Breo Ellipta 50-25mcg Oral Inh (30)

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways by inhibiting multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic and non-allergic mediated inflammation. Vilanterol is a selective long-acting beta2-adrenergic agonist (LABA). It stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. This effect is sustained for at least 24 hours.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Chest pain or pressure, or a rapid heartbeat.
Shakiness or tremors.
Feeling nervous or excitable.
Bone pain.
Changes in vision, eye pain, or severe eye irritation.
Mouth irritation or mouth sores.
Redness or white patches in the mouth or throat.
Feeling extremely tired or weak.

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience difficulty breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek immediate medical attention.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Headache.
Runny nose.
Nose or throat irritation.
Common cold symptoms.
Flu-like symptoms.
Changes in voice.
Back pain.
Joint pain.

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
* If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in conjunction with your other treatments and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.

Important Warnings and Cautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Blood Sugar Control
If you have diabetes (high blood sugar), this medication may cause your blood sugar levels to rise. Discuss with your doctor how to manage your blood sugar levels effectively.

Respiratory Problems
If your breathing problems worsen, your rescue inhaler is not working as well as it should, or you need to use it more frequently, contact your doctor immediately.

Dosage and Administration
Do not exceed the recommended dose or use this medication more often than prescribed. Overdosing on this type of medication can be fatal. Consult your doctor if you have any concerns.

Transitioning from Oral Steroids
When switching from an oral steroid to another form of steroid, you may experience severe and potentially life-threatening side effects, such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. Seek medical attention immediately if you experience any of these symptoms.

Stressful Situations
In cases of severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card indicating that you may need extra steroids in such situations.

Long-term Use and Eye Health
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor and undergo regular eye exams as recommended.

Bone Health
Long-term use of this medication may also lead to osteoporosis (weak bones). Discuss your risk factors with your doctor and undergo bone density tests as advised.

Infection Risk
You may be more susceptible to infections while taking this medication. Practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu.

Viral Infections
If you have not had chickenpox or measles before, avoid exposure to these viruses, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, consult your doctor immediately.

Growth and Development in Children and Teens
This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss any concerns with your doctor.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication for you and your baby.

COPD Patients
If you have chronic obstructive pulmonary disease (COPD), you are at a higher risk of developing pneumonia, which can be severe or even fatal. This medication may also increase the risk of hospitalization due to pneumonia. Discuss your risks with your doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) due to increased systemic exposure to fluticasone furoate and vilanterol, leading to increased risk of cardiovascular and systemic corticosteroid adverse effects.

• Other long-acting beta2-adrenergic agonists (LABAs): Concomitant use is not recommended as it may lead to an overdose of LABA.
• Beta-blockers (including ophthalmic): May block the pulmonary effect of vilanterol and produce severe bronchospasm in patients with asthma/COPD. Cardioselective beta-blockers should be used with caution, if at all.
• Diuretics (non-potassium-sparing): ECG changes and/or hypokalemia associated with non-potassium-sparing diuretics can be acutely worsened by beta-agonists.

• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the effect of vilanterol on the cardiovascular system. Use with extreme caution.
• Other sympathomimetic agents: May potentiate adverse cardiovascular effects.
• Corticosteroids (oral/parenteral): Increased risk of systemic corticosteroid effects.

• Not available

• Worsening shortness of breath
• Increased wheezing
• Increased cough
• Increased use of rescue inhaler (e.g., albuterol)
• Chest pain or palpitations
• Blurred vision or eye pain
• Oral thrush (white patches in mouth/throat)
• Hoarseness or dysphonia
• Muscle cramps or weakness
• Unusual fatigue or weight gain (signs of systemic corticosteroid effects)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of Breo Ellipta in pregnant women. Animal studies have shown reproductive toxicity with both fluticasone furoate and vilanterol at high doses. Untreated asthma in pregnancy poses risks to both mother and fetus.

Caution should be exercised when Breo Ellipta is administered to a nursing woman. It is unknown if fluticasone furoate or vilanterol are excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Breo Ellipta and any potential adverse effects on the breastfed infant from Breo Ellipta or from the underlying maternal condition.

Not indicated for children younger than 12 years for asthma or younger than 18 years for COPD. Growth velocity should be monitored in pediatric patients receiving inhaled corticosteroids.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution should be exercised in elderly patients with co-morbid cardiovascular conditions due to potential beta-agonist effects.

• Breo Ellipta is a once-daily medication. Emphasize consistent daily use, not as a rescue inhaler.
• Always instruct patients to rinse their mouth and spit after each dose to minimize the risk of oral candidiasis (thrush).
• Educate patients on the difference between Breo Ellipta (controller) and their rescue inhaler (for acute symptoms).
• Patients should be advised not to stop Breo Ellipta abruptly, as this can lead to worsening of their underlying respiratory condition or adrenal insufficiency.
• Monitor for signs of pneumonia in COPD patients, as ICS use can increase this risk.
• Be aware of the Black Box Warning regarding increased risk of asthma-related death with LABAs, and ensure appropriate patient selection (not for acute symptoms, not for patients whose asthma is well-controlled on ICS alone).

• Inhaled corticosteroids (e.g., fluticasone propionate, budesonide, mometasone)
• Long-acting beta2-adrenergic agonists (e.g., salmeterol, formoterol, indacaterol, olodaterol)
• Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, umeclidinium, glycopyrronium)
• Oral corticosteroids (for exacerbations)
• Leukotriene receptor antagonists (e.g., montelukast)
• Phosphodiesterase-4 inhibitors (e.g., roflumilast - for severe COPD)
• Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab - for severe asthma)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.