Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal injury with Intracameral Use [See Warnings and Precautions (5.1) ] Corneal Toxicity [See Warnings and Precautions (5.2) ] Corneal Injury due to Insensitivity [ See Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution 0.5%.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort.
Ocular adverse events: stinging, burning, conjunctival redness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Do not use intracamerally since use may damage corneal endothelial cells ( 5.1 ) Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.
( 5.2 ) Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.
( 5.3 ) For Administration by Healthcare Provider: Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration.
( 5.4 ) 5.1 Corneal injury with Intracameral Use Not for injection or intraocular use.
Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution 0.5% may lead to damage of the corneal endothelial cells.
Like all medications, Tetracaine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: