℞. Furosemide S.A.L.F 250 mg Solution for infusion

Furosemide S.A.L.F 250 Mg Solution For Infusion: The use of the high-dose preparation Furosemide S.A.L.F 250 mg solution for infusion is indicated exclusively for patients with greatly reduced glomerular filtration (glomerular filtration values less than 20 ml/min).

  • Imminent and already existing acute renal failure (to maintain fluid excretion and to facilitate parenteral feeding, provided there is still residual filtration).
  • Chronic renal failure in the predialytic stage with fluid retention and hypertension.
  • Terminal renal failure: to maintain residual diuresis.
  • Nephrotic syndrome in patients who do not respond to an oral dose of 120 mg furosemide/day (treatment of the underlying disorder is the primary consideration here).

Posology and method of administration

The dosage should be tailored to individual needs, especially according to the success of therapy. The lowest dose at which the desired effect is obtained should always be used. For Adults The Following Dosage Guidelines Apply:

Furosemide S.A.L.F 250 Mg Solution For Infusion Dosage

Acute Renal Failure: In patients with shock, hypovolaemia and hypotension must be eliminated before the start of treatment by taking appropriate measures. Similarly, amarkedly pronounced disturbance of serum electrolytes and the acid-base equilibrium must be corrected. If a test dose of 40 mg furosemide, injected slowly by the intravenous route, does not bring about increased water excretion, treatment with Furosemide S.A.L.F 250 mg solution for infusion can be started.

50-100 mg furosemide per hour may be administered over the day using aperfusor. The daily dose should be tailored to provide adequate diuresis, but the maximum dose should not exceed 1500 mg furosemide per day.

Chronic Renal Failure In The Predialytic Stage With Fluid Retention And Hypertension, Nephrotic Syndrome: As the natriuretic response depends on numerous variables, e.g. the degree of renal failure, sodium balance etc. and cannot therefore in principle be predicted precisely in individual cases, the correct dose is best determined by increasing the dose gradually. Because of the rapid onset of action, the dose can be stepped up at ½ to hourly intervals. The recommended initial dose should be 0.1 mg per minute in the form of an infusion. As in patients with chronic renal failure the mobilisation of fluids should take place slowly, the dose should be selected so that the patient loses about 1 kg weight (140 mmol Na+) per day on average. In nephrotic syndrome the dose must be carefully determined because of the risk of increased side effects.

Use In Children:Infants and children under 15 years old should be given Furosemide S.A.L.F by the parenteral route only as an exception in threatening situations. The average daily dose is0.5 mg furosemide/kg body weight. By way of exception, up to 1 mg furosemide/kg body weight may be administered intravenously.

Method Of Administration And Duration Of Use

Furosemide S.A.L.F 250 mg solution for infusion Should Usually Be Administered By Means Of Aperfusor. The infusion rate of 0.4 ml Furosemide S.A.L.F 250 mg solution for infusion per minute (equivalent to 4 mg furosemide per minute) must not be exceeded.

In patients with advanced renal failure (serum creatinine >5 mg/dl) the infusion speed should not exceed 0.25 ml Furosemide S.A.L.F 250 mg solution for infusion per minute(equivalent to 2.5 mg furosemide per minute).

If Necessary, The Solution For Infusion Can Be Diluted With Isotonic Saline Solution. The solution for infusion must not be infused together with other medicinal products.

Care Must Be Taken To Ensure That The Ph Of The Ready-To-Use Solution For Infusion Is In The Weakly Alkaline to neutral range (pH not below 7). Acid solutions must not be used as the active substance may precipitate.

The Ready-To-Use Preparation

Furosemide S.A.L.F 250 mg solution for infusion, The ready-to-use preparation was found to be chemically and physically stable for24 hours at 25 °C. From the microbiological standpoint, the ready-to-use preparation must be administered immediately.
  • If the ready-to-use preparation is not employed immediately, the user is responsible for the duration and conditions of storage.
  • In order to achieve optimum efficacy and suppress a counter-regulatory reaction, a continuous infusion of furosemide should be selected in preference to the repeated administration of injections.
  • Furosemide is only administered intravenously if oral application is not possible or is ineffective (e.g. in patients with poor intestinal absorption) or a rapid effect is required. Parenteral administration of Furosemide S.A.L.F should be replaced by oral use as soon as treatment permits.
  • The duration of use depends on the nature and severity of the disorder.

Contraindications

Furosemide S.A.L.F 250 Mg Solution For Infusion Must Not Be Used In:

  • normal renal function or impaired renal function with glomerular filtration values greater than 20 ml/min,because in these cases there is a risk of a too pronounced water and electrolyte loss.
  • hypersensitivity to furosemide,sulfonamides (possible cross allergy with furosemide) or any of the excipients.
  • renal failure with anuria refractory to furosemide therapy.
  • hepatic coma and precomatose states associated with hepatic encephalopathy.
  • severe hypokalaemia.
  • severe hyponatraemia.
  • hypovolaemia or dehydration.
  • nursing mothers.

Furosemide S.A.L.F 250 mg solution for infusion must not be used for bolus injection. It must be infused while monitoring the infusion volume and rate to reduce the risk of accidental overdosage.

Special Warnings And Precautions For Use

Particularly Careful Monitoring Is Necessary In:

  • Patients with hypotension.
  • patients with manifest or latent diabetes mellitus (regular monitoring of the blood sugar level).
  • patients with gout (regular monitoring of the uric acid in the serum).
  • patients with impairment of micturition (e.g. in prostatic hypertrophy, hydronephrosis, ureter stenosis).
  • patients with hypoproteinaemia, e.g. in nephrotic syndrome (careful adjustment of the dose).
  • patients with hepatorenal syndrome (rapidly progressing renal insufficiency combined with severe hepatic disease, e.g. liver cirrhosis).
  • patients who are particularly at risk from an unwanted severe fall in blood pressure, e.g. those with cerebrovascular circulatory disorders or coronary heart disease.
  • premature infants (risk of developing nephrocalcinosis/nephrolithiasis; monitoring of renal function,nephrosonography).

In premature infants with respiratory distress syndrome, diuretic treatment with furosemide in the first weeks of life Can Increase The Risk Of Persistent Ductus Arteriosus.

In Patients With Micturition Disorders (e.g. in patients with prostatic hyperplasia) furosemide may only be used if provision has been made for a free flow of urine, because a sudden flood of urine can lead to urinary retention with over extension of the bladder.

Furosemide Leads To Increased Excretion Of Sodium And Chloride And Consequently, Of Water. Excretion of other electrolytes (particularly potassium, calcium and magnesium) is also increased. As disturbances in the fluid and electrolyte imbalance are frequently observed during therapy with Furosemide S.A.L.F as a result of increased electrolyte excretion, regular monitoring of serum electrolytes is indicated.

Particularly During Long-Term Therapy with Furosemide S.A.L.F the serum electrolytes (especially potassium, sodium, calcium), bicarbonate, creatinine, urea and uric acid as well as the blood sugar should be regularly monitored.

Particularly Close Supervision Is Necessary For Patients With A High Risk Of Developing Electrolyte Disorders or in the case of severe fluid depletion (e.g. as a result of vomiting, diarrhoea or intensive sweating). Hypovolaemia or dehydration as well as pronounced electrolyte disturbances or impairment of the acid-base balance must be corrected. This may necessitate the temporary discontinuation of treatment with furosemide.

The Possible Development Of Electrolyte disturbances is influenced by underlying diseases (e.g. liver cirrhosis, heart failure), co-medication and diet.

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