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.

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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

PDP INFO – TERBUTALINE SULFATE 402168C VIAL
(click image for full-size original)

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

PDP INFO – TERBUTALINE SULFATE 42730C TRAY
(click image for full-size original)
TERBUTALINE SULFATE terbutaline sulfate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.9 mg in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-665-01 25 VIAL, SINGLE-USE in 1 TRAY contains a VIAL, SINGLE-USE (63323-665-00)
1 NDC:63323-665-00 1 mL in 1 VIAL, SINGLE-USE This package is contained within the TRAY (63323-665-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076887 03/10/2011
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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