Rx Item-DEXTENZA- dexamethasone Opthalmic insert .4mg Each by Ocular Therapeutix

DEXTENZA is supplied sterile in a foam carrier within a foil laminate pouch containing:
NDC 70382-204-10 Carton containing 10 pouches (10 inserts)
NDC 70382-204-01 Carton containing 1 pouch (1 insert)

Do not use if pouch has been damaged or broken.

DEXTENZA is intended for single dose only.

Storage: Store refrigerated, between 2�C and 8�C (36�F and 46�F). Do not freeze. Protect from light, keep in package until use. These highlights do not include all the information needed to use DEXTENZA safely and effectively. See full prescribing information for DEXTENZA.
DEXTENZA� (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
Initial U.S. Approval: 1958
RECENT MAJOR CHANGES
Indications and Usage (1) 06/2019
INDICATIONS AND USAGE

DEXTENZA� is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery (1).
DOSAGE AND ADMINISTRATION

DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum and into the canaliculus. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion (2).
DOSAGE FORMS AND STRENGTHS

Ophthalmic intracanalicular insert containing a 0.4 mg dose of dexamethasone (3).
CONTRAINDICATIONS

Active ocular infections (4).
WARNINGS AND PRECAUTIONS

Intraocular Pressure Increase: Monitor intraocular pressure (5.1).
Bacterial Infections: Steroids may mask signs of infections and enhance existing infections (5.2).
Viral Infections: Ocular steroids may prolong the course and exacerbate the severity of ocular viral infections (5.3).
Fungal Infections: Consider fungal invasion in any persistent corneal ulceration (5.4).
Delayed Healing: Ocular steroids may slow the rate of ocular healing. (5.5).

ADVERSE REACTIONS

The most commonly reported adverse reactions were anterior chamber inflammation and elevations in intraocular pressure. These occurred in approximately 6-10% of patients (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Ocular Therapeutix at 1-800-DEXTENZA (339-8369) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2019

Rx Item-DEXTENZA- dexamethasone Opthalmi
RX70382-0204-01

Rx Item-DEXTENZA- dexamethasone Opthalmi
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