Fluticasone 100mcg Diskus (60 Inh)

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds to glucocorticoid receptors in the cytoplasm of target cells (e.g., lymphocytes, mast cells, eosinophils, macrophages) in the airways. This binding leads to the formation of a steroid-receptor complex that translocates to the nucleus, where it modulates gene expression. This results in the inhibition of inflammatory cell infiltration, reduction in the release of inflammatory mediators (e.g., histamine, leukotrienes, prostaglandins), and suppression of cytokine production (e.g., interleukins, TNF-alpha), thereby reducing airway hyperresponsiveness and inflammation.

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 adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow healing
Feeling extremely tired, weak, or irritable; trembling; rapid heartbeat, confusion, sweating, or dizziness (especially if you've missed a dose or recently stopped taking this medication)
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

Severe Breathing Problems

This medication can cause severe breathing problems, which may be life-threatening, shortly after taking a dose. If you experience trouble breathing, worsening breathing, wheezing, or coughing after using this medication, use a rescue inhaler and seek medical help immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor or seek medical attention:

Common cold symptoms
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea, upset stomach, or vomiting
* Muscle pain

Reporting Side Effects

This is not an exhaustive list of possible 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 the 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, may interact with this drug and should not be taken concurrently. Your doctor or pharmacist can provide guidance 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 to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

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

Monitoring Your Condition

If you experience any worsening of your breathing problems, or if your rescue inhaler becomes less effective or is needed more frequently, contact your doctor immediately. It may take several weeks to notice the full effects of this medication.

Stopping the Medication

If you have been taking this medication for an extended period, consult with your doctor before discontinuing use. Your doctor may recommend a gradual tapering off of the medication to minimize potential side effects.

Infection Risk

You may be more susceptible to infections while taking this medication. To reduce this risk, practice good hygiene by washing your hands frequently, and avoid close contact with individuals who have infections, colds, or flu. If you have not previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor promptly.

Transitioning from Oral Steroids

When switching from an oral steroid to a different form of steroid, you may be at risk for severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these.

Managing Stress and Illness

If you suffer a serious injury, undergo surgery, or develop an infection, you may require additional doses of oral steroids to help your body cope with these stresses. Carry a warning card with you to alert healthcare providers of this potential need.

Long-term Use and Eye Health

Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this risk with your doctor and have your eye pressure checked regularly if you are taking this medication long-term.

Bone Health

Long-term use of this medication may also lead to weakened bones (osteoporosis). Consult with your doctor to determine if you are at higher risk for osteoporosis or if you have any questions. Follow your doctor's recommendations for bone density testing.

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 children and teens, so regular growth checks may be necessary.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you and determine the best course of action for you and your baby.

• Ritonavir (strong CYP3A4 inhibitor)
• Cobicistat (strong CYP3A4 inhibitor)

• Ketoconazole (strong CYP3A4 inhibitor)
• Itraconazole (strong CYP3A4 inhibitor)
• Clarithromycin (moderate CYP3A4 inhibitor)
• Atazanavir (strong CYP3A4 inhibitor)
• Indinavir (strong CYP3A4 inhibitor)
• Nelfinavir (strong CYP3A4 inhibitor)
• Saquinavir (strong CYP3A4 inhibitor)

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough, chest tightness)
• Increased need for rescue inhaler (e.g., albuterol)
• Oral candidiasis (white patches in mouth or throat, soreness)
• Hoarseness or dysphonia
• Sore throat
• Headache
• Signs of systemic corticosteroid effects (e.g., fatigue, weakness, nausea, vomiting, dizziness, weight gain, easy bruising, moon face, striae) - especially if used with strong CYP3A4 inhibitors
• Blurred vision or eye pain (rare, but can indicate cataracts or glaucoma with long-term use)

Fluticasone propionate is classified as Pregnancy Category C. While animal studies have shown some teratogenic effects at high doses, human data from epidemiological studies and registries have not shown an increased risk of major birth defects or adverse pregnancy outcomes with inhaled fluticasone. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Uncontrolled asthma poses a greater risk to both mother and fetus than inhaled corticosteroid use.

Fluticasone propionate is considered compatible with breastfeeding. Due to its low systemic absorption and high protein binding, the amount of fluticasone excreted into breast milk is expected to be negligible. Therefore, adverse effects on the breastfed infant are unlikely.

Fluticasone Diskus is approved for children 4 years of age and older for asthma. Monitor growth velocity regularly, as inhaled corticosteroids can potentially affect growth, though the clinical significance of this effect is generally small. Use the lowest effective dose.

No specific dose adjustments are required for elderly patients. However, elderly patients may be more susceptible to systemic corticosteroid effects, particularly if they have co-morbidities or are on other medications that interact with fluticasone. Monitor for bone mineral density changes and ocular effects with long-term use.

• Emphasize that Fluticasone Diskus is a controller medication for asthma prevention and not a rescue inhaler for acute symptoms.
• Proper inhaler technique is paramount for efficacy. Always demonstrate and have the patient demonstrate technique.
• Instruct patients to rinse their mouth thoroughly with water and spit it out after each dose to minimize the risk of oral candidiasis (thrush) and dysphonia.
• Be vigilant for signs of systemic corticosteroid effects (e.g., adrenal suppression, Cushingoid features) especially in patients on high doses or concomitant strong CYP3A4 inhibitors (e.g., ritonavir).
• In pediatric patients, monitor growth velocity regularly. The benefits of controlled asthma generally outweigh the potential for minor growth suppression.
• Patients should not abruptly discontinue fluticasone, especially if they have been on high doses for prolonged periods, as this can precipitate adrenal insufficiency.

• Other inhaled corticosteroids (ICS): Budesonide (Pulmicort Flexhaler, Pulmicort Respules), Mometasone (Asmanex Twisthaler, Asmanex HFA), Beclomethasone (Qvar RediHaler), Ciclesonide (Alvesco)
• Leukotriene receptor antagonists (e.g., Montelukast)
• Long-acting beta-agonists (LABAs) - generally not used as monotherapy for asthma
• Long-acting muscarinic antagonists (LAMAs) - for severe asthma
• Biologic therapies (e.g., Omalizumab, Mepolizumab, Reslizumab, 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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.