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Fluticasone (EENT) (Monograph)

Brand name: Flonase
Drug class: Corticosteroids

Medically reviewed by Drugs.com on Jul 24, 2023. Written by ASHP.

Introduction

Synthetic trifluorinated corticosteroid.1 2 3 6 7 8 26 48 65 66

Uses for Fluticasone (EENT)

Seasonal and Perennial Rhinitis

Symptomatic treatment of seasonal or perennial rhinitis when conventional therapy with antihistamines or decongestants is ineffective or is not tolerated.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123

Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing, postnasal drip, and nasal itching;1 2 7 16 19 27 33 34 46 51 55 59 122 123 124 generally does not relieve signs and symptoms of conjunctivitis, although improvement in ophthalmic manifestations may occur.19 62 110 113

Relieves symptoms in both allergic1 2 7 16 19 27 33 34 46 51 54 55 71 73 74 76 78 110 113 122 123 and nonallergic1 57 113 rhinitis, although experience is more extensive with allergic rhinitis.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123

Has been used successfully prior to the onset of the pollen season for the prophylaxis of symptoms of seasonal allergic rhinitis† [off-label].21

Fluticasone (EENT) Dosage and Administration

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose nasal spray pump.1 6

Avoid contact with the eyes.1

If used once daily, administer preferably in the morning.18 46 110 113 Generally, initiate therapy with once-daily dosing; some patients may obtain greater relief with twice-daily divided dosing.1

Although regular dosing generally provides optimal benefit, as needed (prn) dosing may be adequate in some patients with seasonal allergic rhinitis.1

Clear nasal passages prior to administration.6 b If nasal passages are blocked, a topical nasal decongestant can be administered 5–15 minutes before intranasal administration.2 67 75 79 113

Prime pump prior to initial use or after a period of nonuse (i.e., ≥1 week).1 6 b

Tilt the head slightly forward, insert the nasal adapter into one nostril,6 b and point the tip of the adapter toward the inflamed nasal turbinates and away from the nasal septum.67 79

Pump the drug into one nostril6 b while holding the other nostril closed and concurrently inspire through the nose.6 b Repeat procedure for the other nostril.6 b

After removing the nasal adapter and dust cap, these pieces should be rinsed in warm water and dried thoroughly;6 do not clean by inserting a sharp object into the piece.6

Dosage

Nasal inhaler delivers about 50 mcg of fluticasone propionate per metered spray and about 120 metered sprays per 16-g container.1

Adjust dosage according to individual requirements and response.1 110

Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate.1 6 13 16 27 46 48 51 52 115 This should be explained to the patient in advance to ensure compliance and continuation of the prescribed treatment regimen.1

Generally assess response to the initial dosage 4–7 days after starting therapy; a reduction in maintenance dosage may be possible at that time.1

Pediatric Patients

Seasonal Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: 1 spray (50 mcg) in each nostril once daily (total dose: 100 mcg/day).1 Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.1

Reduce dosage to 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.

Some patients ≥12 years of age with seasonal allergic rhinitis may find as needed (prn) use of 200 mcg (100 mcg in each nostril) doses (no more frequently than once daily) to be effective in controlling symptoms.1 Greater symptom control may be achieved with regular dosing.1

Perennial Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: 1 spray (50 mcg) in each nostril daily (total dose: 100 mcg/day).1 Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.1

Maintenance dose is 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.

Adults

Seasonal Rhinitis
Treatment
Intranasal Inhalation

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total 200 mcg/day).1 Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).1 16 17 18 19 27 46 51 55

Maintenance dose is 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.1 96

Some patients with seasonal allergic rhinitis may find as needed (prn) use of 200-mcg (100 mcg in each nostril) doses (no more frequently than once daily) to be effective in controlling symptoms.1 Greater symptom control may be achieved with regular dosing.1

Prophylaxis† [off-label]
Intranasal Inhalation

Maintenance dose is 2 sprays (100 mcg) in each nostril daily (200 mcg total).121

Perennial Rhinitis
Intranasal Inhalation

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total dose: 200 mcg/day).1 Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).1 16 17 18 19 27 46 51 55

Maintenance dose is 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.1 96

Prescribing Limits

No evidence that higher than recommended dosages or increased frequency of administration is beneficial.13 15 110 113

Exceeding the maximum recommended daily dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing’s syndrome).1

Pediatric Patients

Seasonal Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Perennial Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Adults

Seasonal Rhinitis
Intranasal Inhalation

Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Perennial Rhinitis
Intranasal Inhalation

Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.1

Renal Impairment

No specific dosage recommendations for renal impairment.1

Geriatric Patients

No specific geriatric dosage recommendations.1

Detailed Fluticasone nasal dosage information

Cautions for Fluticasone (EENT)

Contraindications

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Patients being switched from prolonged systemic corticosteroids to intranasal therapy should be monitored carefully since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, and/or severe symptomatic exacerbation of asthma or other clinical conditions may occur.1 115

Systemic corticosteroid dosage should be tapered, and patients should be carefully monitored during dosage reduction.1 115

Infection, Trauma, or Surgery

Use cautiously, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; ocular herpes simplex infections; or septal ulcers, trauma, or surgery in the nasal region.1

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Avoid higher than recommended dosages since suppression of HPA function may occur.1

Immunosuppression

Although risk with intranasal use is unknown, consider the possibility that corticosteroid-induced immunosuppression could occur.1 Avoid exposure to varicella and measles in previously unexposed patients.1

Sensitivity Reactions

Possible immediate hypersensitivity reactions (e.g., wheezing, contact dermatitis, rash, dyspnea, anaphylaxis/anaphylactoid reactions, pruritus, urticaria, angioedema, edema of the face and tongue, and bronchospasm).1 112

General Precautions

Systemic Corticosteroid Effects

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may cause systemic corticosteroid effects (e.g., Cushing’s syndrome, adrenal suppression).1

Nasopharyngeal Effects

Temporary or permanent loss of smell may occur.1

Rarely, localized candidal infections of the nose and/or pharynx.1 104 105 119 Treat suspected local infection appropriately;1 115 may require discontinuance of fluticasone therapy.1 17

Rarely, nasal septal perforations.1 110 113 115

Avoid use until healing occurs in patients with recurrent epistaxis, recent nasal septal ulcers, nasal surgery, or nasal trauma.1

Ophthalmic Effects

Possible increased IOP.1

Cataracts, ocular dryness and irritation, conjunctivitis, blurred vision, and glaucoma have been reported.1 17 84

Oral Effects

Temporary or permanent loss of taste may occur.1

Specific Populations

Pregnancy

Category C.1

Lactation

Other corticosteroids known to be distributed into milk.1 48 Caution if used in nursing women.1

May cause adverse effects (e.g., growth suppression) in nursing infants if distributed into milk.1

Pediatric Use

May be a useful therapeutic alternative to oral corticosteroids in children ≥4 years of age with seasonal or perennial allergic rhinitis since intranasal administration is associated with a decreased risk of adverse systemic effects.

Intranasal corticosteroids may reduce growth velocity in pediatric patients.1 Children 3–9 years of age receiving 200 mcg of fluticasone propionate daily for 1 year did not show evidence of reduction in normal growth velocity.1 No clinically relevant changes in HPA axis or bone mineral density (as assessed by dual X-ray absorptiometry) observed.1

Safety and efficacy not established in children <4 years of age.1 87

Geriatric Use

Adverse effect profile similar to profile in younger adults.1

Common Adverse Effects

Mild, transient nasal burning and stinging,1 3 16 17 21 27 46 51 54 55 aftertaste1 , epistaxis,13 16 17 19 21 22 46 51 54 55 112 124 headache,1 112 124 nausea and vomiting,1 21 abdominal bloating,1 pharyngitis,1 16 17 27 112 cough1 124 and asthma symptoms1 124 are most common.

Drug Interactions

Metabolized by CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

Drugs that affect CYP3A4 activity: Potential pharmacokinetic interaction (altered metabolism of fluticasone).1 Exercise caution when potent CYP3A4 inhibitors are used concomitantly.1

Specific Drugs

Drug

Interaction

Comments

Corticosteroids

Potential pharmacodynamic interaction (increased the risk of hypercorticism, suppression of the HPA axis, decreased growth rate in children) with concomitant use of other inhaled and/or systemically absorbed corticosteroids1 38 79 84

Concomitant use not recommended

Erythromycin

Does not affect the pharmacokinetics of fluticasone1

Ketoconazole

Possible increase in mean plasma fluticasone concentrations and toxicity1

Exercise caution1

Ritonavir

Increases plasma fluticasone concentrations, resulting in decreased plasma cortisol AUC1

Cushing’s syndrome and adrenal suppression reported1

Concomitant use not recommended unless potential benefit outweighs the risk of adverse effects1
Fluticasone nasal drug interactions (more detail)

Fluticasone (EENT) Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the respiratory and GI tracts following nasal inhalation.8 51 52

Systemic bioavailability of less than 2% based on indirect calculations.1 7

Onset

Symptomatic relief usually is evident within 12–48 hours of initiation of therapy in adults and within 36 hours in children.1 13 16 27 46 48 51 52

Optimum effectiveness generally requires 2–4 days in most patients.1 13 16 27 46 48 51 52

Duration

Following discontinuance, symptoms of rhinitis do not recur for 1–2 weeks.10 13 16 27 46 48 52 62

Distribution

Extent

Placental distribution in humans is unknown, but fluticasone crosses the placenta in animals.1

Distribution into milk unknown, but other corticosteroids are distributed.1

Plasma Protein Binding

Approximately 91%.1 48

Elimination

Metabolism

Rapidly metabolized in the liver by the CYP3A4.1 3 8 48 117

Elimination Route

Following oral administration, about 87–100% is excreted in the feces, and less than 5% of the dose is excreted in the urine.2 14 7 8 48 103

Half-life

Plasma half-life: about 3 hours after IV administration.1 7 8 48 103

Stability

Storage

Nasal Suspension

4–30°C.1

Discard the nasal pump spray after 120 sprays.1

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Fluticasone Propionate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension, for intranasal use only

50 mcg/metered spray

Flonase Nasal Spray (with benzalkonium chloride and phenylethyl alcohol)

GlaxoSmithKline

AHFS DI Essentials™. © Copyright 2024, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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