Apraclonidine Hydrochloride

FDA Drug Profile

Apraclonidine Hydrochloride is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: powder.

Drug Details

Generic Name
Apraclonidine Hydrochloride
Brand Names
N/A
Application Number
Sponsor
CARBOGEN AMCIS AG
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
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.