What is Tetracaine Hydrochloride Ophthalmic Solution

Tetracaine Hydrochloride is a sterile aqueous topical anesthetic ophthalmic solution.

Content

ACTIVE: Tetracaine Hydrochloride 5 mg (0.5%); INACTIVES: Boric Acid, Potassium Chloride, Edetate Disodium and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (3.7 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.4%.

Mode of action

Tetracaine hydrochloride is used as a local anaesthetic, which acts by reversibly blocking the propagation and conduction of nerve impulses along nerve axons. Tetracaine stabilises the nerve membrane, preventing the increase in sodium permeability necessary to produce an action potential.

Indication

For procedures in which a rapid and short-acting topical ophthalmic anaesthetic is indicated, such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea, and other short corneal and conjunctival procedures.

Side effects

The following serious ocular adverse reactions are described elsewhere in the labelling:

• Corneal injury with Intracameral Use

• Corneal Toxicity

• Corneal Injury due to Insensitivity

The following adverse reactions have been identified following the 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, and ocular discomfort.

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