Flutic/vilan 100-25mcg Oral Inh(30)

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing bronchial hyperreactivity. Vilanterol is a long-acting beta2-adrenergic agonist (LABA) that stimulates beta2-receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. The combination provides both anti-inflammatory and bronchodilatory effects.

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 medical attention immediately:

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 feeling nervous and 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 medical help immediately.

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
Voice changes
Back pain
* Joint pain

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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 that is similar to this one. If you are unsure, consult your doctor or pharmacist for guidance.

Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or modify the dosage of any medication without first consulting your doctor.

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.

Diabetes and Blood Sugar Control
If you have diabetes (high blood sugar), this medication may cause your blood sugar levels to rise. Consult your doctor about 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. Taking too much of 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, including weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor immediately.

Stressful Situations
If you have a severe injury, undergo surgery, or develop an 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 these situations.

Long-term Use and Eye Health
Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Consult your doctor about this risk, and schedule 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. To minimize this risk, wash your hands frequently, and avoid close contact with people who have infections, colds, or flu.

Chickenpox and Measles
If you have not had chickenpox or measles before, avoid exposure to these diseases, 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, and your doctor will discuss this with you.

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

COPD and Pneumonia Risk
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 your risk of pneumonia and hospitalization due to pneumonia. Discuss this risk with your doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, atazanavir, indinavir, nelfinavir, saquinavir, telithromycin): May significantly increase systemic exposure to fluticasone furoate and vilanterol, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression) and cardiovascular adverse effects (e.g., QTc prolongation, tachycardia) from vilanterol. Co-administration is not recommended.
• Other long-acting beta2-adrenergic agonists (LABAs): Concomitant use is not recommended as it may lead to an overdose of LABA.

• Non-selective beta-blockers (e.g., propranolol): May antagonize the bronchodilatory effect of vilanterol and can produce severe bronchospasm in patients with asthma or COPD. Use with caution, and only if no suitable alternative.
• Diuretics (e.g., thiazide diuretics, loop diuretics): ECG changes and/or hypokalemia may result from beta-agonists, especially at higher doses. The hypokalemic effect of diuretics may be acutely worsened by beta-agonists. Use with caution.
• Tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs): May potentiate the effect of vilanterol on the cardiovascular system. Use with extreme caution, or consider alternative therapy.

• Worsening shortness of breath
• Increased need for rescue inhaler (e.g., albuterol)
• Chest tightness or pain
• Wheezing
• Signs of oral thrush (white patches in mouth/throat)
• Signs of infection (fever, chills, increased cough, change in sputum color/amount)
• Vision changes (blurred vision, halos around lights)
• Palpitations or rapid heart rate
• Tremors
• Muscle cramps or weakness

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Poorly controlled asthma in pregnancy poses risks to both mother and fetus. There are no adequate and well-controlled studies in pregnant women.

It is unknown if fluticasone furoate or vilanterol are excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Use with caution.

Not approved for children under 18 years of age for asthma or COPD. Long-term use of inhaled corticosteroids may affect growth velocity in children and adolescents; monitor growth.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Monitor for comorbidities and potential increased susceptibility to adverse effects.

• Breo Ellipta is a once-daily maintenance treatment and should not be used for acute bronchospasm.
• Patients should be instructed to rinse their mouth with water and spit after each dose to reduce the risk of oral candidiasis.
• The Ellipta inhaler device is breath-actuated and does not require shaking or priming.
• Monitor patients with COPD for pneumonia, as ICS use may increase this risk.
• Caution is advised in patients with cardiovascular disorders, seizure disorders, thyrotoxicosis, or diabetes mellitus due to the LABA component.
• Patients should be advised not to stop therapy abruptly without consulting their physician, especially if they have been on high doses for prolonged periods, due to the risk of adrenal insufficiency.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone furoate, budesonide)
• Long-Acting Muscarinic Antagonist (LAMA) monotherapy (e.g., tiotropium, umeclidinium)
• Short-Acting Beta2-Adrenergic Agonists (SABAs) for rescue (e.g., albuterol)
• Oral corticosteroids (for exacerbations or severe disease)
• Phosphodiesterase-4 (PDE4) inhibitors (e.g., roflumilast for severe COPD)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 facilitate prompt and effective treatment.