These Highlights Do Not Include All The Information Needed To Use Tetracaine Hydrochloride Ophthalmic Solution 0.5% Steri‑unit ®

Warnings and Precautions ( 5.4)                                                                                                                2/2022

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

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.

Risk Summary

There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women.  Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

Risk Summary

There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion.  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition.

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

Safety in the pediatric population has been demonstrated in clinical trials.  Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.

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)] .

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 or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.

The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

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

Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

One drop topically in the eye as needed.  Discard unused portion.

• 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)

One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1)

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

Open package using standard aseptic technique.  The DROP‑TAINER ^®dispenser may then be allowed to fall upon a sterile surface.  The entire outer surface of the DROP‑TAINER ^®dispenser and its contents are sterile.

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

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

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.

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.

Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration [ see Warnings and Precautions ( 5.2 )].

No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available.

Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature.  Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride.

Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

Warnings and Precautions ( 5.4)                                                                                                                2/2022

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

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.

Risk Summary

There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women.  Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

Risk Summary

There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion.  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition.

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

Safety in the pediatric population has been demonstrated in clinical trials.  Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.

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)] .

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 or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.

The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

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

Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

One drop topically in the eye as needed.  Discard unused portion.

• 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)

One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1)

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

Open package using standard aseptic technique.  The DROP‑TAINER ^®dispenser may then be allowed to fall upon a sterile surface.  The entire outer surface of the DROP‑TAINER ^®dispenser and its contents are sterile.

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

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

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.

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.

Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration [ see Warnings and Precautions ( 5.2 )].

No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available.

Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature.  Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride.

Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.