Akten

What is Akten?

• Akten (lidocaine hydrochloride) is a local anesthetic used for ocular surface anesthesia.

Lidocaine

What are the uses of this medicine?

• Akten (lidocaine hydrochloride) is used for ocular surface anesthesia during ophthalmologic procedures.

How does this medicine work?

• Akten (lidocaine hydrochloride) is a 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Akten.

Is this medicine FDA approved?

• Initial U.S. Approval: 1972

How should this medicine be used?

Recommended dosage:

• 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.

Administration:

• For Topical Ophthalmic Use.
• Not for Injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As AKTEN® 3.5% (35 mg/mL) Ophthalmic Gel.

This medicine is available in fallowing brand namesː

• AKTEN

What side effects can this medication cause?

The most common side effects of this medicine include:

• conjunctival hyperemia
• corneal epithelial changes
• headache
• burning upon instillation

What special precautions should I follow?

• AKTEN is indicated for topical ophthalmic use. Not for Injection.
• Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.
• AKTEN is indicated for administration under the direct supervision of a healthcare provider. AKTEN is not intended for patient self-administration.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• permanent corneal opacification and ulceration with accompanying visual loss.
• However, topical ocular application of AKTEN® is not expected to result in systemic exposure.

Treatment of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well controlled studies in pregnant women.

Can this medicine be used in children?

• Safety and efficacy in pediatric patients have been extrapolated from studies in older subjects and studies in pediatric patients using different formulations of lidocaine.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Lidocaine Hydrochloride Anhydrous

Inactive ingredients:

• Hypromelloses
• Sodium Chloride
• Sodium Hydroxide
• Hydrochloric Acid
• Water

Who manufactures and distributes this medicine?

Manufactured by:

• Akorn Operating Company LLC
• Lake Forest, IL
• Made in Switzerland

What should I know about storage and disposal of this medication?

• Store at 15°C to 25°C (59°F to 77°F).
• Keep container closed and protected from light in the original carton until use.
• Discard after use.

• Dailymed label info on Akten
• FDA Akten

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