BUMETANIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Upsher-Smith Laboratories, LLC

INN (International ime):

BUMETANIDE

Sastav:

BUMETANIDE 0.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Bumetanide tablets are 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 tablets 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 is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.

Proizvod sažetak:

Bumetanide Tablets, USP, for oral administration, are available as: Bumetanide Tablets, USP, 0.5 mg are available as light green, round tablets with functional scoring; one side scored and debossed "U-S" above the score and "40" below the score, and the other side unscored and debossed "0.5". Tablets are supplied as: NDC 0832-0540-11 bottles of 100 Bumetanide Tablets, USP, 1 mg are available as yellow, round tablets with functional scoring; one side scored and debossed "U-S" above the score and "41" below the score, and the other side unscored and debossed "1". Tablets are supplied as: NDC 0832-0541-11 bottles of 100 NDC 0832-0541-10 bottles of 1000 Bumetanide Tablets, USP, 2 mg are available as light red, round tablets with functional scoring; one side scored and debossed "U-S" above the score and "42" below the score, and the other side unscored and debossed "2". Tablets are supplied as: NDC 0832-0542-11 bottles of 100 NDC 0832-0542-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

BUMETANIDE- BUMETANIDE TABLET
UPSHER-SMITH LABORATORIES, LLC
----------
BUMETANIDE TABLETS, USP
Rx only
WARNING
BUMETANIDE 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, USP is a loop diuretic, available as scored tablets. Each
tablet for oral
administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In
addition, each tablet
contains the following inactive ingredients: colloidal silicon
dioxide, magnesium stearate,
microcrystalline cellulose and pregelatinized corn starch. The tablets
also contain the
following: 0.5 mg, yellow iron oxide, FD&C blue #2 aluminum lake; 1
mg, yellow iron
oxide; 2 mg, red iron oxide.
Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic
acid. It is a
practically white powder having a calculated molecular weight of
364.42, and 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.
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
phosp