Akten Drug Information
Generic name: LIDOCAINE HYDROCHLORIDE ANHYDROUS
Uses of Akten
1- INDICATIONS AND USAGE AKTEN is indicated for ocular surface anesthesia during ophthalmologic procedures in adults and pediatric patients. AKTEN is an amide local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.
Dosage & Administration of Akten
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.
Side Effects of Akten
Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION.
Warnings & Cautions for Akten
For Topical Ophthalmic Use AKTEN is not for injection or intraocular administration.
Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using AKTEN as accidental injuries can occur due to insensitivity of the eye.
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.
Pregnancy Safety for Akten
Pregnancy Risk Summary There are no adequate and well-controlled studies with AKTEN in pregnant women to inform a drug-associated risk. In animal reproduction studies, subcutaneous administration of lidocaine to pregnant rats at doses >800-fold the human dose based on body surface area did not result in adverse developmental effects. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively.
Pediatric Use of Akten
Pediatric Use The safety and effectiveness of AKTEN for ocular surface anesthesia during ophthalmologic procedures have been established in pediatric patients. Use of AKTEN for this indication has been extrapolated from adequate and well-controlled studies in adults and studies in pediatric patients using different formulations of lidocaine.
Overdosage Information for Akten
Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution. However, topical ocular application of AKTEN is not expected to result in systemic exposure.
Clinical Studies of Akten
The effect of AKTEN® on ocular anesthesia was studied in a multi-center, randomized, controlled, double-blind study. The mean time to anesthesia onset ranged from 20 seconds to 5 minutes and was not affected by AKTEN® dose. The mean time to anesthesia onset was approximately 60 seconds, with a median onset time of 40 seconds for the AKTEN® 3.5% group.
Among the subjects in the AKTEN® groups who achieved anesthesia within 5 minutes, approximately 90% had achieved anesthesia within 60 seconds of application. The anesthetic effect of additional applications of AKTEN® has not been evaluated.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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