Akten®
GoodRxLidocaine 3.5% · ophthalmic gel
Local Anesthetic
Approved uses
Ocular surface anesthesia for ophthalmologic procedures
2 drops to the ocular surface over the planned procedure site; may be reapplied to maintain effect
Anesthesia begins 20 seconds to 1 minute after instillation and lasts 5 to 30 minutes.
Anesthesia for intravitreal injection
2 drops to the ocular surface before injection, the labeled dose
No better than proparacaine drops for immediate pain at intravitreal injection.
Contraindications
None.
Available FormsLidocaine HCl 3.5% (35 mg/mL) preservative-free ophthalmic gel, 1 mL single-patient-use tube, cartons of 1 or 25 tubes
Mechanism of ActionAmide local anesthetic that stabilizes the neuronal membrane by blocking the voltage-gated sodium channels carrying the ionic flux required for initiation and conduction of impulses, abolishing corneal and conjunctival sensation.
Warnings & Precautions
- Topical ophthalmic use only: Not for injection or intraocular administration.
- Corneal injury from insensitivity: The eye must not be touched for at least 10 to 20 minutes after instillation, since accidental injury can occur while sensation is absent.
- Corneal opacification: Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.
- Provider administration: Indicated for administration under the direct supervision of a healthcare provider, not for patient self-administration.
- Anesthetic abuse keratopathy: Prolonged use of any topical ocular anesthetic produces a nonhealing epithelial defect with ring-shaped stromal infiltrate and hypopyon that has been mistaken for Acanthamoeba keratitis; in a 19-patient series of proparacaine and tetracaine abusers, mean time to epithelialization was 20 days and 63% kept using the drops while hospitalized for the resulting ulcer.
Common Side Effects
- Ocular: Conjunctival hyperemia, corneal epithelial changes, and burning on instillation are the most common reactions; the label reports no frequencies.
- Systemic: Headache. Topical ocular application is not expected to produce systemic exposure.
Pregnancy & LactationPregnancy: No adequate and well-controlled studies in pregnant women; subcutaneous dosing in pregnant rats at more than 800 times the human dose on a body surface area basis produced no adverse developmental effects.
Lactation: Secreted in human milk; clinical significance unknown.
Pediatric UseEstablished in pediatric patients, extrapolated from adult trials and from pediatric studies of other lidocaine formulations.