Drug Catalog - Product Detail
LIDOCAINE HCL OPHTH. GEL (AKTEN) GEL 0.035 1ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0792-01 | AKORN | 1 | 3.5% | GEL |
PACKAGE FILES
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11 DESCRIPTION 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 C 14 H 22 N 2 O • 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 Water for Injection 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. Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING AKTEN ® (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel for single-patient use as follows: NDC 17478-792-01 1 mL fill in a white polyfoil tube* NDC 17478-792-25 Package of 25 units of 1 mL fill in a white polyfoil tube* (NDC 17478-792-01) NDC 17478-792-10 5 mL fill in a 10 mL natural, round plastic dropper bottle Storage 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. AKORN Manufactured by: Akorn Operating Company LLC Lake Forest, IL 60045 *Made in Switzerland Patent Pending AE00N Revised 2/2022
Indications & Usage
1 INDICATIONS AND USAGE AKTEN ® is indicated for ocular surface anesthesia during ophthalmologic procedures. AKTEN ® is a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. ( 1 )
Dosage and Administration
2 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. Additional anesthesia may be reapplied as needed. ( 2 )