DailyMed Label: Tetracaine

DailyMed Label: Tetracaine

2024

DailyMed Prescription

Tetracaine

TETRACAINE HYDROCHLORIDE

Bryant Ranch Prepack

NDC: 63629-9160

NDC: 63629-9160

NDC: 63629-9160

NDC: 63629-9160

Tetracaine hydrochloride is 2-(Dimethylamino)ethyl p-(butylamino)benzoate monohydrochloride. It is a white crystalline, odorless powder that is readily soluble in water, physiologic saline solution, and dextrose solution. It has the following structural formula: Tetracaine hydrochloride is a local anesthetic of the ester-linkage type, related to procaine. 1% Solution: A sterile, isotonic, isobaric solution. Each mL contains: Active: 10 mg Tetracaine Hydrochloride Inactives: 7.5 mg Sodium Chloride, Hydrochloric Acid may be added to adjust pH (3.2 to 6.0) and Water for Injection, USP. Nitrogen gas has been used to displace the air in the vials. This formulation does not contain preservatives.

Tetracaine hydrochloride is indicated for the production of spinal anesthesia for procedures requiring two to three hours.

As with all anesthetics, the dosage varies and depends upon the area to be anesthetized, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks. 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) For vaginal delivery (saddle block), from 2 mg to 5 mg in dextrose. 0.5 4th Perineum and lower extremities 1.0 (= 10 mg) 1.0 3rd or 4th Up to costal margin (= 15 mg to 20 mg) Doses exceeding 15 mg are rarely required and should be used only in exceptional cases. 1.5 to 2.0 1.5 to 2.0 2nd, 3rd, or 4th 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. Then 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.

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.

The safety and effectiveness of any spinal anesthetic depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies. The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious systemic side effects. Tolerance varies with the status of the patient; debilitated, elderly patients or acutely ill patients should be given reduced doses commensurate with their weight, age, and physical status. Reduced doses are also indicated for obstetric patients and those with increased intra-abdominal pressure. Caution should be used in administering tetracaine hydrochloride to patients with abnormal or reduced levels of plasma esterases. Blood pressure should be frequently monitored during spinal anesthesia and hypotension immediately corrected. Spinal anesthetics should be used with caution in patients with severe disturbances of cardiac rhythm, shock, and heartblock. 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 There have been no long-term animal studies to evaluate carcinogenic potential and reproduction studies in animals. There is no evidence from human data that tetracaine hydrochloride may be carcinogenic or that it impairs fertility. 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. Vasopressor agents administered for the treatment of hypotension resulting from spinal anesthesia may result in severe persistent hypertension and/or rupture of cerebral blood vessels if oxytocic drugs have also been administered; therefore, vasopressors should be used with extreme caution in the presence of oxytocic drugs. Tetracaine hydrochloride has a recognized use during labor and delivery; the effect of the drug on duration of labor, incidence of forceps delivery, status of the newborn, and later growth and development of the child have not been studied. 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. Pediatric Use: Safety and effectiveness of tetracaine hydrochloride in pediatric patients have not been established.

Systemic adverse reactions to tetracaine hydrochloride are characteristic of those associated with other local anesthetics and can involve the central nervous system and the cardiovascular system. Systemic reactions usually result from high plasma levels due to excessive dosage, rapid adsorption, or inadvertent intravascular injection.

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

1% isotonic isobaric solution: 2 mL vials, box of 10. NDC 63629-9160-1 Storage Store under refrigeration. Protect vials from light. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Parenteral administration of tetracaine hydrochloride stabilizes the neuronal membrane and prevents initiation and transmission of nerve impulses thereby effecting local anesthesia. The onset of action is rapid, and the duration is prolonged (up to two or three hours or longer of surgical anesthesia). Tetracaine hydrochloride is detoxified by plasma esterases to aminobenzoic acid and diethylaminoethanol.

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Tetracaine HCL 20 mg/2mL inj#10 Label