BUMETANIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Cardinal Health 107, LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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.

Product samenvatting:

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 55154-3572-0 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]. Dispense contents in a tight, light-resistant container as defined in the USP with a child- resistant closure, as required. Do not take improper broken tablets, if found in the container. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Refer to package label for Distributor's NDC Number Distributed By: Cardinal Health Dublin, OH 43017 L57474310224 Rev. 11-2019-03

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BUMETANIDE- BUMETANIDE TABLET
CARDINAL HEALTH 107, LLC
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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
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.
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 addi