BUMETANIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Lifesciences Limited

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 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 depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.

Product summary:

Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows: NDC 70771-1024-3 in bottles of 30 tablets with child-resistance closure NDC 70771-1024-9 in bottles of 90 tablets with child-resistance closure NDC 70771-1024-1 in bottles of 100 tablets NDC 70771-1024-5 in bottles of 500 tablets NDC 70771-1024-0 in bottles of 1000 tablets Bumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows: NDC 70771-1025-3 in bottles of 30 tablets with child-resistance closure NDC 70771-1025-9 in bottles of 90 tablets with child-resistance closure NDC 70771-1025-1 in bottles of 100 tablets NDC 70771-1025-5 in bottles of 500 tablets NDC 70771-1025-0 in bottles of 1000 tablets Bumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows: NDC 70771-1026-3 in bottles of 30 tablets with child-resistance closure NDC 70771-1026-9 in bottles of 90 tablets with child-resistance closure NDC 70771-1026-1 in bottles of 100 tablets NDC 70771-1026-5 in bottles of 500 tablets NDC 70771-1026-0 in bottles of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP). Manufactured  by: Zydus Lifesciences Ltd.,   Baddi, India Rev.: 12/23

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUMETANIDE- BUMETANIDE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
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