BUMETANIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE - UNII:0Y2S3XUQ5H)

Available from:

Civica, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity. Bumetanide is contraindicated in anuria. Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition i

Product summary:

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 72572-040 -10)     10 mL Multiple Dose Vial packaged in 10s (NDC 72572-041 -10) This product, including the packaging components, is free of latex.   Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.   To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. 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  for: Civica, Inc. Lehi, Utah 84043 Manufactured  by: Hikma Pharmaceuticals USA Inc. Cherry Hill, NJ 08003 Revised: August 2021 462-928-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUMETANIDE- BUMETANIDE INJECTION
CIVICA, INC.
----------
BUMETANIDE INJECTION, USP
RX ONLY
WARNING: Bumetanide Injection, USP is a potent diuretic which, if
given in
excessive amounts, can lead to a profound diuresis with water and
electrolyte
depletion. Therefore, careful medical supervision is required, and
dose and dosage
schedule have to be adjusted to the individual patient’s needs. (See
DOSAGE AND
ADMINISTRATION.)
DESCRIPTION
Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials
(0.25 mg/mL) for
intravenous or intramuscular injection as a sterile solution.
Each mL contains bumetanide 0.25 mg, sodium chloride 8.5 mg and
ammonium acetate
4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as
preservative in
Water for Injection. pH adjusted to 6.8 – 7.8 with sodium hydroxide.
Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic
acid. It is a
practically white powder, slightly soluble in water, soluble in
alkaline solutions, having the
following structural formula:
C
H
N O S Molecular weight: 364.42
CLINICAL PHARMACOLOGY
Bumetanide is a loop diuretic with a rapid onset and short duration of
action.
Pharmacological and clinical studies have shown that 1 mg bumetanide
has a diuretic
17
20
2
5
potency equivalent to approximately 40 mg furosemide. The major site
of bumetanide
action is the ascending limb of the loop of Henle.
The mode of action has been determined through various clearance
studies in both
humans and experimental animals. Bumetanide inhibits sodium
reabsorption in the
ascending limb of the loop of Henle, as shown by marked reduction of
free-water
clearance (CH O) during hydration and tubular free-water reabsorption
(T H O) during
hydropenia. Reabsorption of chloride in the ascending limb is also
blocked by
bumetanide, and bumetanide is somewhat more chloruretic than
natriuretic.
Potassium excretion is also increased by bumetanide, in a dose-related
fashion.
Bumetanide may have an additional action in the proximal tubule. Since
phosphate
reabsorptio