e injection.
Following the injection, patients should be monitored for elevation in intraocular pressure 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.
3 DOSAGE FORMS AND STRENGTHS
Single use 1 mL vial containing 40 mg/mL of sterile triamcinolone acetonide suspension.
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)].
5 WARNINGS AND PRECAUTIONS
5.1 Ophthalmic Effects
TRIESENCE® suspension should not be administered intravenously. Strict aseptic technique is mandatory.
Risk of infection
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Corticosteroids may enhance the establishment of secondary ocular infections due to fungi or viruses. If an infection occurs during corticosteroid therapy, it should be promptly controlled by suitable antimicrobial therapy.
See also INCREASED RISKS RELATED TO INFECTION (5.3).
Elevated Intraocular Pressure
Increases in intraocular pressure associated with triamcinolone acetonide injection have been observed in 20-60% of patients. This may lead to glaucoma with possible damage to the optic nerve. Effects on intraocular pressure may last up to 6 months following injection and are usually managed by topical glaucoma therapy. A small percentage of patients may require aggressive non-topical treatment. Intraocular pressure as well as perfusion of the optic nerve head should be monitored and managed appropriately.
Endophthalmitis
The rate of infectious culture positive endophthalmitis is 0.5%. Proper aseptic techniques should always be used when administering triamcinolone acetonide. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.
Cataracts
Use of corticosteroids may produce cataracts, particularly posterior subcapsular cataracts.
Patients with Ocular Herpes Simplex
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Corticosteroids should not be used in active ocular herpes simplex.
5.2 Alterations in Endocrine Function
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia. Monitor patients for these conditions with chronic use.
Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment |
