Indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older.

Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.

Reports of epistaxis and nasal ulceration.

Localized infections of the nose and pharynx with Candida albicans.

Reports of nasal septal perforation.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should avoid using FLONASE nasal spray until healing has occurred.

Use of intranasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported after administration of FLONASE nasal spray.

Persons who are using 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 susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure.

When intranasal corticosteroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear.

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.

The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with FLONASE nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products, including FLONASE, with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Co-administration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

There are insufficient data on the use of FLONASE in pregnant women to inform a drug-associated risk. Animal studies: decreased fetal body weight and/or skeletal variations. Following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery.

There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Low concentrations of other corticosteroids have been detected in human milk.

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• Adult dosage greater than 2 sprays in each nostril (total dose, 200 mcg/day). GoToSource

• Use in patients under the age of 4. GoToSource

• Eosinophilic oesophagitis. GoToSource

• Obstructive sleep apnea syndrome. GoToSource 

• Bronchiectasis. GoToSource 

• Treatment of COPD. GoToSource

• Cystic fibrosis. GoToSource

Posterior subcapsular cataracts. GoToSource 

Long-term exposure and increased risk of fractures. GoToSource

Adrenal suppression and cushing’s syndrome secondary to interaction with ritonavir. GoToSource

Nontuberculous mycobacterial (lung infection). GoToSource

Epistaxis (nose bleed). GoToSource

Nasopharyngitis, pyrexia (fever), pharyngolaryngeal pain and nasal ulceration. GoToSource

Oral candidiasis. GoToSource

Nasal septal perforation, osteoporosis (decreased bone density), encephalitis (inflammation of the brain)  and glaucoma. GoToSource

Delayed wound healing. GoToSource

Growth suppression in children. GoToSource 

No major injury lawsuits reported.