Tetracaine Hydrochloride

Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.

None.

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.

Prolonged use of a topical ocular anesthetic including TetracaineHydrochloride Ophthalmic Solution 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.  Symptoms related to systemic toxicity consist mainly of effects on the neurologic and cardiovascular systems.

Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride.  Its chemical formula is C ₁₅H ₂₄N ₂O ₂• HCl and it is represented by the chemical structure:

Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82.  Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5.

Active ingredient:tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine)

Inactive ingredients:sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP

Topical administration of tetracainehydrochloride ophthalmic solution results in localized temporary anesthesia.  The maximum effect is achieved within 10–20 seconds after instillation, with efficacy lasting 10–20 minutes.  Duration of effect can be extended with repeated dosing. [see Corneal toxicity (5.2)and Overdosage (10)] .

Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNITS® is supplied as single patient use, 4 mL filled in 4-mL natural medium- or low-density polyethylene plastic DROP-TAINER® dispensers and natural low-density polyethylene tips with white polypropylene caps in a carton of 12.  Each sterilized DROP-TAINER® dispenser is packaged in a clear PVC and Tyvek blister.  This product does not contain a preservative; discard unused portion.

NDC: 70518-4183-00

NDC: 70518-4183-01

PACKAGING: 12 in 2 CARTON

PACKAGING: 1-4 mL BOTTLE, DROPPER TYPE 0

Storage: Store at 2°C to 25°C (36°F to 77°F). Protect from light. Do not use if solution contains crystals, is cloudy, or discolored.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Eye Care Precaution
Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive up to 20 minutes and that care should be taken to avoid accidental injuries.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Tetracaine Hydrochloride

GENERIC: tetracaine hydrochloride

DOSAGE: SOLUTION

ADMINSTRATION: OPHTHALMIC

NDC: 70518-4183-0

NDC: 70518-4183-1

PACKAGING: 4 mL in 1 BOTTLE, DROPPER

OUTER PACKAGING: 12 in 1 CARTON

ACTIVE INGREDIENT(S):

• Tetracaine Hydrochloride 5mg in 1mL

INACTIVE INGREDIENT(S):

• Sodium Chloride
• Sodium Acetate
• Acetic Acid
• Water

MM1

MM2