Terbutaline Sulfate

INDICATIONS & USAGE Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.

DOSAGE & ADMINISTRATION Terbutaline Sulfate Injection, USP should be used only for subcutaneous administration and not intravenous infusion. Sterility and accurate dosing cannot be assured if the vials are not used in accordance with DOSAGE AND ADMINISTRATION. Discard unused portion after single patient use. The usual subcutaneous dose of Terbutaline Sulfate Injection, USP is 0.25 mg injected into the lateral deltoid area. If significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered. If the patient then fails to respond within another 15 to 30 minutes, other therapeutic measures should be considered. The total dose within 4 hours should not exceed 0.5 mg. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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 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, 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 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, 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.

CONTRAINDICATIONS 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 (see BOXED WARNING: PROLONGED TOCOLYSIS). Hypersensitivity Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

ADVERSE REACTIONS Adverse reactions observed with terbutaline 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 (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 (%) Terbutaline (%) 0.25 mg N=77 0.5 mg N=205 Reaction Central Nervous System Tremor 7.8 38 Nervousness 16.9 30.7 Dizziness 1.3 10.2 Headache 7.8 8.8 Drowsiness 11.7 9.8 Cardiovascular Palpitations 7.8 22.9 Tachycardia 1.3 1.5 Respiratory Dyspnea 0 2 Chest discomfort 1.3 1.5 Gastrointestinal Nausea/vomiting 1.3 3.9 Systemic Weakness 1.3 0.5 Flushed feeling 0 2.4 Sweating 0 2.5 Pain at injection site 2.6 0.5 Epinephrine (%) Epinephrine (%) 0.25 mg N=153 0.5 mg N=61 Reaction Central Nervous System Tremor 16.3 18 Nervousness 8.5 31.1 Dizziness 7.8 3.3 Headache 3.3 9.8 Drowsiness 14.4 8.2 Cardiovascular Palpitations 7.8 29.5 Tachycardia 2.6 0 Respiratory Dyspnea 2 0 Chest discomfort 2.6 0 Gastrointestinal Nausea/vomiting 1.3 11.5 Systemic Weakness 2.6 1.6 Flushed feeling 1.3 0 Sweating 0 0 Pain at injection site 2.6 1.6 Note: Some patients received more than one dosage strength of terbutaline and epinephrine. In addition, there were reports of anxiety, muscle cramps, and dry mouth (less than 0.5%). There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with terbutaline administration.