BUMETANIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

BUMETANIDE

Composition:

BUMETANIDE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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

Product summary:

Bumetanide Tablets USP, for oral administration, are available as: 0.5 mg: Green, round, biconvex, bisected and debossed “E” above and “128” below the bisect on one side and plain on the reverse side and supplied as: 1 mg: Yellow, round, biconvex, bisected and debossed “E” above and “129” below the bisect on one side and plain on the reverse side and supplied as: 2 mg: Beige to light brown, round, biconvex, bisected and debossed “E” above and “130” below the bisect on one side and plain on the reverse side and supplied as: Storage: 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. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS7071 Rev. 04/11 MF0128REV04/11 MG # 16922 Distributed and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUMETANIDE - BUMETANIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
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. 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:
anhydrous lactose, corn starch, magnesium stearate, microcrystalline
cellulose, pregelatinized starch,
talc, with the following dye systems: 0.5 mg- D&C yellow No. 10
aluminum lake, FD&C blue No. 1
aluminum lake and FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No.
10 aluminum lake; 2 mg-
synthetic black iron oxide, synthetic red iron oxide and synthetic
yellow 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:
C
H N O S
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 (cH2O)
during hydration and tubular free-
water reabsorption (TcH2O) 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 al