere, passes into breast milk, the impacts of this exposure on a nursing child are not well understood. The passage of the other two active ingredients, formoterol, and glycopyrrolate, into breast milk has not been determined. If you are breastfeeding or plan to breastfeed, you should discuss the risks & benefits of using Breztri Aerosphere with your doctor.

Missed Dose

• If you have missed a dose of Breztri Aerosphere, take this medication as soon as possible. 
• If it’s close to the time for your next Breztri Aerosphere inhalation dose, skip the missed dose & continue with your regular dosing schedule.
• Do not take extra puffs to compensate for the missed dose.
• If you need help deciding whether to take or skip a missed dose, consult your doctor or pharmacist for advice.
• To avoid missing doses, consider using a medication reminder, such as setting an alarm on your mobile, a reminder app, or a kitchen timer.

[Note: If you missed a Breztri Aerosphere inhalation dose and are unsure when to take the next dose, immediately consult your doctor or pharmacist.]

Overdose 

It’s important not to exceed the prescribed dose of Breztri Aerosphere, as doing so can lead to severe side effects. Overdose symptoms include blurry vision, dizziness, heart palpitations, headaches, fluctuations in blood pressure, muscle cramps, nausea, and vomiting. If you suspect an overdose, immediately call or contact your doctor or America’s Poison Centers. They also offer online resources for assistance. However, if you experience severe symptoms, do not hesitate to call 911 or go to the nearest emergency room. Taking more medication than recommended can significantly increase your risk of serious health complications.

[Note: If you consumed more than the recommended inhalation dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

• Store Breztri Aerosphere at room temperature, ideally between 68–77°F (20–25°C).
• It can tolerate short periods at temperatures between 59–86°F (15–30°C) if necessary.
• Keep the inhaler away from heat and direct sunlight.
• Avoid storing the inhaler in damp places like bathrooms.
• Upon opening, record the date on the inhaler’s label.
• Dispose of the inhaler when the dose indicator shows zero or 3 months after opening (for a 120-puff inhaler) or 3 weeks after opening (for a 28-puff inhaler), whichever comes first.

[Note: Discuss with your healthcare professional or doctor the proper disposal of unused Breztri Aerosphere inhaler and any questions you may have regarding its storage.]

Breztri Aerosphere Interactions

Breztri Aerosphere, containing budesonide, formoterol, and glycopyrrolate, can interact with various substances, including alcohol, food, and other medications. Understanding these interactions can help in managing your treatment more effectively.

Caffeine and Formoterol (Moderate Interaction): Combining caffeine with formoterol can increase side effects such as nervousness, irritability, and an elevated heart rate due to enhanced sympathetic activity. Monitoring pulse and blood pressure is advised when consuming caffeine with this medication.

Glycopyrrolate and Alcohol (Moderate Interaction): Alcohol can increase drowsiness and dizziness when taken with glycopyrrolate. It is recommended to use alcohol cautiously and possibly adjust medication doses as directed by your healthcare provider.

Budesonide and Alcohol (Minor Interaction): Alcohol may interact with budesonide, but the interaction is considered minor. Further professional advice should be sought for detailed information.

Budesonide and Food (Moderate Interaction): Grapefruit juice can significantly increase plasma levels of budesonide by inhibiting CYP450 3A4-mediated metabolism. Regular consumption of grapefruit juice should be avoided to prevent increased systemic effects of budesonide.

Drug Interactions: Beta-2 Adrenergic Bronchodilators and Cardiovascular Risk (Moderate Potential Hazard): These drugs can cause cardiovascular effects such as tachycardia, palpitations, and blood pressure changes. They should be used cautiously in patients with underlying heart conditions or sensitivity to sympathomimetic amines. Interactions with various drug classes include:

• Antibiotics like clarithromycin
• Antifungal drugs such as itraconazole and ketoconazole
• Antiretroviral drugs like atazanavir and nelfinavir
• Theophylline, a drug for COPD
• Diuretics like hydrochlorothiazide and furosemide
• Monoamine oxidase inhibitors such as selegiline
• Tricyclic antidepressants like amitriptyline
• Beta-blockers such as metoprolol
• Other long-acting beta-agonists like salmeterol
• Other corticosteroids, such as prednisone
• Other anticholinergics like tiotropium

[Note: This is not a complete list, and there could be other drugs that may interact with Breztri Aerosphere. Make sure to tell your doctor or pharmacist about any prescription, over-the-counter medicines, & herbal products you’re currently taking.]

Breztri Aerosphere Alternatives

• Duaklir Pressair (aclidinium/formoterol)
• Bevespi Aerosphere (glycopyrrolate/formoterol)
• Stiolto Respimat (tiotropium/olodaterol)
• Anoro Ellipta (umeclidinium/vilanterol)
• Advair (fluticasone/salmeterol)
• Breo Ellipta (fluticasone/vilanterol)
• Symbicort (budesonide/formoterol)
• Brovana (arformoterol)
• Perforomist (formoterol)
• Striverdi (olodaterol)
• Serevent (salmeterol)
• Tudorza Pressair (aclidinium)
• Spiriva (tiotropium)
• Incruse Ellipta (umeclidinium)

[Note: Your doctor will choose what’s the best alternative medication for you. Don’t use any of these alternative medicines without consulting your healthcare giver. Taking them by yourself can cause very serious side effects.] 

Frequently Asked Questions

Should I use the Breztri Aerosphere for sudden breathing problems?

The Breztri Aerosphere should not be used for sudden breathing issues as it is not designed to act quickly enough to relieve these problems. Instead, you should use a rescue medication for immediate relief from acute breathing difficulties. Examples of rescue medications include albuterol (available under brand names like ProAir, Proventil HFA, and Ventolin HFA) and levalbuterol (marketed as Xopenex). It’s crucial to always carry your rescue medication with you to ensure that you can quickly address any sudden breathing challenges as they arise.

Will Breztri Aerosphere cure my COPD?

Breztri Aerosphere is not a cure for chronic obstructive pulmonary disease (COPD), as there is currently no cure for this condition. Nevertheless, regular daily use of Breztri Aerosphere can offer significant benefits for those living with COPD. It can enhance symptom management, making daily activities more manageable & improving overall quality of life. Additionally, it plays a very crucial role in preventing exacerbations, often called flare-ups, which are sudden worsening of symptoms that can be severe and even lead to hospitalizations. By using Breztri Aerosphere as prescribed, individuals may also reduce their risk of hospital stays and lower the likelihood of mortality associated with COPD complications.

Is Breztri the same as Symbicort?

Breztri and Symbicort are both FDA-approved inhalers used for treating respiratory conditions, but they are not the same. Breztri is formulated with three active ingredients: budesonide, glycopyrrolate, and formoterol fumarate. This combination includes a corticosteroid, an anticholinergic, and a long-acting beta-agonist. In contrast, Symbicort contains only two active substances, budesonide and formoterol fumarate, which are a corticosteroid and a long-acting beta-agonist, respectively. While both medications are designed to manage symptoms effectively, they should not be used as rescue inhalers in emergencies. Instead, they are intended for regular, prescribed use to control and prevent symptoms. Following medical advice when using either of these treatments is important to ensure safety and efficacy.

Is the Breztri Aerosphere inhaler a steroid?

The Breztri Aerosphere inhaler does indeed contain a steroid. It includes budesonide, a type of corticosteroid, which is known to weaken the immune system potentially. Due to the presence of this corticosteroid, users of Breztri Aerosphere may experience an increased susceptibility to infections, as their body’s ability to combat such infections can be compromised. This effect is a common characteristic associated with corticosteroids used in various inhalation therapies for their anti-inflammatory properties.

When should I stop using the Breztri Aerosphere inhaler?

You should continue using your Breztri Aerosphere inhaler until a doctor advises you to stop. If you need to discontinue the medication, it’s important to gradually decrease your dosage rather than stopping abruptly. This tapering process helps prevent withdrawal symptoms that may include severe fatigue, joint pain, nausea, and dizziness. Always follow your doctor’s instructions carefully to avoid potential complications from stopping the inhaler.

Can I travel with my Breztri inhaler?

Absolutely, traveling with your Breztri inhaler is permissible. However, it’s crucial to store it correctly to ensure its effectiveness and safety. The inhaler should be kept in a location that remains dry, as moisture can affect the medication inside. Additionally, avoid exposing this medication to direct sunlight or high temperatures, which can degrade the medicine’s quality or even make the inhaler’s container hazardous. When packing, consider placing your inhaler in a protective case or a secure section of your luggage where it’s less likely to be damaged or subjected to extreme conditions. It’s also wise to keep it easily accessible in case you need to use it during your journey. 

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