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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Tissue Ischemia : Avoid extravasation into tissues, which can cause local necrosis. ( 5.1 ) • Hypotension After Abrupt Discontinuation : Sudden cessation of the infusion rate may result in marked hypotension. Reduce the Norepinephrine Bitartrate in Sodium Chloride Injection infusion rate gradually. ( 5.2 ) • Cardiac Arrhythmias: Norepinephrine Bitartrate in Sodium Chloride Injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. ( 5.3 ) 5.1 Tissue Ischemia Administration of Norepinephrine Bitartrate in Sodium Chloride Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite "normal" blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Sodium Chloride Injection [see Dosage and Administration (2.1) ]. Avoid Norepinephrine Bitartrate in Sodium Chloride Injection in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction. Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of Norepinephrine Bitartrate in Sodium Chloride Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation [see Dosage and Administration (2.1) ]. Emergency Treatment of Extravasation To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. 5.2 Hypotension after Abrupt Discontinuation Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the Norepinephrine Bitartrate in Sodiu...
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Tissue Ischemia [see Warnings and Precautions (5.1) ] • Hypotension [see Warnings and Precautions (5.2) ] • Cardiac Arrhythmias [see Warnings and Precautions (5.3) ] The most common adverse reactions are hypertension and bradycardia. The following adverse reactions can occur: Nervous system disorders: Anxiety, headache Respiratory disorders: Respiratory difficulty, pulmonary edema Most common adverse reactions are ischemic injury, bradycardia, anxiety, transient headache, respiratory difficulty, and extravasation necrosis at injection site. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.