TRIESENCE^® SUSPENSION

ONLY AVAILABLE IN THE UNITED STATES

• Designed and FDA Approved for Intraocular Use
  Indications: treatment of uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids, sympathetic ophthalmia, and temporal arteritis. TRIESENCE^® Suspension is also indicated for visualization during vitrectomy.
• Preservative Free
  Does not contain benzyl alcohol.
• Terminally Sterilized
  With terminal sterilization the probability that a unit is non-sterile is one in a million. Other injectable triamcinolone acetonide products that are aseptically processed have a one in a thousand probability of a non-sterile unit occurring.
• Sterile Vial Exterior
  Making it appropriate for OR use.

For reimbursement questions, call Alcon Reimbursement Services at (866) 457-0277 or e-mail ARS@alconlabs.com .

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRIESENCE^® safely and effectively. See full prescribing information for TRIESENCE^®.

TRIESENCE^® (triamcinolone acetonide injectable suspension) 40 mg/mL
Initial U.S. Approval: 1957

INDICATIONS AND USAGE

TRIESENCE^® 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^® is a suspension; it 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 http://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 necessitating dose adjustment.(7)
• NSAIDS including aspirin and salicylates: Increased risk of gastrointestinal side effects. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: November 2007

Full prescribing information available at:
http://ecatalog.alcon.com/pi/Triesence_us_en.pdf