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:

Molecular Weight:

Established Name:
Phenylephrine Hydrochloride

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

Molecular Formula:

Molecular Weight:

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.

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.

For the production of mydriasis.

Do not use in patients with untreated narrow-angle glaucoma or with untreated anatomically narrow angles or where there is hypersensitivity to any component of this preparation.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. The use of this combination may have an adverse effect on individuals suffering from cardiovascular disease, hypertension, and hyperthyroidism, and it may cause CNS disturbances. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. Observe infants closely for at least 30 minutes.

Mydriatics may produce a transient elevation of intraocular pressure.

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, and failure to recognize people. 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, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death.

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. Patients exhibiting signs of overdosage should receive supportive care and monitoring.

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.

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)

Alcon®
a Novartis Company

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

©2004, 2013, 2018 Novartis

T2018-97

Revised: June 2018

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).

©2004, 2010, 2013 Novartis

9014758 US

Alcon®
a Novartis company

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

LOT:

EXP.:

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°-77°F).

Printed in USA
©2004, 2013 Novartis

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

LOT:

EXP.:

H14882 US