Akten® Frequently Asked Questions

3.5% Viscous Topical Ocular Anesthetic Gel Preservative Free

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What is Akten?

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.

What are the features and benefits of Akten?

  • Onset of action between 20 to 60 seconds and persists from 5 to 30 minutes
  • Viscous gel formulation for extended localized contact
  • Only FDA-approved topical lidocaine available for ocular procedures
  • Physiological pH: 5.5 to 7.5
  • Store at room temperature: 15° to 25° C (59° to 77° F)
  • Water soluble

What is Akten indicated for?

Akten is a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.

What procedures will use Akten?

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.

How is Akten administered?

The recommended dose of Akten is 2 drops applied to the ocular surface in the area of the planned procedure. Akten may be reapplied to maintain anesthetic effect.

What are the ingredients of Akten?

Akten contains 35 mg of lidocaine hydrochloride per mL as the active ingredient. Akten also contains Hypromellose, Sodium Chloride, and Water for Injection as inactive ingredients in the 1 mL tube configuration. The pH may be adjusted to 5.5 to 7.5 with Hydrochloric Acid and/or Sodium Hydroxide. Akten is preservative free.

How is Akten packaged?

Akten (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel for single patient use in a 1 mL fill in a white polyfoil tube. The NDC# is 17478-792-01.

Akten use in specific populations.

  • Pregnancy. Pregnancy Category B - 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.

What important safety information should I know about Akten?

Akten has no known contraindications. 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 and www.akorn.com) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is the shelf life of Akten?

Akten has a 24 month shelf life.

How should Akten be stored?

Store at 15° to 25° C (59° to 77° F). Keep container closed and protected from light in the original carton until use. Discard after use.

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