FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Ak-pentolate Manufacturers
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Rebel Distributors Corp.
Ak-pentolate | Rebel Distributors Corp.
Adults: Instill one or two drops of 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 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 1% solution if necessary.
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