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BURINEX INJECTION 0.5mg/ML

Product Information

Registration Status: Active

SIN01421P

BURINEX INJECTION 0.5mg/ML is approved to be sold in Singapore with effective from 1988-05-20. It is marketed by ZUELLIG PHARMA PTE LTD, with the registration number of SIN01421P.

This product contains Bumetanide 0.5mg/ml in the form of INJECTION. It is approved for INTRAVENOUS, INTRAMUSCULAR use.

This product is manufactured by CENEXI in FRANCE, andLEO Pharma A/S in DENMARK.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

A sulfamyl diuretic. [PubChem]

Indication

For the treatment of edema associated with congestive heart failure, hepatic and renal disease including the nephrotic syndrome.

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.

Pharmacokinetics

Absorption
Bumetanide is completely absorbed (80%), and the absorption is not altered when taken with food. Bioavailability is almost complete.
Distribution
Metabolism
45% is secreted unchanged. Urinary and biliary metabolites are formed by oxidation of the N-butyl side chain.
Elimination

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]

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.

Active Ingredient/Synonyms

3-(Aminosulfonyl)-5-(butylamino)-4-phenoxybenzoic acid | 3-Butylamino-4-(phenoxy)-5-sulfamoylbenzoic acid | 3-Butylamino-4-phenoxy-5-sulfamoyl-benzoic acid | 3-Butylamino-4-phenoxy-5-sulfamoylbenzoic acid | Bumetanida | Bumetanidum | Bumetanide |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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