Wixela Inhub Diskus 100/50mcg 60s

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It acts by binding 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). Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA). It selectively stimulates beta2-adrenergic receptors in the bronchial smooth muscle, leading to bronchodilation by increasing cyclic AMP levels, which relaxes smooth muscle and inhibits the release of mediators from mast cells.

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 immediate medical attention:

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, difficulty 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 high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure
Rapid or abnormal heartbeat
Shakiness
Feeling nervous or agitated
Changes in behavior
Vision changes, eye pain, or severe eye irritation
Abnormal burning, numbness, or tingling sensations
Choking
Voice changes
Seizures
Bone pain
Sleep disturbances
Feeling extremely tired or weak
Vaginal itching or discharge
Weight gain
Mouth irritation or mouth sores
Redness or white patches in the mouth or throat

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience difficulty breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek immediate medical attention.

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 symptoms that bother you or persist, contact your doctor:

Headache
Upset stomach or vomiting
Throat irritation
* Signs of a common cold

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are currently taking a similar medication. If you are unsure, consult your doctor or pharmacist to confirm.
Any medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, that may interact with this medication. Certain medications used to treat conditions like HIV, infections, and depression may not be compatible with this drug. Your doctor or pharmacist can advise you on potential interactions.
If you have a milk allergy.

Please note that this is not an exhaustive list of all potential interactions or health problems that may affect the use of this medication. To ensure your safety, it is crucial 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 your existing medications and health conditions.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.

It may take approximately 1 week to experience the full effects of this medication. If you have diabetes (high blood sugar), consult your doctor, as this medication may increase your blood sugar levels.

Monitor your breathing problems closely, and contact your doctor immediately if they worsen, if your rescue inhaler becomes less effective, or if you need to use it more frequently.

Dosage and Administration

Do not exceed the prescribed dose or use this medication more often than directed. Overdose can be fatal, so it is essential to follow your doctor's instructions carefully.

Special Considerations

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 signs such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these symptoms.

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 indicating that you may need extra steroids in these situations.

Long-term Use

Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Consult your doctor and schedule regular eye exams as recommended.

Long-term use may also lead to osteoporosis (weak bones). Discuss your risk factors with your doctor and undergo bone density tests as advised.

Infection Risk

You may be more susceptible to infections while taking this medication. To minimize your risk, practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu.

If you have not had chickenpox or measles before, avoid exposure to these illnesses, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, consult your doctor promptly.

Special Populations

If you are 65 or older, use this medication with caution, as you may be more prone to side effects.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, so consult your doctor.

Pregnancy and Breastfeeding

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

COPD

If you have chronic obstructive pulmonary disease (COPD), you are at a higher risk of developing pneumonia. This medication may further increase this risk, so consult your doctor to discuss your individual situation.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone) - concomitant use is not recommended due to increased systemic exposure to fluticasone and salmeterol, leading to increased risk of cardiovascular and systemic corticosteroid adverse effects.

• Beta-blockers (e.g., propranolol, carvedilol) - may block the bronchodilatory effect of salmeterol and produce severe bronchospasm, especially in patients with asthma. Generally, patients with asthma should not be treated with beta-blockers.
• Diuretics (e.g., furosemide, hydrochlorothiazide) - may potentiate ECG changes and/or hypokalemia associated with LABAs, especially at high doses.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs) (e.g., amitriptyline, phenelzine) - may potentiate the effect of salmeterol on the cardiovascular system. Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs/TCAs.

• Other sympathomimetics - may potentiate adverse cardiovascular effects.
• Non-potassium-sparing diuretics - may worsen ECG changes and/or hypokalemia.

• Not specifically listed for minor interactions with significant clinical impact.

• Worsening asthma/COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler (e.g., albuterol)
• Signs of oral candidiasis (white patches in mouth/throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, adrenal insufficiency symptoms like fatigue, nausea, dizziness)
• Cardiovascular symptoms (e.g., palpitations, chest pain, tremor, nervousness)
• Paradoxical bronchospasm (immediate worsening of breathing after inhalation)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of Wixela Inhub in pregnant women. Animal studies have shown teratogenic effects with fluticasone and salmeterol at high doses. Poorly controlled asthma in pregnancy poses risks to both mother and fetus.

Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Wixela Inhub and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Fluticasone and salmeterol are excreted in animal milk; it is unknown if they are excreted in human milk. Systemic exposure to both drugs is low following inhalation.

Approved for asthma in children aged 4 years and older. Monitor growth velocity in pediatric patients receiving ICS, as long-term use may affect growth. The lowest effective dose should be used. Safety and efficacy in children younger than 4 years have not been established. Not indicated for COPD in pediatric patients.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is generally not required based on age alone. Monitor for age-related comorbidities (e.g., cardiovascular disease, osteoporosis, diabetes) that may be affected by the drug.

• Wixela Inhub is a maintenance medication and should be used regularly, even when symptoms are absent. It is NOT a rescue inhaler.
• Always 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 systemic absorption of fluticasone.
• Patients should be educated on the proper use of the Diskus device, including loading the dose and inhaling correctly.
• Paradoxical bronchospasm is a rare but serious side effect; patients should be instructed to use their rescue inhaler immediately and seek medical attention if it occurs.
• Regular monitoring of asthma/COPD control (e.g., symptom diaries, peak flow readings, frequency of rescue inhaler use) is crucial.
• Be aware of potential drug interactions, especially with strong CYP3A4 inhibitors, which can significantly increase systemic exposure to both components.
• In COPD patients, ICS/LABA combinations have been associated with an increased risk of pneumonia; monitor for signs and symptoms.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone) for asthma.
• Long-Acting Beta2-Adrenergic Agonists (LABA) monotherapy (e.g., salmeterol, formoterol, arformoterol) - generally not recommended for asthma due to black box warning, but used in COPD.
• Long-Acting Muscarinic Antagonists (LAMA) monotherapy (e.g., tiotropium, umeclidinium) for COPD.
• Short-Acting Beta2-Adrenergic Agonists (SABA) for rescue (e.g., albuterol, levalbuterol).
• Oral corticosteroids (for severe exacerbations or refractory disease).
• Leukotriene receptor antagonists (e.g., montelukast) for asthma.
• Phosphodiesterase-4 inhibitors (e.g., roflumilast) for severe COPD.
• Biologics (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 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 it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.