Norepinephrine 16 ug/mL
Norepinephrine Bitartrate · SOLUTION · Long Grove Pharmaceuticals, LLC
Norepinephrine is a solution containing norepinephrine bitartrate at 16 ug/mL, taken intravenous. Manufactured by Long Grove Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Norepinephrine
- Generic Name
- Norepinephrine Bitartrate
- NDC Code (Product)
81298-9659- Manufacturer
- Long Grove Pharmaceuticals, LLC
- Strength
- 16 ug/mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA214628
- Marketing Start
- 02/02/2024
Recall History
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
SterRx, LLC
Lack of Assurance of Sterility
Hospira Inc., A Pfizer Company
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Unique Pharmaceutical, Ltd
Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
Apollo Care, LLC
Lack of Assurance of Sterility
Fresenius Kabi Compounding, LLC
cGMP violations
SterRx, LLC
Lack of Assurance of Sterility
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine bitartrate injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initial dose of 0.25 mL to 0.375 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low to normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation of vital organs. ( 2.2 ) The average maintenance dose ranges from 0.0625 mL to 0.125 mL per minute (from 2 mcg to 4 mcg of base). ( 2.2 ) 2.1 Important Dosage and Administration Instructions Correct Hypovolemia Address hypovolemia before initiation of norepinephrine bitartrate injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions (5.1) ] . Administration Dilute norepinephrine bitartrate injection prior to use [see Dosage and Administration (2.3) ] . Infuse norepinephrine bitartrate 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. Avoid abrupt withdrawal. 2.2 Dosage After an initial dosage of 8 to 12 m…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may result in hypertension. ( 7.1 ) Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. ( 7.4 ) 7.1 MAO-Inhibiting Drugs Co-administration of norepinephrine bitartrate 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 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 with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of norepinephrine bitartrate cannot be avoided in these patients, monitor for hypertension. 7.3 Antidiabetics Norepinephrine bitartrate can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of anti…
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 Biocon Pharma Inc., at 1-866-924-6266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Norepinephrine used for?
Norepinephrine contains Norepinephrine Bitartrate. It is a solution taken intravenous. Consult your doctor for specific uses.
Is Norepinephrine a controlled substance?
Norepinephrine is not classified as a controlled substance by the DEA.
What is the generic name for Norepinephrine?
The generic name for Norepinephrine is Norepinephrine Bitartrate. There are 10 other brand versions of Norepinephrine Bitartrate.
What is the NDC code for Norepinephrine 16 ug/mL?
The NDC (National Drug Code) for Norepinephrine 16 ug/mL is 81298-9659, listed by Long Grove Pharmaceuticals, LLC.
Other Norepinephrine Dosages
Other Norepinephrine Brands
See all →- NOREPINEPHRINE BITARTRATE1 mg/mL0781-3755
- Norepinephrine bitartrate1 mg/mL31722-372
- NOREPINEPHRINE BITARTRATE1 mg/mL72603-180
- Norepinephrine Bitartrate1 mg/mL43066-997
- NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE.128 mg/mL44567-643
- Norepinephrine Bitartrate1 mg/mL51991-983
- NOREPINEPHRINE BITARTRATE16 mg/250mL0338-0116
- NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE.032 mg/mL44567-641
- NOREPINEPHRINE BITARTRATE1 mg/mL51662-1528
- NOREPINEPHRINE BITARTRATE4 mg/250mL0338-0040
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)