NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE injection

Gafacom April 14, 2023

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE

Norepinephrine Bitartrate in Sodium Chloride Injection contains norepinephrine, a catecholamine. Norepinephrine is sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.

Norepinephrine Bitartrate in Sodium Chloride Injection is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol).

Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids.

Norepinephrine Bitartrate in Sodium Chloride Injection is supplied as a sterile aqueous ready to use solution in 250 mL transparent intravenous bags. Each mL contains the equivalent of 16, 32 or 64 micrograms of norepinephrine base supplied as 32, 64 or 128 micrograms per mL of norepinephrine bitartrate monohydrate. It contains sodium chloride (9 mg/mL) and may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a pH of 3.4 to 4.0.

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE injection


INDICATIONS AND USAGE

Norepinephrine Bitartrate in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.

Mechanism of Action

Norepinephrine is a peripheral vasoconstrictor (alpha-adrenergic action) and an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

DOSAGE AND ADMINISTRATION

Correct Hypovolemia: Address hypovolemia before initiation of Norepinephrine Bitartrate in Sodium Chloride Injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia.

Administration

Norepinephrine Bitartrate in Sodium Chloride Injection is a ready to administer product that requires no further dilution prior to infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Infuse Norepinephrine Bitartrate in Sodium Chloride Injection into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs. Avoid using a catheter-tie-in technique.

Discontinuation: When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal. Discard unused portion.

After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion.

Typical maintenance intravenous dosage is 2 to 4 mcg per minute.

Drug Incompatibilities

Avoid contact with iron salts, alkalis, or oxidizing agents.

Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Tissue Ischemia: Administration of Norepinephrine Bitartrate in Sodium Chloride Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Sodium Chloride Injection. Avoid Norepinephrine Bitartrate in Sodium Chloride Injection in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction.

Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

Extravasation of Norepinephrine Bitartrate in Sodium Chloride Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation.

Hypotension after Abrupt Discontinuation: Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the Norepinephrine Bitartrate in Sodium Chloride Injection infusion rate while expanding blood volume with intravenous fluids.

Cardiac Arrhythmias: Norepinephrine Bitartrate in Sodium Chloride Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.

Allergic Reactions Associated with Sulfite: Norepinephrine Bitartrate in Sodium Chloride 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 non-asthmatic people.

DRUG INTERACTIONS

MAO-Inhibiting Drugs: Co-administration of Norepinephrine Bitartrate in Sodium Chloride Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) can cause severe, prolonged hypertension.

If administration of Norepinephrine Bitartrate in Sodium Chloride Injection cannot be avoided in patients who recently have received any of these drugs and in whom, after discontinuation, MAO activity has not yet sufficiently recovered, monitor for hypertension.

Tricyclic Antidepressants: Co-administration of Norepinephrine Bitartrate in Sodium Chloride Injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of Norepinephrine Bitartrate in Sodium Chloride Injection cannot be avoided in these patients, monitor for hypertension.

Antidiabetics: Norepinephrine Bitartrate in Sodium Chloride Injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs.

Halogenated Anesthetics: Concomitant use of Norepinephrine Bitartrate in Sodium Chloride Injection with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.

USE IN SPECIFIC POPULATIONS

Pregnancy: Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated.

Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus.

Lactation: There are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

OVERDOSAGE

Overdosage with Norepinephrine Bitartrate in Sodium Chloride Injection may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output.

In case of overdosage, discontinue Norepinephrine Bitartrate in Sodium Chloride Injection until the condition of the patient stabilizes.

KEYWORDS

  • norepinephrine injection dose
  • norepinephrine bitartrate side effects
  • norepinephrine bitartrate nursing considerations
  • norepinephrine bitartrate drug classification
  • norepinephrine bitartrate vs norepinephrine
  • norepinephrine bitartrate injection
LINKS

Post a Comment

0 Comments