Label: CYCLOMYDRIL- cyclopentolate hydrochloride and phenylephrine hydrochloride solution/ drops

  • NDC Code(s): 0065-0359-02, 0065-0359-05
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 29, 2018

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  • 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:

    
cyclopentolate hydrochloride

    Established Name:
    Cyclopentolate Hydrochloride

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

    Molecular Formula:

    Molecular Weight:

    
phenylephrine hydrochloride

    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.

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  • 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.

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  • INDICATIONS AND USAGE

    For the production of mydriasis.

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  • CONTRAINDICATIONS

    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.

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  • WARNINGS

    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.

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  • PRECAUTIONS

    General

    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.

    Information for Patients

    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.

    Drug Interactions

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

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.

    Pregnancy

    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.

    Nursing Mothers

    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.

    Pediatric Use

    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).

    Geriatric Use

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

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  • ADVERSE REACTIONS

    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.

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

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  • 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.

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  • HOW 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)

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  • SPL UNCLASSIFIED SECTION


    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

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  • 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).

    ©2004, 2010, 2013 Novartis

    9009878-0713

    Alcon®
    a Novartis company

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

    LOT:

    EXP.:

    carton

    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.:

    H12853-0713

    label
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  • INGREDIENTS AND APPEARANCE
    CYCLOMYDRIL 
    cyclopentolate hydrochloride and phenylephrine hydrochloride solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0359
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J) CYCLOPENTOLATE HYDROCHLORIDE 2 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0065-0359-02 2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/1958
    2 NDC:0065-0359-05 5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/1958
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA084300 06/30/1958
    Labeler - Alcon Laboratories, Inc. (008018525)
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