Apraclonidine

FDA Drug Profile — Apraclonidine

Apraclonidine is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Apraclonidine. Available dosage form: solution.

Drug Details

Generic Name
Apraclonidine
Brand Names
Apraclonidine
Application Number
NDA020258
Sponsor
Sandoz Inc
NDC Codes
1
Dosage Forms
SOLUTION
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.