Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: KARO PHARMA AB, Box 16184, 103 24 Stockholm, Sweden
Burinex 5 mg Tablets are indicated in adults in the management of oedema due to congestive heart failure, hepatic cirrhosis and renal disease, including nephrotic syndrome, where high dose diuretic is required.
The dose should be carefully adjusted according to response. As a general rule, dosage should be started at 5 mg daily and then increased by 5 mg every 12-24 hours until the required response is obtained or side effects appear. Consideration should be given to a twice daily dosage, rather than a once daily dosage.
The medicinal product is not recommended for children as there is limited information on safety, efficacy and dosage in children.
The dosage recommendations for adults apply, but in the elderly bumetanide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
Depending on the liver or renal function, the dose should be titrated according to the patient’s response and required therapeutic effect (see section 4.4).
For oral administration.
In high doses and during long-term treatment loop diuretics may cause electrolyte imbalance, dehydration and polyuria.
Symptoms of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, confusion, gastrointestinal disturbances, restlessness, muscle pain and cramps and seizures.
Treatment is adjustment of the fluid and electrolyte imbalance.
3 years.
Keep the blisters in the outer carton in order to protect from light.
Store below 25°C.
PVC/aluminium blister packs of 14 (physician’s sample), 30 and 56 tablets.
Not all pack sizes may be marketed.
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
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