Fluticasone 50mcg 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
Corticosteroid, Inhalant
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluticasone is an inhaled steroid medication used to prevent asthma attacks and improve breathing. It works by reducing inflammation in your lungs. It is not a rescue inhaler and will not help during a sudden asthma attack. You need to use it regularly, usually twice a day, even when you feel well, to keep your asthma under control.
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 one 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 duration the medication remains effective after opening the foil packaging.
Dispose of the inhaler after the specified time period has passed 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 one 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 duration the medication remains effective after opening the foil packaging.
Dispose of the inhaler after the specified time period has passed 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 symptoms improve.
- Do not use for sudden breathing problems; use your rescue inhaler instead.
- Rinse your mouth with water and spit it out after each use to prevent oral thrush (a fungal infection).
- Clean your Diskus inhaler regularly according to instructions.
- Keep track of the number of doses remaining in your Diskus.
- 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:
100 mcg (2 inhalations of 50 mcg) twice daily
Dose Range:
50 - 500 mg
Condition-Specific Dosing:
Asthma (initial):
100 mcg twice daily
Asthma (severe):
250-500 mcg twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4-11 years: 50 mcg twice daily (maximum 100 mcg twice daily)
Adolescent:
12 years and older: Same as adult dosing
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:
Use with caution
Moderate:
Use with caution; monitor for increased systemic effects
Severe:
Use with caution; monitor for increased systemic effects
Pharmacology
Mechanism of Action
Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds to glucocorticoid receptors in the cytoplasm of target cells, leading to the formation of a steroid-receptor complex that translocates to the nucleus. This complex modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin) and the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, eicosanoids). This action reduces inflammation in the airways, decreasing bronchial hyperresponsiveness and improving lung function.
Pharmacokinetics
Absorption:
Bioavailability:
<30% (systemic, due to extensive first-pass metabolism and low oral absorption)
Tmax:
0.5-1 hour
FoodEffect:
Not applicable (inhalation)
Distribution:
Vd:
Approximately 300 L
ProteinBinding:
Approximately 91%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7.8 hours
Clearance:
Approximately 1150 mL/min
ExcretionRoute:
Primarily feces (as metabolites), <5% urine (as metabolites)
Unchanged:
<5% (urine)
Pharmacodynamics
OnsetOfAction:
Within 24 hours (initial improvement), full effect within 1-2 weeks
PeakEffect:
1-2 weeks
DurationOfAction:
12 hours (with twice daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Symptoms of withdrawal, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ Dizziness (if you miss 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
Respiratory Emergency
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 experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
Common cold symptoms
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea
Stomach upset or vomiting
Muscle pain
Reporting Side Effects
This is not an exhaustive list of possible 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Symptoms of withdrawal, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ Dizziness (if you miss 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
Respiratory Emergency
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 experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
Common cold symptoms
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea
Stomach upset or vomiting
Muscle pain
Reporting Side Effects
This is not an exhaustive list of possible 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 despite regular use (contact doctor immediately)
- Signs of oral thrush (white patches in mouth or on tongue, sore throat)
- Blurred vision or eye pain (potential glaucoma/cataracts)
- Signs of infection (fever, chills, increased mucus)
- Signs of adrenal suppression (extreme tiredness, weakness, nausea, vomiting, dizziness, low blood pressure)
- Unexplained weight gain, moon face, easy bruising (signs of Cushing's syndrome)
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, including any 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, should not be taken 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 vital 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 for you to take this medication with your existing treatments 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, including any 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, should not be taken 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 vital 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 for you to take this medication with your existing treatments 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 needs to be used 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 medical professionals of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk, 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). Discuss your individual risk factors with your doctor, and consider having a bone density test as recommended.
Pediatric Use
If you are a parent or caregiver of a child taking this medication, be aware that 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. Consult with your doctor to discuss any concerns.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication with 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 needs to be used 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 medical professionals of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk, 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). Discuss your individual risk factors with your doctor, and consider having a bone density test as recommended.
Pediatric Use
If you are a parent or caregiver of a child taking this medication, be aware that 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. Consult with your doctor to discuss any concerns.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication with 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:
Discontinue gradually under medical supervision. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Ritonavir (strong CYP3A4 inhibitor) - significantly increases systemic fluticasone exposure, leading to potential 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, requiring caution and monitoring for systemic corticosteroid effects.
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
Growth (in pediatric patients)
Rationale: Inhaled corticosteroids can potentially affect growth velocity.
Timing: Prior to initiation of therapy
Ophthalmic exam (for patients with history of glaucoma/cataracts)
Rationale: Corticosteroids can exacerbate these conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma symptoms and control
Frequency: Regularly (e.g., at each follow-up visit)
Target: Well-controlled asthma (minimal symptoms, no nocturnal awakenings, minimal rescue inhaler use)
Action Threshold: Increased symptoms, increased rescue inhaler use, decreased peak flow readings
Pulmonary Function Tests (e.g., FEV1)
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Improvement or maintenance of baseline lung function
Action Threshold: Deterioration in lung function
Oral cavity inspection (for candidiasis)
Frequency: At each follow-up visit
Target: Absence of white patches or soreness
Action Threshold: Presence of oral thrush
Growth velocity (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity for age
Action Threshold: Significant decrease in growth velocity
Signs of systemic corticosteroid effects (e.g., adrenal suppression, Cushingoid features, bone mineral density)
Frequency: Periodically, especially with high doses or prolonged use, or if co-administered with strong CYP3A4 inhibitors
Target: Absence of systemic effects
Action Threshold: Development of signs/symptoms of systemic corticosteroid excess or adrenal insufficiency
Symptom Monitoring
- Increased wheezing
- Shortness of breath
- Chest tightness
- Increased cough
- Increased need for rescue inhaler (e.g., albuterol)
- Oral white patches or soreness (oral candidiasis)
- Hoarseness
- Sore throat
- Blurred vision (cataracts)
- Increased thirst/urination (hyperglycemia)
- Easy bruising
- Moon face
- Weight gain
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, and uncontrolled asthma poses risks to both mother and fetus. Fluticasone is generally considered one of the preferred inhaled corticosteroids during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk. Animal studies show some teratogenicity at high doses.
Second Trimester:
Generally considered safe, continued use for asthma control.
Third Trimester:
Generally considered safe, continued use for asthma control.
Lactation
Considered compatible with breastfeeding. Systemic levels in the mother are low, and excretion into breast milk is expected to be minimal. Benefits of breastfeeding should be weighed against the need for maternal treatment.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Monitor growth velocity regularly. Higher doses or prolonged use may lead to systemic effects, including adrenal suppression. Proper inhaler technique is crucial.
Geriatric Use
No specific dose adjustments are generally required. Monitor for potential systemic corticosteroid effects, especially in patients with co-morbidities like osteoporosis or glaucoma.
Clinical Information
Clinical Pearls
- Fluticasone Diskus is a dry powder inhaler; ensure patients understand proper inhalation technique (quick, deep breath).
- Emphasize that this is a controller medication, not a rescue inhaler for acute asthma attacks.
- Rinsing the mouth after each use is critical to prevent oral candidiasis (thrush).
- Patients should be advised to carry their rescue inhaler (e.g., albuterol) at all times.
- Adherence to daily dosing is key for optimal asthma control.
- For patients transitioning from oral corticosteroids, gradual tapering of oral steroids is necessary to prevent adrenal insufficiency.
Alternative Therapies
- Budesonide (Pulmicort Flexhaler)
- Mometasone (Asmanex Twisthaler)
- Beclomethasone (Qvar RediHaler)
- Ciclesonide (Alvesco)
Cost & Coverage
Average Cost:
Varies widely, typically $150-$300+ per 60 inhalations (Diskus)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand name), Tier 1 (for generic)
General Drug Facts
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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.