Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, Ophthalmic, as hydrochloride [preservative free]:
Akten: 3.5% (1 mL)
Pharmacology
Mechanism of Action
Local anesthetics block both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction.
Pharmacokinetics/Pharmacodynamics
Onset of Action
20 seconds to 5 minutes (median: 40 seconds)
Duration of Action
5 to 30 minutes (median: 15 minutes)
Use: Labeled Indications
Anesthesia, ocular: To provide local anesthesia to ocular surface during ophthalmologic procedures
Contraindications
There are no contraindications listed in the manufacturer's labeling
Dosage and Administration
Dosing: Adult
Anesthesia, ocular: Apply 2 drops to ocular surface in area where procedure will occur; may reapply to maintain effect.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Anesthesia, ocular: Ophthalmic gel: Children and Adolescents: Apply 2 drops to ocular surface in area where procedure to occur; may reapply to maintain effect
Storage
Store at 15°C to 25°C (59°F to 77°F). Protect from light. Discard after use.
Drug Interactions
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Monitor therapy
Adverse Reactions
Frequency not defined.
Central Nervous System: Localized burning
Ophthalmic: Conjunctival hyperemia, diplopia, epithelial keratopathy, visual disturbance
Warnings/Precautions
Concerns related to adverse effects:
- Corneal ulceration: Prolonged use may cause permanent corneal ulceration and/or opacification with loss of vision.
Dosage form specific issues:
- Appropriate use: For ophthalmic use only; not for injection.
Pregnancy
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. Although systemic exposure is not expected following application of the ophthalmic gel, cumulative exposure from all routes of administration should be considered.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience burning or headache. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or blindness (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
