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Brethine Side Effects, and Drug Interactions - Terbutaline Sulfate
SIDE EFFECTS
Adverse reactions observed with Brethine 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 (%) |
|||
|
0.25 mg N=77 |
0.5 mg N=205 |
0.25 mg 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.
DRUG INTERACTIONS
The concomitant use of Brethine with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Terbutaline should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of terbutaline on the vascular system may be potentiated.
Beta-Blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Brethine, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
Diuretics: The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-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. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.
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