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- Not for Injection.
- Corneal Opacification. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.
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.
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.
Safety and efficacy in pediatric patients has been extrapolated from studies in older subjects and studies in pediatric patients using different formulations of lidocaine.
No overall clinical differences in safety or effectiveness were observed between the elderly and other adult patients.
Last reviewed on RxList: 11/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Akten Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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