norepinephrine bitartrate in 0.9% sodium chloride
Norepinephrine Bitartrate in 0.9% Sodium Chloride (Norepinephrine Bitartrate) is a catecholamine used to treat Hypotension, Shock.
Norepinephrine Bitartrate · by Inforlife
Key facts
- Active ingredient
- Norepinephrine Bitartrate
- Drug class
- Catecholamine
- Form
- Injectable
- Strength
- Norepinephrine Bitartrate EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) · Norepinephrine Bitartrate EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) · Norepinephrine Bitartrate EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) · Norepinephrine Bitartrate EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hypotension, shock
- Manufacturer
- Inforlife
- FDA application
- NDA215700
What is Norepinephrine Bitartrate in 0.9% Sodium Chloride?
From the FDA label:Norepinephrine Bitartrate in Sodium Chloride Injection contains the active pharmaceutical ingredient norepinephrine, a catecholamine, in the form of bitartrate salt (monohydrate). 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. The chemical name for norepinephrine bitartrate (monohydrate) is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula: Norepinephrine bitartrate (monohydrate) is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection is supplied as a sterile aqueous ready-to-use solution in 250 mL transparent intravenous bags. Each mL contains 32 mcg, 64 mcg, 128 mcg or 256 mcg of norepinephrine bitartrate monohydrate, equivalent to 16 mcg, 32 mcg, 64 mcg or 128 mcg of norepinephrine base, respectively. Each mL also contains 9 mg of Sodium Chloride USP as a tonicity agent, and may contain Hydrochloric Acid NF and Sodium Hydroxide NF as pH adjusters, for a pH range of 3.4 to 4.0, in Water for Injection. structural formula
How to use
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. Avoid abrupt withdrawal. Discard unused portion. 2.2 Dosage 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…
Side effects
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.
Warnings
Important safety information
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 Bitartrate in Sodium Chloride Injection infusion rate gradually. ( 5.2 ) • Cardiac Arrhythmias: Norepinephrine Bitartrate in Sodium Chloride Injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. ( 5.3 ) 5.1 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 [see Dosage and Administration (2.1) ]. 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 [see Dosage and Administration (2.1) ]. Emergency Treatment of Extravasation To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. 5.2 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. 5.3 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.
Who should not take Norepinephrine Bitartrate in 0.9% Sodium Chloride
None. None. ( 4 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 Chloride Injection cannot be avoided in these patients, monitor for hypertension. 7.3 Antidiabetics Norepinephrine Bitartrate in Sodium Chloride Injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs. 7.4 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.
Drug class
How this class works, per Physiology, Catecholamines - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
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Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Norepinephrine Bitartrate in 0.9% Sodium Chloride treat?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride (Norepinephrine Bitartrate) may be used to treat hypotension, shock, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Norepinephrine Bitartrate in 0.9% Sodium Chloride work?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride is a catecholamine. Catecholamines such as epinephrine and norepinephrine are "fight or flight" messengers that switch on adrenergic (alpha and beta) receptors throughout the body, speeding the heart, raising blood pressure by tightening blood vessels, and opening the airways.
- Is there a coupon or discount for Norepinephrine Bitartrate in 0.9% Sodium Chloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Norepinephrine Bitartrate in 0.9% Sodium Chloride. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Norepinephrine Bitartrate in 0.9% Sodium Chloride?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride is marketed by Inforlife. You can see Inforlife's full profile, rating, and other products on pharmaranks.
- Is Norepinephrine Bitartrate in 0.9% Sodium Chloride a brand-name or generic drug?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride is a brand-name product with the active ingredient Norepinephrine Bitartrate.
- Is Norepinephrine Bitartrate in 0.9% Sodium Chloride available over the counter?
- No. Norepinephrine Bitartrate in 0.9% Sodium Chloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Norepinephrine Bitartrate in 0.9% Sodium Chloride come in?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Norepinephrine Bitartrate in 0.9% Sodium Chloride?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride is classified as catecholamine, per the FDA's Established Pharmacologic Class.
- Is Norepinephrine Bitartrate in 0.9% Sodium Chloride FDA-registered?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride is on record with the U.S. FDA under application number NDA215700. You can verify this on its official FDA label.
- Is Norepinephrine Bitartrate in 0.9% Sodium Chloride safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Norepinephrine Bitartrate in 0.9% Sodium Chloride. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Norepinephrine Bitartrate in 0.9% Sodium Chloride?
- Norepinephrine Bitartrate in 0.9% Sodium Chloride's side effects are taken directly from its FDA label. From the label: 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 hypertensio… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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