Fluticasone/salm Disk 500/50mcg 60s
It is used to treat asthma.Some brands are used to treat COPD (chronic obstructive pulmonary disease).It may be given to you for other reasons. Talk with the doctor.Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
Drug Class
Bronchodilator/Corticosteroid Combination
Pharmacologic Class
Inhaled Corticosteroid (ICS) / Long-Acting Beta2-Adrenergic Agonist (LABA)
Pregnancy Category
Category C
FDA Approved
Aug 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is an inhaler that combines two medicines: a corticosteroid (fluticasone) to reduce inflammation in your lungs and a long-acting bronchodilator (salmeterol) to help open your airways. It's used twice a day to help manage chronic obstructive pulmonary disease (COPD) by making it easier to breathe and reducing flare-ups.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only. Continue using it as directed by your doctor or healthcare provider, even if you feel well. Take your dose at the same time every day.
After each use, rinse your mouth with water and spit it out - do not swallow the rinse water. If you are using multiple inhaled medications, consult your doctor about which one to use first.
Preparing and Taking Your Dose
Only prepare a dose when you are ready to take it. If you prepare a dose and then close the inhaler without taking it, the medication will be wasted and the inhaler may be damaged. When taking your dose, do not breathe out into the inhaler. Close the inhaler after use.
Important Safety Precautions
Do not take an extra dose, even if you did not taste or feel the powder. Do not disassemble the device or wash it, and do not use it with a spacer. Avoid breathing out into the device.
Cleaning and Maintenance
Clean the mouthpiece by wiping it with a dry tissue or cloth. Do not wash the mouthpiece or put it in water.
Tracking Your Doses
The inhaler has a built-in dose counter to track the number of doses remaining. Dispose of the inhaler when the counter reaches "0," one month after opening the foil pouch, or after the expiration date - whichever occurs first.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep it in the foil pouch until you are ready to use it.
Missing a Dose
If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only. Continue using it as directed by your doctor or healthcare provider, even if you feel well. Take your dose at the same time every day.
After each use, rinse your mouth with water and spit it out - do not swallow the rinse water. If you are using multiple inhaled medications, consult your doctor about which one to use first.
Preparing and Taking Your Dose
Only prepare a dose when you are ready to take it. If you prepare a dose and then close the inhaler without taking it, the medication will be wasted and the inhaler may be damaged. When taking your dose, do not breathe out into the inhaler. Close the inhaler after use.
Important Safety Precautions
Do not take an extra dose, even if you did not taste or feel the powder. Do not disassemble the device or wash it, and do not use it with a spacer. Avoid breathing out into the device.
Cleaning and Maintenance
Clean the mouthpiece by wiping it with a dry tissue or cloth. Do not wash the mouthpiece or put it in water.
Tracking Your Doses
The inhaler has a built-in dose counter to track the number of doses remaining. Dispose of the inhaler when the counter reaches "0," one month after opening the foil pouch, or after the expiration date - whichever occurs first.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep it in the foil pouch until you are ready to use it.
Missing a Dose
If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Use exactly as prescribed, twice daily, about 12 hours apart. Do not use more often than prescribed.
- This is not a rescue inhaler. Always carry a separate fast-acting rescue inhaler (e.g., albuterol) for sudden breathing problems.
- Rinse your mouth with water and spit it out after each dose to help prevent oral thrush (a fungal infection in the mouth). Do not swallow the water.
- Do not stop using this medication suddenly without talking to your doctor, as it can worsen your breathing.
- Avoid exposure to irritants like smoke, dust, and allergens that can trigger breathing problems.
- Maintain good oral hygiene and regular dental check-ups.
Available Forms & Alternatives
Available Strengths:
- Fluticasone/salmeterol 55/14mcg In
- Flutic/salmeterol 113/14mcg Inh(60)
- Flutic/salmet 232-14mcg 60 Puffs
- Fluticasone/salm Disk 100/50mcg 60s
- Fluticasone/salm Disk 250/50mcg 60s
- Fluticasone/salm Disk 500/50mcg 60s
- Fluticasone/salm 115/21mcg Inh 120s
- Fluticasone/salm Inh 230/21mcg 120s
- Fluticasone/salm Inh 45/21mcg 120s
Dosing & Administration
Adult Dosing
Standard Dose:
One inhalation of Fluticasone/Salmeterol 500/50 mcg twice daily (morning and evening), approximately 12 hours apart.
Dose Range:
500 - 50 mg
Condition-Specific Dosing:
COPD:
One inhalation of Fluticasone/Salmeterol 500/50 mcg twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for this strength (lower strengths used for asthma in children 4+ years)
Adolescent:
Not established for this strength (lower strengths used for asthma)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific dose adjustment recommended; systemic exposure is low.
Hepatic Impairment:
Mild:
Use with caution; no specific dose adjustment recommended.
Moderate:
Use with caution; consider monitoring for systemic corticosteroid effects.
Severe:
Use with caution; consider monitoring for systemic corticosteroid effects due to potential for increased fluticasone exposure.
Confidence:
Medium
Pharmacology
Mechanism of Action
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.
Pharmacokinetics
Absorption:
Bioavailability:
Fluticasone: <30% (oral), Salmeterol: Low (oral)
Tmax:
Fluticasone: 0.5-1 hour (inhalation), Salmeterol: 10-20 minutes (inhalation)
FoodEffect:
Not applicable for inhaled administration.
Distribution:
Vd:
Fluticasone: ~300 L, Salmeterol: ~16 L/kg
ProteinBinding:
Fluticasone: >90%, Salmeterol: ~96%
CnssPenetration:
Limited
Elimination:
HalfLife:
Fluticasone: ~8 hours (terminal), Salmeterol: ~5.5 hours
Clearance:
Fluticasone: ~1150 mL/min, Salmeterol: ~1000 mL/min
ExcretionRoute:
Fluticasone: Fecal (primarily), Salmeterol: Fecal (major), Renal (minor)
Unchanged:
Fluticasone: <5% (urine), Salmeterol: <1% (urine)
Pharmacodynamics
OnsetOfAction:
Salmeterol: 10-20 minutes (bronchodilation)
PeakEffect:
Salmeterol: 2-4 hours (bronchodilation), Fluticasone: Days to weeks (anti-inflammatory)
DurationOfAction:
Salmeterol: 12 hours (bronchodilation), Fluticasone: Sustained anti-inflammatory effect with twice-daily dosing.
Safety & Warnings
BLACK BOX WARNING
Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, increase the risk of asthma-related death. Data from a large, randomized, placebo-controlled clinical trial in asthma showed that LABAs increase the risk of asthma-related death. This finding is considered a class effect of LABAs. The safety and effectiveness of Fluticasone/Salmeterol in patients with asthma have not been established. Fluticasone/Salmeterol is not indicated for the primary treatment of asthma.
Side 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 agitated
Changes in behavior
Vision changes, eye pain, or severe eye irritation
Unusual 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 don't go away, contact your doctor:
Headache
Nausea 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.
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 agitated
Changes in behavior
Vision changes, eye pain, or severe eye irritation
Unusual 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 don't go away, contact your doctor:
Headache
Nausea 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.
Seek Immediate Medical Attention If You Experience:
- Worsening breathing problems or increased need for your rescue inhaler (seek immediate medical attention).
- Signs of an allergic reaction (rash, hives, swelling of face/mouth, difficulty breathing).
- Signs of infection (fever, chills, increased cough, change in sputum color).
- Oral thrush (white patches in mouth or throat, soreness).
- Chest pain, fast or irregular heartbeat, severe tremor, or nervousness.
- Vision changes (blurred vision, eye pain, halos around lights).
- Signs of adrenal insufficiency (fatigue, weakness, nausea, vomiting, low blood pressure) if stopping systemic steroids.
- Unexplained weight gain, swelling in ankles/feet, muscle weakness, easy bruising.
Before Using This Medicine
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. Be sure to describe the allergic reaction you experienced.
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 should not be taken 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 all your other medications and health conditions.
* Never start, stop, or change the dose of any medication without first consulting 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. Be sure to describe the allergic reaction you experienced.
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 should not be taken 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 all your other medications and health conditions.
* Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
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 with 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. Discuss any concerns 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.
Additional Steroid Needs
In cases of severe injury, surgery, or infection, you may require extra doses of oral steroids to help your body cope with stress. Carry a warning card indicating that you may need additional 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 with your doctor and schedule regular eye exams as recommended.
This medication may also cause osteoporosis (weak bones) with long-term use. 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 this risk, 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 to chickenpox or measles, consult with 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. Regular growth checks may be necessary, so consult with 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 Considerations
If you have chronic obstructive pulmonary disease (COPD), you may be at a higher risk of developing pneumonia. This medication may also increase this risk. Consult with your doctor to discuss this potential risk.
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 with 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. Discuss any concerns 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.
Additional Steroid Needs
In cases of severe injury, surgery, or infection, you may require extra doses of oral steroids to help your body cope with stress. Carry a warning card indicating that you may need additional 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 with your doctor and schedule regular eye exams as recommended.
This medication may also cause osteoporosis (weak bones) with long-term use. 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 this risk, 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 to chickenpox or measles, consult with 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. Regular growth checks may be necessary, so consult with 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 Considerations
If you have chronic obstructive pulmonary disease (COPD), you may be at a higher risk of developing pneumonia. This medication may also increase this risk. Consult with your doctor to discuss this potential risk.
Overdose Information
Overdose Symptoms:
- Salmeterol overdose: Tachycardia, palpitations, tremor, headache, nausea, dizziness, hypokalemia, hyperglycemia.
- Fluticasone overdose (acute): Generally low risk due to low systemic absorption. Chronic overdose may lead to signs of hypercorticism (e.g., Cushingoid features), adrenal suppression.
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Monitor cardiac function and serum potassium levels.
Drug Interactions
Contraindicated Interactions
- Other long-acting beta2-adrenergic agonists (LABAs)
- Acute bronchospasm or status asthmaticus (not for rescue therapy)
- Primary treatment of asthma (LABA monotherapy is contraindicated in asthma without an ICS)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) - may increase systemic exposure to fluticasone and salmeterol, leading to increased risk of cardiovascular and systemic corticosteroid adverse effects.
- Beta-blockers (especially non-selective) - may block the bronchodilatory effect of salmeterol and cause severe bronchospasm in patients with asthma/COPD.
Moderate Interactions
- Diuretics (non-potassium sparing) - may potentiate hypokalemia and ECG changes associated with beta-agonists.
- Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs) - may potentiate the cardiovascular effects of salmeterol.
- Other sympathomimetics - may potentiate adverse cardiovascular effects.
Minor Interactions
- None commonly cited as minor for this combination.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy.
Adrenal Function (e.g., morning cortisol)
Rationale: If switching from systemic corticosteroids, to assess for adrenal suppression.
Timing: Prior to initiation, and periodically during transition.
Ophthalmic Exam (for glaucoma/cataracts)
Rationale: Corticosteroids can increase intraocular pressure and risk of cataracts.
Timing: Prior to initiation, especially in patients with risk factors or prolonged use.
Routine Monitoring
Pulmonary Function Tests (e.g., FEV1)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Improvement from baseline or stabilization of lung function.
Action Threshold: Worsening FEV1 or lack of improvement may indicate inadequate control or need for re-evaluation.
Signs and Symptoms of COPD/Asthma Control
Frequency: At each clinical visit
Target: Reduced exacerbations, improved symptom scores, decreased rescue inhaler use.
Action Threshold: Increased symptoms, increased rescue inhaler use, or frequent exacerbations require re-evaluation of therapy.
Oral Cavity Inspection
Frequency: At each clinical visit
Target: Absence of oral candidiasis.
Action Threshold: Presence of white patches or soreness may indicate oral candidiasis, requiring antifungal treatment and proper rinsing technique.
Growth (in pediatric patients, if applicable for lower strengths)
Frequency: Annually
Target: Normal growth velocity.
Action Threshold: Growth retardation may indicate systemic corticosteroid effects.
Bone Mineral Density (BMD)
Frequency: Periodically, especially in patients with risk factors for osteoporosis or prolonged use.
Target: Stable BMD.
Action Threshold: Significant decrease in BMD may warrant intervention or alternative therapy.
Serum Potassium (if risk factors for hypokalemia)
Frequency: As clinically indicated
Target: Normal range (3.5-5.0 mEq/L)
Action Threshold: Hypokalemia may require potassium supplementation or adjustment of concomitant medications.
Symptom Monitoring
- Worsening shortness of breath
- Increased cough or sputum production
- Increased wheezing
- 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, mood changes)
- Signs of infection (e.g., fever, chills, increased cough/sputum)
- Palpitations, tremor, nervousness (salmeterol effects)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Poorly controlled COPD/asthma poses a greater risk to both mother and fetus than the potential risks of medication.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk due to low systemic absorption.
Second Trimester:
No specific increased risks identified.
Third Trimester:
No specific increased risks identified. Monitor neonates for signs of adrenal insufficiency if mother received high doses of corticosteroids.
Lactation
L3 (Limited data, probably compatible). Both fluticasone and salmeterol are excreted in breast milk in very small amounts. The benefits of breastfeeding should be weighed against the potential risks to the infant.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to low systemic exposure of the mother and low transfer into milk. Monitor infant for signs of systemic corticosteroid effects or beta-agonist effects (e.g., irritability, tremor).
Pediatric Use
This 500/50 mcg strength is not indicated for pediatric patients. Lower strengths (e.g., 100/50, 250/50) are approved for asthma in children 4 years and older. Growth should be monitored in pediatric patients receiving inhaled corticosteroids.
Geriatric Use
No specific dose adjustment is required based on age. However, geriatric patients may be more susceptible to cardiovascular effects of salmeterol or systemic corticosteroid effects of fluticasone due to comorbidities or polypharmacy. Monitor for osteoporosis, cataracts, glaucoma, and cardiovascular status.
Clinical Information
Clinical Pearls
- Fluticasone/salmeterol is a maintenance medication for COPD and should not be used for acute bronchospasm.
- Patients should be instructed on proper inhaler technique (Diskus device) and to rinse their mouth after each dose to prevent oral candidiasis.
- The 500/50 mcg strength is primarily for COPD. Lower strengths are used for asthma.
- Caution is advised when co-administering with strong CYP3A4 inhibitors due to increased systemic exposure and potential for adverse effects.
- Regular monitoring of pulmonary function and symptoms is crucial to assess disease control.
- Patients should be advised about the black box warning regarding LABAs and asthma-related death, emphasizing that this combination is not for acute asthma or as monotherapy for asthma.
Alternative Therapies
- Long-acting muscarinic antagonists (LAMAs) e.g., tiotropium (Spiriva)
- Other LABAs (e.g., indacaterol, olodaterol)
- Other ICS monotherapies (e.g., fluticasone propionate, budesonide)
- Triple therapy (ICS/LABA/LAMA) for severe COPD
Cost & Coverage
Average Cost:
$300 - $600 per 60 doses (1 inhaler)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often preferred brand or generic equivalent)
General Drug Facts
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 details. 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 information about the medication taken, the amount, and the time it happened.