TETRAVISC FORTE- tetracaine hydrochloride liquid

TetraVisc Forte by

Drug Labeling and Warnings

TetraVisc Forte by is a Prescription medication manufactured, distributed, or labeled by OCuSOFT, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

C15H24N2O2-HCI                MW = 300.82

Inactive:

Boric Acid; Edetate Disodium; Hypromellose; Potassium Chloride; Sodium Borate; Sodium 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 product severe keratitis.

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.  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 woman.

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 SUSPECED ADVERSE REACTIONS, contact OCuSOFT, Inc. at 800-239-5469, www.ocusoft.com

DOSAGE AND ADMINISTRATION:

Dosage: One to two drops per eye.

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 in the eye(s) every five to ten minutes.  Five doses maximum.

HOW SUPPLIED:

Tetracaine Hydrochloride Ophthalmic Solution USP, 1.5% is supplied in:

    5 mL multi-drop plastic container

    Single unit dose plastic container

Storage:

Store at a room temperature, 15o-30o C (59o - 86o F).  Keep container tightly closed.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TETRAVISC FORTE 
tetracaine hydrochloride liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54799-504
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)	Tetracaine Hydrochloride	25 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Edetate Disodium (UNII: 7FLD91C86K)
Hypromelloses (UNII: 3NXW29V3WO)
Potassium Chloride (UNII: 660YQ98I10)
Sodium Borate (UNII: 91MBZ8H3QO)
Sodium Chloride (UNII: 451W47IQ8X)
Water (UNII: 059QF0KO0R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-504-05	5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/25/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/25/2009

Labeler - OCuSOFT, INC. (174939207)

Registrant - OCuSOFT, INC. (174939207)

Establishment
Name	Address	ID/FEI	Business Operations
OCuSOFT, INC.		174939207	MANUFACTURE(54799-504)