Tetracaine Hydrochloride
FDA Drug Information • Also known as: Tetracaine Hydrochloride
- Brand Names
- Tetracaine Hydrochloride
- Route
- OPHTHALMIC
- Dosage Form
- SOLUTION/ DROPS
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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: Tetracaine hydrochloride is a white crystalline 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). Image
What Is Tetracaine Hydrochloride Used For?
1 INDICATIONS AND USAGE Tetracaine hydrochloride ophthalmic solution, 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine hydrochloride ophthalmic solution, 0.5%, is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. (1)
Dosage and Administration
2 DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. One drop topically in the eye(s) as needed. (2)
Side Effects (Adverse Reactions)
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: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. (6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Contraindications
4 CONTRAINDICATIONS Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. (4)
Pregnancy and Breastfeeding
8.1 Pregnancy 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.
Overdosage
10 OVERDOSAGE Prolonged use of a topical ocular anesthetic including tetracaine hydrochloride ophthalmic solution, 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Tetracaine hydrochloride ophthalmic solution, USP 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a white LDPE bottle, plugged with white LDPE nozzle and capped with white HDPE cap in the following sizes: NDC 70069-596-01, 5 mL fill in 5 mL Bottle NDC 70069-597-01, 15 mL fill in 15 mL Bottle After opening, this product can be used until the expiration date stamped on the bottle. Storage: Store at 15° to 25°C (59° to 77°F). Protect from light. Do not use if solution contains crystals, cloudy, or discolored.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.