Akten

Akten information, interactions and side effects, 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

Akten™ contains 35 mg of lidocaine hydrochloride per mL as the active ingredient. Akten™ (lidocaine hydrochloride ophthalmic gel) also contains Hypromellose, Sodium Chloride, and Purified Water as inactive ingredients. The pH may be adjusted to 5.5 to 7.5 with Hydrochloric Acid and/or Sodium Hydroxide.

INDICATIONS

Akten™ (lidocaine hydrochloride ophthalmic gel) is a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.

DOSAGE AND ADMINISTRATION

The recommended dose of Akten™ (lidocaine hydrochloride ophthalmic gel) is 2 drops applied to the ocular surface in the area of the planned procedure. Akten™ (lidocaine hydrochloride ophthalmic gel) may be reapplied to maintain anesthetic effect.

HOW SUPPLIED

Dosage forms and Strength

Akten™ (lidocaine hydrochloride ophthalmic gel) Ophthalmic Gel, 3.5% contains 35 mg per mL of lidocaine hydrochloride for topical ophthalmic administration.

Storage And Handling

Akten™ (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel for single patient use as follows:

5mL fill in a 10mL natural, round plastic dropper bottle

(NDC 17478-792-10).

Storage

Store at 15° to 25° C (59° to 77° F)

Keep container closed and protected from light in the original carton until use. Discard after use.

SIDE EFFECTS

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

PRECAUTIONS

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

Nonclinical Toxicology

Carcinogenesis, mutagenesis, Impairment of fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Akten™ (lidocaine hydrochloride ophthalmic gel) .

Use In Specific Populations

Pregnancy. Pregnancy Category B.

Reproduction< studies for lidocaine have been performed in both rats and rabbits. There was no evidence of harm to the fetus at subcutaneous doses up to 50 mg/kg lidocaine (more than 800 fold greater than the human dose on a body weight basis) in the rat model. There are however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

Nursing Mothers

Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Although no systemic exposure is expected with administration of Akten™ (lidocaine hydrochloride ophthalmic gel) , caution should be exercised when Akten™ (lidocaine hydrochloride ophthalmic gel) is administered to a nursing woman.

Pediatric Use

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

Geriatric Use

No overall clinical differences in safety or effectiveness were observed between the elderly and other adult patients.

OVERDOSE

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

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution. However, topical ocular application of Akten™ (lidocaine hydrochloride ophthalmic gel) is not expected to result in systemic exposure.

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