Label: CYCLOGYL- cyclopentolate hydrochloride solution/ drops

  • NDC Code(s): 0065-0395-15, 0065-0396-02, 0065-0396-05, 0065-0396-15, view more
    0065-0397-02, 0065-0397-05, 0065-0397-15
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 19, 2019

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    DESCRIPTION: CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution, USP) is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use. It is supplied in three strengths. The active ingredient is represented by the structural formula:

    
chemical

    Each mL of CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution, USP) contains: Active: cyclopentolate hydrochloride 0.5%, 1% or 2%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY: This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: Should not be used when untreated narrow-angle glaucoma, or untreated anatomically narrow angles are present, or if the patient is hypersensitive to any component of this preparation.

  • WARNINGS

    WARNINGS: FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. This preparation may cause 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. To minimize absorption, use only 1 drop of 0.5% CYCLOGYL solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation.

    Mydriatics may produce a transient elevation of intraocular pressure.

  • 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.

    Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients 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 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: Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution, USP).

    Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered 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 cyclopentolate hydrochloride 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 four (4) hours after examination. Observe infants closely for at least 30 minutes (see WARNINGS).

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

  • ADVERSE REACTIONS:

    Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported.

    Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. 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 anticholinergic drugs, but the central nervous system manifestations as noted above are more common. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, 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.

  • OVERDOSAGE

    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.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.

  • HOW SUPPLIED

    HOW SUPPLIED: In multiple-dose plastic DROP-TAINER® dispensers:

          0.5% CYCLOGYL                  1% CYCLOGYL                    2% CYCLOGYL

    15 mL NDC 0065-0395-15    2 mL NDC 0065-0396-02      2 mL NDC 0065-0397-02

                                                    5 mL NDC 0065-0396-05      5 mL NDC 0065-0397-05

                                                  15 mL NDC 0065-0396-15    15 mL NDC 0065-0397-15

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

    Rx Only

  • SPL UNCLASSIFIED SECTION

    © 2004, 2015, 2018 Novartis

    Distributed by:
    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134


    Alcon®
    a Novartis company
    T2018-115


    Revised: September 2018

  • PRINCIPAL DISPLAY PANEL

    NDC 0065-0395-15

    Alcon®

    Cyclogyl® 0.5%
    (cyclopentolate hydrochloride ophthalmic solution, USP)

    15 mL Sterile

    INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

    FOR TOPICAL OPHTHALMIC USE ONLY.

    Rx Only

    USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes. Read enclosed insert.

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

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

    ©2004, 2011, 2015 Novartis

    ALCON®
    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    Product of Spain

    9013633 US  

    SN:
    LOT:
    EXP.:
    GTIN: 00300650395151
     

    0.5% carton

    NDC 0065-0395-15

    Alcon®

    Cyclogyl® 0.5%
    (cyclopentolate hydrochloride ophthalmic solution, USP)

    Sterile 15 mL

    Rx Only

    INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

    PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.
    FOR TOPICAL OPHTHALMIC USE ONLY

    USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed insert.

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

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

    H14611 US  

    LOT:               EXP.:

    0.5% label

    NDC 0065-0396-05

    Alcon®
    Cyclogyl® 1%
    (cyclopentolate hydrochloride ophthalmic solution, USP)

    5 mL Sterile

    INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

    Rx Only

    USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed Insert.

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

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

    FOR TOPICAL OPHTHALMIC USE ONLY.

    © 2004, 2010, 2015 Novartis  

    Alcon® 

    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    Product of Spain

    9013471 US 

    SN: 
    LOT:
    EXP.:
    GTIN: 00300650396059 
     

    1% carton

    NDC 0065-0396-05

    Alcon®

    Cyclogyl® 1%
    (cyclopentolate hydrochloride ophthalmic solution, USP)

    Sterile 15 mL

    Rx Only

    INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

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

    USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed insert.

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

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

    LOT               EXP.:

    H14509 US  

    1% label

    NDC 0065-0397-15

    Alcon®
    a Novartis company

    Cyclogyl® 2%
    (cyclopentolate hydrochloride ophthalmic solution, USP)

    15 mL Sterile

    Rx Only

    USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed insert.

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

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

    INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 2%. Preservative:benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5

    FOR TOPICAL OPHTHALMIC USE ONLY.

    ©2002-2004, 2010, 2015 Novartis

    Alcon®
    a Novartis company


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

    9012281-1215

    LOT:

    EXP.:

    2% carton

    NDC 0065-0397-15

    Alcon®

    Cyclogyl® 2%
    (cyclopentolate hydrochloride ophthalmic solution, USP)

    Sterile 15 mL

    Rx Only

    INGREDIENTS: Each mL contains: Active: cyclopentolate hydrochloride 2%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

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

    USUAL DOSAGE: Instill one or two drops in the eye which can be repeated in five to ten minutes if necessary. Read enclosed Insert.

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

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

    ©2003-2004, 2015 Novartis

    LOT:

    EXP.:


    H14045-1215

    2% label
  • INGREDIENTS AND APPEARANCE
    CYCLOGYL  
    cyclopentolate hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0395
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J) CYCLOPENTOLATE HYDROCHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0395-151 in 1 CARTON10/15/1975
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08410910/15/1975
    CYCLOGYL  
    cyclopentolate hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0396
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J) CYCLOPENTOLATE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0396-021 in 1 CARTON10/15/1975
    12 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0065-0396-051 in 1 CARTON10/15/1975
    25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0065-0396-151 in 1 CARTON10/15/197507/31/2019
    315 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08411010/15/1975
    CYCLOGYL  
    cyclopentolate hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0397
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J) CYCLOPENTOLATE HYDROCHLORIDE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0397-021 in 1 CARTON10/15/1975
    12 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0065-0397-051 in 1 CARTON10/15/1975
    25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0065-0397-151 in 1 CARTON10/15/1975
    315 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08410810/15/1975
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0395, 0065-0396, 0065-0397)