Fluticasone 50mcg Nasal Sp (120) Rx
It is used to ease allergy signs.
Drug Class
Corticosteroid, Nasal
Pharmacologic Class
Glucocorticoid receptor agonist
Pregnancy Category
Category C
FDA Approved
Oct 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluticasone nasal spray is a medicine that helps reduce inflammation in your nose. It's used to treat symptoms like sneezing, runny nose, stuffy nose, and itchy nose and eyes caused by allergies (hay fever) or other non-allergic nasal problems. It works by calming down the immune response in your nose.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
This medication is for nasal use only. Do not take it by mouth. Avoid getting it in your mouth or eyes, as it may cause burning.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Before using your medication, make sure you understand how to prime the pump, if necessary. Some products may have different priming instructions, and some pumps may need to be primed if they have not been used for a while. Follow the priming instructions provided by your doctor or healthcare provider.
Preparing to Use Your Medication
Shake the medication well before each use.
Blow your nose before using the medication.
Spray the medication up into your nose, avoiding the septum (the wall between your nostrils).
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat, cold, and light.
Keep the medication upright with the cap on when not in use.
Dispose of any unused medication after the labeled number of doses have been used.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use two doses at the same time or take extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
This medication is for nasal use only. Do not take it by mouth. Avoid getting it in your mouth or eyes, as it may cause burning.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Before using your medication, make sure you understand how to prime the pump, if necessary. Some products may have different priming instructions, and some pumps may need to be primed if they have not been used for a while. Follow the priming instructions provided by your doctor or healthcare provider.
Preparing to Use Your Medication
Shake the medication well before each use.
Blow your nose before using the medication.
Spray the medication up into your nose, avoiding the septum (the wall between your nostrils).
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat, cold, and light.
Keep the medication upright with the cap on when not in use.
Dispose of any unused medication after the labeled number of doses have been used.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Use regularly as prescribed, even if you feel better, for best results.
- Shake the bottle gently before each use.
- Prime the pump before first use or if not used for a week or more (spray into the air until a fine mist appears).
- Clear your nasal passages by gently blowing your nose before use.
- Tilt your head slightly forward, insert the nozzle into one nostril, pointing slightly away from the center of your nose (septum). Close the other nostril with your finger.
- Breathe in gently through your nose while pressing down firmly on the pump once.
- Breathe out through your mouth. Repeat for the other nostril.
- Avoid blowing your nose immediately after use.
- Clean the nasal applicator regularly as per instructions.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- It may take several days to a week to feel the full effects of the medication.
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:
2 sprays (50 mcg/spray) per nostril once daily
Dose Range:
100 - 200 mg
Condition-Specific Dosing:
allergicRhinitisInitial:
2 sprays (50 mcg/spray) per nostril once daily (total 200 mcg/day). Once symptoms are controlled, may reduce to 1 spray (50 mcg/spray) per nostril once daily (total 100 mcg/day).
nonAllergicRhinitis:
2 sprays (50 mcg/spray) per nostril once daily (total 200 mcg/day).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4-11 years: 1 spray (50 mcg/spray) per nostril once daily (total 100 mcg/day). If inadequate response, may increase to 2 sprays (50 mcg/spray) per nostril once daily (total 200 mcg/day), then reduce to 1 spray per nostril once daily once symptoms are controlled.
âĨ12 years: Same as adult dosing.
Adolescent:
âĨ12 years: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Use with caution; systemic exposure may increase in severe hepatic impairment due to extensive first-pass metabolism. Monitor for systemic corticosteroid effects.
Pharmacology
Mechanism of Action
Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It exerts its effects by binding to glucocorticoid receptors, leading to the activation of anti-inflammatory genes and the repression of pro-inflammatory genes. This results in the inhibition of mast cells, eosinophils, neutrophils, macrophages, and lipid mediators (e.g., histamine, leukotrienes, prostaglandins) involved in the inflammatory cascade, thereby reducing nasal inflammation, edema, and mucus production.
Pharmacokinetics
Absorption:
Bioavailability:
<2% (systemic bioavailability after intranasal administration)
Tmax:
0.5-1.5 hours (nasal)
FoodEffect:
Not applicable (nasal administration)
Distribution:
Vd:
Not available (due to low systemic absorption)
ProteinBinding:
>99% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7.8 hours (terminal half-life after IV administration)
Clearance:
1150 mL/min (systemic clearance)
ExcretionRoute:
Primarily in feces (as metabolites and unchanged drug)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 12 hours (initial effect), full effect may take several days to weeks
PeakEffect:
Several days to 2 weeks
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 help right away:
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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Nose sores
A whistling sound when breathing
Redness or white patches in the mouth or throat
Changes in eyesight
Abnormal nose discharge
Severe facial pain
Crusting in the nose
Runny nose
Bone pain
Fever or chills
Severe sore throat
Dizziness or fainting
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 do not go away, contact your doctor:
Headache
Nose or throat irritation
Nosebleed
Cough
Upset stomach or vomiting
Stinging or sneezing (may occur for a few seconds after using the medication)
If these side effects or any others concern you, talk to 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 help right away:
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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Nose sores
A whistling sound when breathing
Redness or white patches in the mouth or throat
Changes in eyesight
Abnormal nose discharge
Severe facial pain
Crusting in the nose
Runny nose
Bone pain
Fever or chills
Severe sore throat
Dizziness or fainting
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 do not go away, contact your doctor:
Headache
Nose or throat irritation
Nosebleed
Cough
Upset stomach or vomiting
Stinging or sneezing (may occur for a few seconds after using the medication)
If these side effects or any others concern you, talk to 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:
- Frequent nosebleeds or persistent nasal irritation
- White patches in your nose or throat (signs of fungal infection)
- New or worsening eye problems (e.g., blurred vision, eye pain)
- Slowed growth in children (report to doctor)
- Signs of infection (fever, chills, body aches) if you have been exposed to chickenpox or measles
- Signs of adrenal suppression (unusual tiredness, weakness, nausea, vomiting, dizziness)
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 and its symptoms.
If you are currently taking any of the following medications:
+ Atazanavir
+ Clarithromycin
+ Conivaptan
+ Indinavir
+ Itraconazole
+ Ketoconazole
+ Lopinavir
+ Nefazodone
+ Nelfinavir
+ Ritonavir
+ Saquinavir
+ Telithromycin
+ Voriconazole
Please note that this list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor.
To ensure your safety, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns
It is vital to 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 consulting your doctor first.
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 and its symptoms.
If you are currently taking any of the following medications:
+ Atazanavir
+ Clarithromycin
+ Conivaptan
+ Indinavir
+ Itraconazole
+ Ketoconazole
+ Lopinavir
+ Nefazodone
+ Nelfinavir
+ Ritonavir
+ Saquinavir
+ Telithromycin
+ Voriconazole
Please note that this list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor.
To ensure your safety, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns
It is vital to 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 consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Do not use this medication to treat asthma; instead, consult with your doctor to discuss appropriate treatment options.
This medication may increase the risk of developing cataracts or glaucoma. Be sure to discuss this potential risk with your doctor. Additionally, follow your doctor's recommendations for regular eye exams to monitor your eye health.
Long-term use of this medication may lead to osteoporosis (weak bones). Consult with your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any questions about this potential side effect. Your doctor may also recommend a bone density test to assess your bone health.
If you have not had chickenpox, measles, or the vaccines for these conditions, and you come into contact with someone who has either of these illnesses, inform your doctor immediately. Similarly, if you have been exposed to someone with tuberculosis (TB), consult with your doctor.
If you have recently undergone nose surgery or have a nose injury, ulcers, or sores, discuss this with your doctor before using this medication.
When switching from another form of steroid (such as an oral steroid) to this medication, it is crucial to gradually reduce the dose of the other steroid to avoid potential side effects. Do not suddenly stop taking the other steroid without consulting your doctor.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure to discuss this with your doctor. Additionally, note that different brands of this medication may be suitable for different age groups of children, so consult with your doctor before administering this medication to a child.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the potential benefits and risks of this medication to both you and your baby.
Do not use this medication to treat asthma; instead, consult with your doctor to discuss appropriate treatment options.
This medication may increase the risk of developing cataracts or glaucoma. Be sure to discuss this potential risk with your doctor. Additionally, follow your doctor's recommendations for regular eye exams to monitor your eye health.
Long-term use of this medication may lead to osteoporosis (weak bones). Consult with your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any questions about this potential side effect. Your doctor may also recommend a bone density test to assess your bone health.
If you have not had chickenpox, measles, or the vaccines for these conditions, and you come into contact with someone who has either of these illnesses, inform your doctor immediately. Similarly, if you have been exposed to someone with tuberculosis (TB), consult with your doctor.
If you have recently undergone nose surgery or have a nose injury, ulcers, or sores, discuss this with your doctor before using this medication.
When switching from another form of steroid (such as an oral steroid) to this medication, it is crucial to gradually reduce the dose of the other steroid to avoid potential side effects. Do not suddenly stop taking the other steroid without consulting your doctor.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure to discuss this with your doctor. Additionally, note that different brands of this medication may be suitable for different age groups of children, so consult with your doctor before administering this medication to a child.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to low systemic absorption. Chronic overdose or excessive use may lead to signs of hypercorticism (e.g., Cushing's syndrome, adrenal suppression).
What to Do:
No specific antidote. Treatment is supportive. In cases of chronic overdose, gradual withdrawal of the corticosteroid may be necessary. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Ritonavir
- Cobicistat
Moderate Interactions
- Ketoconazole
- Itraconazole
- Clarithromycin
- Nelfinavir
- Indinavir
- Atazanavir
Confidence Interactions
Monitoring
Baseline Monitoring
Nasal examination
Rationale: To assess baseline nasal mucosa, identify any pre-existing lesions or infections.
Timing: Prior to initiation
Growth monitoring (pediatric patients)
Rationale: To monitor for potential growth suppression with long-term corticosteroid use.
Timing: Prior to initiation
Routine Monitoring
Symptom control (nasal congestion, rhinorrhea, sneezing, itching)
Frequency: Regularly (e.g., weekly initially, then as needed)
Target: Significant reduction or resolution of symptoms
Action Threshold: Persistent or worsening symptoms after 1-2 weeks of consistent use may indicate need for dose adjustment, alternative therapy, or re-evaluation of diagnosis.
Nasal mucosa integrity (for epistaxis, irritation, candidiasis)
Frequency: Periodically (e.g., every 3-6 months for long-term users)
Target: Healthy, intact mucosa
Action Threshold: Persistent epistaxis, nasal septal perforation, or signs of candidiasis require discontinuation or dose reduction and appropriate treatment.
Intraocular pressure (IOP) / Cataract formation (long-term use, high doses)
Frequency: Annually or as clinically indicated, especially in patients with a history of glaucoma/cataracts or family history.
Target: Normal IOP, no cataract progression
Action Threshold: Elevated IOP or cataract development may necessitate ophthalmologic referral and re-evaluation of therapy.
Growth velocity (pediatric patients)
Frequency: Every 3-6 months for long-term users
Target: Normal growth velocity for age
Action Threshold: Significant reduction in growth velocity may require dose reduction or discontinuation.
Symptom Monitoring
- Nasal irritation
- Epistaxis (nosebleeds)
- Headache
- Pharyngitis (sore throat)
- Cough
- Nausea/vomiting
- Signs of systemic corticosteroid effects (e.g., weight gain, moon face, easy bruising, muscle weakness, mood changes) - rare at recommended doses
- Signs of adrenal suppression (fatigue, weakness, dizziness, nausea, vomiting) - rare
- Signs of nasal candidiasis (white patches in nose/throat)
Special Patient Groups
Pregnancy
Generally considered low risk. While older classification is Category C, studies have not shown a clear association with adverse outcomes. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic exposure is minimal, suggesting low risk.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Considered compatible with breastfeeding (L2). Systemic absorption is minimal, and levels in breast milk are expected to be very low. Monitor infant for any adverse effects, though unlikely.
Infant Risk:
Low risk
Pediatric Use
Use with caution. Long-term use of corticosteroids, including fluticasone nasal spray, may affect growth velocity in pediatric patients. Growth should be monitored regularly. The lowest effective dose should be used. Not recommended for children under 4 years of age.
Geriatric Use
No specific dose adjustment is required. Efficacy and safety profiles are similar to younger adults. However, elderly patients may be more susceptible to systemic corticosteroid effects if significant absorption occurs, especially with co-administration of strong CYP3A4 inhibitors.
Clinical Information
Clinical Pearls
- Patients should be instructed on proper administration technique to maximize efficacy and minimize local side effects.
- Full therapeutic benefit may not be seen for several days to 2 weeks; patients should be advised to continue regular use.
- If symptoms are severe, a short course of oral corticosteroids may be used concurrently to achieve initial control, then tapered off as the nasal spray takes effect.
- Advise patients to avoid spraying directly onto the nasal septum to reduce the risk of epistaxis or septal perforation.
- Regular cleaning of the nasal applicator is important to prevent blockage and bacterial contamination.
- Consider potential for systemic effects (e.g., adrenal suppression, growth suppression, ocular effects) with long-term, high-dose use, especially in susceptible populations or with concomitant strong CYP3A4 inhibitors.
Alternative Therapies
- Other intranasal corticosteroids (e.g., mometasone, budesonide, triamcinolone, ciclesonide, beclomethasone)
- Oral antihistamines
- Nasal antihistamines (e.g., azelastine, olopatadine)
- Nasal cromolyn
- Nasal decongestants (short-term use only)
- Leukotriene receptor antagonists (e.g., montelukast)
- Allergen immunotherapy
Cost & Coverage
Average Cost:
$30 - $70 per 120-spray device
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (preferred 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 details. 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 information about the medication taken, the amount, and the time it happened.