Dextenza
(dexamethasone)Dosage & 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 .
By using PrescriberAI, you agree to the AI Terms of Use.
Dextenza Prescribing Information
Ocular Inflammation and Pain Following Ophthalmic Surgery
DEXTENZA is indicated for the treatment of ocular inflammation and pain following ophthalmic surgery .
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 .
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 ].
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.
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 the punctum. DEXTENZA hydrates quickly upon contact with moisture. If DEXTENZA begins to hydrate before fully inserted, discard the product and use a new DEXTENZA.
- DEXTENZA can be visualized when illuminated by a blue light source (e.g., slit lamp or hand held blue light) with yellow filter.
Ophthalmic insert: fluorescent yellow, 3 mm cylindrical-shaped insert containing dexamethasone, 0.4 mg.
Pregnancy
Risk Summary
There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations (see Data).
Data
Animal Data
Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m2 basis. In a rabbit study, topical ocular administration of 0.1%Â dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is approximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m2 basis.
Lactation
Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however the systemic concentration of dexamethasone following administration of DEXTENZA is low [see Clinical Pharmacology ]. There is no information regarding the presence of DEXTENZA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production to inform risk of DEXTENZA to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEXTENZA and any potential adverse effects on the breastfed child from DEXTENZA.
Pediatric Use
The safety and effectiveness of DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery have been established in pediatric patients.
The safety and effectiveness of DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis have been established in 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.
Use of DEXTENZA for these indications is supported by evidence from adequate and well-controlled studies in adults with additional safety data from a single active-controlled study in pediatric patients aged birth to 5 years old [see Clinical Studies ]. A similar safety profile was observed between pediatric and adult patients.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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.
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.
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 ].
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 ].
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 ].
Delayed Healing
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
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.