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 & 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 is supplied in the following dosage forms.
NDC 51662-1449-1
BUMETANIDE INJECTION, USP 1mg/4mL (0.25 mg/mL) 4mL VIAL

HF Acquisition Co LLC, DBA HealthFirst
Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

Bumetanide Injection, USP, 0.25 mg/mL is a sterile, clear, colorless to slightly yellow solution supplied in amber vials as follows:

4 mL Single Dose Vial packaged in 10s (NDC 0641-6008-10)

10 mL Multiple Dose Vial packaged in 10s (NDC 0641-6007-10)

This product, including the packaging components, is free of latex.

Storage

Store at 20° — 25°C (68° — 77°F), excursions permitted to 15° — 30° C (59° – 86°F) [See USP Controlled Room Temperature]. Protect from light.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Manufactured by:

LOGO
(click image for full-size original)

WEST-WARD
PHARMACEUTICALS
Eatontown, NJ 07724 USA

Revised June 2011

462-485-01

PRINCIPAL DISPLAY PANEL — SERIALIZED VIAL LABELING

SERIALIZED VIAL LABELING
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — VIAL LABELING

VIAL LABEL
(click image for full-size original)

BUMETANIDE
bumetanide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1449(NDC:0641-6008)
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
BENZYL ALCOHOL 10 mg in 1 mL
WATER
SODIUM HYDROXIDE
AMMONIUM ACETATE 4 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1449-1 4 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079196 01/11/2020
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1449)

Revised: 02/2020 HF Acquisition Co LLC, DBA HealthFirst

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