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Product Name
:
NORADRENALINE ELSaad
Chemical Name
:
Noradrenaline Bitartrate
Therapeutic Category
:
Cardiovascular drugs
Pharmacologic Category
:
Alpha-/Beta- Agonist
Pharmaceutical Form
:
Ampoule
Composition
:
Noradrenaline 1mg/ml ( Eq 2mg/ml Noradrenaline Bitartrate)
Monitoring Parameters
Dosing
 
Adult

Administration requires the use of an infusion pump.

Note: Norepinephrine dosage is stated in terms of norepinephrine base.

Hypotension/shock: Continuous I.V. infusion:

Initial: 8-12 mcg/minute; titrate to desired response. Usual maintenance range: 2-4 mcg/minute; dosage range varies greatly depending on clinical situation. If patient remains hypotensive despite large doses, evaluate for occult hypovolemia and provide fluid resuscitation as appropriate.

ACLS dosing range (weight-based dosing): Post cardiac arrest care: Initial: 0.1-0.5 mcg/ kg /minute (7-35 mcg/minute in a 70 kg patient); titrate to desired response (AHA, 2010)

Sepsis and septic shock (weight-based dosing): Range from clinical trials: 0.01-3 mcg/ kg /minute (0.7-210 mcg/minute in a 70 kg patient) (Hollenberg, 2004)


Dosing: Pediatric

(For additional information see "Norepinephrine (noradrenaline): Pediatric drug information" )

Administration requires the use of an infusion pump.

Note: Norepinephrine dosage is stated in terms of norepinephrine base.

Hypotension/shock: Continuous I.V. infusion: Initial: 0.05-0.1 mcg/kg/minute; titrate to desired effect; maximum dose: 2 mcg/kg/minute (AHA, 2010; Kleinman, 2007)


Dosing: Geriatric

Refer to adult dosing.

Use
 
Treatment of shock which persists after adequate fluid volume replacement; severe hypotension
Adverse Reactions
 

Cardiovascular: Arrhythmias, bradycardia, peripheral (digital) ischemia

Central nervous system: Anxiety, headache (transient)

Local: Skin necrosis (with extravasation)

Respiratory: Dyspnea, respiratory difficulty

Contraindications
 

Hypersensitivity to norepinephrine, bisulfites (contains metabisulfite), or any component of the formulation; hypotension from hypovolemia except as an emergency measure to maintain coronary and cerebral perfusion until volume could be replaced; mesenteric or peripheral vascular thrombosis unless it is a lifesaving procedure; during anesthesia with cyclopropane (not available in U.S.) or halothane (not available in U.S.) anesthesia (risk of ventricular arrhythmias)

Warnings / Precautions Drug
 

Concurrent drug therapy issues:

• Monoamine oxidase inhibitors (MAO-I): Use with extreme caution in patients taking MAO-Inhibitors; prolong hypertension may result from concurrent use.

Dosage form specific issues:

• Sodium metasulfite: Product may contain sodium metasulfite.

Other warnings/precautions:

• Appropriate use: Assure adequate circulatory volume to minimize need for vasoconstrictors. Avoid hypertension; monitor blood pressure closely and adjust infusion rate.

• Extravasation: Avoid extravasation; infuse into a large vein if possible. Avoid infusion into leg veins. Watch I.V. site closely. [U.S. Boxed Warning]: If extravasation occurs, infiltrate the area with diluted phentolamine (5-10 mg in 10-15 mL of saline) with a fine hypodermic needle. Phentolamine should be administered as soon as possible after extravasation is noted.

Interactions
 

Alpha1-Blockers: May diminish the hypertensive effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize hypotensive effects of Alpha1-Blockers. Alpha1-Blockers may diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Antacids: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Aluminum Hydroxide. Risk C: Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Benzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider therapy modification

Beta-Blockers: May enhance the vasopressor effect of Alpha-/Beta-Agonists (Direct-Acting). Epinephrine used as a local anesthetic for dental procedures will not likely cause clinically relevant problems. Management: Cardioselective beta-blockers and lower doses of epinephrine may confer a more limited risk. Patients who may require acute subcutaneous epinephrine (e.g., bee sting kits) should probably avoid beta blockers. Risk D: Consider therapy modification

Bromocriptine: Alpha-/Beta-Agonists may enhance the adverse/toxic effect of Bromocriptine. Including increased blood pressure, ventricular arrhythmias, and seizure. Risk C: Monitor therapy

Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Carbonic Anhydrase Inhibitors: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy

COMT Inhibitors: May decrease the metabolism of COMT Substrates. Risk C: Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Exceptions: Ergoloid Mesylates. Risk X: Avoid combination

Hyaluronidase: May enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Management: Avoid the use of hyaluronidase to enhance dispersion or absorption of alpha-/beta-agonists. Use of hyaluronidase for other purposes in patients receiving alpha-/beta-agonists may be considered as clinically indicated. Risk D: Consider therapy modification

Inhalational Anesthetics: May enhance the arrhythmogenic effect of Norepinephrine. Risk X: Avoid combination

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination

Ioflupane I 123: Norepinephrine may diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

MAO Inhibitors: May enhance the vasopressor effect of Alpha-/Beta-Agonists (Direct-Acting). Primarily with oral administration of phenylephrine. Risk D: Consider therapy modification

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Risk D: Consider therapy modification

Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha-/Beta-Agonists (Direct-Acting). Risk D: Consider therapy modification

Pregnancy
 
Pregnancy Risk Factor

C


Pregnancy Implications
Animal reproduction studies have not been conducted. Norepinephrine is an endogenous catecholamine and crosses the placenta
Lactation
 

Excretion in breast milk unknown/use caution

Mechanism of Action
 

Stimulates beta 1 -adrenergic receptors and alpha-adrenergic receptors causing increased contractility and heart rate as well as vasoconstriction, thereby increasing systemic blood pressure and coronary blood flow; clinically, alpha effects (vasoconstriction) are greater than beta effects (inotropic and chronotropic effects)

Pharmacodynamics / Kinetics
 

Onset of action: I.V.: Very rapid-acting

Duration: vasopressor: 1-2 minutes

Metabolism: Via catechol-o-methyltransferase (COMT) and monoamine oxidase (MAO)

Excretion: Urine (84% to 96% as inactive metabolites)

 
   
 
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