FUROSEMIDE

Route of administration: intramuscular or intravenous 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 is 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 (approx. 4 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 increasing 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.

This medical product is for single use only. Discard any contents remaining in the ampoule immediately after use.

Furosemide 20mg/2ml Solution for Injection is generally well tolerated. Eosinophilia is rare. Occasionally, thrombocytopenia may occur. In rare cases, leucopenia and, in isolated cases, agranulocytosis, aplastic anaemia or haemolytic anaemia may develop.

Bone marrow depression has been reported as a rare complication and necessitates withdrawal of treatment. Rarely, paraesthesiae may occur. 3). Serum calcium levels may be reduced; in very rare cases tetany has been observed. Nephrocalcinosis / Nephrolithiasis has been reported in premature infants.

Serum cholesterol and triglyceride levels may rise during furosemide treatment. During long term therapy they will usually return to normal within six months. 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.

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

In isolated cases, intrahepatic cholestasis, an increase in liver transaminases or acute pancreatitis may develop. The incidence of allergic reactions, such as skin rashes, photosensitivity, vasculitis, fever, interstitial nephritis or shock is very low, but when these occur treatment should be withdrawn.

g. itching, urticaria, other rashes or bullous lesions, erythema multiforme, bullous pemphigod, exfoliative dermatitis, purpura. As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis after prolonged therapy.

Urinary output must be secured. Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention and require careful monitoring.

Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy. Particularly careful monitoring is necessary in: • patients with hypotension. • patients who are at risk from a pronounced fall in blood pressure.

• patients where latent diabetes may become manifest or the insulin requirements of diabetic patients may increase. g. associated with nephritic syndrome (the effect of furosemide may be weakened and its ototoxicity potentiated). Cautious dose titration is required.

• premature infants (possible development nephrocalcinosis nephrolithiasis; renal function must be monitored and renal ultrasonography performed). Caution should be observed in patients liable to electrolyte deficiency. Regular monitoring of serum sodium, potassium and creatinine is generally recommended during furosemide therapy; particularly close monitoring is required in patients at high risk of developing electrolyte imbalances or in case of significant additional fluid loss.

Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of furosemide. In patients who are at high risk for radiocontrast nephropathy, furosemide is not recommended to be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.

Furosemide 20mg/2ml Solution for Injection is contra-indicated in patients with hypovolaemia or dehydration, anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents or renal failure associated with hepatic coma, severe hypokalaemia, severe hyponatraemia, pre-comatose and comatose states associated with hepatic encephalopathy and breast feeding women.

Hypersensitivity to furosemide or any of the excipients of Furosemide 20mg/2ml Injection. Patients allergic to sulphonamides may show cross-sensitivity to furosemide.