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Tetracaine Hydrochloride Ophthalmic
Solution, USP 0.5% Sterile
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:
Benzoic acid, 4-(butylamino)-,2-(dimethylamino)ethyl ester, monohydrochloride
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.
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.
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.
No studies have been conducted in animals or in humans to evaluate the potential of these effects.
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.
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.
Safety and effectiveness in children have not been established.
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. 01/2018MG #17273
Manufactured by: [LOGO]
Altaire pharmaceuticals, Inc.
Aquebogue, NY 11931 USA
NDC 59390-181-13ALTACAINETetracaine HydrochlorideOphthalmic SolutionUSP, 0.5% STERILERx Only15 mL
Altaire Pharmaceuticals Inc.
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