What are the guidelines for long-term use of Fluticasone (fluticasone) nasal spray?

Long-Term Use of Fluticasone Nasal Spray

Fluticasone nasal spray is safe and effective for indefinite long-term use when clinically indicated, with no clinically significant systemic effects, no impact on growth in children at recommended doses, and no time limit on duration of therapy. 1

Duration of Treatment

• Long-term treatment with nasal corticosteroids including fluticasone is both effective and safe in patients with chronic rhinosinusitis, with studies demonstrating safety for up to 52 weeks of continuous use. 1

• Treatment duration in clinical trials has ranged from 4 weeks to 52 weeks, with no difference in safety profile between short-term (<12 weeks) and long-term (≥12 weeks) use. 1

• For chronic conditions like perennial allergic rhinitis or chronic rhinosinusitis, fluticasone should be used continuously as maintenance therapy, not intermittently or "as needed." 2

• A 12-month safety study of fluticasone furoate 110 mcg once daily in 806 patients with perennial allergic rhinitis demonstrated an adverse event profile typical of intranasal corticosteroids with no evidence of clinically relevant systemic corticosteroid exposure. 3

Safety Profile for Long-Term Use

Systemic Effects

• Long-term use does not affect systemic cortisol levels or hypothalamic-pituitary-adrenal axis function in adults or children. 2

• Studies have consistently failed to demonstrate any clinically relevant effect from intranasal corticosteroids on the hypothalamic-pituitary-adrenal axis. 2

• Plasma concentrations of fluticasone furoate were not quantifiable in the majority of patients following intranasal administration, indicating minimal systemic absorption. 3

Pediatric Growth Considerations

• Fluticasone propionate, mometasone furoate, and budesonide show no effect on growth at recommended doses compared to placebo, even at up to twice the recommended doses. 2

• Growth suppression has been reported only with long-term use of beclomethasone dipropionate that exceeded recommended doses or was administered to toddlers—not with fluticasone at appropriate dosing. 2

Ocular Safety

• No increased risk of lens opacity, elevated intraocular pressure, glaucoma, or other ocular symptoms has been associated with prolonged use of intranasal corticosteroids. 2

• Mean changes in ophthalmic parameters showed no clinically meaningful differences between fluticasone furoate and placebo after 12 months of treatment. 3

Nasal Mucosal Effects

• Nasal mucosa biopsies from patients treated continuously for 1 to 5 years have shown no evidence of atrophy. 2

• The most common adverse event with long-term use is epistaxis, occurring in 4-8% over short periods and up to 20% over one year, but this is generally mild. 2, 3

Dosing for Long-Term Maintenance

Adults and Adolescents (≥12 years)

• Start with 2 sprays (100 mcg) in each nostril once daily (200 mcg total daily dose). 4

• Once symptoms are controlled, reduce to 1 spray in each nostril once daily (100 mcg total daily dose) for maintenance. 4

• For nasal polyposis, fluticasone 200 mcg twice daily is effective for acute treatment, with 200 mcg once daily sufficient to maintain long-term efficacy. 5

Children (4-11 years)

• Use 1 spray (50 mcg) per nostril once daily (100 mcg total daily dose). 2, 4

• This dose can be continued long-term when needed, using the lowest effective dose. 2

Monitoring Requirements During Long-Term Use

• Periodically examine the nasal septum to detect mucosal erosions that may precede septal perforation, a rare complication. 2

• Patients on long-term therapy should consult their physicians to determine if regular ophthalmic monitoring is appropriate. 2

• No routine laboratory monitoring of cortisol levels is necessary, as systemic effects are not clinically significant at recommended doses. 2, 3

Administration Technique to Minimize Side Effects

• Direct the spray away from the nasal septum (use contralateral hand technique) to reduce epistaxis risk by four times. 1, 2

• Prime the bottle before first use by pressing down 6 times, and re-prime if not used for 7 days. 4

• Shake the bottle before each use, blow the nose first, keep head upright, and breathe in gently during spraying. 6, 4

• If using nasal saline irrigations, perform them prior to administering fluticasone spray to avoid rinsing out the medication. 1

Common Pitfalls to Avoid

• Do not discontinue fluticasone when symptoms improve—this is maintenance therapy requiring continuous use for optimal control. 2

• Counsel patients that onset of action is delayed (12 hours) with maximal efficacy reached in days to weeks, not immediately. 2, 6, 4

• Ensure proper administration technique is taught using visual aids or demonstrations, as improper use increases local side effects and reduces efficacy. 2

• Do not confuse intranasal corticosteroids with topical decongestants—fluticasone does not cause rhinitis medicamentosa and is safe for long-term daily use, unlike decongestants which should be limited to 3 days maximum. 2

When to Reassess Treatment

• If no improvement is seen after 3 months of intranasal corticosteroid therapy, consider adding a short course of oral corticosteroids or proceeding to CT imaging and surgical evaluation. 2

• For patients with predictable seasonal patterns, initiate treatment before symptom onset and continue throughout the allergen exposure period. 2

• Follow-up every 6 months is recommended for patients on long-term therapy to assess efficacy and monitor for any adverse effects. 2