ating dose adjustment. (7)
• NSAIDS including aspirin and salicylates: Increased risk of gastrointestinal side effects. (7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Ophthalmic Diseases
1.2 Visualization during Vitrectomy
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Treatment of Ophthalmic Diseases
2.2 Dosage for Visualization during Vitrectomy
2.3 Preparation for Administration
2.4 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Ophthalmic Effects
5.2 Alterations in Endocrine Function
5.3 Increased Risks Related to Infections
5.4 Alterations in Cardiovascular/Renal Function
5.5 Use in Patients with Gastrointestinal Disorders
5.6 Behavioral and Mood Disturbances
5.7 Decrease in Bone Density
5.8 Vaccination
5.9 Effect on Growth and Development
5.10 Use in Pregnancy
5.11 Weight Gain
5.12 Neuromuscular Effects
5.13 Kaposi's Sarcoma
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
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 th |
