Levophed(R) Norepinephrine Bitartrate
FDA Drug Information • Also known as: Levophed(R) Norepinephrine Bitartrate
- Brand Names
- Levophed(R) Norepinephrine Bitartrate
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula: LEVOPHED is supplied in sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains the equivalent of 1 mg base of norepinephrine, sodium chloride for isotonicity, and not more than 0.2 mg of sodium metabisulfite as an antioxidant. It has a pH of 3 to 4.5. The air in the vials has been displaced by nitrogen gas. STRUCTURE
What Is Levophed(R) Norepinephrine Bitartrate Used For?
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 and 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 solution. Each mL of this dilution contains 4 mcg of the base of LEVOPHED. Give this solution by intravenous infusion. Insert a plastic intravenous catheter through a suitable bore needle well advanced centrally into the vein and securely fixed with adhesive tape, avoiding, if possible, a catheter tie-in technique as this promotes stasis. An IV drip chamber or other suitable metering device is essential to permit an accurate estimation of the rate of flow in drops per minute. After observing the response to an initial dose of 2 mL to 3 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation to vital organs. In previously hypertensive patients, it is recommended that the blood pressure should be raised no higher than 40 mm Hg below the preexisting systolic pressure. The average maintenance dose ranges from 0.5 mL to 1 mL per minute (from 2 mcg to 4 mcg of base). High Dosage: Great individual variation occurs in the dose required to attain and maintain an adequate blood pressure. In all cases, dosage of LEVOPHED should be titrated according to the response of the patient. Occasionally much larger or even enormous daily doses (as high as 68 mg base or 17 vials) may be necessary if the patient remains hypotensive, but occult blood volume depletion should always be suspected and corrected when present. Central venous pressure monitoring is usually helpful in detecting and treating this situation. Fluid Intake: The degree of dilution depends on clinical fluid volume requirements. If large volumes of fluid (dextrose) are needed at a flow rate that would involve an excessive dose of the pressor agent per unit of time, a solution more...
Side Effects (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, pallor, intense sweating, and vomiting.
Warnings and Precautions
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 risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of LEVOPHED in patients with profound hypoxia or hypercarbia.
Overdosage
OVERDOSAGE Overdosage with LEVOPHED may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. In case of accidental overdosage, as evidenced by excessive blood pressure elevation, discontinue LEVOPHED until the condition of the patient stabilizes.
How Supplied
HOW SUPPLIED LEVOPHED(R) NOREPINEPHRINE BITARTRATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1315-1 LEVOPHED(R) NOREPINEPHRINE BITARTRATE INJECTION, USP 4mg/4mL 4mL VIAL NDC 51662-1315-2 Pouch containing a single LEVOPHED(R) NOREPINEPHRINE BITARTRATE INJECTION, USP 4mg/4mL 4mL NDC 51662-1315-3 Case containing 10 pouches of LEVOPHED(R) NOREPINEPHRINE BITARTRATE INJECTION, USP 4mg/4mL 4mL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms LEVOPHED (norepinephrine bitartrate) injection, USP, contains the equivalent of 1 mg base of LEVOPHED per 1 mL (4 mg/4 mL). Supplied as: Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Protect from light. Regitine, trademark, CIBA Pharmaceuticals Company. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1150-3.0 Revised: 09/2018 HOW SUPPLIED LOGO
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.