BUMETANIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Bryant Ranch Prepack

INN (Tarptautinis Pavadinimas):

BUMETANIDE

Sudėtis:

BUMETANIDE 1 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Bumetanide Tablets, USP, for oral administration, are available 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: NDC: 63629-4968-5: 60 Tablets in a BOTTLE NDC: 63629-4968-1: 30 Tablets in a BOTTLE NDC: 63629-4968-2: 90 Tablets in a BOTTLE NDC: 63629-4968-3: 28 Tablets in a BOTTLE NDC: 63629-4968-4: 18 Tablets in a BOTTLE 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. KEEP TIGHTLY CLOSED. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

BUMETANIDE- BUMETANIDE TABLET
BRYANT RANCH PREPACK
----------
BUMETANIDE TABLETS, USP
FOR ORAL USE
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 (corn),
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:
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.
Potassium excretion