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.

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 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 summary:

Bumetanide Tablets USP, 1 mg are supplied as white to off white, round biconvex bisected and debossed AC above and 41 below the bisect on one side and plain on the reverse side. NDC 68071-4350-3 BOTTLES OF 30 NDC 68071-4350-6 BOTTLES OF 60 Storage: Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted between 15° to 30°C (59° to 86°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. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2017-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUMETANIDE- BUMETANIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
BUMETANIDE TABLETS, USP
(0.5 MG, 1 MG AND 2 MG)
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, 1 mg and 2 mg
tablets for oral
administration; each tablet also contains the following inactive
ingredients: anhydrous
lactose, magnesium stearate, maize starch, microcrystalline cellulose,
pregelatinized
starch and talc.
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
0N
O
S
USP Dissolution Test Pending.
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
17
2
2
5
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 the proximal tubule, phosphaturia
during bumetanide
induced diuresis is indicative