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warnings and cautions
5 WARNINGS AND PRECAUTIONS WARNINGS AND PRECAUTIONS • Cardiac arrhythmias and ischemia may be induced by Isoproterenol Hydrochloride Injection ( 5.1 ) • Sulfite: Isoproterenol Hydrochloride Injection contains metabisulfite, which may cause allergic reaction ( 5.2 ) 5.1 Cardiac Arrhythmias and Ischemia Isoproterenol may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy. 5.2 Allergic Reactions associated with Sulfite Isoproterenol hydrochloride injection contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes, particularly in patients with a history of allergies. However, the presence of metabisulfite in this product should not preclude its use for treatment in emergency situations, even if the patient is sulfite-sensitive, as the alternatives to using isoproterenol in a life-threatening situation may not be satisfactory.
6 ADVERSE REACTIONS The following adverse reactions have been associated with use of isoproterenol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Nervous system disorders: Nervousness, headache, dizziness, visual blurring Cardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema Respiratory: Dyspnea Other: Flushing of the skin, sweating, mild tremors, pallor, nausea ADVERSE REACTIONS Common adverse reactions with isoproterenol include tachycardia and palpitations ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech Inc at 1-800-862-3895 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.