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Triesence

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Uses

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.

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History

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Other Information

TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL is a synthetic corticosteroid with anti-inflammatory action. Each mL of the sterile, aqueous suspension provides 40 mg of triamcinolone acetonide, with sodium chloride for isotonicity, 0.5% (w/v) carboxymethylcellulose sodium and 0.015% polysorbate 80. It also contains potassium chloride, calcium chloride (dihydrate), magnesium chloride (hexahydrate), sodium acetate (trihydrate), sodium citrate (dihydrate) and water for injection. Sodium hydroxide and hydrochloric acid may be present to adjust pH to a target value 6 – 7.5.

The chemical name for triamcinolone acetonide is 9-Fluro- 11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17- acetal with acetone. Its structural formula of C24H31FO6 is:

chemical

434.50 MW

Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.

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Triesence Manufacturers

  • Alcon Laboratories, Inc.
    Triesence | Alcon Laboratories, Inc.
    No Recall

    Triesence | Alcon Laboratories, Inc.

    Triesence | Alcon Laboratories, Inc.
    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 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.

    2.4 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 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.

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