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Bumetanide (Bumex)

Trade Name : Bumex

Validus Pharmaceuticals LLC

TABLET

Strength 0.5 mg/1

BUMETANIDE Loop Diuretic [EPC],Increased Diuresis at Loop of Henle [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Bumetanide (Bumex) which is also known as Bumex and Manufactured by Validus Pharmaceuticals LLC. It is available in strength of 0.5 mg/1 per ml. Read more

Bumetanide (Bumex) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BUMEXn- Array
  • Fn- or oral use
  • Rx Only
  • 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 (n ).
  • Bumex (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 mgu2014D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mgu2014D&C Yellow No. 10 aluminum lake; 2 mgu2014red 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 followingu00a0structural formula:
  • Bumex is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg Bumex has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of Bumex action is the ascending limb of the loop of Henle.
  • The mode of action has been determined through various clearance studies in both humans and experimental animals. u00a0Bumex inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CHO) during hydration and tubular free-water reabsorption (THO) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by Bumex, and Bumex is somewhat more chloruretic than natriuretic.
  • Potassium excretion is also increased by Bumex, in a dose-related fashion.
  • Bumex may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during Bumex induced diuresis is indicative of this additional action. u00a0This is further supported by the reduction in the renal clearance of Bumex by probenecid, associated with diminution in the natriuretic response. u00a0This proximal tubular activity does not seem to be related to an inhibition of carbonic anhydrase. Bumex does not appear to have a noticeable action on the distal tubule.
  • Bumex decreases uric acid excretion and increases serum uric acid. Following oral administration of Bumex the onset of diuresis occurs in 30 to 60 minutes. u00a0Peak activity is reached between 1 and 2 hours. At usual doses (1u00a0mg to 2 mg) diuresis is largely complete within 4 hours; with higher doses, the diuretic action lasts for 4 to 6 hours. Diuresis starts within minutes following an intravenous injection and reaches maximum levels within 15 to 30 minutes.
  • Several pharmacokinetic studies have shown that bumetanide, administered orally or parenterally, is eliminated rapidly in humans, with a half-life of between 1 and 1u00bd hours. Plasma protein-binding is in the range of 94% to 96%.
  • Oral administration of carbon-14 labeled Bumex to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Urinary and biliary metabolites identified in this study were formed by oxidation of the N-butyl side chain. u00a0Biliary excretion of Bumex amounted to only 2% of the administered dose.
  • Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepaticu00a0and renal disease, including the nephrotic syndrome.
  • Almost equal diuretic response occurs after oral and parenteral administration of bumetanide.u00a0Therefore, if impaired gastrointestinal absorption is suspected or oral administration is notu00a0practical, bumetanide should be given by the intramuscular or intravenous route.
  • Successful treatment with Bumexu00a0tabletsu00a0following instances of allergic reactions to furosemideu00a0suggests a lack of cross-sensitivity.
  • Bumex is contraindicated in anuria. Although Bumex can be used to induce diuresis in renalu00a0insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development ofu00a0oliguria during therapy of patients with progressive renal disease, is an indication foru00a0discontinuation of treatment with Bumex. u00a0Bumex is also contraindicated in patients in hepaticu00a0coma or in states of severe electrolyte depletion until the condition is improved or corrected.u00a0u00a0Bumex is contraindicated in patients hypersensitive to this drug.
  • No data
  • No data
  • The most frequent clinical adverse reactions considered probably or possibly related to Bumexu00a0are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%),u00a0headache (0.6%), nausea (0.6%) and encephalopathy (in patients with pre-existing liveru00a0disease) (0.6%). u00a0u00a0One or more of these adverse reactions have been reported in approximatelyu00a04.1% of patients treated with Bumex.
  • Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with bumetanide use.
  • Less frequent clinical adverse reactions to Bumex are impaired hearing (0.5%), pruritusu00a0(0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal painu00a0(0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%) and vomiting (0.2%).u00a0u00a0One or more of these adverse reactions have been reported in approximately 2.9% of patientsu00a0treated with Bumex.
  • Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients,u00a0are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dryu00a0mouth, upset stomach, renal failure, asterixis, itching, nipple tenderness, diarrhea, prematureu00a0ejaculation and difficulty maintaining an erection.
  • Laboratory abnormalities reported have included hyperuricemia (in 18.4% of patients tested),u00a0hypochloremia (14.9%), hypokalemia (14.7%), azotemia (10.6%), hyponatremia (9.2%),u00a0increased serum creatinine (7.4%), hyperglycemia (6.6%), and variations in phosphorusu00a0(4.5%), CO content (4.3%), bicarbonate (3.1%) and calcium (2.4%). Although manifestationsu00a0of the pharmacologic action of Bumex, these conditions may become more pronounced byu00a0intensive therapy.
  • Also reported have been thrombocytopenia (0.2%) and deviations in hemoglobin (0.8%),u00a0prothrombin time (0.8%), hematocrit (0.6%), WBC (0.3%) and differential counts (0.1%). Thereu00a0have been rare spontaneous reports of thrombocytopenia from postmarketing experience.
  • Diuresis induced by Bumex may also rarely be accompanied by changes in LDH (1.0%), totalu00a0serum bilirubin (0.8%), serum proteins (0.7%), SGOT (0.6%), SGPT (0.5%), alkalineu00a0phosphatase (0.4%), cholesterol (0.4%) and creatinine clearance (0.3%). Increases in urinaryu00a0glucose (0.7%) and urinary protein (0.3%) have also been seen.u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 (1-866-9VALIDUS) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Overdosage can lead to acute profound water loss, volume and electrolyte depletion,u00a0dehydration, reduction of blood volume and circulatory collapse with a possibility of vascularu00a0thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness,u00a0mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacementu00a0of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output andu00a0serum electrolyte levels.
  • Individualize dosage with careful monitoring of patient response.
  • Bumex Tablets for oral administration are elliptical, flat-faced, and bevel-edged, available as:
  • Store atu00a068u00b0 to 77u00b0F (20u00b0 to 25u00b0C); excursions permitted between 59u00b0 to 86u00b0F (15u00b0 to 30u00b0C) [See USP Controlled Room Temperature].
  • Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
  • Manufactured for and n- Distributed by:n- u00a0n- (
  • Product of Italy
  • u00a0
  • u00a9 2018 Validus Pharmaceuticals LLC
  • 60018-04nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0August 2018
  • NDC 30698-630-01Bumexn (bumetanide) Tablets0.5 mg100 TabletsRx Only
  • NDC 30698-631-01Bumexn (bumetanide) Tablets1 mg100 TabletsRx Only
  • NDC 30698-632-01Bumexn (bumetanide) Tablets2 mg100 TabletsRx Only

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