ed for single-use only.
2.2 Administration
Do not use if pouch has been damaged or opened. Do not re-sterilize.
1. Carefully remove foam carrier and transfer to a clean and dry area.
2. If necessary, dilate the punctum with an ophthalmic dilator. Care should be taken not to perforate the canaliculus duringdilation or insertion of DEXTENZA. If perforation occurs, do not insert DEXTENZA.
3. After drying the punctal area, using blunt (non-toothed) forceps, grasp DEXTENZA and insert into the lower lacrimalcanaliculus. DEXTENZA should be placed just below the punctal opening. Excessive squeezing of DEXTENZA may causedeformation.
4. To aid in the hydration of DEXTENZA, 1 to 2 drops of balanced salt solution can be instilled into the punctum. DEXTENZAhydrates quickly upon contact with moisture. If DEXTENZA begins to hydrate before fully inserted, discard the product anduse a new DEXTENZA.
5. DEXTENZA can be visualized when illuminated by a blue light source (e.g., slit lamp or hand held blue light) with yellowfilter.
3 DOSAGE FORMS AND STRENGTHS
Ophthalmic insert: fluorescent yellow, 3 mm cylindrical-shaped insert containing dexamethasone, 0.4 mg.
4 CONTRAINDICATIONS
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpessimplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.
5 WARNINGS AND PRECAUTIONS
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 thetreatment.
5.2 Bacterial Infection
Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulentconditions, 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 herpessimplex) [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 cultureshould 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.
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)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drugcannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adversereactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage,visual ac |
