TRIESENCE 40 mg/mL
triamcinolone acetonide · INJECTION, SUSPENSION · Harrow Eye, LLC
TRIESENCE is a injection, suspension containing triamcinolone acetonide at 40 mg/mL, taken ophthalmic. Manufactured by Harrow Eye, LLC.
Key Facts
- Brand Name
- TRIESENCE
- Generic Name
- triamcinolone acetonide
- NDC Code (Product)
82667-800- Manufacturer
- Harrow Eye, LLC
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SUSPENSION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA022048
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 10/01/2024
Recall History
Oregon Compounding Centers, Inc. dba Creative Compounds
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
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 se…
Contraindications
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 )
Drug Interactions
7 DRUG INTERACTIONS • Amphotericin B: There have been cases reported in which concomitant use of Amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (s ee Potassium Depleting Agents). • Anticholinesterase agents: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. • Anticoagulant agents: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. • Antidiabetic agents: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. • Antitubercular drugs: Serum concentrations of isoniazid may be decreased. • CYP 3A4 inducers (e.g., barbiturates, phenytoin, carbamazepine, and rifampin): Drugs, such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal dr…
Adverse Reactions
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…
Frequently Asked Questions
What is TRIESENCE used for?
TRIESENCE contains triamcinolone acetonide. It is a injection, suspension taken ophthalmic. Consult your doctor for specific uses.
Is TRIESENCE a controlled substance?
TRIESENCE is not classified as a controlled substance by the DEA.
What is the generic name for TRIESENCE?
The generic name for TRIESENCE is triamcinolone acetonide. There are 11 other brand versions of triamcinolone acetonide.
What is the NDC code for TRIESENCE 40 mg/mL?
The NDC (National Drug Code) for TRIESENCE 40 mg/mL is 82667-800, listed by Harrow Eye, LLC.
Other Triamcinolone Brands
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- Nasal Allergy55 ug/111822-0443
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- nasal allergy55 ug/130142-813
- Nasacort Allergy 24HR55 ug/141167-5800
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)