Bumetanide (Page 3 of 3)
OVERDOSAGE
Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.
DOSAGE AND ADMINISTRATION
Dosage should be individualized with careful monitoring of patient response.
Parenteral Administration
Bumetanide Injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.
Parenteral treatment should be terminated and oral treatment instituted as soon as possible.
The usual initial dose is 0.5 to 1 mg intravenously or intramuscularly. Intravenous administration should be given over a period of 1 to 2 minutes. If the response to an initial dose is deemed insufficient, a second or third dose may be given at intervals of 2 to 3 hours, but should not exceed a daily dosage of 10 mg.
Miscibility and Parenteral Solutions
The compatibility tests of bumetanide injection with 5% Dextrose Injection in Water, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection in both glass and plasticized PVC (Viaflex) containers have shown no significant absorption effect with either containers, nor a measurable loss of potency due to degradation of the drug. However, solutions should be freshly prepared and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
Bumetanide Injection, USP, 0.25 mg/mL is a sterile, clear, colorless to slightly yellow solution supplied in amber vials as follows:
Product Code | Unit of Sale | Strength | Each |
570104 | NDC 65219-570-04Unit of 10 | 1 mg/4 mL (0.25 mg/mL) | NDC 65219-570-014 mL Single-Dose Vial |
Discard unused portion.
Product Code | Unit of Sale | Strength | Each |
570110 | NDC 65219-572-10Unit of 10 | 2.5 mg/10mL (0.25 mg/mL) | NDC 65219-572-0110 mL Multiple-Dose Vial |
This container closure is not made with natural rubber latex.
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30° C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for:
Lake Zurich, IL 60047
www.fresenius-kabi.com/us
Made in India
451761
Revised: August 2022
Principal Display Panel – Bumetanide 1 mg/4 mL Vial Label
NDC 65219-570-01 Rx only
Bumetanide
Injection, USP
1 mg/4 mL (0.25 mg/mL)
For Intravenous or
Intramuscular Use
Contains Benzyl Alcohol
4 mL Single-Dose VialDiscard unused portion.
Principal Display Panel – Bumetanide 1 mg/4 mL Shelf Carton
NDC 65219-570-04 Rx only
Bumetanide Injection, USP
1 mg/4 mL (0.25 mg/mL)
For Intravenous or Intramuscular Use 10 x 4 mL Single-Dose Vials
Principal Display Panel – Bumetanide 2.5 mg/10 mL Vial Label
NDC 65219-572-01 Rx only
Bumetanide Injection, USP
2.5 mg/10 mL (0.25 mg/mL)
For Intravenous or Intramuscular Use
Contains Benzyl Alcohol
10 mL Multiple-Dose Vial
Principal Display Panel – Bumetanide 2.5 mg/10 mL Shelf Carton
NDC 65219-572-10 Rx only
Bumetanide Injection, USP
2.5 mg/10 mL (0.25 mg/mL)
For Intravenous or Intramuscular Use
10 x 10 mL Multiple-Dose Vials
BUMETANIDE bumetanide injection | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
|
BUMETANIDE bumetanide injection | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
|
Labeler — Fresenius Kabi USA, LLC (013547657) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Gland Pharma Limited | 858971074 | ANALYSIS (65219-570), ANALYSIS (65219-572), MANUFACTURE (65219-570), MANUFACTURE (65219-572), PACK (65219-570), PACK (65219-572) |
Revised: 09/2022 Fresenius Kabi USA, LLC
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.