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. ( 1 )

None. None. ( 4 )

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 )

5.1For Topical Ophthalmic Use

AKTEN is not for injection or intraocular administration.

5.2Corneal 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.

5.3Corneal Opacification

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

5.4For 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.

8.1Pregnancy 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.