BUMETANIDE- bumetanide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

BUMETANIDE

Composition:

BUMETANIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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

Product summary:

Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 90 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 3/2010 Repackaged by NuCare Pharmaceuticals, Inc. Orange, CA 92867

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUMETANIDE- BUMETANIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
BUMETANIDE TABLETS USP
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, 0.5 mg
(light green), 1 mg (yellow) and 2 mg
(peach) for oral administration; each tablet also contains: anhydrous
lactose, magnesium stearate,
microcrystalline cellulose, corn starch and talc, with the following
colorants: 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 (Ferric oxide red).
Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoyl-benzoic
acid. It is a practically white
powder. It is slightly soluble in water and soluble in alkaline
solutions. It has 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 (
H
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
pla