Akten

Topical:

Lidocaine is a prescription medication used to prevent pain before procedures or to relieve pain due to certain conditions.  Lidocaine patches may be used to treat pain due to post-herpetic neuralgia. Lidocaine ointment, gel, and cream are used to prevent and control pain during procedures, such as intubation and eye surgery, and relieve pain due to conditions such as inflammation of the urethra and sore throat. Lidocaine oral solution is used to treat pain in the mouth.

Injectable:

Injectable lidocaine is used as an anesthetic during surgical procedures.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Store lidocaine at room temperature.

Keep this and all medicines out of the reach of children.

After lidocaine is applied to the eye, do not rub or wipe the eye until the feeling in the eye returns. To do so may cause injury or damage to the eye.

Indications and Usage

Akten is a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.

Dosage and Administration

The recommended dose of Akten is 2 drops applied to the ocular surface in the area of the planned procedure. Additional anesthesia may be reapplied as needed.

Dosage Forms and Strengths

Akten 3.5% (35 mg/mL) Ophthalmic Gel

Warnings and Precautions

• Not for Injection
• Corneal Opacification- prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss

Adverse Reactions

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

To report SUSPECTED ADVERSE REACTIONS, contact Akorn at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please visit www.akorn.com.

Applies to lidocaine ophthalmic: ophthalmic gel/jelly, ophthalmic solution

Along with its needed effects, lidocaine ophthalmic (the active ingredient contained in Akten) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking lidocaine ophthalmic:

• Blurred vision or other changes in vision
• burning feeling at site of application
• redness of the white part of eyes or inside of eyelids

Some side effects of lidocaine ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache