BUMETANIDE injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

GLENMARK PHARMACEUTICALS INC., USA

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 conditi

Resumo do produto:

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 68462-469-54) Discard unused portion. 10 mL Multiple-Dose Vial packaged in 10s (NDC 68462-470-54) 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 Glenmark Pharmaceuticals Inc., USA at 1 [phone], or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Gland Pharma Limited Hyderabad, India Distributed by: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 September 2022

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BUMETANIDE- BUMETANIDE INJECTION
GLENMARK PHARMACEUTICALS INC., USA
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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 dihydrate 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:
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
potency equivalent to approximately 40 mg furosemide. The major site
of bumetanide
action is the ascending limb of the loop of Henle.
C
H
N O S Molecular weight: 364.42
17
20
2
5
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 tubu