FUROSEMIDE

Posology Furosemide Injection 20mg/2ml and 50mg/5ml Adults:

Initially, doses of 20 - 50mg may be administered by the intramuscular route, or by slow intravenous injection at a rate not exceeding 4mg/minute. The diuretic effect of furosemide is proportional to the dosage and, if larger doses are required, they should be given as a controlled infusion at a rate not exceeding 4mg/minute and titrated according to the response.

Elderly:

Elimination of furosemide is generally slower in the elderly. Dosage should be titrated until the required effect is achieved. 5mg/kg weight daily up to a maximum total daily dose of 20mg.

Furosemide Injection 250mg/25ml Adults:

Furosemide Injection 250mg/25ml is for slow intravenous injection at a rate not exceeding 4mg/minute. P. or Ringer's Solution for Injection, and infused over one hour at a drip rate of 80 drops/minute (4mg/minute). If urine output within the next hour is insufficient, a dose of 500mg (two 25ml ampoules) in an appropriate infusion fluid, the total volume of which must be governed by the patient's state of hydration, may be infused at a rate not exceeding 4mg/minute.

If a satisfactory urine output has still not been achieved within one hour following the end of the second infusion, a third dose consisting of 1,000mg (four 25ml ampoules) in an appropriate infusion fluid may be given. The rate of infusion should never exceed 4mg/minute.

If the third infusion (1,000mg over 4 hours) is not effective, dialysis will probably be required. In oliguric or anuric patients with significant fluid overload, it may not be practicable to use the aforementioned method of administration.

In such cases, the use of a constant-rate infusion pump with a micrometer screw-gauge adjustment may be considered for direct administration of the injection into the vein. The rate of infusion should still never exceed 4mg/min. If the response to either method of administration is satisfactory (urine output 40 - 50ml/hour), the effective dose (of up to 1,000mg) may be repeated every 24 hours.

Alternatively, treatment may be maintained by oral administration of Furosemide Tablets, using 500mg by mouth for each 250mg required by injection. Appropriate adjustments to dosage may then be made according to the patient's response.

Undesirable effects can occur with the following frequencies:

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).

The following effects have been reported and are listed below by body system:

MedDRA system organ class database Frequency Undesirable effects Uncommon Thrombocytopenia Rare Eosinophilia Leukopenia Bone marrow depression (necessitates withdrawal of treatment). The haemopoietic status should be therefore be regularly monitored.

Blood and lymphatic system disorders Very Rare Aplastic anaemia or haemolytic anaemia Agranulocytosis Rare Paraesthesia Hyperosmolar coma Nervous system disorders Not known Dizziness, syncope and loss of consciousness (caused by symptomatic hypotension).

3). g. Itching, urticaria, other rashes or bullous lesions, fever, hypersensitivity to light, exudative erythema multiforme (Lyell's syndrome and Stevens-Johnson syndrome), bullous exanthema, exfoliative dermatitis, purpura, AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug rash with eosinophilia and systemic symptoms) Not Known Bullous Pemphigoid Metabolism and nutrition disorders Not Known Symptomatic electrolyte disturbances and Metabolic alkalosis3 Metabolic acidosis4 Hyponatraemia5 Hypokalemia6 Reduction of serum HDL-cholesterol, elevation of serum LDL-cholesterol and elevation of serum triglycerides.

g. with shock) occurs rarely. g. in nephritic syndrome) and/or when intravenous furosemide has been given too rapidly. 2 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.

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.

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 elderly 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.

4). 4). 4). 4). 5). 6).