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ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension), for intra-articular (四)
2018-06-22 06:36:12 来源: 作者: 【 】 浏览:9904次 评论:0
s is confirmed, institute appropriate antimicrobial therapy [see Adverse Reactions ( 6)] . 
Avoid injection of a corticosteroid into an infected site. Local injection of a corticosteroid into a previously infected joint is not usually recommended. Examine any joint fluid present to exclude a septic process. 
Corticosteroid injection into unstable joints is generally not recommended. 
Intra-articular injection may result in damage to joint tissues. 
5.5 Increased Risk of Infections 
Intra-articularly injected corticosteroids are systemically absorbed. Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection. 
Advise patients to inform their health care provider if they develop fever or other signs or symptoms of infection. Advise patients who have not been vaccinated to avoid exposure to chicken pox or measles. Instruct patients to contact their health care provider immediately if they are exposed [see Patient Counseling Information ( 17)] . 
5.6 Alterations in Endocrine Function 
Corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression, with the potential for adrenal insufficiency after withdrawal of treatment, which may persist for months. 
In situations of stress during that period (as in trauma, surgery, or illness), institute corticosteroid replacement therapy. 
Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. 
5.7 Cardiovascular Effects 
Corticosteroids can cause elevations of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with synthetic derivatives. 
Monitor patients with congestive heart failure or hypertension for signs of edema, weight gain, and imbalance in serum electrolytes. Dietary salt restriction and potassium supplementation may be necessary. 
5.8 Renal Effects 
Corticosteroids can cause salt and water retention, and increased excretion of potassium. These effects are less likely to occur with synthetic derivatives. All corticosteroids increase calcium excretion. 
Monitor patients with renal insufficiency for signs of edema, weight gain, and imbalance in serum electrolytes. Dietary salt restriction and potassium supplementation may be necessary. 
5.9 Increased Intraocular Pressure 
Corticosteroid use may be associated with development or exacerbation of increased intraocular pressure. 
Monitor patients with elevated intraocular pressure for potential treatment adjustment. 
5.10 Gastrointestinal Perforation 
Corticosteroid administration is associated with increased risk of gastrointestinal perforation in patients with cer
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