Tropicamide Ophthalmic Solution, USP (Sterile)

Rx only

Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the following chemical structure:

C ₁₇H ₂₀N ₂O ₂

Mol.wt. 284.36

Chemical name:
Benzeneacetamide, N-ethyl-α-(hydroxymethyl)- N-(4-pyridinylmethyl)-.

Each mL contains

ACTIVE: Tropicamide 5 mg (0.5%) or 10 mg (1%); INACTIVES: Boric Acid, Hydrochloric Acid, Edetate Disodium Dihydrate, Purified Water. Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) pH range 4.0 - 5.8. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

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 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength (0.5%) 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 reaction and behavioral disturbance 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 cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC , at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For refraction, one or two drops of the 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, one or two drops of the 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 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:

NCD 68071-4004-2 Box of 2mL


Storage: Store at 20° to 25C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)

[See USP Controlled Room Temperature].

Keep container tightly closed.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW symbol IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9115805 (folded)

9115905 (flat)

pdp