Generic Name: lidocaine hydrochloride ophthalmic gel
Date of Approval: October 7, 2008
Company: Akorn, Inc.
Treatment for: Ocular Anesthesia
FDA Approves Akten
The United States Food and Drug Administration (FDA) has approved Akten (lidocaine hydrochloride) Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation.
Akten is a novel, unit dose, preservative free lidocaine gel product, stored at room temperature and intended to be used in any ocular procedure that requires a topical anesthetic agent including cataract surgery, refractive surgery, Lasik surgery, and intravitreal injection.
Highlights of Akten Prescribing Information
Indications and Usage
Akten is a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.
Dosage and Administration
The recommended dose of Akten is 2 drops applied to the ocular surface in the area of the planned procedure. Additional anesthesia may be reapplied as needed.
Dosage Forms and Strengths
Akten 3.5% (35 mg/mL) Ophthalmic Gel
Warnings and Precautions
- Not for Injection
- Corneal Opacification- prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss
Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation.
To report SUSPECTED ADVERSE REACTIONS, contact Akorn at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, please visit www.akorn.com.