TETRACAINE- tetracaine hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)

Available from:

Cameron Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

1% isotonic isobaric solution: 2 mL vials, box of 10. NDC 42494-437-10 Store under refrigeration. Protect vials from light.

Authorization status:

unapproved drug other

Summary of Product characteristics

TETRACAINE- TETRACAINE HYDROCHLORIDE INJECTION
CAMERON PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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TETRACAINE 1%
TETRACAINE HCL INJECTION, USP
FOR PROLONGED SPINAL ANESTHESIA
RX ONLY
DESCRIPTION
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.
CLINICAL PHARMACOLOGY
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.
INDICATIONS AND USAGE
Tetracaine hydrochloride is indicated for the production of spinal
anesthesia for
procedures requiring two to three hours.
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 sho