Fluticasone HFA 110mcg 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 the formation of a steroid-receptor complex. This complex translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin) and the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, eicosanoids). This action reduces airway hyperresponsiveness, inflammation, and mucus production 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: 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

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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
All 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 together. Your doctor or pharmacist can provide guidance on potential interactions.
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 and health conditions with your doctor and pharmacist. This includes:

All prescription and OTC medications
Natural products
Vitamins
* Any health problems you are experiencing

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.

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 feel 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 stopping. Your doctor may recommend gradually tapering off 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.

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 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 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 your risk and discuss any concerns you may have. Your doctor may recommend a bone density test to monitor your bone health.

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, as they will need to discuss the potential benefits and risks of this medication with you and determine the best course of action for you and your baby.

• Ritonavir
• Ketoconazole
• Itraconazole
• Clarithromycin
• Nelfinavir
• Cobicistat-containing products

• Other strong CYP3A4 inhibitors (e.g., atazanavir, indinavir, saquinavir, telithromycin, voriconazole)

• Increased wheezing
• Shortness of breath
• Cough
• Chest tightness
• Increased need for rescue inhaler
• Nocturnal asthma symptoms
• Oral candidiasis (white patches in mouth/throat)
• Hoarseness
• Sore throat

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Asthma control is important during pregnancy to ensure adequate oxygenation for both mother and fetus. Inhaled corticosteroids are generally preferred over systemic corticosteroids due to lower systemic exposure.

Fluticasone propionate is considered compatible with breastfeeding. Due to its low systemic absorption and high protein binding, the amount transferred into breast milk is expected to be negligible. Benefits of breastfeeding should be weighed against the need for maternal treatment.

Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as long-term use may be associated with a reduction in growth velocity. The lowest effective dose should be used. Proper inhaler technique is crucial and may require a spacer device.

No specific dose adjustment is required. Elderly patients may be more susceptible to systemic corticosteroid effects, though these are rare with inhaled fluticasone at recommended doses. Monitor for bone mineral density changes with long-term use.

• Fluticasone HFA is a controller medication, not a rescue inhaler. Patients must understand this distinction.
• Emphasize the importance of rinsing the mouth and spitting after each dose to prevent oral candidiasis and dysphonia.
• Regular, consistent use is key for optimal asthma control; skipping doses can lead to worsening symptoms.
• Patients should be taught proper inhaler technique, ideally with a demonstration, and encouraged to use a spacer device if recommended.
• Monitor for signs of adrenal suppression, especially in patients transitioning from oral corticosteroids or those on high doses with concomitant strong CYP3A4 inhibitors.
• Consider bone mineral density monitoring in patients on high doses for prolonged periods, or those with other risk factors for osteoporosis.

• Other inhaled corticosteroids (e.g., Budesonide, Mometasone, Beclomethasone, Ciclesonide)
• Leukotriene receptor antagonists (e.g., Montelukast)
• Long-acting beta-agonists (LABAs) - *Note: LABAs should not be used as monotherapy for asthma*
• Oral corticosteroids (for severe exacerbations or severe persistent asthma)
• Biologic therapies (e.g., Omalizumab, Mepolizumab, Benralizumab, Dupilumab) for severe asthma

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.