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:
4 mL Single-Dose Vial packaged in 10s (NDC 68083-496-10)

Discard unused portion.

10 mL Multiple-Dose Vial packaged in 10s (NDC 68083-497-10)
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 Gland Pharma Limited at 864-879-9994 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:

Gland Pharma Limited

Hyderabad, India

ML No: 2/MD/TS/2015/F/G

Revised date: May 2022

PRINCIPAL DISPLAY PANEL

Vial Label (1 mg):

NDC 68083-496-01 Rx only

Bumetanide

Injection, USP

1 mg/4 mL (0.25 mg/mL)

For Intravenous or Intramuscular Use

4 mL Single-Dose Vial

Container
(click image for full-size original)

Carton Label (1 mg):

NDC 68083-496-10 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

carton
(click image for full-size original)

Vial Label (2.5 mg):

NDC 68083-497-01 Rx only

Bumetanide

Injection, USP

2.5 mg/10 mL (0.25 mg/mL)

For Intravenous or Intramuscular Use

10 mL Multiple-Dose Vial

Container
(click image for full-size original)

Carton Label (2.5 mg):

NDC 68083-497-10 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

carton
(click image for full-size original)
BUMETANIDE bumetanide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-496
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:68083-496-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (68083-496-01)
1 NDC:68083-496-01 4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (68083-496-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216434 05/26/2022
BUMETANIDE bumetanide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-497
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:68083-497-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (68083-497-01)
1 NDC:68083-497-01 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (68083-497-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216434 05/26/2022
Labeler — Gland Pharma Limited (918601238)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 858971074 ANALYSIS (68083-496), ANALYSIS (68083-497), MANUFACTURE (68083-496), MANUFACTURE (68083-497), PACK (68083-496), PACK (68083-497)

Revised: 06/2022 Gland Pharma Limited

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