Fluticasone HFA 220mcg Oral Inh

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds to glucocorticoid receptors in the cytoplasm of target cells, leading to a cascade of events that modulate gene expression. This results in the inhibition of inflammatory cell migration and activation (e.g., eosinophils, mast cells, lymphocytes, macrophages) and a reduction in the synthesis and release of inflammatory mediators (e.g., cytokines, chemokines, eicosanoids). This action reduces airway hyperresponsiveness and inflammation in the lungs.

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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 if you miss 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

Respiratory Problems: A Life-Threatening Condition

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 Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, 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, nausea, 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 any symptoms that occurred.
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 issues that may interact with this drug.

To ensure your safety, it is vital to:

Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose 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 for the full effects of this medication to become apparent.

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 individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor promptly.

Changing from Oral Steroids

When transitioning from an oral steroid to another 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.

Stressful Situations

In the event of a 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 with you to alert medical professionals of this potential need.

Long-term Use

Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this 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 weak bones (osteoporosis). Consult with your doctor to determine if you are at higher risk for osteoporosis or if you have any questions. Your doctor may recommend a bone density test to monitor your bone health.

Pediatric Use

If you are a parent or caregiver of a child taking this medication, be aware that the risk of certain side effects may be higher in children. This medication may affect growth in children and teens, and 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, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.

• Ritonavir
• Cobicistat
• Ketoconazole
• Itraconazole

• Other strong CYP3A4 inhibitors (e.g., clarithromycin, telithromycin, nefazodone)

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Oral candidiasis (white patches in mouth or throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, vision changes)
• Paradoxical bronchospasm (rare, immediate worsening of breathing after inhalation)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Inhaled corticosteroids are generally preferred over systemic corticosteroids for asthma control during pregnancy due to lower systemic exposure.

Considered compatible with breastfeeding. Fluticasone propionate is highly protein-bound and has low oral bioavailability, suggesting minimal transfer into breast milk and low infant exposure. Monitor breastfed infant for any adverse effects.

Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as long-term use may be associated with a reduction in growth velocity. Use the lowest effective dose. Risk of adrenal suppression, especially with higher doses or concomitant use of strong CYP3A4 inhibitors.

No specific dose adjustment is required. Monitor for potential systemic corticosteroid effects, such as bone mineral density loss, cataracts, and glaucoma, which may be more prevalent in the elderly population.

• Fluticasone HFA is a controller medication for asthma; it is NOT a rescue inhaler for acute bronchospasm.
• Patients should be instructed on proper inhaler technique to ensure optimal drug delivery to the lungs.
• Rinsing the mouth and gargling with water after each dose is crucial to minimize the risk of oral candidiasis (thrush) and systemic absorption.
• Full therapeutic benefit may not be seen for 1-2 weeks after starting therapy; patients should be advised not to discontinue prematurely.
• Monitor for signs of adrenal suppression, especially in patients transitioning from systemic corticosteroids or those on high doses or concomitant strong CYP3A4 inhibitors.
• Regular follow-up is important to assess asthma control and adjust therapy as needed.

• Budesonide (Pulmicort Flexhaler)
• Mometasone (Asmanex HFA)
• Beclomethasone (Qvar RediHaler)
• Ciclesonide (Alvesco)
• Other inhaled corticosteroids (ICS)

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 your 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 medication taken, the amount, and the time it happened.