IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE:
TRIESENCE® Suspension is indicated for:
-
Treatment of the following ophthalmic diseases: sympathetic
ophthalmia, temporal arteritis, uveitis, and ocular
inflammatory conditions unresponsive to topical
corticosteroids.
- Visualization during vitrectomy.
Contraindications
-
TRIESENCE® Suspension is contraindicated in patients with
systemic fungal infections.
-
TRIESENCE® Suspension is also contraindicated in patients with
hypersensitivity to corticosteroids or any component of
TRIESENCE® Suspension. Rare instances of anaphylactoid
reactions have occurred in patients receiving corticosteroid
therapy.
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 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: May cause increased appetite.
Adverse Reactions
-
Based on a review of the available literature, the most
commonly reported adverse events following ocular
administration of triamcinolone acetonide were elevated
intraocular pressure and cataract progression. These events
have been reported to occur in 20-60% of patients.
-
Less common reactions occurring in up to 2% of patients
include: endophthalmitis (infectious and non-infectious),
hypopyon, injection site reactions (described as blurring and
transient discomfort), glaucoma, vitreous floaters, detachment
of retinal pigment epithelium, optic disc vascular disorder,
eye inflammation, conjunctival hemorrhage and visual acuity
reduced. Cases of exophthalmos have also been reported.
Drug Interactions
-
Anticoagulant Agents –Corticosteroids may enhance or
diminish the anticoagulant effect of anticoagulant agents.
Coagulation indices should be monitored.
-
Antidiabetic Agents –Corticosteroids may increase blood
glucose concentrations. Dose adjustments of antidiabetic
agents may be required.
-
CYP 3A4 Inducers and Inhibitors –CYP 3A4 inducers and
inhibitors may respectively increase or decrease clearance of
corticosteroids, necessitating dose adjustment.
-
NSAIDs –Concomitant use of NSAIDS, including aspirin
and salicylates, with a corticosteroid may increase the risk
of GI side effects.
For additional Important Safety Information about TRIESENCE®
Suspension, please see the accompanying full
Prescribing Information.
Email Address info@triesencehcp.com
Phone Number 1-833-442-7769
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