apraclonidine hydrochloride ophthalmic solution
apraclonidine hydrochloride ophthalmic solution is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including IOPIDINE 1%. Available dosage form: solution/ drops.
Drug Details
- Generic Name
- apraclonidine hydrochloride ophthalmic solution
- Brand Names
- IOPIDINE 1%
- Application Number
- NDA019779
- Sponsor
- Harrow Eye, LLC
- NDC Codes
- 1
- Dosage Forms
- SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- APRACLONIDINE HYDROCHLORIDE
Indications and Usage
INDICATIONS AND USAGE IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. Not for injection or oral ingestion. Topical administration of apraclonidine have been reported to cause cardiovascular collapse requiring intubation and ventilation in pediatric patients 6 years and younger, including neonates. Systemic adverse reactions such as prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, bradycardia, hypertension, hypotension, hypothermia, hypotonia, pallor have also been reported. Appropriate monitoring in a clinical setting should be in place.