Levophed Bitartrate (Intravenous)

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

This medicine should only be given by your doctor or under their direct supervision.

It is very important for your doctor to check your progress closely while you are receiving this medicine to ensure 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. Contact your doctor immediately if you experience itching of the skin, numbness and tingling in the face, fingers, or toes, pain in the arms, legs, or lower back, especially in the calves or heels during exertion, pale, bluish-colored, or cold hands or feet, or weak or absent pulses in the legs.

This medicine may cause heart rhythm problems. Inform your doctor right away if you feel dizzy or lightheaded, have fast or irregular heartbeats, or feel like you might faint.

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, including to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to see how norepinephrine injection affects children. Its safety and effectiveness in children have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of norepinephrine injection. However, older adults are more likely to have age-related issues with their liver, kidneys, or heart, which may require careful monitoring and possible dose adjustments when using this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there could be an interaction. In such situations, your doctor may need to adjust the dose or take other precautions. It is crucial for your healthcare professional to know if you are taking any of the medicines listed below when receiving this medicine. The following interactions are significant, but not all possible interactions are included.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide against treating you with this medication or change other medicines you are taking.

• Dihydroergotamine
• Isocarboxazid
• Phenelzine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

• Blood clots (e.g., mesenteric or peripheral vascular thrombosis, occlusive or thrombotic vascular disease) or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure)—Use with caution. It may worsen these conditions.

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

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

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

In the U.S.

• Levophed
• Levophed Bitartrate

Available Dosage Forms:

• Solution

Therapeutic Class: Vasopressor

Pharmacologic Class: Norepinephrine

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.

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