Flunisolide

Mechanism-of-action class: Glucocorticoid Receptor Agonists.

• Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.

• Hypersensitivity to any of the ingredients.contraindicated

Adults: The recommended starting dose of Flunisolide Nasal Solution is 2 sprays (50 mcg) in each nostril 2 times a day (total dose 200 mcg/day). If needed, this dose may be increased to 2 sprays in each nostril 3 times a day (total dose 300 mcg/day). Pediatric Patients 6 to 14 years: The recommended starting dose of Flunisolide Nasal Solution is 1 spray (25 mcg) in each nostril 3 times a day or 2 sprays (50 mcg) in each nostril 2 times a day (total dose 150 to 200 mcg/day). Flunisolide Nasal Solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy studies, including possible adverse effects on growth, have not been conducted. Maximum total daily doses should not exceed 8 sprays in each nostril for adults (total dose 400 mcg/day) and 4 sprays in each nostril for pediatric patients under 14 years of age (total dose 200 mcg/day). Since there is no evidence that exceeding the maximum recommended dosage is more effective and increased systemic absorption would occur, higher doses should be avoided. After the desired clinical effect is obtained, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms. Approximately 15% of patients with perennial rhinitis may be maintained on as little as 1 spray in each nostril per day. For priming and repriming the nasal spray unit after storage: The patient should remove the dust cover. Put two fingers on “shoulders” of pump unit, and place thumb on bottom of bottle. Push bottle with thumb FIRMLY and QUICKLY 5-6 times or until fine spray appears.

The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and/or depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to flunisolide should be carefully monitored to avoid acute adrenal insufficiency in response to stress. When transferred to flunisolide, careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids. This is particularly important in those patients who have associated asthma or other clinical conditions, where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms. The use of flunisolide with alternate-day prednisone systemic treatment could increase the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, flunisolide treatment should be used with caution in patients already on alternate-day prednisone regimens for any disease. Persons who are on drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure.

Adverse reactions reported in controlled clinical trials and long-term open studies in 595 patients treated with Flunisolide Nasal Solution are described below. Of these patients, 409 were treated for 3 months or longer, 323 for 6 months or longer, 259 for 1 year or longer, and 91 for 2 years or longer. In general, side effects elicited in the clinical studies have been primarily associated with the nasal mucous membranes. The most frequent complaints were those of mild transient nasal burning and stinging, which were reported in approximately 45% of the patients treated with Flunisolide Nasal Solution in placebo-controlled and long-term studies. These complaints do not usually interfere with treatment; in only 3% of patients was it necessary to decrease dosage or stop treatment because of these symptoms. Approximately the same incidence of mild transient nasal burning and stinging was reported in patients on placebo as was reported in patients treated with Flunisolide Nasal Solution in controlled studies, implying that these complaints may be related to the vehicle or the delivery system. The incidence of complaints of nasal burning and stinging decreased with increasing duration of treatment. Other side effects reported at a frequency of 5% or less were: nasal congestion, sneezing, epistaxis and/or bloody mucous, nasal irritation, watery eyes, sore throat, nausea and/or vomiting, and headaches. As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances with the use of Flunisolide Nasal Solutions.

Flunisolide, infused intravenously, at doses up to 4 mg/kg in mice, rats and dogs (approximately 45,300 and 90 times, respectively, the maximum recommended daily intranasal dose in adults and children on a mg/m 2 basis) was without lethality.

• Feb 20, 2002ANDAANDA074805Bausch
• Jun 16, 2022ANDAANDA207802Riconpharma Llc

1. 1Nausea986.6%
2. 2Dyspnoea966.5%
3. 3Pain734.9%
4. 4Anxiety714.8%
5. 5Chronic Kidney Disease704.7%
6. 6Diarrhoea664.5%
7. 7Fatigue654.4%
8. 8Dizziness604.0%
9. 9Asthenia563.8%
10. 10Renal Failure563.8%
11. 11Headache543.6%
12. 12Acute Kidney Injury533.6%
13. 13Drug Ineffective533.6%
14. 14Chest Pain523.5%
15. 15Cough523.5%

The 6 most recently updated of 6 ClinicalTrials.gov registrations naming Flunisolide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Mentored Patient-Oriented Research Career Development Award
  Completed · Phase 1 · Interventional · 57 enrolled · University of California, Los Angeles
  NCT00203684updated 2026-01-22
• Effect of Physiotherapy in Hospitalized COPD Patients
  Completed · Interventional · 49 enrolled · Universidad de Granada
  NCT02509299updated 2020-01-27
• Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
  Unknown · Interventional · 60 enrolled · Universidad de Granada
  NCT02515318updated 2018-07-13
• Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
  Completed · Phase 3 · Interventional · 97 enrolled · GlaxoSmithKline
  NCT00346775updated 2018-01-16
• Flunisolide HFA in Children With Small Airway Disease
  Completed · Interventional · 26 enrolled · University of Louisville
  NCT02404103updated 2017-12-14
• Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
  Completed · Observational · 17,448 enrolled · GlaxoSmithKline
  NCT01347060updated 2017-05-25

Frequently asked questions

How does Flunisolide work?

Mechanism-of-action class: Glucocorticoid Receptor Agonists.

What is Flunisolide used for?

According to FDA labeling, Flunisolide carries indications including: Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Flunisolide?

Flunisolide is classified as Corticosteroids, Glucocorticoids, Glucocorticoid Receptor Agonists, Decreased Capillary Permeability, Decreased Fibroblast Migration, Decreased Glucocorticoid Secretion, Decreased Polymorphonuclear Leukocyte Migration, Decreased Protein Synthesis, Increased Lysosomal Function.

What are the contraindications for Flunisolide?

Flunisolide labeling lists contraindications including: Hypersensitivity to any of the ingredients.. Always consult the full prescribing information and a clinician.