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Triamcinolone (Ophthalmic)


General


Pronunciation

(trye am SIN oh lone)


Brand Names: U.S.

  • Triesence

Indications


Use: Labeled Indications

US labeling:

Ocular disease: Treatment of sympathetic ophthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids

Vitrectomy visualization: Visualization during vitrectomy

Canadian labeling:

Vitrectomy visualization: Visualization during vitrectomy in adult patients.


Contraindications


Hypersensitivity to triamcinolone or any component of the formulation; systemic fungal infections

Canadian labeling: Additional contraindications (not in US labeling): Active ocular herpes simplex


Dosing and Administration


Dosing: Adult

Ocular disease: Intravitreal: Initial: 4 mg as a single dose; additional doses may be given as needed

Visualization during vitrectomy: Intravitreal: 1 to 4 mg


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Ocular disease/visualization during vitrectomy: Refer to adult dosing.


Dosing: Renal Impairment

US labeling: There are no dosage adjustments provided in the manufacturer 's labeling; use with caution.

Canadian labeling: No dosage adjustment necessary when used for visualization during vitrectomy.


Dosing: Hepatic Impairment

US labeling: There are no dosage adjustments provided in the manufacturer 's labeling.

Canadian labeling: No dosage adjustment necessary when used for visualization during vitrectomy.


Reconstitution

Vitrectomy: Canadian labeling: May be diluted with sterile irrigating solution (eg, BSS Sterile Irrigating Solution) prior use. Range of dilution is typically 1:10 to 1: 20. In a clinical study, a 2 mg/mL was administered by diluting 0.05 mL of triamcinolone in 0.95 mL of sterile irrigating solution.


Administration

For intravitreal administration only; do not administer IV. Administer under controlled aseptic conditions (eg, sterile gloves, sterile drape, sterile eyelid speculum). Shake vial vigorously for 10 seconds before withdrawing dose; do not use if agglomerated (clumpy or granular appearance); inject immediately after suspension is withdrawn from the vial. Adequate anesthesia and a broad-spectrum bactericidal agent should be administered prior to injection. If administration is required in the second eye, a new vial/syringe should be used.


Storage

Store at 4 ‚ °C to 25 ‚ °C (39 ‚ °F to 77 ‚ °F); do not freeze. Protect from light.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intraocular, as acetonide:

Triesence: 40 mg/mL (1 mL) [contains polysorbate 80]


Drug Interactions

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

NSAID (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Monitor therapy


Monitoring Parameters

Following injection, monitor for increased intraocular pressure and endophthalmitis; check for perfusion of optic nerve head immediately after injection, tonometry within 30 minutes, biomicroscopy between 2 to 7 days after injection.


Adverse Reactions


>10%: Ocular: Cataract progression (20% to 60%), intraocular pressure increased (20% to 60%)

1% to 10%: Ocular: ≤2%: Blurred vision, conjunctival hemorrhage, discomfort (transient), endophthalmitis, glaucoma, hypopyon, inflammation, optic disc vascular disorder, retinal detachment, vitreous floaters, visual acuity decreased

<1%, postmarketing, and/or case reports: Exophthalmos


Warnings/Precautions


Concerns related to adverse effects:

- Adrenal suppression: Prolonged use may cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

- Hypersensitivity: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

- Immunosuppression: Prolonged use may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with caution in patients with threadworm infection; may cause serious hyperinfection. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

- Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposis sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

- Myopathy: Acute myopathy has been reported with high-dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles.

- Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including euphoria, insomnia, mood swings, and personality changes, and severe depression to psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

- Cardiovascular disease: Use with caution in patients with HF and/or hypertension; corticosteroids have been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

- Diabetes: Use corticosteroids with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

- GI disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, abscess or other pyogenic infection) due to perforation risk.

- Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred, especially during initial treatment with corticosteroids.

- Ocular disease: Use with caution in patients with cataracts and/or glaucoma; elevated intraocular pressure may occur with effects lasting up to 6 months following injection. Use has also been associated with endophthalmitis and cataracts, particularly posterior subcapsular cataracts. Consider routine eye exams in chronic users.

- Osteoporosis: Use with caution in patients with osteoporosis; corticosteroids have been associated with increased bone loss and osteoporotic fractures.

- Renal impairment: Use with caution in patients with renal impairment.

- Thyroid disease: Use with caution in patients with thyroid disease; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid patients.

Special populations:

- Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

- Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer 's labeling.

Other warnings/precautions:

- Appropriate use: For ophthalmic use only; do not administer IV.


Pregnancy Risk Factor

D


Pregnancy Considerations

Adverse events were have been observed in animal reproduction studies. Some studies have shown an association between first trimester corticosteroid use and oral clefts, intrauterine growth restriction, and decreased birth weight. The amount of triamcinolone absorbed systemically following ophthalmic administration is not known. Use of intravitreal triamcinolone in pregnancy has been noted in case reports (Errera 2013; Fazelat 2011).


Actions


Pharmacology

Suppresses the immune system by reducing activity and volume of the lymphatic system


Half-Life Elimination

Intravitreal: Nonvitrectomized patients: 18.7 ‚ ± 5.7 days; Vitrectomized patients: ~3.2 days (based upon 1 patient)


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience blurred vision. Have patient report immediately to prescriber floaters, vision changes, eye pain, or severe eye irritation (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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