Pronunciation:

nor-ep-i-NEF-rin bye-TAR-trate

Brand Names:

• Levophed
• Levophed Bitartrate

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Vasopressor

Pharmacologic—

Norepinephrine

Uses of This Medicine:

Norepinephrine injection is used to raise blood pressure in patients with severe, acute hypotension (short-term low blood pressure).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of norepinephrine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of norepinephrine injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Isocarboxazid
• Phenelzine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Clomipramine
• Cyclopropane
• Desflurane
• Desipramine
• Dextroamphetamine
• Dibenzepin
• Digoxin
• Doxepin
• Enflurane
• Entacapone
• Ergonovine
• Furazolidone
• Furosemide
• Halothane
• Imipramine
• Iobenguane I 123
• Iproniazid
• Isoflurane
• Linezolid
• Lisdexamfetamine
• Lofepramine
• Melitracen
• Methoxyflurane
• Methylene Blue
• Methylergonovine
• Milnacipran
• Moclobemide
• Nialamide
• Nortriptyline
• Opicapone
• Opipramol
• Ozanimod
• Procarbazine
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sevoflurane
• Tianeptine
• Trimipramine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to sulfites, history or
• Asthma—Norepinephrine contains sodium metabisulfite which can trigger attacks in patients with these conditions.

• Blood clots (eg, mesenteric or peripheral vascular thrombosis, occlusive or thrombotic vascular disease) or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Hypercarbia (high carbon dioxide in the blood) or
• Hypoxia (low oxygen in the blood)—Use with caution. May increase risk for more side effects.

• Hypovolemia (low blood volume)—This condition must be corrected first before receiving this medicine. Use of norepinephrine in this condition may increase the risk for more unwanted effects (eg, decreased urine output, lactic acidosis, low blood supply to the tissues).

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

If you are elderly or have blood clotting problems in the legs, you should not receive an infusion of this medicine into the veins of your legs.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause tissue ischemia (low blood supply to the tissue), which may lead to gangrene (skin or tissue damage) of the arm or leg. Check with your doctor right away if you have itching of the skin, numbness and tingling of the face, fingers, or toes, pain in the arms legs, or lower back, especially in the calves or heels upon exertion, pale, bluish-colored, or cold hands or feet, or weak or absent pulses in the legs.

This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have fast or irregular heart beats, or feel like fainting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

chest pain or discomfort

headache

lightheadedness, dizziness, or fainting

nervousness

pounding in the ears

slow, fast, or irregular heartbeat

unusual tiredness or weakness

Incidence not known

Blue lips and fingernails

confusion

coughing that sometimes produces a pink frothy sputum

difficult, fast, noisy breathing

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

increased sweating

itching of the skin

numbness and tingling of the face, fingers, or toes

pain in the arms legs, or lower back, especially in the calves or heels upon exertion

pale, bluish-colored, cold hands or feet

pale skin

swelling in the legs and ankles

weak or absent pulses in the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Anxiety

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.