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U.S. Department of Health and Human Services

Safety

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Aristocort Forte (triamcinolone diacetate) injectable suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010

 

Summary View

 

CONTRAINDICATIONS

  • Aristocort Forte is contraindicated in patients who are hypersensitive to any components of this product.
  • Intramuscular corticosteriod preparations are contraindicated for idiopathic thrombocytopenic purpura.
  • Aristocort Forte is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.
  • Arisotcort Forte is contraindicated for use in premature infants because the formulation contains benzyl alcohol. 
  • Arisotcort Forte is contraindicated in systemic fungal infections, except when administered as an intraarticular injection for localized joint conditions

WARNINGS

General
  • This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissue.. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol...
  • Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy
  • Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. 
  • Results from one multicenter, randomized, placebo controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including Depo-Medrol, should...
Endocrine
  • Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
Infections: General
  • 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, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection.
Neurologic
  •  Reports of severe adverse reactions have been associated with the intrathecal route of administration.
Ophthalmic
  • Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of systemic corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Corticosteroids should not be used in active ocular herpes simplex.

PRECAUTIONS

Gastrointestinal 
  • Steroids should be used with caution in active or latent peptic ulcer, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis...
Intra-Articular and Soft Tissue Administration
  • Intra-articularly injected corticosteroids may be systemically absorbed. Appropriate examination of any joint fluid present is necessary to exclude...
Drug Interactions
  • Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
  • Hepatic Enzyme Inducers (e.g., Barbiturates, Phenytoin, Carbamazepine, Rifampin) Drugs which induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
  • Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin) Drugs which inhibit cytochrome P450 3A4 enzyme activity have the potential to result in increased plasma concentrations of corticosteroids.
  • Ketoconazolehas been reported to significantly decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Nursing Mothers
  • Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing, or discontinue the drug, taking into account the importance of the drug to the mother.
Geriatric Use
  • Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

Allergic Reactions
  • Allergic or hypersensitivity reactions, anaphylactoid reactions, anaphylaxis, angioedema.
Other
  • Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, injection site infections following non-sterile administration malaise, moon face, weight gain.