Tropicamide Ophthalmic Solution, USP

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.

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15 to 30 minutes, and the duration of activity is approximately 3 to 8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

For mydriasis and cycloplegia for diagnostic procedures.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

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.

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.

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.

Tropicamide ophthalmic solution, USP, 0.5% is supplied in an LDPE plastic bottle with a dropper tip as:

NDC: 70518-2759-00

PACKAGING: 1 in 1 CARTON, 15 mL in 1 BOTTLE PLASTIC TYPE 0

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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Tropicamide

GENERIC: Tropicamide

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-2759-0

PACKAGING: 15 mL in 1 BOTTLE, PLASTIC

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

• TROPICAMIDE 5mg in 1mL

INACTIVE INGREDIENT(S):

• BENZALKONIUM CHLORIDE
• SODIUM CHLORIDE
• EDETATE DISODIUM
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE
• WATER

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