Fluticasone/salm 115/21mcg Inh 120s

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing bronchial hyperreactivity and mucus production. Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA) that selectively stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. The combination provides both anti-inflammatory and bronchodilator effects.

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, 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 excitable
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

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 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
* Common cold symptoms

This list is not exhaustive. 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
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.
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 crucial to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins.
Any health problems you have, as they may affect the safety of taking this medication.

Remember to always check with your doctor before starting, stopping, or changing the dose of any medication to ensure safe use and minimize potential interactions.

Important Information About Your Medication

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. It may take approximately 1 week to experience the full effects of this drug.

Diabetes Warning
If you have high blood sugar (diabetes), consult with your doctor, as this medication may increase your blood sugar levels.

Respiratory Problems
If your breathing problems worsen, your rescue inhaler is less effective, or you need to use it more frequently, contact your doctor immediately.

Dosage and Administration
Do not exceed the recommended dose or use this medication more often than prescribed. Overdose can be fatal. Consult with your doctor if you have any concerns.

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. Monitor for 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.

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

Osteoporosis Risk
Long-term use may also lead to weak bones (osteoporosis). 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. Practice good hygiene by washing your hands frequently, and avoid close contact with individuals 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 with your doctor.

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

Pediatric Use
This medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss potential risks and benefits.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of this medication for you and your baby.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat) due to increased systemic exposure to fluticasone and salmeterol, leading to increased risk of cardiovascular events (e.g., QTc prolongation, palpitations) and systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression).

• Other long-acting beta2-adrenergic agonists (LABAs) - increased risk of cardiovascular adverse effects.
• Beta-blockers (especially non-selective) - may block the bronchodilatory effect of salmeterol and cause severe bronchospasm in patients with asthma/COPD.
• Diuretics (loop or thiazide) - increased risk of hypokalemia and ECG changes, especially with high doses of salmeterol.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs) - may potentiate the cardiovascular effects of salmeterol (e.g., QTc prolongation, arrhythmias).

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice) - may increase systemic exposure to fluticasone and salmeterol, requiring caution and monitoring.
• Sympathomimetics - additive cardiovascular effects.
• Xanthine derivatives (e.g., theophylline) - increased risk of hypokalemia and arrhythmias.

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

• Worsening asthma/COPD symptoms (e.g., increased shortness of breath, wheezing, cough, chest tightness)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Oral candidiasis (thrush) - white patches in mouth/throat
• Hoarseness or dysphonia
• Palpitations or rapid heart rate
• Tremor
• Nervousness or anxiety
• Muscle cramps
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, weakness)
• Blurred vision or eye pain (potential glaucoma/cataracts)

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. Uncontrolled asthma poses a greater risk to both mother and fetus than the potential risks of the medication.

Caution should be exercised when Fluticasone/Salmeterol is administered to a nursing woman. It is unknown if fluticasone or salmeterol are excreted in human milk. However, other corticosteroids and beta2-agonists are excreted. The benefits of breastfeeding should be weighed against the potential risks to the infant.

Not indicated for children under 4 years of age. For children 4-11 years, lower strengths (e.g., 100/50 mcg) are typically used for asthma. For adolescents ≥12 years, the 115/21 mcg strength may be used. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth rate.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to the cardiovascular effects of salmeterol (e.g., arrhythmias, hypertension) and systemic corticosteroid effects. Use with caution and monitor for adverse reactions.

• Fluticasone/Salmeterol is a maintenance medication and should NOT be used for acute bronchospasm. Patients must have a short-acting beta-agonist (SABA) for rescue.
• 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 dysphonia.
• Emphasize the importance of regular, twice-daily dosing, approximately 12 hours apart, even when symptoms are well-controlled.
• Educate patients on the correct inhaler technique, as improper use can lead to reduced drug delivery and efficacy.
• Due to the LABA component, a Black Box Warning exists regarding increased risk of asthma-related death. It should only be used in asthma patients as concomitant therapy with an inhaled corticosteroid.
• Monitor for signs of systemic corticosteroid effects (e.g., adrenal suppression, bone density changes, cataracts, glaucoma) with long-term, high-dose use.
• Patients should be advised not to stop therapy abruptly, especially if they have been on high doses, due to the risk of adrenal insufficiency.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone) for asthma not requiring LABA.
• Long-Acting Muscarinic Antagonist (LAMA) monotherapy (e.g., tiotropium) for COPD.
• Oral corticosteroids (for severe exacerbations or refractory disease).
• Leukotriene receptor antagonists (e.g., montelukast).
• Immunomodulators (e.g., omalizumab, mepolizumab, 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.