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Brethine
Generic Name: Terbutaline Sulfate (Injection)
Drug Category: Beta2-Adrenergic Agonist
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 12 years old for a maximum duration of 3 years.
| Approved Uses |
|
The brand product has been discontinued, generic is available. Indicated for the prevention and reversal of bronchospasm in patients 12 years and older with asthma and reversible bronchospasm associated with bronchitis and emphysema. Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 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. 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. Terbutaline, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, and cardiac arrhythmias; in patients with hyperthyroidism or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta adrenergic bronchodilator. 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. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. Immediate hypersensitivity reactions and exacerbations of bronchospasm have been reported after terbutaline administration. Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. There have been rare reports of seizures in patients receiving terbutaline; seizures did not recur in these patients after the drug was discontinued. Terbutaline should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within two weeks of discontinuation of such agents, since the action of terbutaline on the vascular system may be potentiated. Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as terbutaline sulfate, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta agonist is exceeded. The concomitant use of terbutaline sulfate with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. There are no adequate and well-controlled studies of terbutaline sulfate in pregnant women. Animal studies: alterations in behavior and brain development, decreased cellular proliferation. It is not known whether this drug is excreted in human milk. Therefore, terbutaline sulfate should be used during nursing only if the potential benefit justifies the possible risk to the newborn. |
| Off-label Uses |
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• Preterm labor and uterine hyperstimulation. GoToSource • Nocturnal hypoglycemia in type 1 diabetes. GoToSource • Use in patients under the age of 12. GoToSource • Prophylactic treatment for systemic capillary leak syndrome. GoToSource • Use with cefotaxime for treatment of chronic obstructive lung diseases. GoToSource • Priapism. GoToSource |
| Adverse Events |
|
Death, increased heart rate, hyperglycemia (high blood sugar), hypokalemia (low blood potassium level), cardiac arrhythmias, pulmonary edema, and myocardial ischemia after administration of oral or injectable terbutaline for preterm labor management. GoToSource Acute paraparesis (partial paralysis of the lower limbs). GoToSource Hypersensitivity vasculitis (inflammation of blood vessels). GoToSource Ventricular tachycardia (fast heart rate). GoToSource Seizures. GoToSource |
| Litigation |
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Lawsuits filed for birth defects. |
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