HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information neededto use DEXTENZA safely and effectively. See full
prescribing information for DEXTENZA.
DEXTENZA(dexamethasone ophthalmic insert)0.4mg,for intracanalicular use
Initial U.S. Approval: 1958
INDICATIONS AND USAGE
DEXTENZA is a corticosteroid indicated for the treatment ofocular pain following ophthalmic surgery.
DOSAGE AND ADMINISTRATION
DEXTENZA is an ophthalmic insert that is inserted in thelower lacrimal punctum and into the canaliculus. A singleDEXTENZA releases a 0.4 mg dose of dexamethasone for upto 30 days following insertion.
DOSAGE FORMS AND STRENGTHS
Ophthalmic intracanalicular insert containing a 0.4 mg dose ofdexamethasone.
CONTRAINDICATIONS
Active ocular infections.
WARNINGS AND PRECAUTIONS
• Intraocular Pressure Increase: Monitor intraocular pressure.
• Bacterial Infections: Steroids may mask signs of infections andenhance existing infections.
• Viral Infections: Ocular steroids may prolong the course andexacerbate the severity of ocular viral infections.
• Fungal Infections: Consider fungal invasion in any persistentcorneal ulceration.
• Delayed Healing: Ocular steroids may slow the rate of ocularhealing.
ADVERSE REACTIONS
The most commonly reported adverse reactions were anteriorchamber inflammation and elevations in intraocular pressure.
These occurred in approximately 5-9% of patients.
To report SUSPECTED ADVERSE REACTIONS, contactOcular Therapeutix at 1-800-DEXTENZA (339-8369) orFDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Intraocular Pressure Increase
5.2 Bacterial Infection
5.3 Viral Infections
5.4 Fungal Infections
5.5 Delayed Healing
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
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
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribinginformation are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
DEXTENZA® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmicsurgery (1).
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus. A single DEXTENZA releasesa 0.4 mg dose of dexamethasone for up to 30 days following insertion.
DEXTENZA is resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insertif necessary. DEXTENZA is intended for single-use only.
2.2 Administration
Do not use if pouch has been dam |
