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% cyclopentolate hydrochloride ophthalmic solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes.
Mydriatics may produce a transient elevation of intraocular pressure.
There is currently no manufacturer warning information available for this drug.
Cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.
AK-PENTOLATE™ (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 • HCl
The active ingredient is represented by the structural formula:
AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution) USP, 1% & 2%
Each mL contains: Active: Cyclopentolate Hydrochloride 10 mg (1%) or 20 mg (2%).
Preservative: Benzalkonium Chloride 0.1 mg (0.01%).
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.