dextenza
Dextenza (Dexamethasone) is a corticosteroid used to treat Addison Disease, Brain Edema, Bursitis, Ulcerative Colitis.
Dexamethasone · by Ocular Therapeutix
Available as a generic: Dexamethasone
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Dexamethasone
- Drug class
- Corticosteroid
- Form
- Insert
- Strength
- Dexamethasone 0.4MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- addison disease, brain edema, bursitis
- Manufacturer
- Ocular Therapeutix
- Half-life
- about 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.24 per ml — not your price
- FDA application
- NDA208742
What is Dextenza?
From the FDA label:DEXTENZA (dexamethasone ophthalmic insert) is a fluorescent yellow, 3 mm cylindrical-shaped, resorbable, sterile insert for intracanalicular use. DEXTENZA contains 0.4 mg dexamethasone in a polyethylene glycol (PEG) based hydrogel conjugated with fluorescein. DEXTENZA does not contain an antimicrobial preservative. The active ingredient is represented by the chemical structure: The chemical name for dexamethasone is 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of C 22 H 29 FO 5 and a molecular weight of 392.47 g/mol. Dexamethasone is a crystalline powder. Each DEXTENZA contains: Active ingredients: 0.4 mg dexamethasone. Inactive ingredients: 4-arm polyethylene glycol (PEG) N-hydroxysuccinimidyl glutarate (20K), trilysine acetate, N-hydroxysuccinimide-fluorescein, sodium phosphate dibasic, sodium phosphate monobasic, water for injection. Chemical Structure
How to use
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. Ensure DEXTENZA is placed just below the punctal opening. Excessive squeezing of DEXTENZA with forceps may cause deformation. To aid in the hydration of DEXTENZA, 1 to 2 drops of balanced salt solution can be instilled into…
Side effects
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 subcapsular cataract formation; delayed wound healing; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and…
Warnings
Important safety information
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 ). 5.1 Intraocular Pressure Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. 5.2 Bacterial Infection Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection [see Contraindications ( 4 )] . 5.3 Viral Infections Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex) [see Contraindications ( 4 )] . 5.4 Fungal Infections Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate [see Contraindications ( 4 )] . 5.5 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 5.6 Other Potential Corticosteroid Complications The initial prescription and renewal of the medication order of DEXTENZA should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Who should not take Dextenza
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 ).
How long does Dexamethasone stay in your body?
The elimination half-life of dexamethasone is about 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma (terminal) elimination half-life — the label states the mean terminal half-life is 4 hours. Dexamethasone's anti-inflammatory/biologic effect lasts far longer than its blood levels (commonly cited biologic half-life ~36-54 hours), which is why it is dosed less often than the short plasma half-life implies; the drug is largely cleared from the blood within about a day (roughly 4-5 half-lives, ~1 day), but this clearance window is not the same as a drug-test detection window. Dexamethasone is ~77% protein-bound and metabolized by CYP3A4 (renal excretion is less than 10% of clearance), so strong CYP3A4 inhibitors/inducers can lengthen or shorten exposure. The manufacturer notes the effect of renal or hepatic impairment on its pharmacokinetics has not been formally studied.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: HEMADY (dexamethasone) tablets — FDA label, Clinical Pharmacology (DailyMed).
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Dextenza ranks — best-rated corticosteroid for:
Dosage forms
Insert
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Dextenza treat?
- Dextenza (Dexamethasone) may be used to treat addison disease, brain edema, bursitis, ulcerative colitis, collagen diseases, dermatitis herpetiformis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Dextenza work?
- Dextenza is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How much does Dextenza cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.24 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Dextenza?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dextenza. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Dextenza?
- Dextenza is marketed by Ocular Therapeutix. You can see Ocular Therapeutix's full profile, rating, and other products on pharmaranks.
- Is Dextenza a brand-name or generic drug?
- Dextenza is a brand-name product with the active ingredient Dexamethasone. Lower-cost generic equivalents containing Dexamethasone are available — ask your pharmacist.
- Is Dextenza available over the counter?
- No. Dextenza is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Dextenza come in?
- Dextenza is currently marketed as insert, per the FDA's National Drug Code Directory.
- What class of drug is Dextenza?
- Dextenza is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Dextenza FDA-registered?
- Dextenza is on record with the U.S. FDA under application number NDA208742. You can verify this on its official FDA label.
- Is Dextenza safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Dextenza. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Dextenza?
- Dextenza's side effects are taken directly from its FDA label. From the label: 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 P… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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