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Bumetanide | CAS No: 28395-03-1 | GMP-certified suppliers
A medication that treats edema linked to congestive heart failure, hepatic, and renal diseases by promoting effective diuresis to manage fluid retention in at-risk patients.
Therapeutic categories
Primary indications
- For the treatment of edema associated with congestive heart failure, hepatic and renal disease including the nephrotic syndrome
Product Snapshot
- Bumetanide is available in multiple oral and injectable formulations including tablets, capsules, and injection solutions
- It is primarily indicated for the treatment of edema associated with congestive heart failure, hepatic and renal diseases, including nephrotic syndrome
- Bumetanide holds approved regulatory status in the US and Canadian markets
Clinical Overview
Pharmacodynamically, bumetanide exerts potent diuretic effects by inhibiting sodium and chloride reabsorption in the thick ascending limb of the loop of Henle. This action disrupts electrolyte transport, leading to increased excretion of sodium, chloride, and water. The mechanism involves interference with renal cyclic AMP and/or inhibition of the sodium-potassium ATPase pump, reducing active transport of electrolytes and enhancing diuresis. Clinically, bumetanide is considered approximately 40 times more potent than furosemide in patients with normal renal function, with a more predictable pharmacokinetic profile, supporting its use both as an alternative and potentially first-line therapy.
Regarding absorption, distribution, metabolism, and excretion (ADME), bumetanide demonstrates reliable bioavailability and is primarily eliminated via renal pathways. It is classified among drugs mainly renally excreted, necessitating dosage adjustment and careful monitoring in patients with impaired renal function.
Safety considerations include its potential for causing electrolyte imbalances, volume depletion, and nephrotoxicity, as well as inadvertent photosensitivity. Close monitoring of electrolyte levels, renal function, and hydration status is recommended during therapy. The compound is also classified under agents with possible muscle toxicity and should be used cautiously in patients with predisposing conditions.
Bumetanide is an approved pharmaceutical active ingredient found in various global markets. When sourcing the API, quality control must ensure compliance with pharmacopeial standards, with particular attention to purity, polymorphic form, and residual solvents. Suppliers should provide robust documentation guaranteeing batch-to-batch consistency, given the critical nature of diuretic therapy in managing fluid balance in at-risk patient populations.
Identification & chemistry
| Generic name | Bumetanide |
|---|---|
| Molecule type | Small molecule |
| CAS | 28395-03-1 |
| UNII | 0Y2S3XUQ5H |
| DrugBank ID | DB00887 |
Pharmacology
| Summary | Bumetanide is a loop diuretic that targets sodium-potassium-chloride cotransporters in the thick ascending limb of the loop of Henle, inhibiting active reabsorption of sodium and chloride. This action promotes increased excretion of sodium, chloride, and water, leading to diuresis. It is primarily used to manage edema associated with congestive heart failure and renal or hepatic dysfunction. |
|---|---|
| Mechanism of action | Bumetanide interferes with renal cAMP and/or inhibits the sodium-potassium ATPase pump. Bumetanide appears to block the active reabsorption of chloride and possibly sodium in the ascending loop of Henle, altering electrolyte transfer in the proximal tubule. This results in excretion of sodium, chloride, and water and, hence, diuresis. |
| Pharmacodynamics | Bumetanide is a loop diuretic of the sulfamyl category to treat heart failure. It is often used in patients in whom high doses of furosemide are ineffective. There is however no reason not to use bumetanide as a first choice drug. The main difference between the two substances is in bioavailability. Bumetanide has more predictable pharmacokinetic properties as well as clinical effect. In patients with normal renal function, bumetanide is 40 times more effective than furosemide. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Solute carrier family 12 member 1 | Humans | inhibitor |
| Solute carrier family 12 member 2 | Humans | inhibitor |
| Solute carrier family 12 member 4 | Humans | inhibitor |
ADME / PK
| Absorption | Bumetanide is completely absorbed (80%), and the absorption is not altered when taken with food. Bioavailability is almost complete. |
|---|---|
| Half-life | 60-90 minutes |
| Protein binding | 97% |
| Metabolism | 45% is secreted unchanged. Urinary and biliary metabolites are formed by oxidation of the N-butyl side chain. |
| Route of elimination | 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. Biliary excretion of Bumex amounted to only 2% of the administered dose. |
| Clearance | * 0.2 - 1.1 mL/min/kg [preterm and full-term neonates with respiratory disorders] * 2.17 mL/min/kg [neonates receiving bumetanide for volume overload] * 1.8 +/- 0.3 mL/min/kg [geriatric subjects] * 2.9 +/- 0.2 mL/min/kg [younger subjects] |
Formulation & handling
- Bumetanide is a small molecule diuretic available for both oral and parenteral (intravenous, intramuscular) administration.
- Oral formulations should be taken with food to minimize gastrointestinal irritation.
- The compound has low water solubility, requiring appropriate formulation strategies to ensure bioavailability and stability.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patents have expired in both the US and Canada, leading to the availability of generic versions and a mature market environment. Ongoing regulatory approvals support continued market presence across these regions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Bumetanide includes several originator and generic companies involved in production and packaging, indicating a diversified supply base. Branded products are primarily present in the US and Canadian markets. Given the multiple manufacturers and repackagers listed, along with the presence of established generic firms, patent expiry has likely led to existing generic competition. |
|---|
Safety
| Toxicity | Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels. |
|---|
- Overdosage may cause severe fluid and electrolyte depletion leading to circulatory collapse and risk of vascular thrombosis
- Electrolyte imbalances can manifest as neurological and muscular symptoms including weakness, confusion, and cramps
- Handling requires monitoring of fluid and electrolyte status to prevent adverse systemic effects
Bumetanide is a type of Diuretics
Diuretics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), are compounds commonly used in the treatment of conditions such as hypertension, congestive heart failure, and edema. Diuretics, also known as water pills, function by increasing the production of urine, thereby promoting the excretion of excess water and electrolytes from the body.
There are several types of diuretics, including thiazide diuretics, loop diuretics, and potassium-sparing diuretics. Thiazide diuretics, such as hydrochlorothiazide, work by inhibiting the reabsorption of sodium and chloride in the kidneys, leading to increased urine production. Loop diuretics, such as furosemide, act on the loop of Henle in the kidneys to block the reabsorption of sodium and chloride, resulting in a more potent diuretic effect. Potassium-sparing diuretics, like spironolactone, help retain potassium in the body while still promoting diuresis.
These diuretic APIs are widely used in the pharmaceutical industry to formulate medications that effectively manage fluid retention and related conditions. They are available in various forms, including tablets, capsules, and intravenous formulations. Diuretics are often prescribed as part of combination therapies to enhance their effectiveness and minimize adverse effects.
It is important to note that the use of diuretics should be closely monitored by healthcare professionals due to potential side effects such as electrolyte imbalances, dehydration, and hypotension. Proper dosage and patient-specific considerations are crucial to ensure optimal therapeutic outcomes.
In conclusion, diuretics are a vital subcategory of pharmaceutical APIs used to treat conditions characterized by fluid retention. Their mechanisms of action vary, but they all facilitate increased urine production, assisting the body in eliminating excess fluids. The proper use of diuretics, in combination with medical supervision, can effectively manage various cardiovascular and renal conditions.
Bumetanide (Diuretics), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Bumetanide API manufacturers & distributors
Compare qualified Bumetanide API suppliers worldwide. We currently have 4 companies offering Bumetanide API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Industriale Chimica | Producer | Italy | Unknown | CoA, USDMF | 33 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP, USDMF | 51 products |
| Suzhou Lixin Pharmaceutic... | Producer | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, MSDS | 34 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, GMP, WC | 62 products |
When sending a request, specify which Bumetanide API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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