Drug Facts
Composition & Profile
Identifiers & Packaging
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 to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle.; 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° to 25°C (46°-77°F). After opening Cyclogyl can be used until the expiration date on the bottle. ALCON ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain 300037981-0520 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° to 25°C (46° to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 300037980-0520 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° to 25°C (46° to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle. FOR TOPICAL OPHTHALMIC USE ONLY. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain Printed in the USA 300037979 -0520 SN: LOT: EXP.: GTIN: 00300650396059 NDC 0065-0396-05 Alcon Cyclogyl ® 1% (cyclopentolate hydrochloride ophthalmic solution, USP) Sterile 5 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° to 25°C (46° to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA LOT EXP.: 300037978-0520 NDC 0065-0397-15 Alcon 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° to 25°C (46° to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle. 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. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain Printed in USA 300037977-0520 SN: LOT: EXP.: GTIN: 00300650397155 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° to 25°C (46° to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA LOT: EXP.: 300037975-0520
- 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 to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle.
- 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° to 25°C (46°-77°F). After opening Cyclogyl can be used until the expiration date on the bottle. ALCON ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain 300037981-0520 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° to 25°C (46° to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 300037980-0520 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° to 25°C (46° to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle. FOR TOPICAL OPHTHALMIC USE ONLY. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain Printed in the USA 300037979 -0520 SN: LOT: EXP.: GTIN: 00300650396059 NDC 0065-0396-05 Alcon Cyclogyl ® 1% (cyclopentolate hydrochloride ophthalmic solution, USP) Sterile 5 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° to 25°C (46° to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA LOT EXP.: 300037978-0520 NDC 0065-0397-15 Alcon 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° to 25°C (46° to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle. 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. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Spain Printed in USA 300037977-0520 SN: LOT: EXP.: GTIN: 00300650397155 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° to 25°C (46° to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA LOT: EXP.: 300037975-0520
Overview
Rx Only 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. chemical
Indications & Usage
: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Dosage & 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.
Warnings & Precautions
WARNINGS: FOR TOPICAL OPHTHALMIC USE ONLY . NOT FOR INJECTION. This preparation may cause Central Nervous System (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. Therefore, patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration.
Contraindications
: Should not be used if the patient is hypersensitive to any component of this preparation.
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.
Drug Interactions
Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
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