Indications
IHEEZO TM is indicated for ocular surface anesthesia. IHEEZO TM is an ester anesthetic indicated for ocular surface anesthesia. ( 1 )
Contraindications
IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation. IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation. ( 4 )
Warnings and precautions
Not for Injection or Intraocular Administration ( 5.1 ). Corneal Injury Due to Insensitivity ( 5.2 ). Corneal Opacification ( 5.3 ) For Administration by Healthcare Provider : IHEEZO TM is not intended for patient self-administration ( 5.5 ).
5.1Not for Injection or Intraocular Administration
IHEEZO TM should not be injected or intraocularly administered.
5.2Corneal Injury Due to Insensitivity
Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.
5.3Corneal Opacification
Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.
5.4Risk of Contamination Do
not touch the dropper tip to any surface as this may contaminate the gel.
5.5For Administration by Healthcare Provider
IHEEZO TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO TM is not intended for patient self-administration.
Adverse reactions
Most common adverse reaction is mydriasis (approximately 25%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 844.446.6979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
At a glance
- Brand name
- Iheezo
- Active substance
- chloroprocaine hydrochloride
- Route
- Eye
- Dosage form
- Gel
- Applicant
- Harrow Eye
- Status
- Prescription
- FDA approval
- 27 Sept 2022
- Application
- NDA216227-001