Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 3mL and 15mL in plastic dispensers. 1% - 3 mL: NDC 61314-355-01 1% - 15 mL: NDC 61314-355-02 STORAGE: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. Revised: 11-2021; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 61314-355-01 Tropicamide Ophthalmic Solution, USP 1% Rx only STERILE 3 mL SANDOZ A Novartis Division Side Panel: A Sterile Anticholinergic Agent Usual Dosage: One or two drops topically in the eye(s). Read enclosed insert. Precaution: Do not touch dropper tip to any surface, as this may contaminate the solution. Storage: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperature. Keep container tightly closed. 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 4.0 - 5.8. Keep out of the reach of children. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540 Product of Japan 9017187-0620 Rev. 06/2020 3ml-carton
- HOW SUPPLIED 3mL and 15mL in plastic dispensers. 1% - 3 mL: NDC 61314-355-01 1% - 15 mL: NDC 61314-355-02 STORAGE: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. Revised: 11-2021
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 61314-355-01 Tropicamide Ophthalmic Solution, USP 1% Rx only STERILE 3 mL SANDOZ A Novartis Division Side Panel: A Sterile Anticholinergic Agent Usual Dosage: One or two drops topically in the eye(s). Read enclosed insert. Precaution: Do not touch dropper tip to any surface, as this may contaminate the solution. Storage: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperature. Keep container tightly closed. 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 4.0 - 5.8. Keep out of the reach of children. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540 Product of Japan 9017187-0620 Rev. 06/2020 3ml-carton
Overview
Rx Only DESCRIPTION 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: Established name: Tropicamide ophthalmic solution 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), purified water. pH 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. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.
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