Akten®, (lidocaine hydrochloride) Ophthalmic Gel 3.5%, is a prescription topical ocular anesthetic. It is the first FDA-approved ophthalmic gel anesthetic in an optimal 3.5% dose and is preservative free.
Any procedure where a topical anesthetic would be used including: prior to cataract surgery, intravitreal injections, refractive surgery including LASIK, supplemental topical anesthetic after peribulbar or retrobulbar block, contact lens exam of retina, ALT/SLT lasers, retinal lasers, retinal cryoretinopexy, pneumatic retinopexy, scleral depression examinations, conjunctival or corneal foreign body removal, gonioscopy, suture placement, removal of corneal sutures, removal of conjunctival sutures, removal of lid sutures, anterior chamber paracentesis, placement of electroretinographic lenses, lens placement for YAG laser, vitreous biopsy, conjunctival biopsies, minor lid procedures, pterygium surgery, strabismus adjustment surgery, conductive keratoplasty, pars plana vitrectomy, and trabeculectomy.
Pregnancy - Reproduction studies for lidocaine have been performed in both rats and rabbits. There was no evidence of harm to the fetus at subcutaneous doses up to 50 mg/kg lidocaine (more than 800 fold greater than the human dose on a body weight basis) in the rat model. There are however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
Nursing Mothers - Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Although no systemic exposure is expected with administration of Akten®, caution should be exercised when Akten® is administered to a nursing woman.
Pediatric Use - Safety and efficacy in pediatric patients has been extrapolated from studies in older subjects and studies in pediatric patients using different formulations of lidocaine.
Geriatric Use - No overall clinical differences in safety or effectiveness were observed between the elderly and other adult patients.