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Rhinocort Aqua
Generic Name: Budesonide
Drug Category: Corticosteroid
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 1 year.
Approved Uses |
Indicated for treatment of seasonal or perennial allergic rhinitis in adults and children six years of age and older. Instances of nasal septum perforation have been reported following the intranasal application of corticosteroids, including budesonide. Intranasal corticosteroids, including budesonide may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving long-term treatment with RHINOCORT AQUA Nasal Spray. Potential worsening of infections (e.g., existing tuberculosis, fungal bacterial, viral, or parasitic infections; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even a fatal course of chickenpox or measles can occur in susceptible patients. When intranasal steroids 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. Glaucoma, increased intraocular pressure and cataracts have been reported following the intranasal application of corticosteroids, including budesonide. In clinical studies with budesonide administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred. Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred. Caution should be exercised when considering the co-administration of RHINOCORT AQUA Nasal Spray with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). Despite the animal findings, it would appear that the possibility of fetal harm is remote if the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm. Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Budesonide is secreted in human milk. |
Off-label Uses |
• Use in patients under the age of 6. GoToSource • Post endoscopic sinus surgery therapy and nasal lavage. GoToSource • Nasal polyps. GoToSource |
Adverse Events |
Epistaxis (nosebleed), nasal mucosal atrophy or ulceration and septal perforation. GoToSource Adrenal suppression. GoToSource Loss of bone mass. GoToSource Growth suppression in children. GoToSource Posterior subcapsular cataracts, glaucoma and ocular hypertension. GoToSource |
Litigation |
No major injury lawsuits reported. |
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