LEVOPHED- norepinephrine bitartrate injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Norepinephrine Bitartrate (UNII: IFY5PE3ZRW) (Norepinephrine - UNII:X4W3ENH1CV)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Norepinephrine Bitartrate

Composition:

Norepinephrine 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. LEVOPHED should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If LEVOPHED is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite “normal” blood pressure, tissue hypoxia, and lactate acidosis. LEVOPHED should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction

Product summary:

LEVOPHED, norepinephrine bitartrate injection, USP, contains the equivalent of 4 mg base of LEVOPHED per each 4 mL ampul (1 mg/mL). Supplied as: Ampuls of 4 mL in boxes of 10, NDC 0409-1443-04 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature] Protect from light. Regitine, trademark, CIBA Pharmaceuticals Company. Revised: November, 2009 EN-2297 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045, USA

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOPHED- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE
GENERAL INJECTABLES & VACCINES, INC
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LEVOPHED (NOREPINEPHRINE BITARTRATE) 4 MG INJECTION, USP 4 ML AMPULE
DES CRIPTION
RX ONLY
Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or
l-norepinephrine) is a
sympathomimetic amine which differs from epinephrine by the absence of
a methyl group on the
nitrogen atom. Norepinephrine Bitartrate is
(-)-a-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate
(1:1) (salt) monohydrate and has the following structural formula:
LEVOPHED is supplied in sterile aqueous solution in the form of the
bitartrate salt to be administered
by intravenous infusion following dilution. Norepinephrine is
sparingly soluble in water, very slightly
soluble in alcohol and ether, and readily soluble in acids. Each mL
contains the equivalent of 1 mg base
of norepinephrine, sodium chloride for isotonicity, and not more than
2 mg of
sodium metabisulfite as an antioxidant. It has a pH of 3 to 4.5. The
air in the ampuls has been displaced
by nitrogen gas.
CLINICAL PHARMACOLOGY
LEVOPHED functions as a peripheral vasoconstrictor (alpha-adrenergic
action) and as an inotropic
stimulator of the heart and dilator of coronary arteries
(beta-adrenergic action).
INDICATIONS AND 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.
CONTRAINDICATIONS
LEVOPHED should not be given to patients who are hypotensive from
blood volume deficits except as
an emergency measure to maintain coronary and cerebral artery
perfusion until blood volume
replacement therapy can be completed. If LEVOPHED is continuously
administered to maintain blood
pressure in the absence of blood volume replacement, the following may
occur: severe peripheral and
visceral vasoconstriction, decreased renal perfusion and