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Altacaine Ophthalmic Solution

Generic Name: tetracaine hydrochloride
Dosage Form: ophthalmic solution

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.

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% Sterile
Rx Only

DESCRIPTION:

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:

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 to adjust pH.

CLINICAL PHARMACOLOGY:

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.

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 or conjunctiva, 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.

WARNINGS:

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.

PRECAUTIONS:

General:

Do not touch dropper tip to any surface as this may contaminate the solution. As with all anesthetics, continuous and prolonged use should be avoided. Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should be used cautiously in patients with known allergy or cardiac  disease. If signs of sensitivity develop during the treatment or irritation persists or increases, patients should be advised to discontinue use and consult prescribing physician.

Information for Patients:

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

After instillation of this product, the surface of the eye is insensitive and can be scratched without your feeling it. Do not rub eye. Do not instill this product repeatedly because severe eye damage may occur.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No studies have been conducted in animals or in humans to evaluate the potential of these effects.

Pregnancy Category C:

Animal reproduction studies have not been performed with Tetracaine Hydrochloride. It is also not known whether Tetracaine Hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should be given to pregnant women only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is administered to a nursing mother.

Pediatric Use:

 Safety and effectiveness in children have not been established.

ADVERSE REACTIONS:

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 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:

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.

HOW SUPPLIED:

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in 15 mL and 30 mL single drop plastic containers.

STORAGE:

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

Keep container tightly closed. Protect from light.

Rev. 06/2014
MG #17273

Manufactured by:                     [LOGO]
                                                 ALTAIRE PHARMACEUTICALS, INC.
                                                 Aquebogue, NY 11931 USA

PRINCIPAL DISPLAY PANEL

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

ALTACAINE 
tetracaine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59390-181
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL  
BORIC ACID  
EDETATE DISODIUM  
POTASSIUM CHLORIDE  
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:59390-181-13 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/01/2002
Labeler - Altaire Pharmaceuticals Inc. (786790378)
Revised: 06/2014
 
Altaire Pharmaceuticals Inc.



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