Flunisolide .25 mg/mL
Flunisolide · SOLUTION · Bausch & Lomb Incorporated
Flunisolide is a solution containing flunisolide at .25 mg/mL, taken nasal. Manufactured by Bausch & Lomb Incorporated.
Key Facts
- Brand Name
- Flunisolide
- Generic Name
- Flunisolide
- NDC Code (Product)
24208-344- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- .25 mg/mL
- Dosage Form
- SOLUTION
- Route
- NASAL
- Marketing Status
- Application #
- ANDA074805
- Marketing Start
- 02/20/2002
Recall History
Ingenus Pharmaceuticals Llc
Out of specification for related substances (impurities).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 necessa…
Warnings
WARNINGS 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…
Contraindications
CONTRAINDICATIONS Hypersensitivity to any of the ingredients.
Adverse Reactions
ADVERSE REACTIONS 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 in…
Frequently Asked Questions
What is Flunisolide used for?
Flunisolide contains Flunisolide. It is a solution taken nasal. Consult your doctor for specific uses.
Is Flunisolide a controlled substance?
Flunisolide is not classified as a controlled substance by the DEA.
What is the generic name for Flunisolide?
The generic name for Flunisolide is Flunisolide. There are no other listed brand versions of Flunisolide.
What is the NDC code for Flunisolide .25 mg/mL?
The NDC (National Drug Code) for Flunisolide .25 mg/mL is 24208-344, listed by Bausch & Lomb Incorporated.
Other Flunisolide Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)