BUMEX
Details
- Status
- Prescription
- First Approved
- 1983-02-28
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
BUMEX Approval History
What BUMEX Treats
5 indicationsBUMEX is approved for 5 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Edema
- Congestive Heart Failure
- Hepatic Disease
- Renal Disease
- Nephrotic Syndrome
BUMEX Boxed Warning
WARNING Bumex ® (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 ) ....
WARNING Bumex ® (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 ) .
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BUMEX FDA Label Details
ProIndications & Usage
FDA Label (PDF)Bumex 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 Bumex tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
WARNING Bumex ® (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 DO...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.