Wixela Inhub Diskus 250/50mcg 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). This reduces airway hyperresponsiveness and inflammation. Salmeterol is a long-acting beta2-adrenergic agonist (LABA). It selectively stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. This effect is mediated by activation of adenyl cyclase, which increases intracellular cyclic AMP (cAMP) levels.

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 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
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 sores
Redness or white patches in the mouth or throat

Important Warning: 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 medical help immediately.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:

Headache
Upset stomach or vomiting
Throat irritation
* Common cold symptoms

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 using a similar medication. If you are unsure, consult your doctor or pharmacist to determine if the medication is similar.
Any prescription or over-the-counter (OTC) medications, natural products, or vitamins you are taking that may interact with this medication. Certain medications used to treat conditions like HIV, infections, or depression may not be suitable to take with this drug. Your doctor or pharmacist can advise you on potential interactions.
If you have a milk allergy, as this may be relevant to your treatment.

Please note that this is not an exhaustive list of all potential drug interactions or health concerns related to this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications (prescription or OTC), natural products, and vitamins you are taking.
Discuss your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.

Effectiveness and Monitoring
It may take approximately 1 week to experience the full effect of this medication. If you have diabetes (high blood sugar), consult your doctor, as this drug may increase blood sugar levels. Immediately contact your doctor if your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more frequently.

Dosage and Administration
Do not exceed the recommended dose or use this medication more often than prescribed. Overdose can be fatal, so it is crucial to follow your doctor's instructions. If you have any concerns, discuss them with your doctor.

Transitioning from Oral Steroids
When switching 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. If you experience any of these symptoms, contact your doctor immediately.

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 indicating that you may need extra steroids in such situations.

Long-term Use and Potential Side Effects
Prolonged use of this medication may increase the 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 the risk, wash 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 to chickenpox or measles, consult your doctor.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more prone to side effects. In children and teenagers, this medication may affect growth in some cases, so regular growth checks may be necessary. Consult your doctor to discuss any concerns.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

COPD Considerations
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 discuss your condition with your doctor.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat-containing products, telithromycin, nefazodone) due to increased systemic exposure to fluticasone and salmeterol, leading to increased risk of systemic corticosteroid effects and cardiovascular adverse events.

• Beta-blockers (including ophthalmic): May block the bronchodilatory effect of salmeterol and produce severe bronchospasm, especially in patients with asthma. Should generally not be used together.
• Other long-acting beta2-adrenergic agonists (LABAs): Concomitant use is not recommended as it may lead to overdose.
• Diuretics (loop or thiazide): May cause ECG changes and/or hypokalemia, which can be acutely worsened by beta-agonists, especially at higher doses.
• Tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs): May potentiate the cardiovascular effects of salmeterol (e.g., prolongation of QTc interval, arrhythmias). Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs.

• Non-potassium-sparing diuretics: Increased risk of hypokalemia.
• Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia and ECG changes.
• Corticosteroids (oral/parenteral): Increased risk of systemic corticosteroid effects.
• Sympathomimetics: Additive cardiovascular effects.

• Not specifically identified as minor, but general caution with other drugs affecting heart rate or potassium levels.

• Frequency and severity of asthma/COPD symptoms (e.g., shortness of breath, wheezing, cough, chest tightness)
• Use of rescue inhaler (SABA)
• Nocturnal symptoms
• Exacerbation frequency
• Signs of oral candidiasis (thrush)
• Signs of paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Signs of cardiovascular effects (e.g., palpitations, tremor, chest pain)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, mood changes)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown teratogenic effects with high doses of fluticasone and salmeterol.

L3 (Moderate risk). It is not known whether fluticasone or salmeterol are excreted in human milk. However, other corticosteroids and beta2-agonists are excreted. Caution should be exercised when administered to a nursing mother. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Wixela Inhub 250/50 mcg is approved for asthma in patients 12 years of age and older. For children 4-11 years, lower strengths of fluticasone/salmeterol (e.g., 100/50 mcg) may be used. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as growth suppression can occur. The lowest effective dose should be used.

No dosage adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular effects of salmeterol (e.g., arrhythmias, tremors) and systemic corticosteroid effects (e.g., osteoporosis, cataracts, glaucoma). Monitor for comorbidities and potential drug interactions.

• Emphasize that this is a maintenance medication, not a rescue inhaler. Patients must have a SABA for acute symptoms.
• Proper inhaler technique is crucial for efficacy. Demonstrate and have the patient demonstrate back.
• Rinsing the mouth after each dose is essential to prevent oral candidiasis (thrush).
• Warn patients about the black box warning regarding LABA use in asthma and the importance of not using additional LABA-containing products.
• Monitor for signs of systemic corticosteroid effects, especially with higher doses or prolonged use, and in patients with risk factors.
• Counsel patients on the importance of adherence, even when feeling well, to maintain asthma/COPD control.
• Be aware of potential drug interactions, especially with strong CYP3A4 inhibitors, beta-blockers, and drugs that prolong the QTc interval.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone)
• Long-Acting Muscarinic Antagonist (LAMA) monotherapy (e.g., tiotropium, umeclidinium) for COPD
• Short-Acting Beta2-Adrenergic Agonist (SABA) for rescue (e.g., albuterol, levalbuterol)
• Oral corticosteroids (for severe exacerbations or refractory disease)
• Leukotriene receptor antagonists (e.g., montelukast)
• Phosphodiesterase-4 inhibitors (e.g., roflumilast) for severe COPD
• Biologic therapies (e.g., omalizumab, mepolizumab, 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 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.