BUMETANIDE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Edenbridge Pharmaceuticals LLC.

INN (Միջազգային անվանումը):

Bumetanide

Կազմը:

Bumetanide 0.5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

Bumetanide Tablets USP, for oral administration, are available as: 0.5 mg: Light green colored, elliptical, flat-face, beveled edged tablets, engraved "BUMEX 0.5" on one side, and supplied as: NDC 42799-119-01 bottles of 100 1 mg: Yellow colored, elliptical, flat-face, beveled edged tablets, engraved "BUMEX 1" on one side, and supplied as: NDC 42799-120-01 bottles of 100 NDC 42799-120-02 bottles of 500 2 mg: Peach colored, elliptical, flat-face, beveled edged tablets, engraved "BUMEX 2" on one side, and supplied as: NDC 42799-121-01 bottles of 100 NDC 42799-121-02 bottles of 500 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.

Լիազորման կարգավիճակը:

New Drug Application Authorized Generic

Ապրանքի հատկությունները

BUMETANIDE - BUMETANIDE TABLET
EDENBRIDGE PHARMACEUTICALS LLC.
----------
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