Description
NDC: 82584-792-25
Akten (Lidocaine HCl 3.5%) Ophthalmic Gel, 1 mL — Théa Pharma Inc.
| Active ingredients | Lidocaine hydrochloride 3.5% (35 mg/mL) |
| Dosage form | Ophthalmic gel |
| Route | Topical ophthalmic |
| Size | 1 mL single-patient-use tube |
| Manufacturer | Théa Pharma Inc. |
| NDC | 82584-792-25 |
Indications and Usage
An amide local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures, in adult and pediatric patients.
Dosage and Administration
The recommended dose is 2 drops applied to the ocular surface in the area of the planned procedure. The gel may be reapplied as needed to maintain the anesthetic effect. It is administered by a healthcare provider.
Warnings and Precautions
- Not for injection or intraocular administration
- Prolonged use may cause permanent corneal damage
- Patients should not touch the eye for at least 10 to 20 minutes after application
- Not intended for patient self-administration
Contraindications
None.
Adverse Reactions
The most common adverse reactions include conjunctival hyperemia, corneal epithelial changes, headache, and a burning sensation upon application.
Storage and Handling
Store at 15°C to 25°C (59°F to 77°F) in the original carton, protected from light. Discard after use.
How Supplied
Supplied as a clear ophthalmic gel in single-patient-use 1 mL tubes, available individually or in cartons of 25 tubes.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
