Important Safety Information

Local Nasal Effects: In clinical trials up to 52 weeks, epistaxis and nasal ulcerations were observed more frequently and some epistaxis events were more severe in patients treated with QNASL Nasal Aerosol than those who received placebo. Candida albicans infections of the nose, mouth, or throat may occur in patients using intranasal corticosteroids. Periodically monitor patients for signs of adverse effects on the nasal mucosa and discontinue QNASL Nasal Aerosol if such effects are observed. Patients with recent nasal ulcers, nasal surgery, or nasal trauma should avoid use of QNASL Nasal Aerosol until healed

There were no instances of nasal septal perforation observed in clinical trials with QNASL Nasal Aerosol; however, instances of nasal septal perforation have been reported in patients following the intranasal application of other beclomethasone dipropionate products. Periodically monitor patients for signs of adverse effects on the nasal mucosa and discontinue QNASL Nasal Aerosol if such effects are observed

Glaucoma, cataracts, and increased intraocular pressure may be associated with intranasal corticosteroid use. Closely monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following the nasal administration of other beclomethasone dipropionate products and orally inhaled beclomethasone dipropionate products. Angioedema, urticaria, and rash have been reported after the administration of QNASL Nasal Aerosol. Discontinue QNASL Nasal Aerosol if any such reactions occur

Patients who have immune system problems or use drugs that suppress the immune system (e.g., corticosteroids) may be more susceptible to infections than healthy individuals. Patients may experience a more serious or even fatal course of chickenpox or measles. QNASL Nasal Aerosol should be used with caution, or not at all, in patients with active or quiescent tuberculosis; untreated fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex

Systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear if intranasal corticosteroids are used at very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue QNASL Nasal Aerosol slowly

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Growth of pediatric patients receiving QNASL Nasal Aerosol should be routinely monitored

The most common adverse reactions observed in trials of 2 to 6 weeks with QNASL Nasal Aerosol with an incidence of greater than or equal to 1% and greater than placebo include: nasal discomfort (5.2%), epistaxis (1.9%), and headache (2.3%)

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References:

  1. QNASL Nasal Aerosol Prescribing Information. Horsham, PA: Teva Respiratory; June 2012.
  2. van Bavel JH, Ratner PH, Amar NJ, et al. Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2012;33:386-396.
  3. Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK. Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis. Allergy Asthma Proc. 2012;33:249-257.
  4. Data on file (Leach C: Nasal Deposition Analysis of QNASL, Flonase, and Nasonex Final Report). Teva Respiratory, LLC; 2012.
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