Terbutaline Sulfate (Page 3 of 3)
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/m 2 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/m 2 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 AND 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
Terbutaline Sulfate Injection, USP
Product Code | Unit of Sale | Strength | Each |
660501 | NDC 63323-665-01Unit of 25 | 1 mg per mL | NDC 63323-665-002 mL Amber, Type 1 GlassSingle Dose Vial |
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.
www.fresenius-kabi.com/us
451001E
Revised: April 2022
PACKAGE LABEL — PRINCIPAL DISPLAY – Terbutaline Sulfate 1 mL Single Dose Vial Label
NDC 63323-665-00 660501
TERBUTALINE SULFATE
INJECTION, USP
1 mg per mL
For Subcutaneous Injection Only.
Sterile
Do not use if solution is discolored.
Protect from light. Rx only
1 mL Single Dose Vial
PACKAGE LABEL — PRINCIPAL DISPLAY – Terbutaline Sulfate 1 mL Single Dose Vial Tray Label
NDC 63323-665-01 660501
TERBUTALINE SULFATE
INJECTION, USP
1 mg per mL
For Subcutaneous Injection Only.
Do not use if solution is discolored.
Rx only
25 Single Dose Vials, 1 mL
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Labeler — Fresenius Kabi USA, LLC (608775388) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Fresenius Kabi USA, LLC | 023648251 | MANUFACTURE (63323-665) |
Revised: 07/2022 Fresenius Kabi USA, LLC
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