Drug Catalog - Product Detail
Bumetanide Tab 0.5 MG 100 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42799-0119-01 | EDENBRIDGE PHARMACEUTICALS | 100 | 0.5MG | TABLET |
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Description
DESCRIPTION Bumetanide is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mg—D&C Yellow No. 10 aluminum lake; 2 mg—red 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: bumetanide-01
How Supplied
HOW SUPPLIED Bumetanide Tablets USP, for oral administration, are available as: 0.5 mg : Light green colored, elliptical, flat-face, beveled edged tablets, engraved "BUMEX 0.5" on one side, and supplied as: NDC 42799-119-01 bottles of 100 1 mg : Yellow colored, elliptical, flat-face, beveled edged tablets, engraved "BUMEX 1" on one side, and supplied as: NDC 42799-120-01 bottles of 100 NDC 42799-120-02 bottles of 500 2 mg : Peach colored, elliptical, flat-face, beveled edged tablets, engraved "BUMEX 2" on one side, and supplied as: NDC 42799-121-01 bottles of 100 NDC 42799-121-02 bottles of 500 Store tablets at 59° to 86°F (15° to 30°C). Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. To report SUSPECTED ADVERSE REACTIONS, call 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Dosage should be individualized with careful monitoring of patient response. Oral Administration The usual total daily dosage of bumetanide tablets is 0.5 mg to 2 mg and in most patients is given as a single dose. If the diuretic response to an initial dose of bumetanide tablets is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5-hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby bumetanide tablets is given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, the dosage should be kept to a minimum and, if necessary, dosage increased very carefully. Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide in proportion to furosemide in patients allergic to furosemide. Parenteral Administration Bumetanide injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical. Parenteral treatment should be terminated and oral treatment instituted as soon as possible.