Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland
Furosemide is a potent diuretic and is recommended for use when prompt and effective diuresis is required.
Furosemide Injection 20mg/2ml and 50mg/5ml are appropriate for use in emergencies or where oral therapy is not feasible. The indications include cardiac, pulmonary, hepatic and renal oedema.
Furosemide Injection 250mg/25ml is for use in the management of oliguria due to acute or chronic renal insufficiency with a glomerular filtration rate below 20ml/minute.
Furosemide Injection 20mg/2ml and 50mg/5ml are for intramuscular or for intravenous administration and must always be given slowly. Furosemide Injection 250mg/25ml is for slow intravenous administration.
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.
Elimination of furosemide is generally slower in the elderly. Dosage should be titrated until the required effect is achieved.
Dosages for children range from 0.5-1.5mg/kg weight daily up to a maximum total daily dose of 20mg.
Furosemide Injection 250mg/25ml is for slow intravenous injection at a rate not exceeding 4mg/minute.
An initial dose of 250mg (one 25ml ampoule) may be added to about 225ml Sodium Chloride Injection B.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.
Elimination of furosemide is generally slower in the elderly. Dosage should be titrated until the required effect is achieved.
Dosages for children must be determined on the basis of the severity of the renal insufficiency and on the clinical response to initial doses.
Overdose can cause massive diuresis resulting in dehydration, volume depletion and electrolyte disturbances with consequent hypotension and cardiac toxicity. High doses have the potential to cause transient deafness and may precipitate gout (disturbed uric acid secretion).
Benefits of gastric decontamination are uncertain. In patients presenting within 1 hour of ingestion, consider activated charcoal (50g for adults: 1g/kg for children)
Observe for a minimum of 4 hours – monitor pulse and blood pressure.
Treat hypotension and dehydration with appropriate IV fluids
Monitor urinary output and serum electrolytes (including chloride and bicarbonate). Correct electrolyte imbalances. Monitor 12 lead ECG in patients with significant electrolyte disturbances
3 years (36 months).
If only part used, discard the remaining solution.
Keep in outer carton.
Do not store above 25°C.
Do not refrigerate or freeze.
2ml, 5ml & 25ml One point cut (OPC) amber glass ampoules, glass type 1 Ph.Eur. packed in cardboard cartons to contain 10 × 2ml or 10 × 5ml or 10 × 25ml ampoules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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