Tetracaine

FDA label, BPI LABS LLC, subarachnoid, effective 2025-12-17. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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Preparation and administration

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Basis

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Inject solution at rate of about 1 mL per 5 seconds. The extent and degree of spinal anesthesia depend upon dosage, specific gravity of the anesthetic solution, volume of solution used, force of the injection, level of puncture, position of the patient during and immediately after injection, etc. When spinal fluid is added to 1% tetracaine hydrochloride injection, some turbidity results, the degree depending on the pH of the spinal fluid, the temperature of the solution during mixing, as well as the amount of drug and diluent employed.

Liberation of base (which is completed within the spinal canal) is held to be essential for satisfactory results with any spinal anesthetic. The specific gravity of spinal fluid at 25°C/25°C varies under normal conditions from 1.0063 to 1.0075. The 1% concentration in saline solution has a specific gravity of 1.0060 to 1.0074 at 25°C/25°C.

A hyperbaric solution may be prepared by mixing equal volumes of the 1% solution and Dextrose Solution 10%. Examine vials carefully before use. Do not use solution if crystals, cloudiness, or discoloration is observed. This formulation of tetracaine hydrochloride does not contain antimicrobial or bacteriostatic agents; therefore, unused portions should be discarded.

Sterilization of Vials The tetracaine hydrochloride injection is sterile within an undamaged vial. To destroy bacteria on the exterior of vials use heat sterilization (autoclaving) before opening. Immersion in antiseptic solution is not recommended. Autoclave at 15-pounds pressure, at 121°C (250°F), for 15 minutes. Autoclaving increases likelihood of crystal formation.

Suggested Dosage for Spinal Anesthesia Using 1% Tetracaine HCl Injection, USP
Extent of Anesthesia Dose of solution (mL) Volume of spinal fluid (mL) Site of injection (lumbar interspace)
Perineum 0.5 (= 5 mg)* 0.5 4 th
Perineum and lower extremities 1.0 (= 10 mg) 1.0 3 rd or 4 th
Up to costal margin(= 15 mg to 20 mg)** 1.5 to 2.0 1.5 to 2.0 2 nd, 3 rd, or 4 th

Drug interactions

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Label text (1 paragraph)

Drug Interactions: Tetracaine hydrochloride should not be used if the patient is being treated with a sulfonamide because aminobenzoic acid inhibits the action of sulfonamides. Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs Acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

Contraindications

CONTRAINDICATIONS: Spinal anesthesia with tetracaine hydrochloride is contraindicated in patients with known hypersensitivity to tetracaine hydrochloride or to drugs of a similar chemical configuration (ester-type local anesthetics), or aminobenzoic acid or its derivatives; and in patients for whom spinal anesthesia as a technique is contraindicated. The decision as to whether or not spinal anesthesia should be used for an individual patient should be made by the physician after weighing the advantages with the risks and possible complications.

Contraindications to spinal anesthesia as a technique can be found in standard reference texts, and usually include generalized septicemia, infection at the site of injection, certain diseases of the cerebrospinal system, uncontrolled hypotension, etc.

Pregnancy and lactation

Pregnancy

Pregnancy Category C: There have been no animal reproduction studies conducted with tetracaine hydrochloride. It is not known whether tetracaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tetracaine hydrochloride should be given to a pregnant woman only if clearly needed and the potential benefits outweigh the risk.

Lactation

Nursing Mothers: It is not known whether tetracaine hydrochloride is excreted in human milk; however, it is rapidly metabolized following absorption into the plasma. Because many drugs are excreted in human milk, caution should be exercised when tetracaine hydrochloride is administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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