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AK-Pentolate (Cyclopentolate Hydrochloride Ophthalmic) - Description and Clinical Pharmacology

 
 



Rx only

DESCRIPTION:

Cyclopentolate Hydrochloride Ophthalmic Solution is an anticholinergic prepared as a sterile, borate buffered solution for topical ocular use. It is supplied in two strengths.

Chemical name:

2-(Dimethylamino)ethyl 1-hydroxy-α-phenylcyclopentaneacetate hydrochloride

MW=327.85 C17H25NO3 • HCI

The active ingredient is represented by the structural formula:

Cyclopentolate Hydrochloride Ophthalmic Solution USP 1% & 2%

Each mL contains: Active: Cyclopentolate Hydrochloride 10 mg (1%) or 20 mg (2%).

Inactives: Boric Acid, Edetate Disodium, Potassium Chloride (except 2% strength), Sodium Carbonate and/or Hydrochloric Acid may be added to adjust pH (3.0 to 5.5) and Purified Water USP.

Preservative: Benzalkonium Chloride 0.1 mg (0.01%).

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.

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