Nasacort AQ (triamcinolone acetonide) Nasal Spray September 2008
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.|
Summary of Changes to Contraindications and Warnings
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
PATIENT PACKAGE INSERT (new)
WARNINGS AND PRECAUTIONS
Local Nasal Effects: Epistaxis
In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in patients treated with Nasacort AQ Nasal Spray than those who received placebo [see Adverse Reactions (6)].
Local Nasal Effects: Candida Infection
...Therefore, patients using Nasacort AQ Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.
Glaucoma and Cataracts
Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or have not been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known...
Hypothalamic-Pituitary-Adrenal Axis Effects: Hypercorticism and Adrenal Suppression
When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercoticism and adrenal suppression may appear...
Effect on Growth
Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving Nasacort AQ Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including Nasacort AQ Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].