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Tetracaine Injection (Tetracaine Hydrochloride Injection) - Warnings and Precautions

 
 



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.

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 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.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility: 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.

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.

Labor and Delivery: 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.

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.

Pediatric Use: Safety and effectiveness of tetracaine hydrochloride in pediatric patients have not been established.

Page last updated: 2010-04-14

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