Tetracaine (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
PONTOCAINE is indicated for the production of spinal anesthesia for procedures requiring two to three hours.
Dosage
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.
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 either the NIPHANOID or the 1% Solution, 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. This cloudiness is due to the release of the base from the hydrochloride. 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. A solution of the instantly soluble form (NIPHANOID) in spinal fluid has only a slightly greater specific gravity. 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% (which is available in ampuls of 3 mL).
If the NIPHANOID form is preferred, it is first dissolved in Dextrose Solution 10% in a ratio of 1 mL dextrose to 10 mg of the anesthetic. Further dilution is made with an equal volume of spinal fluid. The resulting solution now contains 5% dextrose with 5 mg of anesthetic agent per milliliter.
A hypobaric solution may be prepared by dissolving the NIPHANOID in Sterile Water for Injection, USP (1 mg per milliliter). The specific gravity of this solution is essentially the same as that of water, 1.000 at 25°C/25°C.
Examine ampuls carefully before use. Do not use solution if crystals, cloudiness, or discoloration is observed.
These formulations of tetracaine hydrochloride do not contain preservatives; therefore, unused portions should be discarded and the reconstituted NIPHANOID should be used immediately.
STERILIZATION OF AMPULS
The drug in intact ampuls is sterile. The preferred method of destroying bacteria on the exterior of ampuls before opening is heat sterilization (autoclaving). Immersion in antiseptic solution is not recommended.
Autoclave at 15-pound pressure, at 121°C (250°F), for 15 minutes. The NIPHANOID form may also be autoclaved in the same way but may lose its snowlike appearance and tend to adhere to the sides of the ampul. This may slightly decrease the rate at which the drug dissolves but does not interfere with its anesthetic potency.
Autoclaving increases likelihood of crystal formation. Unused autoclaved ampuls should be discarded. Under no circumstance should unused ampuls which have been autoclaved be returned to stock.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tetracaine (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tetracaine (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Tetracaine (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tetracaine (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tetracaine (injection) in pediatric patients.
Contraindications
Spinal anesthesia with PONTOCAINE 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.
Warnings
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHENEVER ANY LOCAL ANESTHETIC DRUG IS USED.
Large doses of local anesthetics should not be used in patients with heartblock.
Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.
Contains acetone sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Precautions
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 PONTOCAINE 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, or heartblock.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Tetracaine (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Tetracaine (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Tetracaine (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tetracaine (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tetracaine (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tetracaine (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tetracaine (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Tetracaine (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Tetracaine (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Tetracaine (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tetracaine (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tetracaine (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tetracaine (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tetracaine (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tetracaine (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Tetracaine (injection) Administration in the drug label.
Monitoring
There is limited information regarding Tetracaine (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Tetracaine (injection) and IV administrations.
Overdosage
There is limited information regarding Tetracaine (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Tetracaine (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Tetracaine (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Tetracaine (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Tetracaine (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Tetracaine (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Tetracaine (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Tetracaine (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Tetracaine (injection) How Supplied in the drug label.
Storage
There is limited information regarding Tetracaine (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Tetracaine (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Tetracaine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Tetracaine (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Tetracaine (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.