"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Bumex (bumetanide) is 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 Bumex (bumetanide) following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
DOSAGE AND ADMINISTRATION
Dosage should be individualized with careful monitoring of patient response.
The usual total daily dosage of Bumex (bumetanide) 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 Bumex (bumetanide) 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 Bumex (bumetanide) 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, Bumex (bumetanide) can be substituted at approximately a 1:40 ratio of Bumex (bumetanide) to furosemide in patients allergic to furosemide.
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.
Tablets, 0.5 mg (light green), bottles of 100 (NDC 0004-0125-01) and 5000 (NDC 0004-012511); 1 mg (yellow), bottles of 100 (NDC 0004-0121-01), 500 (NDC 0004-0121-14) and 5000 (NDC 0004-0121-11); 2 mg (peach), bottles of 100 (NDC 0004-0162-01) and 5000 (NDC 00040162-11).
Imprint on tablets: 0.5 mg–ROCHE BUMEX (bumetanide) 0.5; 1 mg–ROCHE BUMEX (bumetanide) 1; 2 mg–ROCHE BUMEX (bumetanide) 2.
Store tablets at 59° to 86°F (15° to 30°C).
Validus Pharmaceuticals LLC, 19 Cherry Hill Road, Suite 310, Parsippany, NJ 07054. 1-866-9VALIDUS. (1-866-982-5438), email@example.com. (Rev 9/2009).
Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.
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