FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Akten® is indicated for ocular surface anesthesia during ophthalmologic procedures.
History
There is currently no drug history available for this drug.
Other Information
Akten® (lidocaine hydrochloride ophthalmic gel) 3.5% is a sterile, preservative-free, single patient use ophthalmic gel preparation for topical ocular anesthesia. Lidocaine hydrochloride is designated chemically as acetamide, 2-(diethylamino)-N-(2,6- dimethylphenyl) monohydrochloride with a molecular formula of C14H22N2O HCl and molecular weight of 270.8. The structural formula of the active ingredient is:
Akten® contains 35 mg of lidocaine hydrochloride per mL as the active ingredient. Akten® also contains Hypromellose, Sodium Chloride, and Water for Injection as inactive ingredients in the 1 mL tube configuration. Akten® contains Hypromellose, Sodium Chloride, and Purified Water as inactive ingredients in the 5 mL in 10 mL bottle configuration. The pH may be adjusted to 5.5 to 7.5 with Hydrochloric Acid and/or Sodium Hydroxide.
Sources
Akten Manufacturers
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Akorn, Inc.
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