Levophed

There are many drugs that are known to interact with norepinephrine.

You should tell your doctor about all prescription, non-prescription, illegal, recreational, herbal and nutritional or dietary drugs you are taking, especially:

• Blood pressure drugs
• Monoamine oxidase inhibitors (MAOIs) such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue injection, phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl), and tranylcypromine (Parnate)
• Antidepressants such as amitriptyline (Elavil), amoxapine (Asendin) clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Aventyl), protriptyline (Vivactil), trimipramine (Surmontil)

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;

• little or no urinating;

• 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.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.101

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101

• Importance of informing patients of other important precautionary information.101 (See Cautions.)

• It is used to treat low blood pressure.

• Tell all of your health care providers that you take Levophed. This includes your doctors, nurses, pharmacists, and dentists.
• Have your blood pressure checked often. Talk with your doctor.
• If you have a sulfite allergy, talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad headache.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Anxiety.
• Trouble breathing.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

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.

General

Avoid Hypertension: Because of the potency of Levophed 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. Headache may be a symptom of hypertension due to overdosage.

Site of Infusion: Whenever possible, infusions of Levophed 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 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 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.

Drug 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 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. 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility:Studies have not been performed.

Pregnancy Category C:
Animal reproduction studies have not been conducted with Levophed. It is also not known whether Levophed can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Levophed 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 is administered to a nursing woman.

Pediatric Use:
Safety and effectiveness in pediatric patients has not been established.

Geriatric Use:
Clinical studies of Levophed 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 infusions should not be administered into the veins in the leg in elderly patients (see PRECAUTIONS, General)
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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.