Akten

Lidocaine Hydrochloride Anhydrous · Gel · Ophthalmic

Prescription (Rx) Amide Local Anesthetic Antiarrhythmic

Uses

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. ( 1 )

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. 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. ( 2 )

Dosage forms and strengths

Ophthalmic Gel: 3.5% lidocaine hydrochloride in single-patient use tubes. Ophthalmic Gel: 3.5% lidocaine hydrochloride in single-patient-use tubes. ( 3 )

Contraindications

None. None. ( 4 )

Warnings and precautions

For Topical Ophthalmic Use: AKTEN is not for injection or intraocular administration. ( 5.1 ) 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. ( 5.2 ) Corneal Opacification: Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. ( 5.2 ) For Administration by Healthcare Provider: AKTEN is not intended for patient self-administration. ( 5.3 ) 5.1 For Topical Ophthalmic Use AKTEN is not for injection or intraocular administration. 5.2 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. 5.3 Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. 5.4 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.

Side effects

Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. ( 6 ) 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.

Use in specific populations

8 USE IN SPECIFIC POPULATIONS . 8.1 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 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when AKTEN is administered to a nursing woman. 8.4 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. 8.5 Geriatric Use No overall clinical differences in safety or effectiveness were observed between the elderly and other adult patients.

Pregnancy

8.1 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 2 to 4% and 15 to 20%, respectively.

Pediatric use

8.4 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.

Geriatric use

8.5 Geriatric Use No overall clinical differences in safety or effectiveness were observed between the elderly and other adult patients.

Overdosage

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.

Description

(lidocaine hydrochloride ophthalmic gel) 3.5% contains lidocaine hydrochloride, an amide local anesthetic, as a sterile ophthalmic gel for topical ophthalmic use. AKTEN does not contain an anti-microbial preservative. Lidocaine hydrochloride is designated chemically as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl) monohydrochloride with a molecular formula of C 14 H 22 N 2 O ∙ HCl and molecular weight of 270.8. The structural formula of the active ingredient is: Each mL of AKTEN contains 35 mg of lidocaine hydrochloride as the active ingredient. Inactive ingredients: hypromellose, sodium chloride, and water for injection. The pH may be adjusted to 5.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. AKTEN does not contain an anti-microbial preservative. Chemical Structure

Mechanism of action

12.1 Mechanism of Action Lidocaine hydrochloride is an amide local anesthetic agent that stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.

How supplied

(lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel in single-patient-use tubes as follows: NDC 82584-792-01 1 mL fill in a white polyfoil tube Made in Switzerland NDC 82584-792-25 Package of 25 units of 1 mL fill in a white polyfoil tube Storage Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use. Discard after use.

Storage

Storage Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use. Discard after use.

Label text from the FDA structured product label by Thea Pharma Inc. (revised Apr 23, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Lidocaine Hydrochloride Anhydrous in 1 product

Akten NDC products (1)

NDC	Strength & form	Labeler	Type
82584-792	Lidocaine Hydrochloride Anhydrous 35 mg/mL Gel	Thea Pharma Inc.	NDA

Frequently asked questions

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Akten is listed by 1 labeler in the FDA NDC directory, including Thea Pharma Inc..