Dopamine Hydrochloride

5 WARNINGS AND PRECAUTIONS Tissue ischemia : Severe peripheral and visceral vasoconstriction can occur. Address hypovolemia prior to use, monitor extremities, and infuse into large vein. ( 5.1 ) Cardiac arrhythmias : Monitor closely. ( 5.2 ) Hypotension after abrupt discontinuation : Gradually reduce infusion rate while expanding blood volume with intravenous fluids. ( 5.3 ) Severe hypersensitivity reactions due to sodium metabisulfite excipient : May cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals. ( 5.4 ) 5.1 Tissue Ischemia Administration of dopamine to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and hypouresis, tissue hypoxia, lactic acidosis, and poor systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Dopamine HCl Injection [see Dosage and Administration ( 2.2 )] . Gangrene of the extremities has occurred in patients with occlusive vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of Dopamine HCl Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein [see Dosage and Administration ( 2.1 )] , check the infusion site frequently for free flow, and monitor for signs of extravasation. 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 0.1 to 0.2 mg/kg of phentolamine mesylate up to a maximum of 10 mg per dose in pediatric patients. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. 5.2 Cardiac Arrhythmias Dopamine may cause arrhythmias. Monitor patients with arrhythmias and treat appropriately. 5.3 Hypotension after Abrupt Discontinuation Sudden cessation of the infusion may result in marked hypotension. Gradually reduce the infusion rate while expanding blood volume with intravenous fluids. 5.4 Severe Hypersensitivity Reactions due to Sodium Metabisulfite Excipient Dopamine HCl Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Tissue Ischemia [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Hypotension [see Warnings and Precautions ( 5.3 )] Severe Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] The following adverse reactions have been identified during postapproval use of dopamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: anginal pain, palpitation Gastrointestinal Disorders: nausea, vomiting Metabolism and Nutrition Disorders: azotemia Nervous System Disorders : headache, anxiety Respiratory Disorders : dyspnea Skin and Subcutaneous Tissue Disorders : piloerection Vascular Disorders : hypertension The most common adverse reaction is localized vasoconstriction due to extravasation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .