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American Regent, Inc.
5 Ramsey Road
Shirley, NY 11967
niCARdipine Hydrochloride Injection, USP
For Intravenous Use
VIALS MUST BE DILUTED BEFORE INFUSION
INDICATIONS AND USAGE: Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits.
IMPORTANT SAFETY INFORMATION
Contraindications: Do not use in patients with advanced aortic stenosis.
WARNINGS AND PRECAUTIONS
Closely monitor response in patients not limited to those with angina, heart failure, impaired hepatic function or renal impairment and avoid too rapid or excessive blood pressure drop during treatment.
To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins. To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours.
Most common adverse reactions are headache (15%), hypotension (6%), tachycardia (4%) and nausea/vomiting (5%).
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. The following adverse reaction has been identified during post-approval use of nicardipine hydrochloride injection: decreased oxygen saturation (possible pulmonary shunting).
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy Category C. Based on animal data may cause fetal harm. Nicardipine hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: Minimally excreted into human milk. Consider the possibility of infant exposure.
Pediatric Use: Safety and efficacy in patients under the age of 18 have not been established.
For treatment of overdosage, implement standard measures including monitoring of cardiac and respiratory functions.
For additional safety information, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.