Wixela Inhub Diskus 500/50mcg 60s

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It exerts its effects by binding to glucocorticoid receptors, leading to the activation of anti-inflammatory genes and the repression of pro-inflammatory genes. This reduces inflammation in the airways, decreasing bronchial hyperreactivity and mucus production. Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA). It selectively stimulates beta2-adrenergic receptors on bronchial smooth muscle cells, leading to activation of adenyl cyclase, increased intracellular cyclic AMP (cAMP) levels, and subsequent relaxation of bronchial smooth muscle, resulting in bronchodilation.

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, 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 excitable.
Changes in behavior.
Vision changes, eye pain, or severe eye irritation.
Unusual burning, numbness, or tingling sensations.
Choking.
Changes in voice.
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.

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 medications can cause side effects, but many people experience none or only mild symptoms. 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.
Nausea 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 taking a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
Any prescription or over-the-counter (OTC) medications, natural products, or vitamins you are taking, as some may interact with this medication. Specifically, certain medications 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.
If you have a milk allergy.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications, health problems, and supplements with your doctor and pharmacist to ensure safe use.

To guarantee your safety, inform your doctor and pharmacist about all the following:
All prescription and OTC medications you are taking
Any natural products or vitamins you are using
Your health problems

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult your doctor to ensure it is safe to do so with this medication.

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 effects 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 prescribed dose or use this medication more often than directed. 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 these situations.

Long-term Use and Potential Risks
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor about this potential risk. Additionally, long-term use may cause osteoporosis (weak bones). Discuss your risk factors with your doctor and undergo bone density tests as recommended.

Infection Prevention
To minimize the risk of infection, practice good hygiene by washing your hands frequently and avoiding close contact with people who have infections, colds, or flu.

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

Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. In children and adolescents, this medication may affect growth in some cases, so regular growth checks may be necessary. Consult your doctor about this potential risk.

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 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 this with your doctor.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat-containing products) due to increased systemic exposure to fluticasone and salmeterol, leading to increased risk of cardiovascular and systemic corticosteroid adverse effects.
• Other long-acting beta2-adrenergic agonists (LABAs) due to increased risk of cardiovascular adverse effects.

• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of salmeterol and cause severe bronchospasm, especially in patients with asthma. Use with caution and only if no suitable alternative.
• Diuretics (loop or thiazide): May potentiate ECG changes and/or hypokalemia associated with beta-agonists, especially at high doses.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the cardiovascular effects of salmeterol (e.g., arrhythmias, hypertension). Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs.
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, certain antihistamines, macrolides): Increased risk of ventricular arrhythmias with salmeterol.

• Other sympathomimetics: Additive cardiovascular effects.
• Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia and ECG changes.

• Not specifically identified as minor, but general caution with drugs affecting electrolyte balance.

• Worsening asthma/COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Signs of oral candidiasis (white patches in mouth or throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, mood changes)
• Signs of infection (e.g., fever, chills, increased sputum production, change in sputum color)
• Cardiovascular symptoms (e.g., palpitations, chest pain, tremor, nervousness)

Category C. There are no adequate and well-controlled studies of fluticasone/salmeterol in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Poorly controlled asthma in pregnancy poses risks to both mother and fetus.

Caution is advised. It is unknown if fluticasone or salmeterol are excreted in human milk. Systemic levels are low after inhalation. The developmental and health benefits of breastfeeding should be considered 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.

Wixela Inhub 500/50 mcg is indicated for asthma in adolescents 12 years and older. Lower strengths are available for younger children. Monitor growth velocity in pediatric patients receiving ICS, as they may experience a reduction in growth velocity. 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., tremor, palpitations) and systemic corticosteroid effects (e.g., bone density loss, cataracts, glaucoma). Monitor for comorbidities and concomitant medications.

• Wixela Inhub is a maintenance medication and should be used regularly, even when symptoms are absent. It is NOT a rescue inhaler.
• Emphasize proper Diskus inhaler technique, including loading the dose, exhaling fully away from the device, inhaling rapidly and deeply, holding breath, and rinsing mouth.
• Patients should be instructed to always have a short-acting beta-agonist (SABA) available for acute asthma symptoms.
• Counsel patients on the black box warning regarding the increased risk of asthma-related death with LABAs, and that this combination should only be used when ICS alone is insufficient.
• Monitor for signs of oral candidiasis and reinforce mouth rinsing after each dose.
• Be aware of potential drug interactions, especially with strong CYP3A4 inhibitors and beta-blockers.
• For patients transitioning from oral corticosteroids, monitor for adrenal insufficiency and taper oral steroids slowly.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone) for patients whose asthma is controlled on ICS alone.
• Long-acting Muscarinic Antagonists (LAMAs) (e.g., tiotropium) for COPD.
• Oral corticosteroids (for severe exacerbations or refractory disease).
• Leukotriene receptor antagonists (e.g., montelukast).
• Biologic therapies (e.g., omalizumab, mepolizumab, dupilumab) for severe asthma.
• Short-acting beta-agonists (SABAs) for rescue relief.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.