LEVOPHED(R) NOREPINEPHRINE BITARTRATE

FDA Drug Profile — LEVOPHED(R) NOREPINEPHRINE BITARTRATE

Drug Details

Generic Name
LEVOPHED(R) NOREPINEPHRINE BITARTRATE
Brand Names
LEVOPHED(R) NOREPINEPHRINE BITARTRATE
Application Number
NDA007513
Sponsor
HF Acquisition Co LLC, DBA HealthFirst
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients
NOREPINEPHRINE BITARTRATE

Indications and Usage

INDICATIONS & USAGE For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension.

Warnings

WARNINGS LEVOPHED should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result. LEVOPHED Bitartrate Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.