Drugs Details

Drugs Info of Levophed Bitartrate
Drugs Details
  • Drugs Type  : FDA
  • Date : 28th Feb 2015 02:25 am
  • Brand Name : Levophed Bitartrate
  • Generic Name : norepinephrine (Pronunciation: nor ep i NEF rin)
Descriptions

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 (norepinephrine bitartrate)  structural formula illustration

LEVOPHED (norepinephrine bitartrate) 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.

What are the possible side effects of norepinephrine (Levophed Bitartrate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • pain, burning, irritation, discoloration, or skin changes where the injection is given;
  • sudden numbness, weakness, or cold feeling anywhere in your body;
  • slow or uneven heart rate;
  • blue lips or fingernails, mottled skin;
  • urinating less than usual or not at all;
  • trouble...

Read All Potential Side Effects and See Pictures of Levophed »

This monograph has been modified to include the generic and brand name in many instances.

Indications

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

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 (norepinephrine bitartrate) can be administered before and concurrently with blood volume replacement.

Diluent: LEVOPHED (norepinephrine bitartrate) 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 (norepinephrine bitartrate) to 1,000 mL of a 5 percent dextrose containing solution. Each mL of this dilution contains 4 mcg of the base of LEVOPHED (norepinephrine bitartrate) . 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 (norepinephrine bitartrate) 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 dilute than 4 mcg per mL should be used. On the other hand, when large volumes of fluid are clinically undesirable, a concentration greater than 4 mcg per mL may be necessary.

Duration of Therapy: The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy. Infusions of LEVOPHED (norepinephrine bitartrate) should be reduced gradually, avoiding abrupt withdrawal. In some of the reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.

Adjunctive Treatment in Cardiac Arrest

Infusions of LEVOPHED (norepinephrine bitartrate) are usually administered intravenously during cardiac resuscitation to restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. [LEVOPHED (norepinephrine bitartrate) 's powerful beta-adrenergic stimulating action is also thought to increase the strength and effectiveness of systolic contractions once they occur.]

Average Dosage: To maintain systemic blood pressure during the management of cardiac arrest, LEVOPHED (norepinephrine bitartrate) is used in the same manner as described under Restoration of Blood Pressure in Acute Hypotensive States.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.

Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Avoid contact with iron salts, alkalis, or oxidizing agents.

How Supplied

LEVOPHED (norepinephrine bitartrate) injection, USP, contains the equivalent of 1 mg base of LEVOPHED (norepinephrine bitartrate) per 1 mL (4 mg/4 mL). Supplied as:

5 mL vials (4 mL fill, 4 mg/4 mL) in boxes of 10 (NDC No. 0409-3375-04)

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.

Created: June, 2007. Hospira, Inc., Lake Forest, IL 60045 USA.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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.

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 (norepinephrine bitartrate) 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.

Read the Levophed (norepinephrine bitartrate) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

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 (norepinephrine bitartrate) 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 (norepinephrine bitartrate) in patients with profound hypoxia or hypercarbia. LEVOPHED (norepinephrine bitartrate) 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.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

LEVOPHED (norepinephrine bitartrate) 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 (norepinephrine bitartrate) 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.

Precautions

General

Avoid Hypertension: Because of the potency of LEVOPHED (norepinephrine bitartrate) and because of varying response to pressor substances, the possibility always exists that dangerously high blood pressure may be produced with overdoses of this pressor agent. It is desirable, therefore, to record the blood pressure every two minutes from the time administration is started until the desired blood pressure is obtained, then every five minutes if administration is to be continued.

The rate of flow must be watched constantly, and the patient should never be left unattended while receiving LEVOPHED (norepinephrine bitartrate) . Headache may be a symptom of hypertension due to overdosage.

Site of Infusion: Whenever possible, infusions of LEVOPHED (norepinephrine bitartrate) should be given into a large vein, particularly an antecubital vein because, when administered into this vein, the risk of necrosis of the overlying skin from prolonged vasoconstriction is apparently very slight. Some authors have indicated that the femoral vein is also an acceptable route of administration. A catheter tie-in technique should be avoided, if possible, since the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Occlusive vascular diseases (for example, atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger's disease) are more likely to occur in the lower than in the upper extremity. Therefore, one should avoid the veins of the leg in elderly patients or in those suffering from such disorders. Gangrene has been reported in a lower extremity when infusions of LEVOPHED (norepinephrine bitartrate) were given in an ankle vein.

Extravasation: The infusion site should be checked frequently for free flow. Care should be taken to avoid extravasation of LEVOPHED (norepinephrine bitartrate) into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug. Blanching along the course of the infused vein, sometimes without obvious extravasation, has been attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage.

This also may progress on rare occasions to superficial slough, particularly during infusion into leg veins in elderly patients or in those suffering from obliterative vascular disease. Hence, if blanching occurs, consideration should be given to the advisability of changing the infusion site at intervals to allow the effects of local vasoconstriction to subside.

IMPORTANT — Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of Regitine® (brand of phentolamine) , an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with LEVOPHED (norepinephrine bitartrate) . It is also not known whether LEVOPHED (norepinephrine bitartrate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. LEVOPHED (norepinephrine bitartrate) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LEVOPHED (norepinephrine bitartrate) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

Geriatric Use

Clinical studies of LEVOPHED (norepinephrine bitartrate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

LEVOPHED (norepinephrine bitartrate) infusions should not be administered into the veins in the leg in elderly patients (see PRECAUTIONS, General).

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Overdosage with LEVOPHED (norepinephrine bitartrate) 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 (norepinephrine bitartrate) until the condition of the patient stabilizes.

ContrainDications

LEVOPHED (norepinephrine bitartrate) 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 (norepinephrine bitartrate) 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 (norepinephrine bitartrate) 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 (norepinephrine bitartrate) 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 (norepinephrine bitartrate) 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 (norepinephrine bitartrate) in patients with profound hypoxia or hypercarbia.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

LEVOPHED (norepinephrine bitartrate) functions as a peripheral vasoconstrictor (alpha-adrenergic action) and as an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Levophed Bitartrate

Generic Name: norepinephrine (Pronunciation: nor ep i NEF rin)

  • What is norepinephrine (Levophed)?
  • What are the possible side effects of norepinephrine (Levophed)?
  • What is the most important information I should know about norepinephrine (Levophed)?
  • What should I discuss with my health care provider before receiving norepinephrine (Levophed)?
  • How is norepinephrine given (Levophed)?
  • What happens if I miss a dose (Levophed)?
  • What happens if I overdose (Levophed)?
  • What should I avoid while receiving norepinephrine (Levophed)?
  • What other drugs will affect norepinephrine (Levophed)?
  • Where can I get more information?

What is norepinephrine (Levophed)?

Norepinephrine is similar to adrenaline. It works by constricting (narrowing) the blood vessels and increasing blood pressure and blood glucose (sugar) levels.

Norepinephrine is used to treat life-threatening low blood pressure (hypotension) that can occur with certain medical conditions or surgical procedures. This medication is often used during CPR (cardio-pulmonary resuscitation).

Norepinephrine may also be used for purposes not listed in this medication guide.

What are the possible side effects of norepinephrine (Levophed)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • pain, burning, irritation, discoloration, or skin changes where the injection is given;
  • sudden numbness, weakness, or cold feeling anywhere in your body;
  • slow or uneven heart rate;
  • blue lips or fingernails, mottled skin;
  • urinating less than usual or not at all;
  • trouble breathing;
  • problems with vision, speech, or balance; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Levophed (norepinephrine bitartrate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about norepinephrine (Levophed)?

If possible before receiving norepinephrine, tell your doctor if you have high blood pressure, diabetes, coronary artery disease, circulation problems, varicose veins, overactive thyroid, asthma, or a sulfite allergy.

Also tell your doctor about all other medicines you use, especially blood pressure medication or an antidepressant.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received this medication.

Tell your caregivers at once if you have a serious side effect such as cold feeling anywhere in your body, blue lips or fingernails, trouble breathing, urinating less than usual, irritation or skin changes where the medicine is injected, slow heart rate, sudden numbness or weakness, confusion, severe headache, or problems with vision, speech, or balance.

Side Effects Centers
  • Levophed

Patient Detailed How Take

What should I discuss with my health care provider before receiving norepinephrine (Levophed)?

If possible before you receive norepinephrine, tell your doctor if you have:

  • high blood pressure (hypertension);
  • diabetes;
  • coronary artery disease;
  • circulation problems;
  • varicose veins;
  • overactive thyroid; or
  • asthma or a sulfite allergy.

FDA pregnancy category C. It is not known whether norepinephrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether norepinephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible before you are treated with norepinephrine to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

How is norepinephrine given (Levophed)?

Norepinephrine is injected into a vein through an IV. You will receive this injection in a hospital or emergency setting.

Norepinephrine is usually given for as long as needed until your body responds to the medication. Some people must receive norepinephrine for several days.

Your blood pressure, breathing, and other vital signs will be watched closely while you are receiving norepinephrine.

Tell your caregivers if you feel any pain, irritation, cold feeling, or other discomfort of your skin or veins where the medicine is injected. Norepinephrine can damage the skin or tissues around the injection site if the medication accidentally leaks out of the vein.

Side Effects Centers
  • Levophed

Patient Detailed Avoid Taking

What happens if I miss a dose (Levophed)?

Since norepinephrine is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

What happens if I overdose (Levophed)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow heart rate or severe headache, sweating, vomiting, increased sensitivity to light, pale skin, and stabbing chest pain.

What should I avoid while receiving norepinephrine (Levophed)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect norepinephrine (Levophed)?

If possible before you receive norepinephrine, tell your doctor about all other medicines you use, especially:

  • blood pressure medications;
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or
  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan, Silenor), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and other drugs may interact with norepinephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about norepinephrine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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