Drugplain

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE .128 mg/mL

NOREPINEPHRINE BITARTRATE · INJECTION, SOLUTION · WG Critical Care, LLC

No Recall History
Plain English

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE is a injection, solution containing norepinephrine bitartrate at .128 mg/mL, taken intravenous. Manufactured by WG Critical Care, LLC.

Key Facts

Brand Name
NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE
Generic Name
NOREPINEPHRINE BITARTRATE
NDC Code (Product)
44567-643
Manufacturer
WG Critical Care, LLC
Strength
.128 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA215700
Marketing Start
09/15/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective388 reports
condition aggravated282 reports
hypotension265 reports
off label use250 reports
sepsis234 reports
multiple organ dysfunction syndrome229 reports
cardiogenic shock204 reports
stress199 reports
general physical health deterioration180 reports
renal failure172 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Initiate 8 to 12 mcg/min and adjust the rate to maintain blood pressure sufficient to maintain the circulation of vital organs. ( 2.2 ) • The average maintenance dose ranges from 2 to 4 mcg/min. ( 2.2 ) 2.1 Important Dosage and Administration Instructions 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 [see Warnings and Precautions (5.1) ] . 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 [see Warnings and Precautions (5.1) ]. Avoid using a catheter-tie-in technique . Discontinuation When discontinuing the infusion, reduce the flow rate gradually. Avo…

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants of the triptyline or imipramine types may result in hypertension. ( 7.1 , 7.2) • Antidiabetics: Norepinephrine can decrease insulin sensitivity and raise blood glucose. ( 7.3) • Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. ( 7.4 ) 7.1 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. 7.2 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 Chlori…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Tissue Ischemia [see Warnings and Precautions (5.1) ] • Hypotension [see Warnings and Precautions (5.2) ] • Cardiac Arrhythmias [see Warnings and Precautions (5.3) ] The most common adverse reactions are hypertension and bradycardia. The following adverse reactions can occur: Nervous system disorders: Anxiety, headache Respiratory disorders: Respiratory difficulty, pulmonary edema Most common adverse reactions are ischemic injury, bradycardia, anxiety, transient headache, respiratory difficulty, and extravasation necrosis at injection site. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE used for?

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE contains NOREPINEPHRINE BITARTRATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE a controlled substance?

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE?

The generic name for NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE is NOREPINEPHRINE BITARTRATE. There are 10 other brand versions of NOREPINEPHRINE BITARTRATE.

What is the NDC code for NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE .128 mg/mL?

The NDC (National Drug Code) for NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE .128 mg/mL is 44567-643, listed by WG Critical Care, LLC.

Product NDC

44567-643

Package NDC

44567-643-10

Other NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE Dosages

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)