Arnuity Ellipta 200mcg Oral Inh 14

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds to glucocorticoid receptors, inhibiting the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) and suppressing the migration of inflammatory cells (e.g., eosinophils, mast cells, lymphocytes, macrophages, neutrophils) to the site of inflammation. This reduces airway hyperresponsiveness and inflammation in the lungs.

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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or abdomen
+ Moon face
+ Severe headache
+ Slow wound healing
Symptoms of withdrawal or missed dose, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ Dizziness
Other severe symptoms, including:
+ Flushing
+ Redness or white patches in the mouth or throat
+ Mouth irritation or sores
+ Bone or joint pain
+ Changes in vision
+ Changes in voice
+ Difficulty speaking

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble 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 mild ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Signs of a common cold
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea
Upset stomach or nausea
Vomiting
* Muscle pain

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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. 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.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, should not be taken with this drug. Your doctor or pharmacist can advise you on potential interactions.
Please note that this is not an exhaustive list of all medications or health conditions that may interact with this drug.

To ensure your safety, it is vital to discuss all of your medications (prescription and OTC), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or change the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

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

Monitoring Your Condition

If your breathing problems worsen, your rescue inhaler is not effective, or you need to use it more frequently, contact your doctor immediately. It may take a few weeks to experience the full benefits of this medication. If you have been taking this medication for an extended period, consult your doctor before stopping, as you may need to gradually taper off the medication.

Infection Prevention

You may be more susceptible to infections while taking this medication. To minimize the risk, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and avoid exposure to chickenpox and measles if you have not had these illnesses before. If you have been exposed to chickenpox or measles, consult your doctor promptly.

Special Precautions

When transitioning from an oral steroid to another form of steroid, you may be at risk for 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. Additionally, if you suffer a severe injury, undergo surgery, or develop an infection, you may require extra doses of oral steroids to help your body cope with the stress. Carry a warning card indicating that you may need additional steroids in certain situations.

Long-term Use and Potential Side Effects

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor to discuss this potential risk and schedule regular eye pressure checks if you are taking this medication long-term. Furthermore, long-term use may also lead to osteoporosis (weak bones). Discuss your individual risk with your doctor and undergo bone density tests as recommended.

Special Considerations for Children

If you are a child or teenager taking this medication, your doctor will closely monitor you for potential side effects, which may be more likely to occur in younger patients. This medication may affect growth in some cases, and regular growth checks may be necessary.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat): May significantly increase systemic fluticasone furoate exposure, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression).

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem): Potential for increased systemic exposure, but less pronounced than with strong inhibitors. Monitor for systemic corticosteroid effects.

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased need for rescue inhaler
• Oral candidiasis (white patches in mouth or throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, weakness) - rare with inhaled doses
• Blurred vision or eye pain (potential for glaucoma/cataracts with long-term use)

Available data from published epidemiologic studies and postmarketing experience with fluticasone furoate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Asthma control is important during pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

There are no available data on the presence of fluticasone furoate in human milk, the effects on the breastfed infant, or the effects on milk production. Other corticosteroids are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Arnuity Ellipta and any potential adverse effects on the breastfed infant from Arnuity Ellipta or from the underlying maternal condition.

Safety and effectiveness for asthma have been established in children aged 5 years and older. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. The lowest effective dose should be used.

No dosage adjustment is required based on age. Clinical studies did not identify differences in safety or effectiveness between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

• Arnuity Ellipta is a once-daily inhaled corticosteroid for maintenance treatment of asthma; it is NOT a rescue inhaler for acute bronchospasm.
• Patients should be instructed on proper inhaler technique and to rinse their mouth with water and spit after each dose to minimize the risk of oral candidiasis.
• Regular, consistent use is crucial for optimal asthma control. Patients should not stop therapy abruptly.
• Monitor pediatric patients for growth velocity, as inhaled corticosteroids can affect growth.
• Be aware of potential drug interactions with strong CYP3A4 inhibitors, which can increase systemic corticosteroid exposure.

• Other inhaled corticosteroids (ICS): Fluticasone propionate (Flovent HFA, Flovent Diskus), Budesonide (Pulmicort Flexhaler), Mometasone (Asmanex Twisthaler), Beclomethasone (Qvar RediHaler), Ciclesonide (Alvesco).
• ICS/LABA combinations (for patients not adequately controlled on ICS alone): Fluticasone furoate/Vilanterol (Breo Ellipta), Fluticasone propionate/Salmeterol (Advair Diskus/HFA), Budesonide/Formoterol (Symbicort), Mometasone/Formoterol (Dulera).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.