Fluticasone Allergy Nasal 50mcg Sp
It is used to ease allergy signs.
Drug Class
Corticosteroid, Nasal
Pharmacologic Class
Glucocorticoid receptor agonist
Pregnancy Category
Category B
FDA Approved
Oct 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluticasone nasal spray is a medicine that helps reduce inflammation in your nose caused by allergies. It's a type of steroid that works directly in your nose to relieve symptoms like sneezing, runny nose, stuffy nose, and itchy nose. It's not for immediate relief and works best when used regularly every day.
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. It is essential to use this medication only as directed.
This medication is for nasal use only. Do not take it by mouth, and avoid getting it in your eyes or mouth, as it may cause burning.
Continue using this medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Preparing the Medication
Before using the medication, make sure to:
Shake the container well.
Blow your nose to clear your nostrils.
Prime the pump according to the instructions provided, if necessary. Some products may have different priming procedures, and some pumps may need to be primed if not used for a while.
Administering the Medication
Spray the medication up your nose only.
Avoid spraying the medication onto the septum (the wall between the two nostrils).
Storage and Disposal
Store the medication at room temperature.
Protect it from heat, cold, and light.
Keep the container upright with the cap on.
* Discard any unused medication after the labeled number of doses have been used.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use 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. It is essential to use this medication only as directed.
This medication is for nasal use only. Do not take it by mouth, and avoid getting it in your eyes or mouth, as it may cause burning.
Continue using this medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Preparing the Medication
Before using the medication, make sure to:
Shake the container well.
Blow your nose to clear your nostrils.
Prime the pump according to the instructions provided, if necessary. Some products may have different priming procedures, and some pumps may need to be primed if not used for a while.
Administering the Medication
Spray the medication up your nose only.
Avoid spraying the medication onto the septum (the wall between the two nostrils).
Storage and Disposal
Store the medication at room temperature.
Protect it from heat, cold, and light.
Keep the container upright with the cap on.
* Discard any unused medication after the labeled number of doses have been used.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Use regularly as directed, even when symptoms improve, 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 nasal septum (the wall between your nostrils).
- Close the other nostril with your finger.
- While sniffing gently, press down firmly on the pump to spray.
- Breathe out through your mouth.
- Repeat for the other nostril.
- Avoid blowing your nose immediately after use.
- Clean the nozzle regularly as per instructions.
- Avoid contact with eyes.
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, then may reduce to 1 spray per nostril once daily for maintenance.
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
allergicRhinitis:
Initial: 2 sprays (50 mcg/spray) per nostril once daily (total 200 mcg/day). Maintenance: 1 spray (50 mcg/spray) per nostril once daily (total 100 mcg/day) once symptoms are controlled.
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 symptoms persist, may increase to 2 sprays per nostril once daily (total 200 mcg/day), then reduce to 1 spray per nostril once daily once symptoms are controlled.
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 adjustment needed; low systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Use with caution; systemic exposure may increase in severe impairment due to extensive first-pass metabolism.
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 transcription of anti-inflammatory proteins and the repression of pro-inflammatory mediators (e.g., cytokines, chemokines, eicosanoids). This action reduces inflammation, edema, pruritus, and mucus production in the nasal passages.
Pharmacokinetics
Absorption:
Bioavailability:
<2% (systemic, due to extensive first-pass metabolism)
Tmax:
0.5-1.5 hours (nasal)
FoodEffect:
Not applicable for nasal administration
Distribution:
Vd:
Large (approximately 318 L)
ProteinBinding:
~99% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
~7.8 hours (terminal)
Clearance:
High (approximately 1150 mL/min)
ExcretionRoute:
Primarily fecal (as metabolites)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 12 hours (initial effect)
PeakEffect:
Several days (optimal effect may take 3-4 days of regular use)
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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 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. Many people may not experience any side effects or may only have mild ones. If you notice 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, discuss them with your doctor.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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 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. Many people may not experience any side effects or may only have mild ones. If you notice 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, discuss them with your doctor.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor for medical advice. 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 or severe nosebleeds
- Nasal sores or ulcers that do not heal
- Signs of a new infection (e.g., fever, persistent sore throat, unusual fatigue)
- Vision changes or eye pain (rare, but can indicate glaucoma or cataracts with long-term use)
- Unusual weakness or fatigue (signs of adrenal suppression, especially with high doses or prolonged use)
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, any of its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: atazanavir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole. Please note that this is not an exhaustive list of interacting medications.
All of your current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe treatment.
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety and optimal treatment outcomes.
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: atazanavir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole. Please note that this is not an exhaustive list of interacting medications.
All of your current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe treatment.
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety and optimal treatment outcomes.
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. As a precaution, follow your doctor's recommendations for regular eye exams to monitor your eye health.
Long-term use of this medication may lead to osteoporosis, a condition characterized by weak bones. Consult with your doctor to determine if you have a higher risk of developing osteoporosis or if you have any questions or concerns. Your doctor may recommend a bone density test to assess your bone health.
If you have not had chickenpox, measles, or the corresponding vaccines, and you come into contact with someone who has either of these illnesses, consult with your doctor. Similarly, if you have been exposed to someone with tuberculosis (TB), inform your doctor promptly.
If you have recently undergone nose surgery, experienced a nose injury, or have nose ulcers or sores, discuss this with your doctor before using this medication.
When switching from another form of steroid (such as oral steroids) to this medication, it is crucial to gradually reduce the dose of the other steroid to avoid potential side effects. Do not abruptly 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, 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. As a precaution, follow your doctor's recommendations for regular eye exams to monitor your eye health.
Long-term use of this medication may lead to osteoporosis, a condition characterized by weak bones. Consult with your doctor to determine if you have a higher risk of developing osteoporosis or if you have any questions or concerns. Your doctor may recommend a bone density test to assess your bone health.
If you have not had chickenpox, measles, or the corresponding vaccines, and you come into contact with someone who has either of these illnesses, consult with your doctor. Similarly, if you have been exposed to someone with tuberculosis (TB), inform your doctor promptly.
If you have recently undergone nose surgery, experienced a nose injury, or have nose ulcers or sores, discuss this with your doctor before using this medication.
When switching from another form of steroid (such as oral steroids) to this medication, it is crucial to gradually reduce the dose of the other steroid to avoid potential side effects. Do not abruptly 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, 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 (e.g., using much higher doses than recommended for prolonged periods) could lead to systemic corticosteroid effects such as Cushingoid features, adrenal suppression, growth retardation in children, or cataracts/glaucoma.
What to Do:
If you suspect a chronic overdose or experience unusual symptoms, contact your doctor or poison control center immediately. For acute ingestion, medical attention is generally not required due to low bioavailability. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Ritonavir (strong CYP3A4 inhibitor): Concomitant use is not recommended due to significant increase in fluticasone systemic exposure, leading to potential for Cushing's syndrome and adrenal suppression.
Moderate Interactions
- Other strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, cobicistat-containing products): May increase systemic exposure to fluticasone, requiring caution and monitoring for systemic corticosteroid effects.
Confidence Interactions
Monitoring
Baseline Monitoring
Nasal mucosa examination
Rationale: To assess baseline condition and identify any pre-existing irritation, infection, or septal perforation.
Timing: Prior to initiation of therapy
Routine Monitoring
Symptom improvement (nasal congestion, rhinorrhea, sneezing, itching)
Frequency: Daily, then periodically
Target: Significant reduction or resolution of allergic rhinitis symptoms
Action Threshold: If no improvement after 1-2 weeks, reassess diagnosis or treatment plan.
Nasal mucosa for irritation, candidiasis, or septal perforation
Frequency: Periodically, especially with long-term use
Target: Healthy, intact mucosa
Action Threshold: Discontinue if perforation occurs; treat candidiasis if present; reduce dose or discontinue if severe irritation.
Growth velocity (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months) with long-term use
Target: Normal growth rate for age
Action Threshold: If growth suppression is observed, consider dose reduction or discontinuation.
Symptom Monitoring
- Nasal congestion
- Rhinorrhea (runny nose)
- Sneezing
- Nasal itching
- Post-nasal drip
- Eye itching/watering (associated with allergic rhinitis)
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy. Fluticasone propionate nasal spray is classified as Pregnancy Category B. Studies in animals have shown no evidence of teratogenicity, and systemic exposure in humans is very low.
Trimester-Specific Risks:
First Trimester:
Low risk; systemic absorption is minimal.
Second Trimester:
Low risk; systemic absorption is minimal.
Third Trimester:
Low risk; systemic absorption is minimal.
Lactation
Considered compatible with breastfeeding (Lactation Risk L2). Due to low systemic absorption and high protein binding, it is unlikely to be excreted in breast milk in clinically significant amounts.
Infant Risk:
Low risk to the infant.
Pediatric Use
Use with caution in children, especially with long-term use, due to the potential for growth suppression. Monitor growth velocity regularly. Not recommended for children under 4 years of age.
Geriatric Use
No specific dose adjustment is required. Efficacy and safety are similar to younger adults. Use with caution in patients with pre-existing conditions that may be exacerbated by systemic corticosteroids, although systemic absorption is low.
Clinical Information
Clinical Pearls
- Fluticasone nasal spray is a preventative treatment for allergies and is not intended for immediate relief of acute symptoms. Consistent daily use is key for optimal effectiveness.
- Patients should be instructed on proper administration technique to ensure the medication reaches the nasal passages effectively and to minimize side effects like nosebleeds.
- Advise patients that full therapeutic benefit may take several days of consistent use.
- Rinsing the mouth after use is not necessary as it is a nasal spray, but cleaning the nasal applicator regularly is important to prevent contamination.
Alternative Therapies
- Other intranasal corticosteroids (e.g., mometasone, budesonide, triamcinolone, ciclesonide)
- Oral antihistamines (e.g., loratadine, cetirizine, fexofenadine)
- Intranasal antihistamines (e.g., azelastine, olopatadine)
- Oral decongestants (e.g., pseudoephedrine, phenylephrine)
- Intranasal decongestants (e.g., oxymetazoline - for short-term use only)
- Cromolyn sodium nasal spray
- Leukotriene receptor antagonists (e.g., montelukast)
Cost & Coverage
Average Cost:
$15 - $40 per 120-spray bottle (50 mcg/spray)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic and some brand formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.