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.
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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....