FRUSOL Oral solution Ref.[27733] Active ingredients: Furosemide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

4.1. Therapeutic indications

Furosemide is indicated in all conditions requiring prompt diuresis, including cardiac, pulmonary, hepatic and renal oedema, peripheral oedema due to mechanical obstruction or venous insufficiency and hypertension.

It is also indicated for the maintenance therapy of mild oedema of any origin.

4.2. Posology and method of administration

Posology

Adults

The usual initial daily dose is 40mg. This may be adjusted until an effective dose is achieved.

Paediatric population

1 to 3mg/Kg body weight daily up to a maximum total dose of 40mg/day.

Elderly

In the elderly, Furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Method of administration

For oral use.

Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. For further instructions see section 6.6.

The medication should be administered in the morning to avoid nocturnal diuresis.

4.9. Overdose

Symptoms

Overdosing may lead to dehydration and electrolyte depletion through excessive diuresis. Severe potassium loss may lead to serious cardiac arrhythmias.

Management

Treatment of overdose consists of fluid replacement and electrolyte imbalance correction.

6.3. Shelf life

24 months.

3 months after first opening.

6.4. Special precautions for storage

Store at or below 25°C.

6.5. Nature and contents of container

Bottles: Amber (Type III) glass.

Closures: HDPE, EPE wadded, tamper evident, child resistant.

Capacity: 150ml.

6.6. Special precautions for disposal and other handling

Keep out of the sight and reach of children.

Instruction for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes:

Ensure that the enteral feeding tube is free from obstruction before administration.

  1. Flush the enteral tube with water, a minimum flush volume of 5mL is required.
  2. Administer the required dose of Furosemide Oral Solution gently and slowly into enteral tube, with a suitable measuring device.
  3. Flush the enteral tube with water again. A minimum flush volume of 5mL is required. However, for large bore size tubes (18 Fr) a minimum flush volume of 10mL should be used.

This product has not been tested with latex NG or PEG tubes and therefore should not be used with tubes made from latex.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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