warnings and cautions
5 WARNINGS AND PRECAUTIONS Epistaxis, nasal septal perforation, Candida albicans infection, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal septal ulcers, nasal surgery, or trauma. ( 5.1 ) 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 ) 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 patient with the above because of the potential for worsening of these infections. ( 5.3 ) Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue triamcinolone acetonide nasal spray slowly. ( 5.4 ) Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving triamcinolone acetonide nasal spray. ( 5.5 , 8.4 ) 5.1 Local Nasal Effects Epistaxis In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in patients treated with triamcinolone acetonide nasal spray than those who received placebo [ see Adverse Reactions ( 6 ) ]. Nasal Septal Perforation In clinical trials, nasal septum perforation was reported in one adult patient treated with triamcinolone acetonide nasal spray. Candida Infection In clinical studies with triamcinolone acetonide nasal spray, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local or systemic therapy and discontinuation of triamcinolone acetonide nasal spray. Therefore, patients using triamcinolone acetonide 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. Impaired Wound Healing Because of the inhibitory effect of corticosteroids on wound healing, patients who have experience recent nasal ulcers, surgery, or trauma should not use triamcinolone acetonide nasal spray until healing has occurred. 5.2 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. 5.3 Immunosuppression 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. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (see the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; 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. 5.4 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 hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of triamcinolone acetonide nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms. 5.5 Effect on Growth Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving triamcinolone acetonide nasal spray. To minimize the systemic effects of intranasal corticosteroids, including triamcinolone acetonide nasal spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [ see Use in Specific Populations ( 8.4 ) ].