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Flunisolide (nasal): Drug information

Flunisolide (nasal): Drug information
(For additional information see "Flunisolide (nasal): Patient drug information" and see "Flunisolide (nasal): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Corticosteroid, Nasal
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: Kidney Impairment: Adult

There are no dosage adjustment provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustment provided in manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Flunisolide (nasal): Pediatric drug information")

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)

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Nasal:

Generic: 25 mcg/actuation (0.025%) (25 mL)

Generic Equivalent Available: US

Yes

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

Rhinitis: Management of the nasal symptoms associated with seasonal or perennial rhinitis

Use: Off-Label: Adult

Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment); Chronic rhinosinusitis; Non-allergic rhinitis; Symptomatic relief of viral rhinosinusitis

Medication Safety Issues
Sound-alike/look-alike issues:

Flunisolide may be confused with Flumadine®, fluocinonide

Adverse Reactions

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

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

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).

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

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

Pregnancy Considerations

An agent with less systemic absorption is preferred for the treatment of allergic rhinitis during pregnancy (BSACI [Scadding 2017]).

Breastfeeding Considerations

It is not known if sufficient quantities of flunisolide are absorbed following inhalation to produce detectable amounts in breast milk.

Other corticosteroids have been found in breast milk; therefore, the manufacturer recommends caution be used if administered to a breastfeeding woman.

Mechanism of Action

Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; does not depress hypothalamus

Pharmacokinetics

Absorption: ~50%

Pricing: US

Solution (Flunisolide Nasal)

25 MCG/ACT (0.025%) (per mL): $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.

Brand Names: International
  • Bronilide (FR);
  • Nasalide (KR);
  • Syntaris (AE, BH, DE, KW);
  • Tarisin (PK)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Chow AW, Benninger MS, Brook I, et al, “IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” Clin Infect Dis, 2012, 54(8):e72-112. [PubMed 22438350]
  2. Dykewicz MS, Wallace DV, Baroody F, et al. Treatment of seasonal allergic rhinitis: an evidence-based focused 2017 guideline update. Ann Allergy Asthma Immunol. 2017;119(6):489-511.e41. [PubMed 29103802]
  3. Flunisolide nasal solution [prescribing information]. Allendale, NJ: Rising Pharmaceuticals, Inc.; January 2012.
  4. Marcus CL, Brooks LJ, Draper KA, et al, "Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome," Pediatrics, 2012, 130(3):576-84. [PubMed 22926173]
  5. Meltzer EO, Orgel HA, Backhaus JW, et al. Intranasal flunisolide spray as an adjunct to oral antibiotic therapy for sinusitis. J Allergy Clin Immunol. 1993;92(6):812-823. [PubMed 8258615]
  6. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 suppl):S1-S39. [PubMed 25832968]
  7. Scadding GK, Kariyawasam HH, Scadding G, et al. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (revised edition 2017; first edition 2007). Clin Exp Allergy. 2017;47(7):856-889. doi:10.1111/cea.12953 [PubMed 30239057]
  8. Varricchio A, Capasso M, De Lucia A, et al. Intranasal flunisolide treatment in patients with non-allergic rhinitis. Int J Immunopathol Pharmacol. 2011;24(2):401-409. [PubMed 21658314]
  9. Wise SK, Lin SY, Toskala E, et al. International consensus statement on allergy and rhinology: allergic rhinitis. Int Forum Allergy Rhinol. 2018;8(2):108-352. [PubMed 29438602]
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