SPL Set ID: 9f4b177e-4d7d-4255-afeb-522c7d4594c6

Rx only A sterile aqueous solution for subcutaneous injection. WARNING: PROLONGED TOCOLYSIS 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 (see CONTRAINDICATIONS, Prolonged Tocolysis). DESCRIPTION Terbutaline Sulfate Injection, USP, is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each mL of solution contains: 1 mg of terbutaline sulfate USP (0.82 mg of the free base), and Water for Injection, USP. Sodium chloride is used for isotonicity, and hydrochloric acid for adjustment to a pH of 3.0 to 5.0. Terbutaline sulfate is (±)-a-[(tert-butyl-amino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The structural formula is: Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Formula1.jpg