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Omnaris
Generic Name: Ciclesonide Nasal Spray
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 Allergic Rhinitis: • The treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Treatment of Perennial Allergic Rhinitis: • The treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older. The recommended dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). In clinical studies with OMNARIS Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has occurred. Instances of nasal septal perforation have been reported in patients following the intranasal application of corticosteroids. 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. Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. In clinical studies, epistaxis was observed more frequently in patients treated with OMNARIS Nasal Spray than those who received placebo. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; or in patients with untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections. 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. Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving OMNARIS Nasal Spray. There are no adequate and well-controlled studies in pregnant women. Animal studies: fetal loss, reduced fetal weight, cleft palate and skeletal abnormalities. Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. It is not known if ciclesonide is excreted in human milk. However, other corticosteroids are excreted in human milk. |
| Off-label Uses |
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• Dosage greater than 2 sprays in each nostril (200 mcg) per day. GoToSource • Use in patients under the age of 6. GoToSource • Prophylaxis of post-traumatic fat embolism syndrome. GoToSource • Eosinophilic esophagitis. GoToSource • Hard metal lung disease. GoToSource • Severe asthma. GoToSource • Non-specific chronic/recurrent pharyngitis. GoToSource |
| Adverse Events |
|
Candidiasis. GoToSource Elevated intraocular pressure. GoToSource Bronchospasm. GoToSource Hypothalamic-pituitary-adrenal axis suppression. GoToSource Nasal septum perforation. GoToSource Glaucoma and increased risk of cataract development, reduction in bone mineral density, growth suppression and epistaxis (nosebleed). GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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