Company:

Akorn

Local anesthetic

Lidocaine HCl 3.5% (35mg/mL); ophthalmic gel; preservative-free.

Ocular surface anesthesia during ophthalmologic procedures.

Akten is a local anesthetic agent that stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and lasts for 5 to 30 minutes.

A total of 209 patients in a double-blind study were randomized to receive either Akten 1.5%, Akten 2.5%, Akten 3.5%, or sham. In this trial, 92% of the Akten 3.5% group achieved ocular anesthesia within 5 minutes of application. The mean time to anesthesia onset was 60 seconds. The duration of anesthesia ranged from 5 to 30 minutes with a mean time of 15 minutes for the Akten 3.5% group. The anesthetic effect of additional applications of Akten has not been evaluated.

For single patient use. 2 drops to the ocular surface in area of planned procedure; may reapply as needed.

Not for injection. Prolonged use may cause corneal opacification. Pregnancy (Cat. B).

Conjunctival hyperemia, corneal epithelial changes, headache, burning upon instillation.

Gel—5mL

10/16/08