Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.2 Posology and method of administration** **Orally:** 1 mg daily. In refractory cases the dose can be increased gradually till a satisfactory response has been obtained. Rarely will it be necessary to exceed a dose of 4 mg daily. In high dose therapy consideration should be given to a twice daily dosing. _Children:_ The dose is calculated on the basis of 0.03–0.06 mg/kg daily. _Elderly:_ Adjust dosage according to response; a dose of 0.5 mg daily may be sufficient in some elderly patients. Where intramuscular administration is considered appropriate a dose of 1 mg should be given initially and the dose then be adjusted according to the diuretic response.
ORAL
Medical Information
**4.1 Therapeutic indications** Burinex® is indicated whenever diuretic therapy is required in the treatment of oedema _e.g._ associated with congestive heart failure, cirrhosis of the liver, renal diseases including the nephrotic syndrome. Acute pulmonary oedema, drug induced fluid retention, and drug poisoning that can be treated by forced diuresis. Hypertension.
**4.3 Contraindications** For Burinex® Tablets: - Hypersensitivity to active substance or to any of the excipients - Severe electrolyte depletion - Persisting anuria - Hepatic encephalopathy including coma
C03CA02
bumetanide
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
allphamed PHARBIL Arzneimittel GmbH
Active Ingredients
Documents
Package Inserts
Burinex Tablet PI.pdf
Approved: April 20, 2022