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TetraVisc (OCuSOFT, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID .6 mL in 1 BOTTLE, DROPPER (54799-505-01) Label Information
LIQUID 5 mL in 1 BOTTLE, DROPPER (54799-505-05) Label Information

Complete TetraVisc Information

  • DESCRIPTON:


    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:


    CH 3(CH 2)3NH      COOCH2CH2N(CH3)2.HCI



  • 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.


  • 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 excercised 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 SUSPECTED ADVERSE REACTIONS, contact OCuSOFT, Inc. at (800) 233-5469 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 maximum three doses.
    For Prolonged Anesthesia As In Cataract Extraction:
    Instill one or two drops in the eye(s) every five to ten minutes maximum five doses.


  • HOW SUPPLIED:

    Tetracaine Hydrochloride Ophthalmic Solution , USP 0.5% is supplied in:
    5 mL multi-drop plastic container NDC 54799-505-05
    0.6 mL single unit dose plastic container NDC 54799-505-01


  • Storage:

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


  • INGREDIENTS AND APPEARANCE
    TETRAVISC 
    tetracaine hydrochloride liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54799-505
    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)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54799-505-05 5 mL in 1 BOTTLE, DROPPER
    2 NDC:54799-505-01 0.6 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/02/2005
    Labeler - OCuSOFT, Inc. (174939207)
    Registrant - OCuSOFT, Inc. (174939207)
    Establishment
    Name Address ID/FEI Business Operations
    Altaire Pharmaceuticals, Inc. 786790378 manufacture