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Triesence (Triamcinolone Acetonide Ophthalmic) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

Visualization during Vitrectomy

TRIESENCE® suspension is indicated for visualization during vitrectomy.

DOSAGE AND ADMINISTRATION

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.

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.

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 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.

DOSAGE FORMS AND STRENGTHS

Single use 1 mL vial containing 40 mg/mL of sterile triamcinolone acetonide suspension.

HOW SUPPLIED/STORAGE AND HANDLING

TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL is supplied as 1 mL of a 40 mg/mL sterile triamcinolone acetonide suspension in a flint Type 1 single use glass vial with a gray rubber stopper and an open target aluminum seal. Each labeled vial is sealed in a polycarbonate blister with a backing material which provides tamper evidence and is stored in a carton.

• 1 mL single use vial (NDC 0065-0543-01)

Storage

Store at 4° - 25° C (39° - 77° F); Do Not Freeze. Protect from light by storing in carton.

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