DailyMed Label: Cyclomydril

DailyMed Label: Cyclomydril

2023

DailyMed Prescription

Cyclomydril

cyclopentolate hydrochloride and phenylephrine hydrochloride

Alcon Laboratories, Inc.

NDC: 0065-0359

NDC: 0065-0359

NDC: 0065-0359

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 phenylephrine hydrochloride

For the production of mydriasis.

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.

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.

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma. The effect of long-term use of this preparation has not been established, therefore, it should be restricted to short-term use. Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in 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. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential. Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed. It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is administered to a nursing woman. Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for 4 hours after examination. Observe infants closely for at least 30 minutes (see PRECAUTIONS ). No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

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)

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.

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