TETRACAINE HYDROCHLORIDE- tetracaine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AMICI PHARMACEUTICALS LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea, other short corneal and conjunctival procedures. Should not be used by the patient without physician supervision, or in those persons showing hypersensitivity to any component of this preparation. This product should never be prescribed for the patient’s own use.

Product summary:

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is supplied in a plastic bottle with a controlled drop tip in the following size: 15 mL - NDC 69292-317-15

Authorization status:

unapproved drug other

Summary of Product characteristics

TETRACAINE HYDROCHLORIDE- TETRACAINE HYDROCHLORIDE SOLUTION
AMICI PHARMACEUTICALS LLC
_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 HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.5%
(STERILE)
RX ONLY
DESCRIPTION:
Tetracaine Hydrochloride is a sterile aqueous topical anesthetic
ophthalmic solution. The active
ingredient is represented by the chemical structure:
C
H N O ·HCI
Mol. wt. 300.83
Benzoic acid, 4-[butylamino]-, 2-[dimethylamino]ethyl ester,
monohydrochloride.
EACH ML CONTAINS: ACTIVE: Tetracaine Hydrochloride 5 mg (0.5%);
INACTIVES: Boric Acid,
Potassium Chloride, Edetate Disodium and Purified Water. Sodium
Hydroxide and/or Hydrochloric
Acid may be added to adjust pH (3.7 - 6.0). PRESERVATIVE ADDED:
Chlorobutanol 0.4%.
CLINICAL PHARMACOLOGY:
Topical anesthetics stabilize the neuronal membrane and prevent the
initiation and transmission of nerve
impulses, thereby effecting local anesthesia. The onset of anesthesia
usually begins within 30 seconds
and lasts a relatively short period of time.
INDICATIONS AND USAGE:
For procedures in which a rapid and short-acting topical ophthalmic
anesthetic is indicated such as in
tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival
scraping for diagnostic
purposes, suture removal from the cornea, other short corneal and
conjunctival procedures.
CONTRAINDICATIONS:
Should not be used by the patient without physician supervision, or in
those persons showing
hypersensitivity to any component of this preparation. This product
should never be prescribed for the
patient’s own use.
WARNINGS:
15
24
2
2
Prolonged use results in diminished duration of anesthesia and
retarded healing. This may cause the
drug to be used more frequently creating a “vicious circle.”
Subsequent corneal infection and/or
corneal opacification with accompanying permanent visual loss or
corneal perforation may occur.
PRECAUTIONS: