BUMETANIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Bryant Ranch Prepack

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

NDC: 71335-1692-5: 60 Tablets in a BOTTLE NDC: 71335-1692-1: 30 Tablets in a BOTTLE NDC: 71335-1692-2: 90 Tablets in a BOTTLE NDC: 71335-1692-3: 28 Tablets in a BOTTLE NDC: 71335-1692-4: 18 Tablets in a BOTTLE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BUMETANIDE- BUMETANIDE TABLET
BRYANT RANCH PREPACK
----------
BUMETANIDE TABLETS, USP
RX ONLY
WARNING
BUMETANIDEISAPOTENTDIURETICWHICH, IFGIVENINEXCESSIVEAMOUNTS,
CANLEADTOAPROFOUNDDIURESISWITHWATERANDELECTROLYTEDEPLETION.THEREFORE,
CAREFULMEDICALSUPERVISIONISREQUIRED,ANDDOSEANDDOSAGESCHEDULEHAVETOBEADJUSTEDTOTHEINDIVIDUALPATIENT'SNEEDS_(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 somewhat more chloruretic than
natriuretic