BUMETANIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Cardinal Health 107, LLC

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

Bumetanide Tablets, USP for oral administration are available as: 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. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-4345-0 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]. Dispensed in Unit Dose Package. For Institutional Use Only. Do not take improper broken tablets, if found in the container. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Distributed by: Cardinal Health Dublin, OH 43017 L56459810124 Mfg. Rev. 10-2018-02 AV 04/19 (P) AvPAK

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

BUMETANIDE- BUMETANIDE TABLET
CARDINAL HEALTH 107, LLC
----------
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 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
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)
17
2
2
5
2
C
2
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 of this additional ac