BUMETANIDE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

A-S Medication Solutions

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity. Bumetanide is contraindicated in anuria. Although bumetanide tablets 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 tablets. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte

Ապրանքի ամփոփագիր:

Product: 50090-5124 NDC: 50090-5124-0 90 TABLET in a BOTTLE

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

BUMETANIDE- BUMETANIDE TABLET
A-S MEDICATION SOLUTIONS
----------
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 is a loop diuretic, available as scored tablets.
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:
Each bumetanide tablet intended 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, corn starch,
lactose monohydrate, magnesium stearate, povidone and talc. In
addition, each 0.5 mg tablet contains
D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake and
ferric oxide black; each 1 mg
tablet contains D&C Yellow No. 10 aluminum lake and ferric oxide red;
each 2 mg tablet contains mg
D&C Yellow No. 10 aluminum lake and ferric oxide red.
Bumetanide tablet meets USP Dissolution Test 2.
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