These highlights do not include all the information needed to use QNASL Nasal Aerosol safely and effectively. See full prescribing information for QNASL Nasal Aerosol.
QNASL™ (beclomethasone dipropionate) Nasal Aerosol
For Intranasal Use Only
Initial U.S. Approval: 1976
RECENT MAJOR CHANGES
Indications and Usage (
1.1) 12/14
Dosage and Administration, Allergic Rhinitis (
2.1) 12/14
Warnings and Precautions, Local Nasal Effects (
5.1) 12/14
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. (1.1)
DOSAGE AND ADMINISTRATION
QNASL Nasal Aerosol is for intranasal use only.
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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). ( 2.1)
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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). ( 2.1)
DOSAGE FORMS AND STRENGTHS
QNASL Nasal Aerosol is available in two strengths:
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Each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate. ( 3)
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Each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate. ( 3)
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Each strength is supplied in an 8.7 g canister containing 120 actuations; QNASL 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations. ( 3)
CONTRAINDICATIONS
Patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients. (4)
WARNINGS AND PRECAUTIONS
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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. ( 5.1)
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Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. ( 5.2)
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Hypersensitivity, rash, and urticaria may occur after administration of QNASL Nasal Aerosol. ( 5.3)
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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. ( 5.4)
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Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue QNASL Nasal Aerosol slowly. ( 5.5)
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Potential reduction in growth velocity in pediatric patients. Monitor growth routinely in pediatric patients receiving QNASL Nasal Aerosol. ( 5.6, 8.4)
ADVERSE REACTIONS
The most common adverse reactions (≥ 1% and greater than placebo) in patients 12 years of age and older include nasal discomfort, epistaxis, and headache. (6.1)
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 9/2015
