preferable Alcaine Generic Name: proparacaine hydrochloride Dosage Form: ophthalmic solution Overview Side Effects Dosage Professional Reviews More Support Group Q & A Pricing & Coupons DESCRIPTION: Alcaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula: Established name: Proparacaine Hydrochloride Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. Molecular Weight: 330.85 Each mL contains: Active: proparacaine hydrochloride 5 mg 0.5%. Preservative: benzalkonium chloride (0.01%). Inactives: glycerin and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Slideshow A Joint Effort: A Provider's Guide To Orthopedic Pain Options CLINICAL PHARMACOLOGY: Alcaine ophthalmic solution is a rapidly-acting topical anesthetic, with induced anesthesia lasting approximately 10-20 minutes. INDICATIONS AND USAGE: Alcaine ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures. CONTRAINDICATIONS: Alcaine ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation. WARNINGS: NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss. PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females. Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Alcaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman 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 proparacaine hydrochloride is administered to a nursing woman. Pediatric Use: Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients. Geriatric Use: No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients. ADVERSE REACTIONS: Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported. Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported. DOSAGE AND ADMINISTRATION: Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating. Short corneal and conjunctival procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. NOTE: Alcaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution. HOW SUPPLIED: Alcaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in 15 mL DROP-TAINER dispensers. NDC 0998-0016-15 Storage: Bottle must be stored in unit carton to protect contents from light. Store bottles under refrigeration at 2 - 8 C (36 - 46 F). Rx Only 2004 Alcon, Inc. ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, Texas 76134 USA Printed in USA MedInfo@AlconLabs.com 1-800-757-9195 249039-0609 PRINCIPAL DISPLAY PANEL NDC 0998-0016-15 Alcon Alcaine (proparacaine hydrochloride ophthalmic solution USP) 0.5% 15 mL Sterile Rx Only PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution. USUAL DOSAGE: 1 or 2 drops. Read enclosed insert. Bottles must be stored in unit carton to protect from light. STORAGE: Store between 2º-8ºC (36º-46ºF). Alcaine (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution. INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). Preservative: benzalkonium chloride 0.01%. Inactives : glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water pH range 4.0 to 6.0 2001, 2004, 2009 Alcon, Inc. 1-800-757-9195 MedInfo@AlconLabs.com Alcon ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, Texas 76134 USA Printed in USA 359039-0509 LOT: EXP.: NDC 0998-0016-15 Alcon Alcaine (proparacaine hydrochloride ophthalmic solution USP) 0.5% Sterile 15 mL Rx Only PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution. USUAL DOSAGE: 1 or 2 drops. Read enclosed insert. STORAGE: Store between 2º-8ºC (36º-46ºF). Bottles must be stored in unit carton to protect from light. Alcaine (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution. INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 2001, 2004 Alcon, Inc. LOT/EXP.: H12934-0813 Alcaine proparacaine hydrochloride solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0998-0016 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPARACAINE HYDROCHLORIDE (PROPARACAINE) PROPARACAINE HYDROCHLORIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE GLYCERIN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:0998-0016-15 1 BOTTLE in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA080027 10/19/1973 Labeler - Alcon Laboratories, Inc. (008018525) Registrant - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations Alcon Research Ltd 007672236 manufacture(0998-0016) Revised: 01/2016 Alcon Laboratories, Inc. Next User Reviews Print this page Add to My Med List More about Alcaine (proparacaine ophthalmic) Side Effects Dosage Information Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: ophthalmic anesthetics Consumer resources Alcaine Alcaine (Advanced Reading) Professional resources Proparacaine (FDA) Other brands: Ophthetic Related treatment guides Ophthalmic Surgery FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Novartis Pharmaceuticals Corporation Drug Class Ophthalmic anesthetics Related Drugs ophthalmic anesthetics lidocaine ophthalmic , tetracaine ophthalmic , proparacaine ophthalmic , Akten , TetraVisc Ophthalmic Surgery lidocaine ophthalmic , proparacaine ophthalmic , Omidria , Balanced Salt Solution , Akten , BSS Plus , Navstel , BSS , Ophthetic , Endosol Extra , More... 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