Introduction

Synthetic trifluorinated corticosteroid.

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.

Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing, postnasal drip, and nasal itching; generally does not relieve signs and symptoms of conjunctivitis, although improvement in ophthalmic manifestations may occur.

Relieves symptoms in both allergic and nonallergic rhinitis, although experience is more extensive with allergic rhinitis.

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

Fluticasone (EENT) Dosage and Administration

Administration

Intranasal Administration

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

Avoid contact with the eyes.

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

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

Clear nasal passages prior to administration. If nasal passages are blocked, a topical nasal decongestant can be administered 5–15 minutes before intranasal administration.

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

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

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

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

Dosage

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

Adjust dosage according to individual requirements and response.

Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate. This should be explained to the patient in advance to ensure compliance and continuation of the prescribed treatment regimen.

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

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). Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.

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. Greater symptom control may be achieved with regular dosing.

Perennial Rhinitis

Intranasal Inhalation

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

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

Adults

Seasonal Rhinitis

Treatment

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total 200 mcg/day). Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).

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

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. Greater symptom control may be achieved with regular dosing.

Prophylaxis† [off-label]

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

Perennial Rhinitis

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total dose: 200 mcg/day). Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).

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

Prescribing Limits

No evidence that higher than recommended dosages or increased frequency of administration is beneficial.

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

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.

Perennial Rhinitis

Intranasal Inhalation

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

Adults

Seasonal Rhinitis

Intranasal Inhalation

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

Perennial Rhinitis

Intranasal Inhalation

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

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.

Renal Impairment

No specific dosage recommendations for renal impairment.

Geriatric Patients

No specific geriatric dosage recommendations.

Contraindications

• Known hypersensitivity to fluticasone or any ingredient in the formulation.

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.

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

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.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

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

Immunosuppression

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

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).

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).

Nasopharyngeal Effects

Temporary or permanent loss of smell may occur.

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

Rarely, nasal septal perforations.

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

Ophthalmic Effects

Possible increased IOP.

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

Oral Effects

Temporary or permanent loss of taste may occur.

Specific Populations

Pregnancy

Category C.

Lactation

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

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

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. 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. No clinically relevant changes in HPA axis or bone mineral density (as assessed by dual X-ray absorptiometry) observed.

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

Geriatric Use

Adverse effect profile similar to profile in younger adults.

Common Adverse Effects

Mild, transient nasal burning and stinging, aftertaste , epistaxis, headache, nausea and vomiting, abdominal bloating, pharyngitis, cough and asthma symptoms are most common.

Administration

Intranasal Administration

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

Avoid contact with the eyes.

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

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

Clear nasal passages prior to administration. If nasal passages are blocked, a topical nasal decongestant can be administered 5–15 minutes before intranasal administration.

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

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

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

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

Dosage

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

Adjust dosage according to individual requirements and response.

Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate. This should be explained to the patient in advance to ensure compliance and continuation of the prescribed treatment regimen.

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

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). Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.

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. Greater symptom control may be achieved with regular dosing.

Perennial Rhinitis

Intranasal Inhalation

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

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

Adults

Seasonal Rhinitis

Treatment

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total 200 mcg/day). Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).

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

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. Greater symptom control may be achieved with regular dosing.

Prophylaxis† [off-label]

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

Perennial Rhinitis

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total dose: 200 mcg/day). Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).

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

Prescribing Limits

No evidence that higher than recommended dosages or increased frequency of administration is beneficial.

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

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.

Perennial Rhinitis

Intranasal Inhalation

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

Adults

Seasonal Rhinitis

Intranasal Inhalation

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

Perennial Rhinitis

Intranasal Inhalation

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

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.

Renal Impairment

No specific dosage recommendations for renal impairment.

Geriatric Patients

No specific geriatric dosage recommendations.

Metabolized by CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

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

Specific Drugs