Cyclopentolate Hydrochloride Solution/ Drops

Cyclopentolate Hydrochloride Solution/ Drops

Cyclopentolate Hydrochloride Solution/ Drops Recall

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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

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:

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%).

Cyclopentolate Hydrochloride Solution/ Drops Manufacturers


  • Akorn, Inc.
    Cyclopentolate Hydrochloride Solution/ Drops [Akorn, Inc.]
  • Rebel Distributors Corp
    Cyclopentolate Hydrochloride Solution/ Drops [Rebel Distributors Corp]
  • Physicians Total Care, Inc.
    Cyclopentolate Hydrochloride Solution/ Drops [Physicians Total Care, Inc.]
  • Bausch & Lomb Incorporated
    Cyclopentolate Hydrochloride Solution/ Drops [Bausch & Lomb Incorporated]

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