cyclopentolate hydrochloride
Drug Details
- Generic Name
- cyclopentolate hydrochloride
- Brand Names
- Cyclogyl
- Application Number
- ANDA084108
- Sponsor
- Alcon Laboratories, Inc.
- NDC Codes
- 3
- Dosage Forms
- SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- CYCLOPENTOLATE HYDROCHLORIDE
Indications and Usage
INDICATIONS AND USAGE Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Warnings
WARNINGS For topical ophthalmic use. Not for injection. This preparation may cause Central Nervous System (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, USP per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation. Mydriatics may produce a transient elevation of intraocular pressure. Patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration. Mydriatics may produce a transient elevation of intraocular pressure.