Tetracaine

Before taking tetracaine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to tetracaine or to any of its ingredients
• have heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tetracaine falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Tetracaine should be given to a pregnant woman only if clearly needed.

• Keep this and all medicines out of the reach of children.
• Unused portions of the injectable solution should be discarded, since the formulation contains no preservatives.

Storage

Ophthalmic

Tight, light-resistant containers at 15–30°C; avoid freezing.a c

Topical

Tight, light-resistant containers at 2–8°C.a b

• Importance of not touching or rubbing eye(s) until anesthesia from ophthalmic solution has worn off.a b c

• Advise patient not to instill ophthalmic solution repeatedly; risk of severe eye damage.b c

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b

• Importance of informing patients of other important precautionary information. (See Cautions.)

Tetracaine HCl Injection, USP
for Prolonged Spinal Anesthesia

Rx only

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 and/or Sodium Hydroxide 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 ampules.

This formulation does not contain preservatives.

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.

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.

A small number of reactions to Tetracaine hydrochloride may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage.

Central nervous system effects are characterized by excitation or depression. The first manifestation may be nervousness, dizziness, blurred vision, or tremors, followed by drowsiness, convulsions, unconsciousness and possibly respiratory and cardiac arrest. Since excitement may be transient or absent, the first manifestation may be drowsiness, sometimes merging into unconsciousness and respiratory and cardiac arrest. Other central nervous system effects may be nausea, vomiting, chills, constriction of the pupils, or tinnitus.

Cardiovascular system reactions include depression of the myocardium, blood pressure changes (usually hypotension), and cardiac arrest.

Allergic reactions, which may be due to hypersensitivity, idiosyncrasy, or diminished tolerance, are characterized by cutaneous lesions (eg. urticaria), edema, and other manifestations of allergy. Detection of sensitivity by skin testing is of limited value. Severe allergic reactions including anaphylaxis have rarely occurred and are not usually dose-related.

Reactions Associated with Spinal Anesthesia Techniques: Central Nervous System: post-spinal headache, meningismus, arachnoiditis, palsies, or spinal nerve paralysis. Cardiovascular: hypotension due to vasomotor paralysis and pooling of the blood in the venous bed. Respiratory: respiratory impairment or paralysis due to the level of anesthesia extending to the upper thoracic and cervical segments. Gastrointestinal: nausea and vomiting.

Treatment of Reactions: Toxic effects of local anesthetics require symptomatic treatment; there is no specific cure. The most important measure is oxygenation of the patient by maintaining an airway and supporting ventilation. Supportive treatment of the cardiovascular system includes intravenous fluids and, when appropriate, vasopressors (preferably those that stimulate the myocardium). Convulsions are usually controlled with adequate oxygenation alone but intravenous administration in small increments of a barbiturate (preferably an ultrashort-acting barbiturate such as thiopental and thiamylal), or diazepam can be utilized. Intravenous barbiturates or anticonvulsant agents should only be administered by those familiar with their use and only if ventilation and oxygenation have first been assured. In spinal anesthesia, sympathetic blockade also occurs as a pharmacological action, resulting in peripheral vasodilation and often hypotension. The extent of the hypotension will usually depend on the number of dermatomes blocked. The blood pressure should therefore be monitored in the early phases of anesthesia. If hypotension occurs, it is readily controlled by vasoconstrictors administered either by the intramuscular or the intravenous route, the dosage of which would depend on the severity of the hypotension and the response to treatment.

1% isotonic isobaric solution: 2 mL Ampules, box of 25.

NDC 17478-045-32

Storage: Store under refrigeration. Protect ampules from light.

Akorn
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

GTC00N
Rev. 12/08