TRIESENCE

TRIESENCE is an FDA-registered drug product whose active ingredient is TRIAMCINOLONE ACETONIDE. It is labelled by Harrow Eye, LLC taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 82667-800, application NDA022048, label effective 20260605. It is one of 91 FDA drug label records sharing the active ingredient TRIAMCINOLONE ACETONIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TRIAMCINOLONE ACETONIDE are most often described in connection with: triesence suspension, ophthalmic diseases, sympathetic ophthalmia, temporal arteritis, ocular inflammatory, conditions unresponsive, topical corticosteroids, synthetic corticosteroid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 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 ) 1.1 Ophthalmic Diseases TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL is indicated for: • sympathetic ophthalmia, • temporal arteritis, • uveitis, and • ocular inflammatory conditions unresponsive to topical corticosteroids. 1.2 Visualization During Vitrectomy TRIESENCE suspension is indicated for visualization during vitrectomy.

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 ) 2.1 Dosage for Treatment of Ophthalmic Diseases The initial recommended dose of TRIESENCE suspension is 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment. 2.2 Dosage for Visualization During Vitrectomy The recommended dose of TRIESENCE ® suspension is 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally. 2.3 Preparation for Administration STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be vigorously shaken for 10 seconds before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, TRIESENCE suspension should be injected without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing organisms that can cause infection. 2.4 Administration The injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection. Following the injection, patients should be monitored for elevation in intraocular pressure (IOP) and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay. Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, and injection needles should be changed before TRIESENCE suspension is administered to the other eye.

4 CONTRAINDICATIONS Corticosteroids are contraindicated in patients with systemic fungal infections. Triamcinolone is contraindicated in patients who are hypersensitive to corticosteroids or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. [ see Adverse Reactions (6) ]. • Patients with systemic fungal infections. ( 4 ) • Hypersensitivity to triamcinolone or any component of this product. ( 4 )

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse event data were collected from 300 published articles containing data from controlled and uncontrolled clinical trials which evaluated over 14000 eyes treated with different concentrations of triamcinolone acetonide. The most common dose administered within these trials was triamcinolone acetonide 4 mg administered as primary or adjunctive therapy primarily as a single injection. The most common reported adverse events following administration of triamcinolone acetonide were elevated IOP and cataract progression. These events have been reported to occur in 20% to 60% of patients. Less common reactions occurring in up to 2% include endophthalmitis (infectious and non-infectious), hypopyon, injection site reactions (described as blurring and transient discomfort), glaucoma, vitreous floaters, and detachment of retinal pigment epithelium, optic disc vascular disorder, eye inflammation, conjunctival hemorrhage, and visual acuity reduced. Cases of exophthalmos have also been reported. Common adverse reactions for systemically administered corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain. Other reactions reported to have occurred with the administration of corticosteroids include: Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon facies, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness), suppression of growth in children Fluid and Electrolyte Disturbances: Potassium loss, hypokalemic alkalosis, sodium retention Gastrointestinal: Abdominal distention, elevation in serum liver enzymes levels (usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis Metabolic: Negative nitrogen balance due to protein catabolism Musculoskeletal: Aseptic necrosis of femoral and humeral heads, charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures Neurological: Arachnoiditis, convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually following discontinuation of treatment, insomnia, meningitis, neuritis, neuropathy, paraparesis/paraplegia, paresthesia, sensory disturbances, vertigo Reproductive: Alteration in motility and number of spermatozoa

FDA lists 91 drug label records with TRIAMCINOLONE ACETONIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is TRIESENCE used for?
1 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 ) 1.1 Ophthalmic Diseases TRIESENCE (triamcinolone acetonide injectable …

Who makes TRIESENCE?
Harrow Eye, LLC is the labeler of record for TRIESENCE. 91 FDA label records share the active ingredient TRIAMCINOLONE ACETONIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does TRIESENCE come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TRIESENCE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TRIAMCINOLONE ACETONIDE?
Yes. 91 FDA drug label records list TRIAMCINOLONE ACETONIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has TRIESENCE been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.