FDA

Norepinephrine Bitartrate in 0.9% Sodium Chloride

Approved 6 Oct 2022IntravenousSolution

The FDA lists this product in 10 strengths and forms.

Indications

Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine in Sodium Chloride Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ( 1 )

Contraindications

None. None. ( 4 )

Warnings and precautions

Tissue Ischemia : Avoid extravasation into tissues, which can cause local necrosis ( 5.1 ) Hypotension After Abrupt Discontinuation : Sudden cessation of the infusion rate may result in marked hypotension. Reduce the Norepinephrine in Sodium Chloride Injection infusion rate gradually. ( 5.2 ) Cardiac Arrhythmias : Norepinephrine in Sodium Chloride Injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease.

( 5.3 )

5.1Tissue Ischemia Administration of Norepinephrine 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 in Sodium Chloride Injection [see Dosage and Administration ( 2.1 )] . Avoid Norepinephrine 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 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 [see Dosage and Administration ( 2.1 )] .

Warnings and precautions

( 5.3 )

5.1Tissue Ischemia Administration of Norepinephrine in Sodium Chloride Injection

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

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 (see Clinical Considerations ) .

In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data ) . Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m 2 basis for four days during organogenesis (see Data ) .

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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. Data Animal Data A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow.

Decreases in fetal oxygenation, urine and lung liquid flow were also observed. Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses. In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7-10).

Norepinephrine Bitartrate in 0.9% Sodium Chloride

Indications

Contraindications

Warnings and precautions

5.1Tissue Ischemia Administration of Norepinephrine in Sodium Chloride Injection

Two medicines in one question?

Norepinephrine Bitartrate in 0.9% Sodium Chloride

Indications

Contraindications

Warnings and precautions

5.1Tissue Ischemia Administration of Norepinephrine in Sodium Chloride Injection

Two medicines in one question?

5.2Hypotension after Abrupt Discontinuation

5.3Cardiac Arrhythmias Norepinephrine in Sodium Chloride

Interactions

7.1MAO-Inhibiting Drugs Co-administration of Norepinephrine in Sodium Chloride Injection

7.2Tricyclic Antidepressants Co-administration of Norepinephrine in Sodium Chloride Injection

7.3Antidiabetics Norepinephrine in Sodium Chloride

7.4Halogenated Anesthetics

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information

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