FUROSEMIDE

Route of administration: intramuscular or intravenous use.

Adults:

Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded. 5 mg per minute is not exceeded. Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible.

It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema. To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections.

Where continuous furosemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approximately four hours) is to be preferred to a regimen with higher bolus doses at longer intervals.

Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they be given by slow intravenous infusion.

The recommended maximum daily dose of furosemide administration is 1,500 mg.

Elderly:

The dosage recommendations for adults apply, but in the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved. 5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.

Undesirable effects can occur with the following frequencies:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000, including isolated reports), not known (cannot be estimated from the available data) Blood and lymphatic system disorders: Uncommon: thrombocytopenia Rare: Eosinophilia, leukopenia, bone marrow depression (necessitates withdrawal of treatment).

The haemopoietic status should be therefore be regularly monitored.

Very Rare:

Aplastic anaemia or haemolytic anaemia, agranulocytosis Nervous system disorders: Rare: Paraesthesia, hyperosmolar coma Not known: Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).

Endocrine disorder:

Glucose tolerance may decrease with furosemide. In patients with diabetes mellitus this may lead to a deterioration of metabolic control; latent diabetes mellitus may become manifest. Insulin requirements of diabetic patients may increase.

g. in nephritic syndrome) and/or when intravenons furosemide has been given too rapidly.

Uncommon:

Deafness (sometimes irreversible) Cardiac disorders: Uncommon: Cardiac arrhythmias Furosemide may cause a reduction in blood pressure which, if pronounced may cause signs and symptoms such as impairment of concentration and reactions, light headedness, sensations of pressure in the head, headache, dizziness, drowsiness, weakness, disorders of vision, dry mouth, orthostatic intolerance.

The diuretic effect of furosemide can result in hypovolaemia and dehydration, especially in the elderly. There is an increased risk of thrombosis.

3) • Hypotension. • Hypovolaemia. • Severe electrolyte disturbances – particularly hypokalaemia, hyponatraemia and acid-base disturbances. Furosemide is not recommended • In patients at high risk for radiocontrast nephropathy - it should not be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.

• In patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Particular caution and/or dose reduction required:

Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.

2) • difficulty with micturition including prostatic hypertrophy (increased risk of urinary retention: consider lower dose). g. nephritic syndrome (effect of furosemide may be impaired and its ototoxicity potentiated - cautious dose titration required).

• acute hypercalcaemia (dehydration results from vomiting and diuresis – correct before giving furosemide). Treatment of hypercalcaemia with a high dose of furosemide results in fluid and electrolyte depletion - meticulous fluid replacement and correction of electrolyte required.

• Patients who are at risk from a pronounced fall in blood pressure • premature infants (possible development nephrocalcinosis/nephrolithiasis; renal function must be monitored and renal ultrasonography performed). 5 for other interactions) • concurrent NSAIDs should be avoided – if not possible diuretic effect of furosemide may be attenuated • ACE-inhibitors & Angiotensin II receptor antagonists – severe hypotension may occur – dose of furosemide should be reduced/stopped (3 days) before starting or increasing the dose of these Laboratory monitoring requirements: • Serum sodium Particularly in the older people or in patients liable to electrolyte deficiency • Serum potassium The possibility of hypokalaemia should be taken into account, in particular in patients with cirrhosis of the liver, those receiving concomitant treatment with corticosteroids, those with an unbalanced diet and those who abuse laxatives.

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