Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Tropicamide Ophthalmic Solution USP, 1% (15 mL) filled in 15 mL Natural LDPE Bottle and natural LDPE nozzles with red colored HDPE caps. NDC 85766-040-15 (relabeled from NDC 70069-121-01) STORAGE: Store at 8°C to 27°C (46°F-80°F). Do not refrigerate or store at high temperatures. Avoid freezing. Keep container tightly closed. Rx only Distributed by: Sportpharm 2237 N Commerce Parkway, STE 1, Weston, Florida-33326 Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label
- HOW SUPPLIED Tropicamide Ophthalmic Solution USP, 1% (15 mL) filled in 15 mL Natural LDPE Bottle and natural LDPE nozzles with red colored HDPE caps. NDC 85766-040-15 (relabeled from NDC 70069-121-01) STORAGE: Store at 8°C to 27°C (46°F-80°F). Do not refrigerate or store at high temperatures. Avoid freezing. Keep container tightly closed. Rx only Distributed by: Sportpharm 2237 N Commerce Parkway, STE 1, Weston, Florida-33326 Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label
Overview
Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Established name: Tropicamide ophthalmic solution, USP Chemical name: Benzeneacetamide, N -ethyl-α-(hydroxymethyl)- N -(4-pyridinylmethyl). 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), Water for injection. pH range 4.0 - 5.8. Image
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. 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 punctuate 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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