BUMETANIDE Tablet Ref.[6685] Active ingredients: Bumetanide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Therapeutic indications

Bumetanide is indicated for the treatment of oedema associated with e.g. congestive heart failure, renal dysfunction including nephrotic syndrome and cirrhosis of the liver in adults.

In oedema of renal or cardiac origin where high doses of a potent short – acting diuretic are required, Bumetanide 5 mg may be used in adults.

Posology and method of administration

Posology

Most patients require a daily dose of 1 mg given as a single morning or early evening dose. Depending on the patient’s response, a second dose can be given 6-8 hours later. In refractory cases, the dose can be increased until a satisfactory diuretic response is obtained, or infusions of bumetanide can be given.

Dosage in the elderly

Adjust the dosage according to the response. A dose of 0.5 mg bumetanide per day may be sufficient in some elderly patients.

Paediatric population

Not recommended for children under 12 years of age as there is limited information on safety, efficacy and dosage in children.

Method of administration

For oral use.

Overdose

Signs and symptoms

If overdose has occurred or is suspected symptoms should be those caused by excessive diuresis.

Management

Steps should be taken to empty the stomach either by emesis or gastric lavage. General measures should be taken to restore blood volume, maintain blood pressure and correct electrolyte disturbances.

Shelf life

2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PVdC/Al calendar blister packs: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets.

High density polyethylene containers with tamper-evident polypropylene caps: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets.

Polypropylene containers with tamper-evident polyethylene caps with optional polyethylene ullage filler: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets.

Not all pack types/sizes may be marketed.

Special precautions for disposal and other handling

None.

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