Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Tropicamide ophthalmic solution, USP, 0.5% is supplied in an LDPE plastic bottle with a dropper tip as: NDC 61314-354-01 15mL STORAGE Store at 8° to 25°C (46° to 77°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. After opening, this product can be used until the expiration date on the bottle.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 61314-354-01 Tropicamide Ophthalmic Solution, USP 0.5% Rx only STERILE 15 mL SANDOZ carton
- HOW SUPPLIED Tropicamide ophthalmic solution, USP, 0.5% is supplied in an LDPE plastic bottle with a dropper tip as: NDC 61314-354-01 15mL STORAGE Store at 8° to 25°C (46° to 77°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. After opening, this product can be used until the expiration date on the bottle.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 61314-354-01 Tropicamide Ophthalmic Solution, USP 0.5% Rx only STERILE 15 mL SANDOZ carton
Overview
Rx Only DESCRIPTION Tropicamide Ophthalmic Solution, USP, 0.5% is an anticholinergic prepared as a sterile topical ophthalmic solution. 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 0.5%. 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 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 cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs. 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.
Drug Interactions
Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
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