Flunisolide (Page 2 of 3)

Information for Patients

Patients should use flunisolide at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. It is not acutely effective and the prescribed dosage should not be increased. Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of flunisolide are fully manifested. One to two weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, or if the condition worsens, or if sneezing or nasal irritation occurs.

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying Patient Instructions carefully.

Patients should be advised to clear their nasal passages of secretions prior to use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In mice, flunisolide at an oral dose of 500 mcg/kg/day (approximately 6 times the maximum recommended daily intranasal dose in adults and children on a mg/m 2 basis) for 21 months was negative for carcinogenic effects. In rats, administration of flunisolide at an oral dose of 2.5 mcg/kg/day (less than the maximum recommended daily intranasal dose in adults and children on a mg/m 2 basis) for 24 months resulted in an increased incidence of mammary gland adenoma and islet cell adenoma of the pancreas in females. There were no significant increases in the incidence of any tumor type in rats at an oral dose of 1.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults and children on a mg/m 2 basis).

Flunisolide showed no mutagenic activity in in vitro test systems including the Ames Assay and the Rec-Assay, and no clastogenic activity in either the in vitro chromosomal aberration assay in Chinese hamster lung fibroblast cells or the in vivo mouse bone marrow chromosomal aberration assay.

Flunisolide, at an oral dose of 200 mcg/kg/day (approximately 4 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis) produced impaired fertility in female rats, but was devoid of such effect at oral doses less than or equal to 40 mcg/kg/day (approximately equal to the maximum recommended daily intranasal dose in adults on a mg/m 2 basis).

Pregnancy

As with other corticosteroids, flunisolide has been shown to be teratogenic and fetotoxic in rabbits and rats at oral doses of 40 and 200 mcg/kg/day, respectively (approximately 2 and 4 times, respectively, the maximum recommended daily intranasal dose in adults on a mg/m 2 basis). There are no adequate and well-controlled studies in pregnant women. Flunisolide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when flunisolide is administered to nursing women.

Pediatric Use

Flunisolide Nasal Solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy have not been assessed in this age group. Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Flunisolide Nasal Solution, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Flunisolide Nasal Solution, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Geriatric Use

Clinical studies of Flunisolide Nasal Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose reduction for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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 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. Temporary or permanent loss of the sense of smell and taste have also been reported with the use of flunisolide nasal solutions.

Systemic corticosteroid side effects were not reported during the controlled clinical trials. If recommended doses are exceeded, or if individuals are particularly sensitive, symptoms of hypercorticism, i.e., Cushing’s syndrome, could occur. Cases of growth suppression have been reported for intranasal corticosteroids (including Flunisolide Nasal Solution) ( see PRECAUTIONS, Pediatric Use ).

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

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.

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 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. Now your pump is primed. The patient must prime the pump unit again if it has not been used for 5 days or more, or if it has been disassembled for cleaning.

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