Bumex (Bumetanide) - Summary

BUMEX SUMMARY

BUMEX^®
brand of
bumetanide
TABLETS

Bumex^® (bumetanide) is a loop diuretic, available as scored tablets, 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) for oral administration; each tablet also contains lactose, magnesium stearate, microcrystalline cellulose, cornstarch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 and FD&C Blue No. 1; 1 mg—D&C Yellow No. 10; 2 mg—red iron oxide.

Bumex 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 following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

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NEWS HIGHLIGHTS

Published Studies Related to Bumex (Bumetanide)

Loop Diuretics Increase Bone Turnover and Decrease BMD in Osteopenic Postmenopausal Women: Results From a Randomized Controlled Study With Bumetanide. [2006.01]
To study effects of loop diuretics on bone, 87 women were randomized to 1 year of treatment with bumetanide or placebo. Compared with placebo, bumetanide decreased BMD by 2% at the total hip and by 1.4% at the whole body. Levels of biochemical bone markers were lower in the placebo than in the bumetanide group. Thus, treatment with loop diuretics affects bone metabolism. INTRODUCTION: Loop diuretics may affect bone because they increase the renal calcium excretion and alters the diurnal rhythm of plasma PTH levels. We studied the effects of 1 year of treatment with the loop diuretic bumetanide on bone metabolism... CONCLUSIONS: Treatment with loop diuretics affects bone turnover and decreases BMD. Further studies may reveal whether loop diuretics should be considered as a risk factor for fracture.

Bumetanide inhibits rapid kindling in neonatal rats. [2009.09]
PURPOSE: To examine the effects of bumetanide, a selective blocker of Na+-K+-2Cl- cotransporter (NKCC1), on hippocampal excitability and rapid kindling in immature rats. METHODS: Studies were performed in Wistar rats of three ages: postnatal day 11 (P11, neonatal), P14 (postneonatal), and P21 (preadolescent)...

Decreased seizure activity in a human neonate treated with bumetanide, an inhibitor of the Na(+)-K(+)-2Cl(-) cotransporter NKCC1. [2009.05]
Neonatal seizures have devastating consequences for brain development and are inadequately treated by available antiepileptics...

The bumetanide-sensitive Na-K-2Cl cotransporter NKCC1 as a potential target of a novel mechanism-based treatment strategy for neonatal seizures. [2008.09]
Seizures that occur during the neonatal period do so with a greater frequency than at any other age, have profound consequences for cognitive and motor development, and are difficult to treat with the existing series of antiepileptic drugs. During development, gamma-aminobutyric acid (GABA)ergic neurotransmission undergoes a switch from excitatory to inhibitory due to a reversal of neuronal chloride (Cl()) gradients...

Bumetanide enhances phenobarbital efficacy in a neonatal seizure model. [2008.02]
INTERPRETATION: Thus, alteration of Cl- transport by bumetanide enables the anticonvulsant action of phenobarbital in immature brain. This is a mechanistic demonstration of rational anticonvulsant polypharmacy. The combination of these agents may comprise an effective therapy for early-life seizures.

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Clinical Trials Related to Bumex (Bumetanide)

Pilot Study of Bumetanide for Newborn Seizures [Recruiting]
The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications, will be a safe and well tolerated medication, compared with conventional antiepileptic drugs alone.

Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects [Recruiting]
To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects

Bumetanide vs. Furosemide in Heart Failure [Not yet recruiting]
Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide vs. furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. Patients will be subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess functional capacity; patient recruitment and retention success, as well as medication adherence, will also be assessed.

Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension [Completed]
Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate in elevating blood pressure and are useful in selecting effective antihypertensive therapy. 2,3

The researchers hypothesize that:

1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure control in patients with untreated hypertension as well as in patients with treatment refractory or resistant hypertension that are managed by Clinical Hypertension Specialists.

2. Renin-guided therapeutics will reduce the number of medications required to maintain blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more medications, while under the care of a Clinical Hypertension Specialist.

3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care provided by Clinical Hypertension Specialists.

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