Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Nasal:
Generic: 25 mcg/actuation (0.025%) (25 mL)
Pharmacology
Mechanism of Action
Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; does not depress hypothalamus
Pharmacokinetics/Pharmacodynamics
Absorption
~50%
Use: Labeled Indications
Rhinitis: Management of the nasal symptoms associated with seasonal or perennial rhinitis
Use: Off Label
Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment)yes
Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults and the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, flunisolide (nasal), among other intranasal corticosteroids, is effective and recommended as an adjunctive treatment to antibiotic therapy for the management of ABRS, primarily when a history of allergic rhinitis exists (according to IDSA guidelines).
Chronic rhinosinusitisbyes
Based on the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) guidelines for adult sinusitis, flunisolide (nasal), among other intranasal corticosteroids, is effective and recommended (with or without nasal saline irrigation) for the symptomatic relief of chronic rhinosinusitis. Data from a multicenter, double-blind, randomized study supports the use of intranasal flunisolide as adjunct therapy to oral anitbiotics in patients with chronic rhinosinusitis Meltzer 1993.
Non-allergic rhinitisb
Data from a single blinded, randomized and controlled study conducted over 8 weeks supports the use of flunisolide in the treatment of adults with non-allergic rhinitis. Additional trials may be necessary to further define the role of drug flunisolide in this condition Varricchio 2011.
Symptomatic relief of viral rhinosinusitisyes
Based on the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) guidelines for adult sinusitis topical intranasal steroids (including flunisolide), analgesics and/or nasal saline irrigation may be recommended for symptomatic relief of viral rhinosinusitis Rosenfeld 2015.
Contraindications
Hypersensitivity to flunisolide or any component of the formulation
Documentation of allergenic cross-reactivity for intranasal steroids is limited; however, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Active or quiescent tuberculosis; untreated fungal, bacterial, or viral infections; children <6 years
Dosage and Administration
Dosing: Adult
Rhinitis (seasonal/perennial): Intranasal: Two 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)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Seasonal and perennial rhinitis: 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)
Administration
Before first use, prime by pressing pump 5-6 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.
Storage
Store at 15°C to 25°C (59°F to 77°F).
Drug Interactions
Desmopressin: Corticosteroids (Nasal) may enhance the hyponatremic effect of Desmopressin. Avoid combination
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. Consider therapy modification
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
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
Warnings/Precautions
Concerns related to adverse effects:
- Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery or nasal trauma until healing has occurred.
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).
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse effects were observed in some animal reproduction studies. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP, 2005; Wallace, 2008).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience burning or stinging. Have patient report immediately to prescriber stuffy nose, severe nosebleeds, nasal sores, whistling sound when breathing, thrush, sneezing, chills, or sore throat (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
