Fluticasone 250mcg Diskus (60 Inh)
It is used to treat asthma.Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.
Drug Class
Anti-asthmatic; Corticosteroid
Pharmacologic Class
Inhaled Corticosteroid (ICS)
Pregnancy Category
Not available
FDA Approved
Aug 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluticasone is an inhaled medicine that helps reduce swelling and irritation in your lungs. It's used to prevent asthma attacks and improve breathing over time. It's not for sudden breathing problems.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better. Establish a routine by taking your medication at the same time every day.
Important Administration Instructions
This medication is for inhalation only. After each use, rinse your mouth with water, but do not swallow the rinse water. Instead, spit it out.
If you are using multiple inhaled medications, consult your doctor about which medication to use first.
Only prepare a dose when you are ready to take it. If you prepare a dose and then close the inhaler without using it, the medication will be wasted and the inhaler may be damaged.
Avoid breathing out into the inhaler. After taking your dose, close the inhaler.
Do not disassemble the device or wash it. This medication should not be used with a spacer, and you should not breathe out into the device.
Cleaning and Maintenance
Clean the mouthpiece by gently wiping it with a dry tissue or cloth. Avoid washing the mouthpiece or submerging it in water.
Storage and Disposal
Store your medication at room temperature in a dry location, avoiding bathrooms.
Keep the medication in its foil packaging until you are ready to use it. Be aware of the expiration date or the number of days the medication remains effective after opening the foil packaging.
Dispose of the inhaler after the specified number of days or when the dose counter reaches "0", whichever occurs first.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed dose.
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better. Establish a routine by taking your medication at the same time every day.
Important Administration Instructions
This medication is for inhalation only. After each use, rinse your mouth with water, but do not swallow the rinse water. Instead, spit it out.
If you are using multiple inhaled medications, consult your doctor about which medication to use first.
Only prepare a dose when you are ready to take it. If you prepare a dose and then close the inhaler without using it, the medication will be wasted and the inhaler may be damaged.
Avoid breathing out into the inhaler. After taking your dose, close the inhaler.
Do not disassemble the device or wash it. This medication should not be used with a spacer, and you should not breathe out into the device.
Cleaning and Maintenance
Clean the mouthpiece by gently wiping it with a dry tissue or cloth. Avoid washing the mouthpiece or submerging it in water.
Storage and Disposal
Store your medication at room temperature in a dry location, avoiding bathrooms.
Keep the medication in its foil packaging until you are ready to use it. Be aware of the expiration date or the number of days the medication remains effective after opening the foil packaging.
Dispose of the inhaler after the specified number of days or when the dose counter reaches "0", whichever occurs first.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed dose.
Lifestyle & Tips
- Use regularly as prescribed, even if you feel well.
- Do not use for sudden asthma attacks; use a rescue inhaler for those.
- Rinse your mouth with water and spit it out after each dose to prevent oral thrush (yeast infection).
- Do not swallow the rinse water.
- Keep track of the number of doses remaining in your Diskus device.
- Clean the mouthpiece of the Diskus device with a dry tissue if needed; do not wash it.
- Avoid smoking and exposure to irritants that can worsen asthma.
Available Forms & Alternatives
Available Strengths:
- Fluticasone 50mcg Nasal Sp (120) Rx
- Fluticasone 0.05% Cream 15gm
- Fluticasone 0.05% Cream 30gm
- Fluticasone 0.005% Ointment 30gm
- Fluticasone 0.05% Cream 60gm
- Fluticasone 0.005% Ointment 60gm
- Fluticasone 0.005% Ointment 15gm
- Fluticasone 0.05% Lotion 60ml
- Fluticasone 0.05% Lotion 60ml
- Fluticasone Allergy Nasal 50mcg Sp
- Fluticasone HFA 220mcg Oral Inh
- Fluticasone HFA 110mcg Oral Inh
- Fluticasone HFA 44mcg Inh 120inh
- Fluticasone 250mcg Diskus (60 Inh)
- Fluticasone 50mcg Diskus (60 Inh)
- Fluticasone 100mcg Diskus (60 Inh)
Dosing & Administration
Adult Dosing
Standard Dose:
250 mcg (1 inhalation) twice daily
Dose Range:
100 - 500 mg
Condition-Specific Dosing:
Asthma (maintenance):
Initial dose based on prior asthma therapy. Max 500 mcg twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children 4-11 years: 50-100 mcg twice daily. Children âĨ12 years: 100-250 mcg twice daily (initial), max 500 mcg twice daily.
Adolescent:
Adolescents âĨ12 years: 100-250 mcg twice daily (initial), max 500 mcg twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; systemic exposure is low.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Use with caution; monitor for increased systemic corticosteroid effects.
Severe:
Use with caution; monitor for increased systemic corticosteroid effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It acts by binding to glucocorticoid receptors in the cytoplasm, translocating to the nucleus, and modulating gene expression. This leads to the inhibition of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines) and inflammatory cells (e.g., mast cells, eosinophils, lymphocytes, macrophages, neutrophils), thereby reducing airway hyperresponsiveness and inflammation in the lungs.
Pharmacokinetics
Absorption:
Bioavailability:
13.6% (oral inhalation, systemic)
Tmax:
0.5-1 hour (systemic)
FoodEffect:
Not applicable (inhaled)
Distribution:
Vd:
318 L
ProteinBinding:
91% (to human plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
7.8 hours (terminal)
Clearance:
1150 mL/min (systemic)
ExcretionRoute:
Feces (primarily as metabolites), Urine (<5% as metabolites)
Unchanged:
<5% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 24 hours (for anti-inflammatory effects), full therapeutic benefit may take 1-2 weeks or longer.
PeakEffect:
1-2 weeks (for maximal clinical improvement)
DurationOfAction:
12-24 hours (allowing for twice-daily dosing)
Safety & Warnings
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 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 a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow healing
Feeling extremely tired, weak, or irritable; trembling; rapid heartbeat, confusion, sweating, or dizziness (especially if you've missed a dose or recently stopped taking this medication)
Flushing
Redness or white patches in the mouth or throat
Mouth irritation or mouth sores
Bone or joint pain
Changes in vision
Changes in voice
Difficulty speaking
Severe Breathing Problems: A Life-Threatening Condition
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.
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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Common cold symptoms
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea, upset stomach, or vomiting
* Muscle pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 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 a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow healing
Feeling extremely tired, weak, or irritable; trembling; rapid heartbeat, confusion, sweating, or dizziness (especially if you've missed a dose or recently stopped taking this medication)
Flushing
Redness or white patches in the mouth or throat
Mouth irritation or mouth sores
Bone or joint pain
Changes in vision
Changes in voice
Difficulty speaking
Severe Breathing Problems: A Life-Threatening Condition
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.
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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Common cold symptoms
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea, upset stomach, or vomiting
* Muscle pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 asthma symptoms (e.g., increased wheezing, shortness of breath, need for rescue inhaler)
- White patches or soreness in the mouth or throat (oral thrush)
- Hoarseness or voice changes
- Signs of infection (fever, chills, increased mucus, change in mucus color)
- Blurred vision or eye pain
- Unusual tiredness, weakness, nausea, vomiting, dizziness (signs of adrenal suppression)
- Rash or hives (allergic reaction)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, may interact with this drug and should not be taken concurrently. Your doctor or pharmacist can provide guidance on potential interactions.
It is important to note that this is not an exhaustive list of all medications or health conditions that may interact with this drug. Therefore, it is vital to discuss all your medications and health problems with your doctor and pharmacist to ensure safe treatment.
To guarantee your safety, you must:
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.
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, may interact with this drug and should not be taken concurrently. Your doctor or pharmacist can provide guidance on potential interactions.
It is important to note that this is not an exhaustive list of all medications or health conditions that may interact with this drug. Therefore, it is vital to discuss all your medications and health problems with your doctor and pharmacist to ensure safe treatment.
To guarantee your safety, you must:
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 Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring Your Condition
If you experience any worsening of your breathing problems, or if your rescue inhaler becomes less effective or is needed more frequently, contact your doctor immediately. It may take several weeks for the full effects of this medication to become apparent.
Stopping the Medication
If you have been taking this medication for an extended period, consult with your doctor before discontinuing its use. Your doctor may recommend a gradual tapering off of the medication to minimize potential side effects.
Infection Risk
You may be more susceptible to infections while taking this medication. To reduce 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 previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor promptly.
Transitioning from Oral Steroids
When switching from an oral steroid to a different form of steroid, there is a risk of 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.
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 with you to alert healthcare providers of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this risk with your doctor and have your eye pressure checked regularly if you are taking this medication long-term.
Bone Health
Long-term use of this medication may also lead to weakened bones (osteoporosis). Consult with your doctor to determine if you are at higher risk for osteoporosis or if you have any questions. Your doctor may recommend a bone density test to monitor your bone health.
Use in Children
If the patient is a child, this medication should be used with caution, as the risk of certain side effects may be higher in children. This medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss any concerns with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you and determine the best course of action for you and your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring Your Condition
If you experience any worsening of your breathing problems, or if your rescue inhaler becomes less effective or is needed more frequently, contact your doctor immediately. It may take several weeks for the full effects of this medication to become apparent.
Stopping the Medication
If you have been taking this medication for an extended period, consult with your doctor before discontinuing its use. Your doctor may recommend a gradual tapering off of the medication to minimize potential side effects.
Infection Risk
You may be more susceptible to infections while taking this medication. To reduce 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 previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor promptly.
Transitioning from Oral Steroids
When switching from an oral steroid to a different form of steroid, there is a risk of 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.
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 with you to alert healthcare providers of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this risk with your doctor and have your eye pressure checked regularly if you are taking this medication long-term.
Bone Health
Long-term use of this medication may also lead to weakened bones (osteoporosis). Consult with your doctor to determine if you are at higher risk for osteoporosis or if you have any questions. Your doctor may recommend a bone density test to monitor your bone health.
Use in Children
If the patient is a child, this medication should be used with caution, as the risk of certain side effects may be higher in children. This medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss any concerns with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you and determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to low systemic absorption.
- Chronic overdose may lead to signs of hypercorticism (e.g., Cushing's syndrome, adrenal suppression).
What to Do:
Call 1-800-222-1222 (Poison Control). In case of chronic overdose, reduce dose gradually under medical supervision. Symptomatic and supportive care.
Drug Interactions
Major Interactions
- Ritonavir (strong CYP3A4 inhibitor): Concomitant use is not recommended due to potential for significant increase in fluticasone systemic exposure and risk of Cushing's syndrome and adrenal suppression.
Moderate Interactions
- Other strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, cobicistat-containing products): May increase systemic fluticasone exposure; use with caution and monitor for systemic corticosteroid effects.
Confidence Interactions
Monitoring
Baseline Monitoring
Asthma symptom control assessment
Rationale: To establish baseline disease severity and guide initial dosing.
Timing: Prior to initiation of therapy
Spirometry (FEV1)
Rationale: To assess baseline lung function.
Timing: Prior to initiation of therapy
Oral cavity inspection
Rationale: To check for existing oral candidiasis.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma symptom control assessment
Frequency: Regularly (e.g., every 1-3 months initially, then every 3-12 months once stable)
Target: Minimal symptoms, infrequent rescue inhaler use
Action Threshold: Increased symptoms, increased rescue inhaler use, nocturnal awakenings
Spirometry (FEV1)
Frequency: Annually or as clinically indicated
Target: Maintenance or improvement of lung function
Action Threshold: Significant decline in FEV1
Oral cavity inspection
Frequency: Regularly (e.g., at each follow-up visit)
Target: Absence of oral candidiasis
Action Threshold: Presence of white patches or soreness
Growth monitoring (pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity
Action Threshold: Growth retardation
Ophthalmic examination (long-term, high-dose use)
Frequency: Annually or as clinically indicated
Target: Absence of cataracts or glaucoma
Action Threshold: Visual changes, increased intraocular pressure
Adrenal function (if systemic corticosteroid effects suspected)
Frequency: As clinically indicated
Target: Normal cortisol levels
Action Threshold: Symptoms of adrenal insufficiency or suppression
Symptom Monitoring
- Increased wheezing
- Shortness of breath
- Chest tightness
- Cough
- Increased use of rescue inhaler
- Oral white patches or soreness (oral candidiasis)
- Hoarseness or voice changes (dysphonia)
- Blurred vision or eye pain (cataracts/glaucoma)
- Unexplained weight gain, moon face, easy bruising (Cushingoid features)
- Fatigue, weakness, nausea, vomiting (adrenal insufficiency)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Asthma control is important during pregnancy. Limited data suggest no increased risk of major birth defects.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies show some teratogenicity at high doses.
Second Trimester:
Generally considered safer than systemic corticosteroids.
Third Trimester:
Monitor for adrenal hypofunction in neonates exposed to high doses in utero.
Lactation
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for fluticasone and any potential adverse effects on the breastfed infant from fluticasone or from the underlying maternal condition. Fluticasone is minimally excreted into breast milk.
Infant Risk:
Low risk of adverse effects on breastfed infant due to low systemic absorption and high protein binding.
Pediatric Use
Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. Use the lowest effective dose. Not for use in children under 4 years of age for asthma.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dose adjustment is generally not required.
Clinical Information
Clinical Pearls
- Fluticasone Diskus is a dry powder inhaler; patients must inhale forcefully and deeply to receive the dose.
- Emphasize the importance of rinsing the mouth and spitting after each dose to prevent oral candidiasis and dysphonia.
- This medication is a controller medication and should be used daily, not as a rescue inhaler for acute symptoms.
- Patients should be educated on how to check the dose counter on the Diskus device.
- Adrenal suppression is rare with recommended doses but can occur, especially with higher doses or in combination with strong CYP3A4 inhibitors.
- Regular follow-up is crucial to assess asthma control and adherence.
Alternative Therapies
- Budesonide (Pulmicort Flexhaler)
- Mometasone (Asmanex Twisthaler)
- Beclomethasone (Qvar RediHaler)
- Ciclesonide (Alvesco)
- Leukotriene receptor antagonists (e.g., Montelukast)
- Long-acting beta-agonists (LABAs) - *Note: LABAs should not be used as monotherapy for asthma.*
Cost & Coverage
Average Cost:
$200 - $400 per 60 inhalations Diskus
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 information. If you have any questions or concerns about this 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.