Fluticasone/salm Disk 250/50mcg 60s

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds 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). This reduces airway hyperresponsiveness and inflammation. 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 intracellular cyclic AMP (cAMP) levels, which relaxes smooth muscle. The long lipophilic side chain of salmeterol allows it to bind to the exosite of the beta2-receptor, providing a prolonged duration of action (up to 12 hours).

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. 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 concern you or persist, contact your doctor:

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. 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 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 drug interactions or health problems that may affect the use of this medication.

To ensure your safety, it is crucial to discuss all of your medications (prescription and OTC), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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 effects of this medication. If you have diabetes (high blood sugar), consult your doctor, as this drug may increase your 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. Overdosing on this type of medication has been fatal. Consult your doctor if you have any concerns.

Steroid Replacement Therapy
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, and contact your doctor immediately if you experience any of these signs. In cases of injury, surgery, or infection, you may require additional oral steroid doses to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in certain situations.

Long-term Use and Potential Risks
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor and undergo 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 and Prevention
You may be more susceptible to infections while taking this medication. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals 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 adolescents, this medication may affect growth in some cases, and 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, consult your doctor to weigh the benefits and risks of using this medication.

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. Discuss this with your doctor to determine the best course of treatment.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) due to increased systemic exposure to fluticasone and salmeterol, leading to increased risk of Cushing's syndrome, adrenal suppression, and cardiovascular effects (e.g., QTc prolongation, palpitations).
• 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 in asthma patients. Use cardioselective beta-blockers with extreme caution, if at all.
• Diuretics (loop or thiazide): May potentiate hypokalemia and/or ECG changes 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.
• QTc-prolonging drugs (e.g., Class IA and III antiarrhythmics, macrolides, some antipsychotics): Increased risk of ventricular arrhythmias with salmeterol.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice): May increase systemic exposure to fluticasone and salmeterol, requiring caution and monitoring for adverse effects.
• Xanthine derivatives (e.g., theophylline): May potentiate the hypokalemic effect of salmeterol.
• Non-potassium-sparing diuretics: May potentiate ECG changes and/or hypokalemia associated with beta-agonists.

• Not specifically identified as minor, but general caution with other sympathomimetics due to additive effects.

• Worsening asthma/COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler (SABA)
• Paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Signs of systemic corticosteroid effects (e.g., oral candidiasis, hoarseness, easy bruising, weight gain, mood changes, fatigue)
• Cardiovascular symptoms (e.g., palpitations, chest pain, increased heart rate)
• Hypokalemia symptoms (e.g., muscle weakness, cramps, arrhythmias)
• Hyperglycemia symptoms (e.g., increased thirst, urination)
• Signs of infection (e.g., fever, increased cough, sputum changes)

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

L3 (Moderately Safe). It is not known whether fluticasone or salmeterol are excreted in human milk. Other corticosteroids are excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fluticasone/Salmeterol and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Use with caution.

Not indicated for children under 4 years of age. For children 4-11 years with asthma, lower strengths (e.g., 100/50 mcg or 50/50 mcg) are available. Monitor growth velocity closely in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. Monitor for signs of adrenal suppression.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals to the effects of the drug cannot be ruled out. Use with caution in elderly patients with co-morbidities such as cardiovascular disease, diabetes, or glaucoma, as they may be more susceptible to the systemic effects of beta-agonists and corticosteroids.

• Fluticasone/salmeterol is a maintenance therapy and should not be used for acute bronchospasm. Patients should always have a rescue inhaler (e.g., albuterol) available.
• Proper inhaler technique is crucial for efficacy. Educate patients on how to use the Diskus device correctly, including loading the dose, exhaling fully away from the device, inhaling quickly and deeply, and holding their breath.
• Rinsing the mouth and spitting out water after each dose is essential to minimize the risk of oral candidiasis (thrush) and dysphonia (hoarseness).
• Patients should be advised not to stop the medication abruptly, as this can lead to worsening asthma or COPD symptoms and potential adrenal insufficiency if on high doses for prolonged periods.
• Regular follow-up is important to assess symptom control, lung function, and monitor for potential adverse effects, especially systemic corticosteroid effects and cardiovascular effects.
• The black box warning regarding increased risk of asthma-related death with LABAs should be discussed with patients, emphasizing that the combination with an ICS mitigates this risk, but the drug should not be used for acute symptoms or in rapidly deteriorating asthma.

• Inhaled corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone) for asthma not controlled by SABA alone.
• Long-acting beta2-adrenergic agonists (LABA) monotherapy (e.g., salmeterol, formoterol, arformoterol, indacaterol, olodaterol) for COPD (not recommended for asthma monotherapy due to black box warning).
• Long-acting muscarinic antagonists (LAMA) monotherapy (e.g., tiotropium, umeclidinium, glycopyrronium) for COPD.
• Triple therapy (ICS/LABA/LAMA) for severe COPD (e.g., Trelegy Ellipta, Breztri Aerosphere).
• Leukotriene receptor antagonists (e.g., montelukast) for asthma.
• Oral corticosteroids for severe exacerbations or refractory disease.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. If you have any questions or concerns about this medication, don't 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.