Beclomethasone dipropionate

1. INDICATIONS AND USAGE QNASL Nasal Aerosol is a corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older.

Beclomethasone dipropionate is a prodrug that is extensively converted to the active metabolite, beclomethasone-17-monopropionate. The precise mechanism through which beclomethasone dipropionate affects rhinitis symptoms is unknown. Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines). Beclomethasone-17-monopropionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide and 25 times that of beclomethasone dipropionate. The clinical significance of these findings is unknown.

2. DOSAGE AND ADMINISTRATION Administer QNASL Nasal Aerosol by the intranasal route only. The dose counter should read “120” for QNASL 80 mcg Nasal Aerosol 120-actuation product and “60” for QNASL 40 mcg Nasal Aerosol 60-actuation product. QNASL Nasal Aerosol does not require priming. See accompanying illustrated Patient Information and Instructions for Use leaflet for proper use of QNASL Nasal Aerosol. QNASL Nasal Aerosol is for intranasal use only. The recommended dose of QNASL 80 mcg Nasal Aerosol in patients 12 years and older is 320 mcg per day administered as 2 actuations in each nostril once daily (maximum total daily dose of 4 actuations per day). The recommended dose of QNASL 40 mcg Nasal Aerosol in children aged 4 to 11 years of age is 80 mcg per day administered as 1 actuation in each nostril once daily (maximum total daily dose of 2 actuations per day).

4. CONTRAINDICATIONS QNASL Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients. Patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients.

5. WARNINGS AND PRECAUTIONS Nasal discomfort, epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. Eye Disorders. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts. Hypersensitivity, rash, and urticaria may occur after administration of QNASL Nasal Aerosol. Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.

Systemic and local corticosteroid use may result in the following: Epistaxis, nasal discomfort, nasal ulcerations, Candida albicans infection, and impaired wound healing Eye Disorders Hypercorticism, adrenal suppression, and growth reduction Immunosuppression The most common adverse reactions (≥ 1% and greater than placebo) in patients 12 years of age and older include nasal discomfort, epistaxis, and headache. The most common adverse reactions (≥ 2% and greater than placebo) in children 4 to 11 years of age include headache, pyrexia, upper respiratory tract infection, and nasopharyngitis.

No drug interaction studies have been performed with QNASL Nasal Aerosol.

Store at temperature between 20° and 25°C (68° and 77°F), excursions are permitted between 15° and 30°C (59° and 86°F).