Mydriacyl™ (tropicamide ophthalmic solution, USP) Rx Only

MYDRIACYL™ (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:

Each mL of MYDRIACYL™ (tropicamide ophthalmic solution, USP) 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 range 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 15-30 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 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 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.

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.

3 mL and 15 mL in plastic DROP-TAINER^® dispensers.

1%         3 mL: NDC 0065-0355-03

            15 mL: NDC 0998-0355-15

STORAGE: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed.

© 2021 Alcon Inc.
Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134
T2018-39

Revised: November 2021

W300051445-1121                                  Alcon

NDC 0998-0355-15

Alcon^®

Mydriacyl^® 1%
(tropicamide ophthalmic solution, USP)

15 mL Sterile

Rx Only

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.

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 range 4.0-5.8.

©2002, 2010 Alcon, Inc.

Alcon^®
ALCON LABORATORIES, INC.
Fort Worth, Texas. 76134 USA
Product of Japan
9016373 US

STORAGE: Store at 8º-27ºC (46º-80ºF). Do not refrigerate or store at high temperatures. Keep container tightly closed.

FOR TOPICAL OPHTHALMIC USE ONLY.

SN:
LOT:
EXP.:
GTIN: 00309980355156

NDC 0998-0355-15
Alcon^®
Mydriacyl^® 1%
(tropicamide ophthalmic solution, USP)

Sterile 15 mL

Rx Only         FOR TOPICAL OPHTHALMIC USE ONLY
A Sterile Anticholinergic Agent.
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 range 4.0-5.8.
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 8º-27ºC (46º-80ºF).
Do not refrigerate or store at high temperatures.
Keep container tightly closed.
ALCON LABORATORIES, INC.
Fort Worth, Texas. 76134 USA            Printed in USA
©2002, 2004 Alcon Laboratories, Inc.

H15341 US

LOT:                  EXP.: