CYCLOGYL- cyclopentolate hydrochloride solution/ drops

Cyclogyl by

Drug Labeling and Warnings

Cyclogyl by is a Prescription medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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
 

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.:

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 
 

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  

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.:

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

INGREDIENTS AND APPEARANCE

CYCLOGYL  
cyclopentolate hydrochloride solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0065-0395
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J)	CYCLOPENTOLATE HYDROCHLORIDE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0395-15	1 in 1 CARTON	10/15/1975
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA084109	10/15/1975

CYCLOGYL  
cyclopentolate hydrochloride solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0065-0396
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J)	CYCLOPENTOLATE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0396-02	1 in 1 CARTON	10/15/1975
1		2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0065-0396-05	1 in 1 CARTON	10/15/1975
2		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 0065-0396-15	1 in 1 CARTON	10/15/1975	07/31/2019
3		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA084110	10/15/1975

CYCLOGYL  
cyclopentolate hydrochloride solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0065-0397
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J)	CYCLOPENTOLATE HYDROCHLORIDE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0397-02	1 in 1 CARTON	10/15/1975
1		2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0065-0397-05	1 in 1 CARTON	10/15/1975
2		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 0065-0397-15	1 in 1 CARTON	10/15/1975
3		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA084108	10/15/1975

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-0395, 0065-0396, 0065-0397)