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Akten Gel
  • Professionals
  • FDA PI

Akten Gel

Generic name:lidocaine hydrochloride
Dosage form: ophthalmic gel
Drug class:Ophthalmic anesthetics

Medically reviewed by Drugs.com. Last updated on Nov 1, 2021.

Indications and Usage for Akten Gel

AKTEN® is indicated for ocular surface anesthesia during ophthalmologic procedures.

Akten Gel Dosage and Administration

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.

Dosage Forms and Strengths

AKTEN® Ophthalmic Gel, 3.5% contains 35 mg per mL of lidocaine hydrochloride for topical ophthalmic administration.

Contraindications

None.

Warnings and Precautions

For Topical Ophthalmic Use

AKTEN® is indicated for topical ophthalmic use. Not for Injection.

Corneal Opacification

Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

For Administration by Healthcare Provider

AKTEN® is indicated for administration under the direct supervision of a healthcare provider. AKTEN® is not intended for patient self-administration.

Adverse Reactions

Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation.

USE IN SPECIFIC POPULATIONS

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....