Cyclomydril: Package Insert / Prescribing Info

Cyclomydril Description

CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures:

Established Name:
Cyclopentolate Hydrochloride

Chemical Name:
2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride)

Molecular Formula:
C17H25NO3 • HCl

Molecular Weight:
327.85 g/mol

Established Name:
Phenylephrine Hydrochloride

Chemical Name:
3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-.

Molecular Formula:
C9H13NO2 • HCl

Molecular Weight:
203.67 g/mol

Each mL of CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains:
Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.
Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water.

Cyclomydril - Clinical Pharmacology

Cyclopentolate hydrochloride is an anticholinergic drug and phenylephrine hydrochloride is an adrenergic drug. This combination induces mydriasis that is greater than that of either drug alone at its respective concentration. The concentrations of cyclopentolate hydrochloride and phenylephrine hydrochloride have been selected to induce mydriasis with little accompanying cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

Indications and Usage for Cyclomydril

For the production of mydriasis.

Contraindications

Do not use in patients with hypersensitivity to any component of this preparation.

Warnings

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. This preparation may cause central nervous system (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate.

Precautions

Adverse Reactions/Side Effects

Ocular

The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis.

Nonocular

Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. Other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, vasodilation, urinary retention, diminished gastrointestinal motility, convulsion, bradycardia, apnea, necrotizing colitis and abdominal distention (in newborns and especially premature infants), skin rash, drowsiness, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death. Systemic toxicity can result from topical application of sympathomimetic drugs: headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.

Related/similar drugs

Overdosage

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Pulmonary oedema or cardiac arrest may occur due to phenylephrine toxicity. Severe intoxication is characterized by central nervous system depression, coma, circulatory and respiratory failure, and death.
Patients exhibiting signs of overdosage should receive supportive care and monitoring.

Cyclomydril Dosage and Administration

Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.

How is Cyclomydril supplied

CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is supplied as a sterile solution in 2 mL and 5 mL, in plastic DROP-TAINER® dispensers.

2 mL NDC 0065-0359-02

5 mL NDC 0065-0359-05

Storage: Store at 8°C to 25°C (46°F - 77°F)

Distributed by:
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, Texas 76134-2099

© 2025 Alcon Inc.

Revised: May 2025.

300065206-1223

PRINCIPAL DISPLAY PANEL

NDC 0065-0359-05

Alcon
Cyclomydril®
(cyclopentolate
hydrochloride,
phenylephrine
hydrochloride
ophthalmic
solution)

5 mL Sterile

Rx Only

Sterile Ophthalmic Solution

USUAL DOSAGE: Instill one drop
in each eye every five to ten
minutes. Read enclosed insert.

FOR TOPICAL OPHTHALMIC USE
ONLY

WARNING: Do not touch
dropper tip to any surface as
this may contaminate the
solution.

INGREDIENTS: Each mL
contains: Active:
cyclopentolate hydrochloride
0.2%, phenylephrine
hydrochloride 1%.
Preservative: benzalkonium
chloride 0.01%. Inactives:
edetate disodium, boric acid,
hydrochloric acid and/or
sodium carbonate (to adjust
pH), purified water.

STORAGE: Store at 8°-25° C
(46° to 77° F).

Alcon

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA

SN:
LOT:
EXP.:
GTIN: 00300650359054


300048632-0821

NDC 0065-0359-05

Alcon
Cyclomydril®
(cyclopentolate
hydrochloride,
phenylephrine
hydrochloride
ophthalmic
solution)

Sterile 5 mL

Rx Only

INGREDIENTS: Each mL contains: Actives: cyclopentolate
hydrochloride 0.2%, phenylephrine hydrochloride 1%.
Preservative: benzalkonium chloride 0.01%. Inactives:
edetate disodium, boric acid, hydrochloric acid and/or
sodium carbonate (to adjust pH), purified water.

WARNING: Do not touch dropper tip to any surface as this
may contaminate the solution.

USUAL DOSAGE: Instill one drop in each eye every five to
ten minutes. Read enclosed insert.

STORAGE: Store at 8°-25° C (46° to 77° F).

Printed in USA

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

LOT:

EXP.:

300048631-0821