Bumetanide 0.5 MG Oral Tablet

INDICATIONS AND USAGE 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. CONTRAINDICATIONS 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 depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] dyspnoea` `[4] off label use` `[5] nausea` `[6] diarrhoea` `[7] dizziness` `[8] headache` `[9] pain` `[10] asthenia`

4 years ago

ROUND GREEN 5 25

HOW SUPPLIED

BUMEtanIDE Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows: NDC 68382-525-06 in bottles of 30 tablets with child-resistance closure NDC 68382-525-16 in bottles of 90 tablets with child-resistance closure NDC 68382-525-01 in bottles of 100 tablets NDC 68382-525-05 in bottles of 500 tablets NDC 68382-525-10 in bottles of 1000 tablets

BUMEtanIDE Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows: NDC 68382-526-06 in bottles of 30 tablets with child-resistance closure NDC 68382-526-16 in bottles of 90 tablets with child-resistance closure NDC 68382-526-01 in bottles of 100 tablets NDC 68382-526-05 in bottles of 500 tablets NDC 68382-526-10 in bottles of 1000 tablets

BUMEtanIDE Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows: NDC 68382-527-06 in bottles of 30 tablets with child-resistance closure NDC 68382-527-16 in bottles of 90 tablets with child-resistance closure NDC 68382-527-01 in bottles of 100 tablets NDC 68382-527-05 in bottles of 500 tablets NDC 68382-527-10 in bottles of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP). Manufactured by: Zydus Lifesciences Ltd., Baddi, India Distributed by: Zydus Pharmaceuticals ( USA) Inc. Pennington, NJ 08534 Rev.: 01/23

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