Mydriacil

What is Mydriacil and how is it used?

Mydriacil is a prescription medicine used to treat the symptoms of Refraction (Mydriasis) and Funduscopic Exam (Cyclopegia). Mydriacil may be used alone or with other medications.

Mydriacil belongs to a class of drugs called Cyclopegics/Mydriatics.

What are the possible side effects of Mydriacil?

Mydriacil may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• unusual changes in mood or behavior,
• fast, slow, or uneven heart rate,
• shortness of breath, and
• lightheadedness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Mydriacil include:

• blurred vision,
• mild stinging or the eyes,
• increased sensitivity to light,
• dry mouth, and
• headache

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Mydriacil. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

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 Contains

Active: tropicamide 0.5% or 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.

INDICATIONS

For mydriasis and cycloplegia for diagnostic procedures.

DOSAGE AND 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.

HOW SUPPLIED

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

0.5% - 15 mL: NDC 0998-0354-15
1% - 3 mL: NDC 0065-0355-03
15 mL: NDC 0998-0355-15

Storage

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

Manufactured By: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA. Revised: Dec 2017

SIDE EFFECTS

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.

DRUG INTERACTIONS

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

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.

PRECAUTIONS

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

Pediatric Use

Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (see WARNINGS). Keep this and all medications out of the reach of children.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

OVERDOSE

No Information Provided

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

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.

PATIENT INFORMATION

Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.