Tetracaine Hydrochloride

TETRACAINE HYDROCHLORIDE- tetracaine hydrochloride solution/ drops
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

One drop topically in the eye(s) as needed.

3 DOSAGE FORMS AND STRENGTHS

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a clear, colorless, ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.

4 CONTRAINDICATIONS

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation.

5 WARNINGS AND PRECAUTIONS

5.1 Corneal Injury with Intracameral Use

Not for injection or intraocular use. Do not use intracamerally because use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may lead to damage of the corneal endothelial cells.

5.2 Corneal Toxicity

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

5.3 Corneal Injury Due to Insensitivity

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.

5.4 For Administration by Healthcare Provider

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

6 ADVERSE REACTIONS

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

The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution, USP 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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

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

8.2 Lactation

Risk Summary

There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution, USP 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, USP 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%.

8.3 Females and Males of Reproductive Potential

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

8.4 Pediatric Use

Safety of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

8.5 Geriatric Use

No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% have been observed between elderly and younger patients.

10 OVERDOSAGE

Prolonged use of a topical ocular anesthetic including Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.

11 DESCRIPTION

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a sterile, clear, colorless, topical local anesthetic for ophthalmic use only containing tetracaine hydrochloride as the active pharmaceutical ingredient.

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

CHEM
(click image for full-size original)

Tetracaine hydrochloride is a fine, white, crystalline, odorless powder with a molecular weight of 300.82

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

Preservative: chlorobutanol 0.4%

Inactive ingredients: boric acid, potassium chloride, edetate disodium dihydrate, water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0).

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

12.3 Pharmacokinetics

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

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

14 CLINICAL STUDIES

Topical administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% 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 Warnings and Precautions ( 5.2) and Overdosage ( 10)] .

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