Tetracaine Hydrochloride Ophthalmic Solution, USP 0_5 percent

Tetracaine Hydrochloride Ophthalmic

Solution, USP 0.5% Sterile

Rx Only

Tetracaine Hydrochloride 0.5% is a sterile topical ophthalmic solution useful in producing surface anesthesia of the eye. The active ingredient is represented by the structural formula:

The structural formula for Tetracaine Hydrochloride 0.5% is a sterile topical ophthalmic solution useful in producing surface anesthesia of the eye.

Established name:

Tetracaine Hydrochloride

Chemical name:

Benzoic acid, 4-(butylamino)-,2-(dimethylamino)ethyl ester, monohydrochloride

CONTAINS:

Active: Tetracaine Hydrochloride 0.5%; Preservative: Chlorobutanol; Inactive: Boric Acid, Edetate Disodium, Potassium Chloride, Water for Injection, USP. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH.

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% acts by decreasing the permeability of the neuronal membrane, thereby decreasing the flux of sodium, potassium and other ions associated with propagation of the nerve impulse. The onset of anesthesia usually begins within 30 seconds and lasts a relatively short period of time.

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 or conjunctiva, 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.

For topical ophthalmic use only. Not for parenteral use. Not for injection. Do not use solution if it contains crystals or if it is cloudy or discolored. 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. Prolonged use may also produce severe keratitis.

Transient symptoms (signs) such as stinging, burning and conjunctival redness may occur. A rare, severe, immediate type allergic corneal reaction has been reported characterized by acute diffuse epithelial keratitis with filament formation and/or sloughing of large areas of necrotic epithelium, diffuse stromal edema, descemetitis and iritis.

To Report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 631-722-5988 or 1-800-258-2471, 9am - 5pm EST Monday – Friday, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.  

For Tonometry and Other Procedures of Short Duration:
Instill one or two drops just prior to evaluation.

For Minor Surgical Procedures such as Foreign Body or Suture Removal:
Instill one or two drops every five to ten minutes for one to three doses.

For Prolonged Anesthesia as in Cataract Extraction:
Instill one or two drops in the eye(s) every five to ten minutes for three to five doses.

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in a 15mL size.

Store at room temperature, 15°-30°C (59°-86°F).

Keep container tightly closed. Protect from light.

Rev. 01/2018
MG #17273

Manufactured by:       [LOGO]

      Altaire pharmaceuticals, Inc.

      Aquebogue, NY 11931 USA

NDC 59390-181-13
ALTACAINE
Tetracaine Hydrochloride
Ophthalmic Solution
USP, 0.5% STERILE
Rx Only
15 mL

PRINCIPAL DISPLAY PANEL NDC 59390-181-13 ALTACAINE Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% STERILE Rx Only 15 mL