Drug Facts
Composition & Profile
Identifiers & Packaging
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); 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). 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
- 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)
- 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). 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
Overview
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: C 17 H 25 NO 3 • HCl Molecular Weight: 327.85 g/mol Established Name: Phenylephrine Hydrochloride Chemical Name: 3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-. Molecular Formula: C 9 H 13 NO 2 • HCl Molecular Weight: 203.67 g/mol 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
Indications & Usage
For the production of mydriasis.
Dosage & 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.
Warnings & Precautions
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. 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.
Contraindications
Do not use in patients with hypersensitivity to any component of this preparation.
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. 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, convulsion, bradycardia, apnea, necrotizing colitis and abdominal distention (in newborns and especially premature infants), skin rash, drowsiness, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death. Systemic toxicity can result from topical application of sympathomimetic drugs: headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.
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