Norepinephrine Injection Concentrate

Name: Norepinephrine Injection Concentrate

Norepinephrine Injection Concentrate Description

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, USP is (-)-α-(aminomethyI)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula:

C8H11NO3·C4H6O6·H2O M.W. 337.28

Norepinephrine Bitartrate Injection USP 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 3.0 to 4.5. The air in the vials has been displaced by nitrogen gas.

Contraindications

Norepinephrine bitartrate injection 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 norepinephrine bitartrate injection 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.

Norepinephrine bitartrate injection 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) unless, in the opinion of the attending physician, the administration of norepinephrine bitartrate injection is necessary as a life-saving procedure.

Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of norepinephrine bitartrate injection during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation.

The same type of cardiac arrhythmias may result from the use of norepinephrine bitartrate injection in patients with profound hypoxia or hypercarbia.

Overdosage

Overdosage with norepinephrine bitartrate injection may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. In case of accidental overdosage, as evidenced by excessive blood pressure elevation, discontinue norepinephrine bitartrate injection until the condition of the patient stabilizes.

How is Norepinephrine Injection Concentrate Supplied

Norepinephrine Bitartrate Injection USP contains the equivalent of 4 mg base of norepinephrine bitartrate, USP per each 4 mL vial (1 mg/mL), and is available as follows:

NDC Number Size Package Size

0703-1153-03

4 mL amber
glass vial
(1 mg/mL)

10 per
shelf carton

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from light.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Rev. A 3/2015

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Package/Label Display Panel

Norepinephrine Bitartrate Injection USP 1 mg/mL, 4 mL x 10 Vials, Carton Text

  NDC 0703-1153-03 Rx only

Norepinephrine

Bitartrate Injection USP

4 mg/mL

(1 mg/mL)

FOR IV INFUSION ONLY

  Protect from Light. 10 Vials

TEVA

NOREPINEPHRINE BITARTRATE 
norepinephrine bitartrate injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0703-1153
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE) NOREPINEPHRINE 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM METABISULFITE  
WATER  
Packaging
# Item Code Package Description
1 NDC:0703-1153-03 10 VIAL, SINGLE-USE in 1 CARTON
1 NDC:0703-1153-01 4 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040455 04/01/2003
Labeler - Teva Parenteral Medicines, Inc. (794362533)
Revised: 11/2016   Teva Parenteral Medicines, Inc.
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