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:

Fresenius Kabi Logo

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 Vial Label
(click image for full-size original)

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 1 mg/4 mL Shelf Carton
(click image for full-size original)

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 Vial Label
(click image for full-size original)

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

Principal Display Panel – Bumetanide 2.5 mg/10 mL Shelf Carton
(click image for full-size original)
BUMETANIDE bumetanide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-570
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUMETANIDE (BUMETANIDE) BUMETANIDE 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
AMMONIUM ACETATE 4 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65219-570-04 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (65219-570-01)
1 NDC:65219-570-01 4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (65219-570-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216434 09/26/2022
BUMETANIDE bumetanide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-572
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUMETANIDE (BUMETANIDE) BUMETANIDE 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
AMMONIUM ACETATE 4 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65219-572-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (65219-572-01)
1 NDC:65219-572-01 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (65219-572-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216434 09/26/2022
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

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