Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 3 mL and 15 mL in plastic DROP-TAINER® dispensers. 0.5% 15 mL: NDC 0998-0354-15 1% 3 mL: NDC 0065-0355-03 15 mL: NDC 0998-0355-15 STORAGE: Store at 8°C to 27°C (46°F-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. Rx Only; PRINCIPAL DISPLAY PANEL NDC 0065-0355-03 ALCON ® DROP-TAINER ® DISPENSER UNIT OF USE Mydriacyl ® 1 % (tropicamide ophthalmic solution, USP) 3 mL Sterile INGREDIENTS: Each mL contains: Active: Tropicamide 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH range 4.0-5.8 Rx Only USUAL DOSAGE: One or two drops topically in the eye(s). Read enclosed insert. STORAGE: Store at 8°-27°C (46°-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. © 2004, 2010 Alcon, Inc. Alcon ® ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 350544-0210 LOT: EXP.: NDC 0065-0355-03 ALCON ® Mydriacyl ® (tropicamide ophthalmic solution USP) 1 % 3 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: Tropicamide 1%. USUAL DOSAGE: One or two drops topically in the eye(s). Read enclosed insert. STORAGE: Store at 8°-27°C (46°-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. © 2000, 2004 Alcon, Inc. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA H13299-0214 LOT: EXP.:
- HOW SUPPLIED 3 mL and 15 mL in plastic DROP-TAINER® dispensers. 0.5% 15 mL: NDC 0998-0354-15 1% 3 mL: NDC 0065-0355-03 15 mL: NDC 0998-0355-15 STORAGE: Store at 8°C to 27°C (46°F-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. Rx Only
- PRINCIPAL DISPLAY PANEL NDC 0065-0355-03 ALCON ® DROP-TAINER ® DISPENSER UNIT OF USE Mydriacyl ® 1 % (tropicamide ophthalmic solution, USP) 3 mL Sterile INGREDIENTS: Each mL contains: Active: Tropicamide 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH range 4.0-5.8 Rx Only USUAL DOSAGE: One or two drops topically in the eye(s). Read enclosed insert. STORAGE: Store at 8°-27°C (46°-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. © 2004, 2010 Alcon, Inc. Alcon ® ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 350544-0210 LOT: EXP.: NDC 0065-0355-03 ALCON ® Mydriacyl ® (tropicamide ophthalmic solution USP) 1 % 3 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: Tropicamide 1%. USUAL DOSAGE: One or two drops topically in the eye(s). Read enclosed insert. STORAGE: Store at 8°-27°C (46°-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. © 2000, 2004 Alcon, Inc. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA H13299-0214 LOT: EXP.:
Overview
MYDRIACYL ® (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure: Each mL of MYDRIACYL ® (tropicamide ophthalmic solution, USP) contains: Active: tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water; pH range 4.0-5.8. chemical
Indications & Usage
For mydriasis and cycloplegia for diagnostic procedures.
Dosage & Administration
For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
Warnings & Precautions
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered. Mydriatics may produce a transient elevation of intraocular pressure. Remove contact lenses before using.
Contraindications
Contraindicated in persons showing hypersensitivity to any component of this preparation.
Adverse Reactions
Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
Drug Interactions
Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
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