Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)
AMICI PHARMACEUTICALS LLC
OPHTHALMIC
PRESCRIPTION DRUG
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, 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. This product should never be prescribed for the patient’s own use.
Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is supplied in a plastic bottle with a controlled drop tip in the following size: 15 mL - NDC 69292-317-15
unapproved drug other
TETRACAINE HYDROCHLORIDE- TETRACAINE HYDROCHLORIDE SOLUTION AMICI PHARMACEUTICALS LLC _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 is a sterile aqueous topical anesthetic ophthalmic solution. The active ingredient is represented by the chemical structure: C H N O ·HCI Mol. wt. 300.83 Benzoic acid, 4-[butylamino]-, 2-[dimethylamino]ethyl ester, monohydrochloride. EACH ML CONTAINS: ACTIVE: Tetracaine Hydrochloride 5 mg (0.5%); INACTIVES: Boric Acid, Potassium Chloride, Edetate Disodium and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (3.7 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.4%. CLINICAL PHARMACOLOGY: Topical anesthetics stabilize the neuronal membrane and prevent the initiation and transmission of nerve impulses, thereby effecting local anesthesia. 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, 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. This product should never be prescribed for the patient’s own use. WARNINGS: 15 24 2 2 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. PRECAUTIONS: read_full_document