Terbutaline Sulfate (Page 2 of 2)

Adverse Reactions to Terbutaline Sulfate

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.

OVERDOSAGE

The median sc lethal dose of terbutaline in mature rats was approximately 165 mg/kg (approximately 2,700 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The median sc lethal dose of terbutaline in young rats was approximately 2,000 mg/kg (approximately 32,000 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. There is no specific antidote. Treatment consists of discontinuation of terbutaline together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of terbutaline.

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.

HOW SUPPLIED

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Discard unused portion after single patient use.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light. Do not use if solution is discolored.
Vial stoppers do not contain natural rubber latex.
APP
APP Pharmaceuticals, LLC
Schaumburg, IL 60173
451001DRevised: February 2011

Sample Package Label

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TERBUTALINE SULFATE terbutaline sulfate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9962(NDC:63323-665)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Terbutaline Sulfate (Terbutaline) Terbutaline Sulfate 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-9962-01 1 VIAL in 1 BAG contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BAG (0404-9962-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076887 01/12/2022
Labeler — Henry Schein, Inc. (012430880)

Revised: 01/2022 Henry Schein, Inc.

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