CYCLOGYL - cyclopentolate hydrochloride solution/ drops
Alcon Laboratories, Inc.
0.5% carton0.5% label1% carton1% label2% carton2% label
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
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Molecular Weight=327.85
Molecular Formula: C17 H25 NO3 �HCl
Established name: Cyclopentolate Hydrochloride
Chemical name: 2-(Dimethylamino)ethyl 1-hydroxy-?-phenylcyclopentaneacetate hydrochloride
Each mL 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
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 papillary 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 AND USAGE
Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.