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Administer by intravenous infusion. Monitor blood pressure every 23 minutes until it stabilizes and then every 5 minutes. Ecg should be continuously monitor. Do not administer into the veins of legs of elderly patients. Avoid extravasation. If extravasation occur, infiltrate the site as soon as possible with 1015 ml of NS containing 510 mg of Phentolamine for adults. Use a syringe with a fine hypodermic needle and liberally infiltrate throughout the ischemic area. Sympathetic blockade with Phentolamine causes immediate and noticeable local hyperemic changes if the area is infiltrated within 12 hours of extravasation. For prevention of extravasation, Phentolamine may be added to each 1000 ml of solution containing norepinephrine. Dilution: concentrate for injection must be diluted prior to administration. Fluids containing dextrose offer protection against loss of potency due to oxidation; therefore, 5% dextrose in water or 5% percent dextrose and sodium chloride are generally preferred diluents. Although the manufacturer states that norepinephrine should not be diluted in normal saline alone, available data supports stability of norepinephrine in NS at concentrations up to 16 mcg / ml. Manufacturers recommend diluting 4 mg of norepinephrine in 1000 ml of D5W for concentration of 4 mcg / ml. However, more commonly used dilution in clinical practice is 4 mg of norepinephrine in 250 ml of D5W injection for a concentration of 16 mcg / ml. In fluid - restricted patients, concentrations of up to 32 mcg / ml have been used. Intravenous infusion: Infuse IV preferably into antecubital vein of arm using an infusion pump or other device to control flow rate. Femoral vein may also be used. Do not use catheter tie - in technique because obstruction to blow flow around tubing may lead to stasis and increase local concentration of norepinephrine. Rate should be titrated according to patient response. Observe IV infusion site frequently during administration. If blanching along vein occurs, change infusion site. Care should be taken to avoid extravasation because norepinephrine can cause local necrosis.
Body As Whole: Ischemic injury due to potent vasoconstrictor action and tissue hypoxia. Cardiovascular System: Bradycardia, probably as reflex result of rise in blood pressure, arrhythmias. 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 correct, hypotension may recur when LEVOPHED is discontinue, or blood pressure may be maintained at risk of severe peripheral and visceral vasoconstriction 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 report. Overdoses or conventional doses in hypersensitive persons cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating, and vomiting.
Caution should be observed to avoid extravasation of norepinephrine during intravenous administration. Check infusion sites frequently for free - flow. Peripheral vasoconstriction or ischemia, tissue necrosis, and / or gangrene in the surrounding area can occur following extravasation. Blanching along the course of infused vein, sometimes without obvious extravasation, has been attributed to vasa vasorum constriction with increased permeability of vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough, particularly during infusion into leg veins in geriatric patients or in those suffering from obliterative peripheral vascular disease. Hence, if blanching occurs, consideration should be given to the advisability of changing infusion site at intervals to allow the effects of local vasoconstriction to subside. If extravasation occur, affected area should be infiltrated as soon as possible, to prevent necrosis, using normal saline solution containing phentolamine, injected liberally throughout the ischemic area using a fine hypodermic needle. Ischemic areas may be identified by their cool, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and noticeable local hyperemic changes if the area is infiltrated within 12 hours of extravasation. Phentolamine antidote should be given as soon as possible after extravasation is observe.
Norepinephrine Bitartrate Injection is a concentrate, potent drug which must be diluted in dextrose containing solutions prior to infusion. Infusion of LEVOPHED should be given into large vein. Blood volume depletion should always be correct as fully as possible before any vasopressor is administer. 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. Average Dosage: Add 4 mL ampul of LEVOPHED To 1 000 mL of 5 percent dextrose containing solution. Each mL of this dilution contains 4 mcg of base of LEVOPHED. Give this solution by intravenous infusion. Insert plastic intravenous catheter through suitable bore needle well advanced centrally into the vein and securely fix with adhesive tape, avoiding, if possible, catheter tie - in technique as this promotes stasis. A drip chamber or other suitable metering device is essential to permit accurate estimation of the rate of flow in drops per minute. After observing response to an initial dose of 2 mL to 3 mL per minute, adjust the rate of flow to establish and maintain low normal blood pressure sufficient to maintain circulation to vital organs. In previously hypertensive patients, it is recommended that blood pressure should be raised no higher than 40 mm Hg below preexisting systolic pressure. The average maintenance dose ranges from 0. 5 mL To 1 mL per minute. High Dosage: Great individual variation occurs in the dose required to attain and maintain 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 may be necessary if patient remains hypotensive, but occult blood volume depletion should always be suspect and correct when present. Central venous pressure monitoring is usually helpful in detecting and treating this situation. Fluid Intake: degree of dilution depends on clinical fluid volume requirements. If large volumes of fluid are needed at a flow rate that would involve excessive dose of pressure agent per unit of time, solution more diluted than 4 mcg per mL should be used on other hand, when large volumes of fluid are clinically undesirable, concentration greater than 4 mcg per mL may be necessary. Duration of Therapy: infusion should be continued until adequate Blood Pressure and tissue perfusion are maintained without Therapy. Infusions of LEVOPHED should be reduced gradually, avoiding abrupt withdrawal. In some reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days. Infusions of LEVOPHED are usually administered intravenously during cardiac resuscitation. To restore and maintain adequate blood pressure after effective heartbeat and ventilation have been established by other means. Average Dosage: To maintain systemic Blood Pressure during management of cardiac arrest, LEVOPHED is used in the same manner as described under Restoration of Blood Pressure in Acute Hypotensive States.
Whenever possible, infusions of LEVOPHED should be given into large vein, particularly antecubital vein because, when administered into this vein, risk of necrosis of overlying skin from prolonged vasoconstriction is apparently very slight. Some authors have indicated that femoral vein is also an acceptable route of administration. Catheter tie - in techniques should be avoid, if possible, since obstruction of blood flow around tubing may cause stasis and increase local concentration of drug. Occlusive vascular diseases are more likely to occur in lower than in upper extremity. Therefore, one should avoid veins of leg in elderly patients or in those suffering from such disorders. Gangrene has been reported in lower extremity when infusions of LEVOPHED are given in the ankle vein.
There are no absolute contraindications to administration of norepinephrine. As mentioned above, norepinephrine use may be contraindicate to treating hypotension that is likely secondary to cardiogenic mechanisms. Additionally, for hypotension primarily related to hypovolemia, norepinephrine is probably not the best agent. The Fda does state that its use could be consideration in low volume states, but only as an emergency measure for maintaining coronary or cerebral perfusion pressure while waiting for appropriate volume resuscitation. Generally, use of norepinephrine should be avoided in patients with mesenteric or peripheral vascular thrombosis as subsequent vasoconstriction will increase area of ischemia and infarction. Profound hypoxia or hypercarbia can sensitize the myocardium to unstable arrhythmias, which could be exacerbated or even be initiated by use of norepinephrine - this is also the case with specific anesthetic agents, such as halothane and cyclopropane. Levophed, preparation of norepinephrine, typically used in clinical setting, contains sodium metabisulfite, which may cause allergic reactions in susceptible individuals. This effect may be more common in asthmatics. Care is necessary when using norepinephrine concomitantly with monoamine oxidase inhibitors or amitriptyline and imipramine - type antidepressants. The combination of any of these drugs can lead to severe, prolonged hypertension.
|Ingredients||Molecular Formula||Molecular Weight|
|Hydrous Dextrose USP||198.17|
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