Triamcinolone acetonide (ophthalmic)
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Corticosteroid
Dosing in kidney impairment
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia: Monitor patients for these conditions and taper doses gradually. 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. Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.
Corticosteroids should not be used in cerebral malaria. 5.4 Alterations in Cardiovascular/Renal Function Corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium. These effects are less likely to occur with the synthetic derivatives except when used in large doses.
Dietary salt restriction and potassium supplementation may be necessary. These agents should be used with caution in patients with hypertension, congestive heart failure, or renal insufficiency. Literature reports suggest an association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with caution in these patients. 5.5 Use in Patients With Gastrointestinal Disorders There is an increased risk of gastrointestinal perforation in patients with certain GI disorders.
Preparation and administration
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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.
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.
Drug interactions
Check triamcinolone acetonide (ophthalmic) against a medication listLabel text (6 paragraphs)
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 drug metabolizing enzyme activity may enhance metabolism of corticosteroid and require that the dosage of corticosteroid be increased.
• CYP 3A4 inhibitors (e.g., ketoconazole, macrolide antibiotics): Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects. • Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. • Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with concurrent use. • Digitalis: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
• Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids thereby increasing their effect. • NSAIDs including aspirin and salicylates: Concomitant use of aspirin or other non-steroidal antiinflammatory agents and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
• Potassium depleting agents (e.g., diuretics, Amphotericin B): When corticosteroids are administered concomitantly with potassium-depleting agents, patients should be observed closely for development of hypokalemia. • Skin tests: Corticosteroids may suppress reactions to skin tests. • Toxoids and live or inactivated vaccines: Due to inhibition of antibody response, patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. • Anticoagulant agents: May enhance or diminish anticoagulant effects.
Monitor coagulation indices. ( 7 ) • Antidiabetic agents: May increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required. ( 7 ) • CYP 3A4 inducers and inhibitors: May respectively increase or decrease clearance of corticosteroids necessitating dose adjustment. ( 7 ) • Non-steroidal anti inflammatory drugs (NSAIDs), including aspirin and salicylates: Increased risk of gastrointestinal side effects. ( 7 )
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for triamcinolone acetonide (ophthalmic). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Teratogenic Effects: Pregnancy Category D [see Warnings and Precautions (5.10) ] Multiple cohort and case controlled studies in humans suggest that maternal corticosteroid use during the first trimester increases the rate of cleft lip with or without cleft palate from about 1/1000 infants to 3- 5/1000 infants. Two prospective case control studies showed decreased birth weight in infants exposed to maternal corticosteroids in utero. Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys.
In rats and rabbits, triamcinolone acetonide was teratogenic at inhalation doses of 0.02 mg/kg and above and in monkeys, triamcinolone acetonide was teratogenic at an inhalation dose of 0.5 mg/kg (1/4 and 7 times the recommended human dose). Dose-related teratogenic effects in rats and rabbits included cleft palate and/or internal hydrocephaly and axial skeletal defects, whereas the effects observed in monkeys were cranial malformations. These effects are similar to those noted with other corticosteroids. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Infants born to mothers who received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Lactation
8.3 Nursing Mothers Corticosteroids are secreted in human milk. Reports suggest that steroid concentrations in human milk are 5% to 25% of maternal serum levels, and that total infant daily doses are small, less than 0.2% of the maternal daily dose. The risk of infant exposure to steroids through breast milk should be weighed against the known benefits of breastfeeding for both the mother and baby.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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