Fluticasone HFA 44mcg Inh 120inh

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It exerts its effects by binding to glucocorticoid receptors in the cytoplasm of target cells, leading to the modulation of gene expression. This results in the inhibition of inflammatory cells (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines), thereby reducing 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 signs or symptoms, contact your doctor or seek medical attention immediately:

Allergic reaction symptoms, 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
Infection symptoms, such as:
+ 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 adrenal gland problems, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Cushing's syndrome symptoms, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Withdrawal symptoms, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ 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
Speech difficulties

Breathing Problems: A Life-Threatening 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. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical attention:

Common cold symptoms
Nose or throat irritation
Headache
Fatigue or weakness
Flu-like symptoms
Diarrhea
Stomach upset 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.
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, 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 and health conditions with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you experience any worsening of your breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increase in the frequency of using your rescue inhaler, contact your doctor immediately.

You may not notice the full effects of this medication for several weeks. If you have been taking this medication for an extended period, consult with your doctor before stopping, as you may need to gradually taper off the medication to avoid potential side effects.

As this medication can increase your risk of developing infections, it is crucial to practice good hygiene by washing your hands frequently and avoiding 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.

When transitioning from an oral steroid to a different 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 with you to alert medical professionals that you may need additional steroids in these situations.

Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk, and have your eye pressure checked regularly if you are taking this medication for an extended period.

Prolonged use of this medication may also lead to osteoporosis (weak bones). Discuss your individual risk factors with your doctor, and consider undergoing a bone density test as recommended by your doctor.

If you are a child or teenager taking this medication, your doctor will closely monitor you for potential side effects, as the risk may be higher in younger patients. This medication may affect growth in children and teens, so regular growth checks may be necessary.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Ritonavir
• Ketoconazole
• Other strong CYP3A4 inhibitors (e.g., cobicistat-containing products, itraconazole, clarithromycin, telithromycin, nefazodone)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil)

• Increased wheezing
• Shortness of breath
• Cough
• Chest tightness
• Increased use of rescue inhaler (e.g., albuterol)
• Oral thrush (white patches in mouth/throat)
• Hoarseness/dysphonia
• Sore throat
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain) - rare with inhaled doses but possible with high doses or drug interactions.

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 corticosteroids. Data from observational studies and postmarketing experience with fluticasone propionate do not suggest an increased risk of major birth defects or miscarriage.

Low levels of fluticasone propionate are expected to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fluticasone propionate and any potential adverse effects on the breastfed infant from fluticasone propionate or from the underlying maternal condition. Generally considered compatible with breastfeeding due to low systemic absorption.

Inhaled corticosteroids, including fluticasone HFA, may cause a reduction in growth velocity in pediatric patients. Monitor growth regularly. Use the lowest effective dose. Safety and effectiveness in children younger than 4 years have not been established.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustment is generally not required, but monitor for potential adverse effects, especially if co-morbidities or polypharmacy are present.

• Emphasize proper inhaler technique and rinsing the mouth after each use to minimize local side effects like oral candidiasis and dysphonia.
• Fluticasone HFA is a maintenance medication and should be used consistently, even when symptoms are absent. It is not a rescue inhaler.
• Patients should be advised to carry their rescue inhaler (e.g., albuterol) for acute asthma symptoms.
• Counsel patients on the importance of adherence to therapy for optimal asthma control and prevention of exacerbations.
• Be aware of potential drug interactions with strong CYP3A4 inhibitors, which can lead to systemic corticosteroid effects.

• 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, short-term)

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 medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.