Triesence
Generic Name: triamcinolone acetonide injectable suspension
Date of Approval: November 29, 2007
Company: Alcon, Inc.
Treatment for: Use in Eye Surgery
FDA Approves Triesence
The United States Food and Drug Administration (FDA) has approved Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid. Triesence is indicated for visualization during vitrectomy and treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
The active ingredient in Triesence, triamcinolone acetonide, has been used for many years to treat retinal disease. This new approval of Triesence brings ophthalmologists a sterile, preservative-free formulation of the compound specifically developed for use in the eye to treat various retinal inflammatory conditions.
Eye inflammation most commonly occurs in response to infection, allergy, surgery or trauma (i.e., blow to the eye, foreign body, chemical injury). Uveitis, one form of eye inflammation treatable with Triesence, is one of the more common types of inflammation. With uveitis, the uveal tract of the eye, including the iris, the ciliary body and the choroid, becomes inflamed. This can result from ocular trauma or an existing systemic disease. In typical uveitis the patient experiences eye pain, photophobia and excessive tearing. Sufferers report a deep, dull aching of the eye and surrounding area. While haziness may be present, visual acuity is not usually impaired to any great extent.
Vitrectomy is a type of eye surgery in which some or all of the vitreous humor is removed from the eye. This type of surgery is often performed in patients with diabetic retinopathy, a detached retina, a macular hole or other conditions. Triesence assists retinal surgeons with visualization during these types of surgery.
Triesence Highlights of Prescribing Information
Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL
These highlights do not include all the information needed to use Triesence safely and effectively. See full prescribing information for Triesence.
Triesence 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.
- Visualization during vitrectomy.
Triesence Dosage and Administration
- Initial recommended dose of Triesence for all indications except visualization: 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.
- Recommended dose of Triesence for visualization: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally.
Dosage Forms and Strengths
Triesence: Single use 1 mL vial containing 40 mg/mL of triamcinolone acetonide suspension.
Triesence Contraindications
Triesence is contraindicated in patients with
- systemic fungal infections
- hypersensitivity to triamcinolone or any component of this product.
Warnings and Precautions
- Triesence is a suspension; it should not be administered intravenously.
- Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and hyperglycemia: Monitor patients for these conditions and taper doses gradually.
- Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection.
- Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels.
- GI perforation: Increased risk in patients with certain GI disorders.
- Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
- Decreases in bone density: Monitor bone density in patients receiving long term corticosteroid therapy.
- Live or live attenuated vaccines: Do not administer Triesence to patients receiving immunosuppressive doses of corticosteroids.
- Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy.
- Use in pregnancy: Fetal harm can occur with first trimester use.
- Weight gain: Triesence may cause increased appetite.
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.
Triesence Drug Interactions
Triesence interacts with the following drugs:
- Anticoagulant agents May enhance or diminish anticoagulant effects. Monitor coagulation indices.
- Antidiabetic agents May increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required.
- CYP 3A4 inducers and inhibitors May respectively increase or decrease clearance of corticosteroids necessitating dose adjustment.
- NSAIDS including aspirin and salicylates Increased risk of gastrointestinal side effects.
How Supplied/Storage and Handling
Triesence (triamcinolone acetonide injectable suspension) is supplied as 1 mL of a 40 mg/mL sterile triamcinolone acetonide suspension in a flint Type 1 single use glass vial with a gray rubber stopper and a natural flip-off seal. Each labeled vial is sealed in a polycarbonate blister with a backing material which provides tamper evidence and is stored in a carton.
- 1 mL single use vial (NDC 0065-0543-01)
Store at 4° - 25° C (39° - 77° F); Do Not Freeze. Protect from light by storing in carton.
Information for Patients
Patients should discuss with their physician if they have had recent or ongoing infections or if they have recently received a vaccine.
There are a number of medicines that can interact with corticosteroids such as triamcinolone. Patients should inform their health-care provider of all the medicines they are taking, including over-the counter and prescription medicines (such as phenytoin, diuretics, digitalis or digoxin, rifampin, amphotericin B, cyclosporine, insulin or diabetes medicines, ketoconazole, estrogens including birth control pills and hormone replacement therapy, blood thinners such as warfarin, aspirin or other NSAIDS, barbiturates), dietary supplements, and herbal products. If patients are taking any of these drugs, alternate therapy, dosage adjustment, and/or special test may be needed during the treatment.
Patients should be advised of common adverse reactions that could occur with corticosteroid use to include elevated intraocular pressure, cataracts, fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
For more information on Triesence, please visit www.alcon.com.
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More Triesence resources:
Temporal Arteritis, Uveitis, Vitrectomy
