Fluticasone Propionate eent

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

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†.21

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

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

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

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

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

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

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

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

Adults

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

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

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

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.