What is the correct way to prescribe Fluticasone Propionate (Fluticasone) 50 micrograms (MCG) per actuation suspension and what is the allowed number of refills according to FDA guidelines?

Prescribing Fluticasone Propionate 50 MCG/ACT Suspension

Prescription Format and Administration

Fluticasone propionate 50 mcg/actuation nasal spray suspension should be prescribed as 1-2 sprays per nostril once daily (total daily dose 100-200 mcg), with the prescription written for a specific quantity (e.g., one 16g bottle containing 120 metered sprays) and can be refilled without restriction as it is not a controlled substance under FDA regulations. 1

Specific Prescribing Instructions

For the prescription itself, write:

• Drug name: Fluticasone propionate nasal spray 50 mcg/actuation
• Quantity: One bottle (typically 16g containing 120 sprays)
• Directions: Spray 1-2 sprays in each nostril once daily
• Refills: As needed (no FDA restriction on refills for this non-controlled medication) 1

Dosing Recommendations by Indication

For allergic rhinitis in adults and adolescents (≥12 years):

• Initial dose: 2 sprays per nostril once daily (200 mcg total daily dose) 1
• Maintenance dose: May reduce to 1 spray per nostril once daily (100 mcg total) once symptoms are controlled 1
• Once-daily dosing is as effective as twice-daily administration and should be the preferred regimen 1

Important timing consideration:

• Administer once daily in the morning for optimal patient adherence and efficacy 1
• Maximum benefit may take several days to weeks to achieve 2

Administration Technique

Instruct patients to:

• Shake the bottle gently before each use
• Prime the pump if using for the first time or if unused for >1 week
• Spray away from the nasal septum (toward the outer wall of the nostril) to minimize epistaxis risk 2
• Avoid blowing nose immediately after administration

Refill Regulations

FDA classification:

• Fluticasone propionate nasal spray is not a controlled substance
• No federal limit exists on the number of refills that can be prescribed
• Prescribers may authorize refills for up to one year from the date of issue (state laws may vary)
• Consider prescribing 3-6 refills for chronic allergic rhinitis to ensure continuity of care

Safety Monitoring

Common local adverse effects to counsel patients about:

• Nasal irritation and epistaxis (most common) 2
• Headache
• Pharyngitis

Systemic absorption considerations:

• Minimal systemic absorption occurs at recommended intranasal doses 2
• No clinically significant HPA axis suppression at therapeutic doses 2
• Safe for long-term use when prescribed appropriately 1

Clinical Pitfalls to Avoid

Do not confuse formulations:

• The 50 mcg/actuation strength is specifically for nasal spray formulation
• This is distinct from fluticasone propionate inhalers used for asthma (which come in different strengths: 44,110,220 mcg/actuation for HFA-MDI or 50,100,250 mcg for DPI) 3
• Verify the route of administration when prescribing

Avoid prescribing errors:

• Do not prescribe "as needed" dosing—intranasal corticosteroids require regular daily use for efficacy 1
• Do not prescribe twice-daily dosing unless once-daily dosing fails, as once-daily is equally effective and improves adherence 1