TETRACAINE- tetracaine hcl injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

tetracaine hydrochloride (UNII: 5NF5D4OPCI) (tetracaine - UNII:0619F35CGV)

זמין מ:

Akorn

INN (שם בינלאומי):

tetracaine hydrochloride

הרכב:

tetracaine hydrochloride 10 mg in 1 mL

מסלול נתינה (של תרופות):

SUBARACHNOID

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

1% isotonic isobaric solution: 2 mL Ampules, box of 25. NDC 17478-045-32 Storage: Store under refrigeration. Protect ampules from light.

מצב אישור:

unapproved drug other

מאפייני מוצר

TETRACAINE- TETRACAINE HCL INJECTION
AKORN
_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 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.
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 shoul