LEVOPHED(R) NOREPINEPHRINE BITARTRATE 1 mg/mL
LEVOPHED(R) NOREPINEPHRINE BITARTRATE · INJECTION, SOLUTION, CONCENTRATE · HF Acquisition Co LLC, DBA HealthFirst
LEVOPHED(R) NOREPINEPHRINE BITARTRATE is a prescription injection, solution, concentrate containing levophed(r) norepinephrine bitartrate at 1 mg/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- LEVOPHED(R) NOREPINEPHRINE BITARTRATE
- Generic Name
- LEVOPHED(R) NOREPINEPHRINE BITARTRATE
- NDC Code (Product)
51662-1315- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- NDA007513
- Drug Class
- Catecholamine [EPC]; Catecholamines [CS]
- Marketing Start
- 10/18/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS & USAGE For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension.
Dosage & Administration
DOSAGE & ADMINISTRATION Norepinephrine Bitartrate Injection is a concentrated, potent drug which must be diluted in dextrose containing solutions prior to infusion. An infusion of LEVOPHED should be given into a large vein (see PRECAUTIONS). Restoration of Blood Pressure in Acute Hypotensive States Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, LEVOPHED can be administered before and concurrently with blood volume replacement. Diluent: LEVOPHED should be diluted in 5 percent dextrose injection or 5 percent dextrose and sodium chloride injections. These dextrose containing fluids are protection against significant loss of potency due to oxidation. Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately (for example, by use of a Y-tube and individual containers if given simultaneously). Average Dosage: Add the content of the vial (4 mg/4 mL) of LEVOPHED to 1,000 mL of a 5 percent dextrose containing solu…
Warnings
WARNINGS LEVOPHED should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result. LEVOPHED Bitartrate 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 nonasthmatic people.
Contraindications
CONTRAINDICATIONS LEVOPHED should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If LEVOPHED is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite "normal" blood pressure, tissue hypoxia, and lactate acidosis. LEVOPHED should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of LEVOPHED is necessary as a life-saving procedure. Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of LEVOPHED during cyclopropane and halothane anesthesia is generally considered contraindicated because of the …
Adverse Reactions
ADVERSE REACTIONS The following reactions can occur: Body As A Whole: Ischemic injury due to potent vasoconstrictor action and tissue hypoxia. Cardiovascular System: Bradycardia, probably as a reflex result of a rise in blood pressure, arrhythmias, and stress cardiomyopathy. Nervous System: Anxiety, transient headache. Respiratory System: Respiratory difficulty. Skin and Appendages: Extravasation necrosis at injection site. Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy. If plasma volumes are not corrected, hypotension may recur when LEVOPHED is discontinued, or blood pressure may be maintained at the risk of severe peripheral and visceral vasoconstriction (e.g., decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischemic injury. Gangrene of extremities has been rarely reported. Overdoses or conventional doses in hypersensitive persons (e.g., hyperthyroid patients) cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pal…
Frequently Asked Questions
What is LEVOPHED(R) NOREPINEPHRINE BITARTRATE used for?
LEVOPHED(R) NOREPINEPHRINE BITARTRATE contains LEVOPHED(R) NOREPINEPHRINE BITARTRATE. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is LEVOPHED(R) NOREPINEPHRINE BITARTRATE a controlled substance?
LEVOPHED(R) NOREPINEPHRINE BITARTRATE is not classified as a controlled substance by the DEA.
What is the generic name for LEVOPHED(R) NOREPINEPHRINE BITARTRATE?
The generic name for LEVOPHED(R) NOREPINEPHRINE BITARTRATE is LEVOPHED(R) NOREPINEPHRINE BITARTRATE. There are no other listed brand versions of LEVOPHED(R) NOREPINEPHRINE BITARTRATE.
What is the NDC code for LEVOPHED(R) NOREPINEPHRINE BITARTRATE 1 mg/mL?
The NDC (National Drug Code) for LEVOPHED(R) NOREPINEPHRINE BITARTRATE 1 mg/mL is 51662-1315, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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