BUMETANIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

REMEDYREPACK INC.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 cond

Product samenvatting:

Bumetanide Tablets USP, for oral administration, are available as: 2 mg: Peach colored, elliptical, flat-face, beveled edged tablets, engraved "BUMEX 2" on one side, and supplied as: NDC: 70518-3191-00 PACKAGING: 30 in 1 BLISTER PACK Store at 68° to 77°F (20° to 25°C); excursions permitted between 59° to 86°F (15° to 30°C) (see USP Controlled Room Temperature). Dispense contents in a tight, light-resistant container as defined in USP with a child-resistant closure, as required. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

BUMETANIDE- BUMETANIDE TABLET
REMEDYREPACK INC.
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BUMETANIDE TABLETS USP
FOR ORAL USE
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 is a loop diuretic available as 0.5 mg (light green), 1 mg
(yellow) and 2 mg
(peach) tablets for oral administration; each tablet also contains
anhydrous lactose,
magnesium stearate, microcrystalline cellulose, pregelatinized starch
and talc, with the
following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and
FD&C Blue No. 1
aluminum lake; 1 mg—D&C Yellow No. 10 aluminum lake; 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
phosphate
reabsorption takes place largely in