TRIESENCE(triamcinolone acetonide injectable suspension) 40mg/mL
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRIESENCE ® (triamcinolone acetonide injectable suspension) 40 mg/mL safely and effectively. See full prescribing information for TRIESENCE ® suspension.
TRIESENCE ® (triamcinolone acetonide injectable suspension)
40 mg/mL
Initial U.S. Approval: 1957
INDICATIONS AND USAGE
TRIESENCE® suspension is a synthetic corticosteroid indicated for:
• Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. (1.1)
• Visualization during vitrectomy. (1.2)
DOSAGE AND ADMINISTRATION
• Initial recommended dose for all indications except visualization: 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment. (2.1)
• Recommended dose for visualization: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally. (2.2)
DOSAGE FORMS AND STRENGTHS
Single use 1 mL vial containing 40 mg/mL of triamcinolone acetonide suspension. (3)
CONTRAINDICATIONS
• Patients with systemic fungal infections. (4)
• Hypersensitivity to triamcinolone or any component of this product. (4)
WARNINGS AND PRECAUTIONS
• TRIESENCE® suspension should not be administered intravenously. (5.1)
• Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure. (5.1)
• Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia: Monitor patients for these conditions and taper doses gradually. (5.2)
• Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection. (5.3)
• Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels. (5.4)
• GI perforation: Increased risk in patients with certain GI disorders. (5.5)
• Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. (5.6)
• Decreases in bone density: Monitor bone density in patients receiving long term corticosteroid therapy. (5.7)
• Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of corticosteroids. (5.8)
• Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy. (5.9)
• Use in pregnancy: Fetal harm can occur with first trimester use. (5.10)
• Weight gain: May cause increased appetite. (5.11)
To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Anticoagulant agents: May enhance or diminish anticoagulant effects. Monitor coagulation indices. (7)

• Antidiabetic agents: May increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required. (7)
• CYP 3A4 inducers and inhibitors: May respectively increase or decrease clearance of corticosteroids necessit