℞. Fusid® Teva 20 mg/ 2 ml Solution for I.M or I.V injection

Furosemide-Baxter 20 mg Solution For Injection is indicated when adequate diuresis is not achieved with oral administration of furosemide or when oral use is not possible:

  • oedemas and/or ascites resulting from disorders of the heart or liver.
  • oedemas due to disorders of the kidneys.
  • oedemas due to burns.
  • pulmonary oedema (e.g. in acute heart failure).
  • supporting measure in cerebral oedema.
  • oliguria as a result of a gestosis, if necessary after correction of a volume deficiency state (oedemas and/or hypertension in gestoses are not an indication!).
  • hypertensive crisis (in addition to other therapeutic measures).
Furosemide Baxter 20 mg furosemide per 2 ml
Furosemide Baxter 20 mg furosemide per 2 ml

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-Baxter 20 mg Solution For Injection Dosage

Dosage In Oedemas And/Or Ascites Resulting From Disorders Of The Heart Or Liver: Initial dose 2-4 ml (equivalent to 20-40 mg furosemide) IV. With oedemas that are difficult to mobilise, this dose can be repeated at appropriate intervals until the onset of diuresis.

Dosage In Oedemas Due To Disorders Of The Kidneys: Initial dose 2-4 ml (equivalent to 20-40 mg furosemide) IV. With oedemas that are difficult to mobilise, this dose can be repeated at appropriate intervals until the onset of diuresis.

Dosage In In Nephrotic Syndrome the dose must be carefully determined because of the risk of increased side effects.

Dosage In Oedemas Due To Burns: The daily and/or single dose may be between 4 and 10 ml (equivalent to 40- 100 mg furosemide), in exceptional cases of impaired renal function up to 25 ml (equivalent to 250 mg furosemide). Intravascular volume deficiency must be corrected before using Furosemide-Baxter 20 mg solution for injection.

Dosage In Pulmonary Oedema (E.G. In Acute Heart Failure): Use in conjunction with other therapeutic measures. Initial dose 2-4 ml (equivalent to 20-40 mg furosemide) IV. If an increase in diuresis is still not achieved, administration can be repeated after 30-60 minutes, where necessary doubling the dose.

As A Supporting Measure In Cerebral Oedema: The daily and/or single dose may be between 4 and 10 ml (equivalent to 40- 100 mg furosemide). In exceptional cases of impaired renal function up to 25 ml (equivalent to 250 mg furosemide) may be administered.

Dosage In Oliguria Due To A Gestosis: The expected benefits must be very carefully weighed against possible risks. Intravascular volume deficiency must be corrected before using Furosemide-Baxter 20 mg solution for injection. The dose may be between 1 and 10 ml (equivalent to 10-100 mg furosemide) daily. Oedemas and/or hypertension in gestoses are not an indication for Furosemide-Baxter 20 mg solution for injection.

Dosage In Hypertensive Crisis: 2-4 ml (equivalent to 20-40 mg furosemide) in addition to other therapeutic measures.

Use In Children: Infants and children under 15 years old should be given Furosemide-Baxter by the parenteral route only as an exception in threatening situations. The average daily dose is 0.5 mg furosemide/kg body weight. By way of exception, up to 1 mg furosemide/kg body weight can be injected intravenously.

Method Of Administration And Duration Of Use

Furosemide-Baxter 20 mg Solution For Injection Are Usually Given Intravenously. In exceptional cases in which neither oral nor intravenous administration is possible, Furosemide-Baxter 20 mg solution for injection can be administered by the intramuscular route, but not in acute situations (e.g. not in pulmonary oedema) and not in high doses.

With intravenous administration, Furosemide-Baxter 20 mg solution for injection Should Be Injected Slowly. The injection speed of 0.4 ml solution for injection (equivalent to 4 mg furosemide) per minute must not be exceeded.

In Patients With Advanced Renal Failure (serum creatinine >5 mg/dl) the injection speed should not exceed 0.25 ml solution for injection per minute(equivalent to 2.5 mg furosemide per minute). In cases where it is necessary to increase the dose to 25 ml (equivalent to 250 mg furosemide), this dose should be administered by means of a perfusor. If necessary the solution for injection can be diluted with isotonic saline solution.

Furosemide-Baxter 20 mg solution for injection Must Not Be Mixed With Other Medicinal Products In The Same Syringe.

Care must be taken to ensure that the pH of the ready-to-use injection solution 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

Both (Furosemide-Baxter 20 mg solution for injection) The ready-to-use preparation was found to be chemically and physically stable for 24 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-Baxter 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-Baxter 20 mg Solution For Injection Must Not Be Used In:

  • 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.

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-Baxter as a result of increased electrolyte excretion, regular monitoring of serum electrolytes is indicated.

Particularly During Long-Term Therapy with Furosemide-Baxter 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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