Drugplain

DEXTENZA .4 mg/1

dexamethasone · INSERT · Ocular Therapeutix, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Dextenza is a corticosteroid insert placed in the tear drainage canal of the eye to reduce inflammation and pain following cataract surgery. It releases dexamethasone directly into the eye over several days.

Key Facts

Brand Name
DEXTENZA
Generic Name
dexamethasone
NDC Code (Product)
70382-204
Manufacturer
Ocular Therapeutix, Inc.
Strength
.4 mg/1
Dosage Form
INSERT
Route
INTRACANALICULAR, OPHTHALMIC
Marketing Status
Application #
NDA208742
Drug Class
Corticosteroid [EPC]
Marketing Start
01/07/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use21,792 reports
fatigue16,867 reports
diarrhoea16,747 reports
plasma cell myeloma13,930 reports
nausea13,670 reports
pneumonia13,459 reports
death13,058 reports
drug ineffective12,632 reports
neutropenia11,376 reports
pyrexia10,767 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DEXTENZA ® is a corticosteroid indicated for: The treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients. ( 1.1 ). The treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged 2 years and older. The use of DEXTENZA is not recommended for the treatment of ocular itching associated with allergic conjunctivitis in pediatric patients who require sedation for the insertion procedure. ( 1.2 ). 1.1 Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA is indicated for the treatment of ocular inflammation and pain following ophthalmic surgery ( 1.1 ). 1.2 Itching Associated with Allergic Conjunctivitis DEXTENZA is indicated for the treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged 2 years and older ( 1.2 ). Limitations of Use The use of DEXTENZA is not recommended for the treatment of ocular itching associated with allergic conjunctivitis in pediatric patients who require sedation for the insertion procedure [see Use in Specific Populations ( 8.4 )] .

Dosage & Administration

2 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 ). 2.1 General Dosing Information DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus. A single DEXTENZA insert releases a 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 insert if necessary. DEXTENZA is intended for single-use only. 2.2 Administration Do not use if pouch has been damaged or opened. Do not re-sterilize. Carefully remove foam carrier and transfer to a clean and dry area. If necessary, dilate the punctum with an ophthalmic dilator. Care should be taken not to perforate the canaliculus during dilation or insertion of DEXTENZA. If perforation occurs, do not insert DEXTENZA. After drying the punctal area, using blunt (non-toothed) forceps, grasp DEXTENZA and insert into the lower lacrimal canaliculus by pulling the lid temporally and inserting nasally.…

Contraindications

4 CONTRAINDICATIONS DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. Active ocular infections ( 4 ).

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Intraocular Pressure Increase [see Warnings and Precautions ( 5.1 )] Bacterial Infection [see Warnings and Precautions ( 5.2 )] Viral Infection [see Warnings and Precautions ( 5.3 )] Fungal Infection [see Warnings and Precautions ( 5.4 )] Delayed Healing [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions were anterior chamber inflammation and elevations in intraocular pressure. These occurred in approximately 6-10% of patients ( 6 ). 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior su…

Frequently Asked Questions

What is DEXTENZA used for?

Dextenza is a corticosteroid insert placed in the tear drainage canal of the eye to reduce inflammation and pain following cataract surgery. It releases dexamethasone directly into the eye over several days.

Is DEXTENZA a controlled substance?

DEXTENZA is not classified as a controlled substance by the DEA.

What is the generic name for DEXTENZA?

The generic name for DEXTENZA is dexamethasone. There are 12 other brand versions of dexamethasone.

What is the NDC code for DEXTENZA .4 mg/1?

The NDC (National Drug Code) for DEXTENZA .4 mg/1 is 70382-204, listed by Ocular Therapeutix, Inc..

Product NDC

70382-204

Package NDC

70382-204-01

Other Dexamethasone Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)