cyclopentolate hydrochloride and phenylephrine hydrochloride
Drug Details
- Generic Name
- cyclopentolate hydrochloride and phenylephrine hydrochloride
- Brand Names
- Cyclomydril
- Application Number
- ANDA084300
- Sponsor
- Alcon Laboratories, Inc.
- NDC Codes
- 1
- Dosage Forms
- SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- CYCLOPENTOLATE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Indications and Usage
INDICATIONS AND USAGE For the production of mydriasis.
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. 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.