BOXED WARNING WARNING: PROLONGED TOCOLYSIS Terbutaline Sulfate has not been approved for and should not be used for prolonged tocolysis (beyond 48-72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration. [See CONTRAINDICATIONS, Prolonged Tocolysis.]
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WARNINGS Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of terbutaline sulfate than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Use of Anti-Inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. Cardiovascular Effects Terbutaline sulfate, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of terbutaline sulfate at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, terbutaline sulfate, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Seizures There have been rare reports of seizures in patients receiving terbutaline; seizures did not recur in these patients after the drug was discontinued.
ADVERSE REACTIONS Adverse reactions observed with terbutaline sulfate injection are similar to those commonly seen with other sympathomimetic agents. All these reactions are transient in nature and usually do not require treatment. The following table compares adverse reactions seen in patients treated with terbutaline sulfate injection (0.25 mg and 0.5 mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients. Incidence (%) of Adverse Reactions Terbutaline (%) Epinephrine (%) 0.25mg N=77 0.5 mg N=205 0.25mg N=153 0.5 mg N=61 Reaction Central Nervous System Tremor 7.8 38.0 16.3 18.0 Nervousness 16.9 30.7 8.5 31.1 Dizziness 1.3 10.2 7.8 3.3 Headache 7.8 8.8 3.3 9.8 Drowsiness 11.7 9.8 14.4 8.2 Cardiovascular Palpitations 7.8 22.9 7.8 29.5 Tachycardia 1.3 1.5 2.6 0.0 Respiratory Dyspnea 0.0 2.0 2.0 0.0 Chest discomfort 1.3 1.5 2.6 0.0 Gastrointestinal Nausea/vomiting 1.3 3.9 1.3 11.5 Systemic Weakness 1.3 0.5 2.6 1.6 Flushed feeling 0.0 2.4 1.3 0.0 Sweating 0.0 2.4 0.0 0.0 Pain at injection site 2.6 0.5 2.6 1.6 Note: Some patients received more than one dosage strength of terbutaline sulfate and epinephrine. In addition, there were reports of anxiety, muscle cramps, and dry mouth (<0.5%). There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with terbutaline administration. To report SUSPECTED ADVERSE REACTIONS, contact Areva Pharamceuticals Inc. at 1-855-853-4760 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.