Version May 2024
Rhinitis, perennial or s easonal: Intranasal (25 mcg/spray):
Children ≥6 years and Adolescents ≤14 years: Initial: 1 spray (25 mcg) per nostril 3 times daily or 2 sprays (50 mcg) per nostril twice daily (total daily dose: 150 to 200 mcg/day); maximum daily dose: 4 sprays per nostril/day (200 mcg/day); once symptoms are controlled, the dose should be reduced to the lowest effective dose; 1 spray (25 mcg) per nostril once daily may be effective in some patients (total daily dose: 50 mcg/day)
Adolescents ≥15 years: Initial: 2 sprays (50 mcg) per nostril twice daily (total daily dose: 200 mcg/day); if needed, may increase to 2 sprays (50 mcg) per nostril 3 times daily (total daily dose: 300 mcg/day); maximum daily dose: 8 sprays per nostril/day (400 mcg/day); once symptoms are controlled, the dose should be reduced to the lowest effective dose; 1 spray (25 mcg) per nostril once daily may be effective in some patients (total daily dose: 50 mcg/day)
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Flunisolide (nasal): Drug information")
Note: For patients with mucous crusting, rinsing with saline nasal spray before flunisolide administration can remove mucous crusting and improve nasal coating (Ref). If nasal obstruction is so severe that sprays cannot penetrate, consider concomitant use of an intranasal decongestant for up to 5 days (Ref).
Allergic rhinitis, perennial or seasonal: Intranasal: 2 sprays (50 mcg) in each nostril twice daily (total daily dose: 200 mcg/day); may increase to 2 sprays in each nostril 3 times daily (total daily dose: 300 mcg/day); maximum dose: 8 sprays/day in each nostril (total daily dose: 400 mcg/day).
Nonallergic rhinitis (off label): Intranasal: 2 sprays (50 mcg) in each nostril twice daily (total daily dose: 200 mcg/day); may increase to 2 sprays in each nostril 3 times daily (total daily dose: 300 mcg/day); maximum dose: 8 sprays/day in each nostril (total daily dose: 400 mcg/day) (Ref).
There are no dosage adjustment provided in manufacturer's labeling.
There are no dosage adjustment provided in manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not always defined.
>10%:
Dermatologic: Burning sensation of the nose (≤13%)
Respiratory: Nasal congestion (15%), stinging sensation of the nose (≤13%)
1% to 10%:
Central nervous system: Anosmia
Respiratory: Dry nose, nasal mucosa irritation, rhinitis, sneezing
<1%, postmarketing, and/or case reports: Nasal mucosa ulcer
Hypersensitivity to flunisolide or any component of the formulation
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Pediatric patients may be more susceptible to systemic toxicity. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible.
• Delayed wound healing: Avoid use in patients with recent nasal septal ulcers, nasal surgery or nasal trauma until healing has occurred.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox and/or measles should be avoided, especially if not immunized; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered.
• Local nasal effects: Nasal septal perforation, nasal ulceration, epistaxis, and localized Candida albicans infections of the nose and/or pharynx may occur. Monitor patients periodically for adverse nasal effects; discontinuation of therapy may be necessary if an infection occurs. If nasal effects occur, use with caution until area is healed.
Special populations:
• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing's syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).
Other warnings/precautions:
• Appropriate use: Not for use in the presence of untreated localized infections involving the nasal mucosa. Do not use for longer than 3 weeks if no clinical signs of improvement. Avoid excessive doses; systemic effects may occur.
• Withdrawal: Symptoms of corticosteroid withdrawal (eg, joint pain, muscle pain, lassitude, depression) may occur when transferring from a systemic corticosteroid to a topical corticosteroid.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Nasal:
Generic: 25 mcg/actuation (0.025%) (25 mL)
Yes
Solution (Flunisolide Nasal)
25 MCG/ACT (0.025%) (per mL): $2.55 - $2.88
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
When used short term as adjunctive therapy in acute bacterial rhinosinusitis (ABRS), intranasal steroids show modest symptomatic improvement and few adverse effects; improvement is primarily due to increased sinus drainage. Use should be considered optional in ABRS; however, intranasal corticosteroids should be routinely prescribed to ABRS patients who have a history of or concurrent allergic rhinitis (Chow 2012).
For intranasal use only. Shake well prior to each use. Before first use, prime by pressing pump 5 to 6 times or until a fine spray appears. Repeat priming if ≥5 days between use or if dissembled for cleaning. Administer at regular intervals. Blow nose to clear nostrils. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. Do not spray into eyes. Discard after labeled number of doses has been used, even if bottle is not completely empty.
Intranasal: For use in nostril only; do not spray in eyes or mouth. Before first use, prime by pressing pump 5 to 6 times or until a fine spray appears. Repeat priming if ≥5 days between use, or if dissembled for cleaning. Administer at regular intervals. Blow nose to clear nostrils. Insert applicator into nostril, keeping bottle upright and head bent forward, and close off the other nostril. Do not spray directly into septum. Breathe in through nose. While inhaling, press pump to release spray.
Store at 15°C to 25°C (59°F to 77°F).
Management of nasal symptoms associated with seasonal or perennial rhinitis (FDA approved in ages ≥6 years and adults)
Intranasal corticosteroids have also been used as an adjunct to antibiotics in empiric treatment of acute bacterial rhinosinusitis primarily in patients with history of allergic rhinitis (Chow 2012) and in pediatric patients with mild obstructive sleep apnea syndrome who cannot undergo adenotonsillectomy or who still have symptoms after surgery (Marcus 2012).
Flunisolide may be confused with Flumadine, fluocinonide.
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Esketamine: Corticosteroids (Nasal) may diminish the therapeutic effect of Esketamine. Management: Patients who require a nasal corticosteroid on an esketamine dosing day should administer the nasal corticosteroid at least 1 hour before esketamine. Risk D: Consider therapy modification
An agent with less systemic absorption is preferred for the treatment of allergic rhinitis during pregnancy (BSACI [Scadding 2017]).
Mucous membranes for signs of fungal infection, growth (pediatric patients), signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular changes
Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; does not depress hypothalamus
Absorption: ~50%
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