Country: United States
Language: English
Source: NLM (National Library of Medicine)
BUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE - UNII:0Y2S3XUQ5H)
Aphena Pharma Solutions - Tennessee, LLC
BUMETANIDE
BUMETANIDE 1 mg
ORAL
PRESCRIPTION DRUG
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 unti
Bumetanide Tablets, USP, for oral administration, are available as 0.5 mg Green, round, biconvex, bisected and debossed “E” above and “128” below the bisect on one side and plain on the reverse side and supplied as: NDC 0185-0128-01 bottles of 100 NDC 0185-0128-05 bottles of 500 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 0185-0129-01 bottles of 100 NDC 0185-0129-05 bottles of 500 2 mg Beige to light brown, round, biconvex, bisected and debossed “E” above and “130” below the bisect on one side and plain on the reverse side and supplied as: NDC 0185-0130-01 bottles of 100 NDC 0185-0130-05 bottles of 500 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. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc. Princeton, NJ 08540 46192277 Rev. September 2016 MF0128REV09/16
Abbreviated New Drug Application
BUMETANIDE- BUMETANIDE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, 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 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: C H N O S 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 ( H 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. Potas Read the complete document