FUROSEMIDE 20mg/2ml Injection

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COMPOSITION :

Furosemide Injection 20 mg/2 ml, each ml contains : Furosemide 10 mg.

 

DESCRIPTIONS : 

Furosemide contains Furosemide as active ingredient available in Injection 20 mg/2 ml.

 

INDICATIONS : 

  • Oedema due to cardiac, hepatic and renal disease.
  • Adjunctive therapy in acute pulmonary oedema and cerebral oedema where intense and rapid onset of diuresis is desired. 

 

DOSAGE AND ADMINISTRATIONS : 

In general, the dose used must be the lowest which is sufficient to achieve the desired effect.

Adults and Adolescents ≥ 15 years : Unless otherwise prescribed, the initial dose is 20 – 40 mg (1 – 2 ampoules) intravenously or in exceptional cases, intramuscularly (see Administration).

If after a single dose of 20 – 40 mg (1 – 2 ampoules), the diuretic effect is not satisfactory, the dose may be increased stepwise by 20 mg (1 ampoule) at 2-hourly intervals until a satisfactory effect is obtained. The individual dose thus established should then be given once or twice daily.

Acute Pulmonary Oedema : An initial dose of 40 mg (2 ampoules) is administered intravenously. If a satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly intravenously.

Cerebral Oedema : The following procedure is recommended pending further experience : Intravenous injection of 20 – 40 mg, 3 times daily.

Forced Diuresis : 20 – 40 mg (1 – 2 ampoules) is given in addition to infusion of electrolyte solution.

Further treatment depends on the elimination of urine and must include substitution of the fluid and electrolyte losses.

In poisoning with acid or basic substances, the elimination rate can be further increased by alkalization or acidification, respectively, of the urine.

Infants and Children < 15 years : In principle, Furosemide should be administered orally. Parenteral administration (if necessary, continuous drip infusion) is indicated only in life-threatening conditions. The dosage schedule is Furosemide 1 mg/kg body weight up to a maximum of 20 mg (1 ampoule) daily.

Administrations : 

Intravenous administration of Furosemide is indicated in all cases where oral administration is either not feasible or is ineffective (e.g., in impaired intestinal absorption) or where a rapid effect is necessary. Intravenous injection of Furosemide should be given slowly, not exceeding an injection rate of 4 mg/min.

Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenously administration are feasible. Intramuscular injection is not suitable for the treatment of acute conditions e.g.,  pulmonary oedema.

A change from parenteral to oral administration should be carried out as soon as possible.

Furosemide injection solution has a pH of about 9; it has no buffering capacity. For this reason, the active ingredient may precipitate at pH values < 7. Therefore, if Furosemide is diluted, care must be taken to ensure that the pH of the solution is within the slightly alkaline to neutral range. Normal saline is suitable as diluent. Diluted solutions should be used as soon as possible.

Furosemide must not be mixed with other drugs in the same syringe.

The duration of treatment is determined by the doctor and will depend on the nature and severity of illness.

 

OVERDOSAGE : 

Medical treatment may be required in the event of an overdose. Therefore, inform the doctor if overdosage is suspected.

The clinical picture of an acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss e.g., hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias (including AV block and ventricular fibrillation). Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.

No specific antidote to Furosemide is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures eg., gastric lavage or those designed to reduce absorption (e.g., activated charcoal).

Clinically relevant disturbances in electrolyte and fluid balance must be corrected. Together with the prevention and treatment of serious complications resulting from such disturbances and of other effects on the body, this corrective action may necessitate general and specific intensive medical monitoring and therapeutic measures.

Special Notes : Although administration of Furosemide only rarely leads to hypokalaemia, a potassium-rich diet (lean meat, potatoes, bananas, tomatoes, cauliflower, spinach, dried fruit, etc) is always advisable. Occasionally, treatment with potassium-containing or potassium-sparing preparations may be indicated.

Emergency Measures to be Taken in the Event of Anaphylactic Shock : Generally, the following emergency procedure is recommended : At the first signs (sweating, nausea, cyanosis), interrupt the injection immediately, but leave the venous cannula in place or perform venous cannulation. In addition to the usual emergency measures, ensure that the patient remains lying down, with the legs raised and airways patent. 

Emergency Drug Therapy : Immediately administer Epinephrine (Adrenaline) intravenously : In the first instance, slowly inject 1 ml of a solution containing Epinephrine 0.1 mg/ml while monitoring pulse and blood pressure (watch for disturbances in cardiac rhythm). Repeat as required.

Then volume substitution intravenous e.g., plasma expanders, human albumin and balanced electrolyte solution.

Subsequently, Glucocorticoids intravenous e.g., 250 – 1000 mg Methylprednisolone. Repeat as required. 

The dosage recommendations refer to adults of normal weight. In children, the reduction of dose should be in relation to body weight. 

Other therapeutic measures e.g., artificial respiration, oxygen inhalation and antihistaminics.

 

CONTRAINDICATIONS : 

  • Patients with renal failure accompanied by lack of urine formation (anuria). 
  • Hepatic coma and pre-coma.
  • Electrolyte deficiencies e.g., severely reduced blood levels of potassium (hypokalaemia) or of sodium (hyponatraemia).
  • Decreased volume of blood in the body (hypovolaemia) with or without reduced blood pressure (hypotension) or dehydration.
  • Hypersensitivity to Furosemide or any of the excipients of this product. 
  • Patients allergic to Sulphonamides (e.g., Sulphonamide antibiotics or Sulphonylureas) may show cross-sensitivity to Furosemide.
  • Use in pregnancy & lactation : Furosemide must not be given during pregnancy unless there are compelling medical reasons because Furosemide crosses the placental barrier. If Furosemide is given during pregnancy, fetal growth must be monitored. Furosemide must not be used during breastfeeding because Furosemide passes into breast milk and inhibits lactation.

 

WARNINGS AND PRECAUTIONS : 

  • Patients whose outflow is obstructed (e.g., those with prostatic hypertrophy, ureterostenosis or hydronephrosis), careful monitoring is required, especially at the beginning of treatment.
  • Particularly careful surveillance is necessary in : Hypotension; patients at particular risk from a pronounced fall in blood pressure; latent or manifest diabetes mellitus; gout; renal failure in association with severe liver disease (hepatorenal syndrome); reduced protein content in the blood; premature infants.
  • Serum sodium, potassium and creatinine should be monitored regularly. Patients at high risk of developing electrolyte imbalances, and those with significant additional fluid loss due to e.g.,  vomiting, diarrhoea, or intense sweating must be closely monitored. Hypovolaemia or dehydration, as well as any significant disturbances in electrolyte content and acid-base balance, must be corrected. A temporary discontinuation of treatment with Furosemide may become necessary. Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy.

 

DRUG INTERACTIONS : 

  • Certain electrolyte disturbances e.g., hypokalaemia or hypomagnesaemia, may develop during treatment and increase the toxicity of certain other drugs (e.g., Digitalis preparations and drugs inducing QT interval prolongation syndrome).
  • Corticosteroids, Carbenoxolone, large amounts of Liquorice and prolonged use of laxatives may increase the risk of hypokalaemia.
  • The toxic effects of Aminoglycosides on the ear and of other drugs having the same potential may be increased by concomitant administration of Furosemide. 
  • Toxic effects on the ear are possible if Cisplatin and Furosemide are used concurrently. When Furosemide is used to increase urine excretion during Cisplatin treatment, it must only be given in low doses (e.g., 40 mg in patients with normal kidney function) and in conjunction with a positive fluid balance, since otherwise the toxic effects of Cisplatin on the kidneys may increase.
  • Furosemide may potentiate the harmful effects on the kidney of nephrotoxic antibiotics.
  • Concurrent administration of nonsteroidal anti-inflammatory medicines may reduce the effect of Furosemide and in patients with dehydration or hypovolaemia may cause acute renal failure. The toxicity of Salicylates may be increased.
  • Attenuation of the effect of Furosemide may also occur following concurrent administration of Phenytoin.
  • Concurrent use of antihypertensive agents or other medicines with blood pressure-lowering potential may lead to a more pronounced fall in blood pressure.
  • When an ACE inhibitor is given for the 1st time or when a 1st dose increase is given, severe hypotension and a deterioration in renal function may result. Therefore, consideration must be given to interrupting the administration of Furosemide temporarily or, as a minimum, to reducing the dose of Furosemide 3 days before starting treatment with the ACE inhibitor or before increasing its dose.
  • Medicines e.g., Probenecid or Methotrexate which, like Furosemide, are secreted significantly via the renal tubuli, may reduce the effect of Furosemide. On the other hand, Furosemide may decrease renal elimination of such medicines. 
  • The effects of antidiabetics and blood pressure-increasing medicines (e.g., Epinephrine, Norepinephrine) may be reduced and those of Theophylline or curare-type muscle relaxants may be increased.
  • Furosemide reduces the excretion of Lithium salts which may lead to an increase in serum Lithium levels and consequently, in Lithium toxicity. For this reason, Lithium levels should be carefully monitored in patients receiving this combination.
  • Intravenous administration of Furosemide within 24 hours after the ingestion of Chloral Hydrate may, in isolated cases, lead to reddening of the skin with a sensation of heat, sweating, restlessness, nausea, increase in blood pressure, and rapid heart beat (tachycardia). Therefore, concurrent use of Chloral Hydrate and Furosemide should be avoided.

 

ADVERSE REACTIONS : 

    • Furosemide increases excretion of sodium and chloride, and consequently water; excretion of other electrolytes, in particular, potassium, calcium, and magnesium is increased as well. Symptomatic electrolyte disturbances and metabolic alkalosis may develop and be manifested as a gradually increasing electrolyte deficit, or – where, e.g., higher doses are used in patients with normal renal function – as acute severe electrolyte losses.
    • Warning signs of electrolyte disturbances include increased thirst, headache, confusion, muscle cramps, tetany, muscle weakness, disorders of cardiac rhythm and gastrointestinal symptoms. Influencing factors for the development of electrolyte disturbances, are, e.g., underlying diseases (such as liver cirrhosis or cardiac failure), concurrent medication. Potassium deficiency may occur, particularly as a result of vomiting or diarrhoea.
    • The diuresis resulting from Furosemide may be too strong and may lead or contribute to hypovolaemia and dehydration, especially in elderly patients. Severe fluid depletion may lead to an increase in the concentration of the blood (haemoconcentration) with a tendency for thromboses to develop.
    • A reduction in blood pressure especially if pronounced, may result in signs and symptoms e.g., an impairment of concentration and reactions, lightheadedness, sensations of pressure in the head, headache, dizziness, drowsiness, weakness, visual impairment, dryness of the mouth and disturbed circulatory regulation on standing up or standing.
    • In patients with e.g., bladder-emptying disorders, an enlargement of the prostate gland (prostatic hyperplasia) or a narrowing of the urethra, acute retention of urine with possible secondary complications may occur.
    • Levels of serum lipids (cholesterol and triglycerides) may rise during Furosemide treatment. There may be transient increases in serum levels of creatinine and urea.
    • The concentration of uric acid in the blood is frequently increased during Furosemide treatment. This may lead to gout attacks in predisposed patients.
    • Glucose tolerance may be reduced during Furosemide treatment. 
    • Gastrointestinal disorders e.g., nausea, vomiting or diarrhoea may occur in rare cases, as may, in isolated cases, an arrest in bile flow in the liver (intrahepatic cholestasis), an increase in liver transaminases or an acute inflammation of the pancreas (acute pancreatitis).
    • Usually transient hearing disorders and/or noises in the ears (tinnitus) may occur in rare cases, particularly in patients with renal failure, in those with hypoproteinaemia (e.g., in the nephrotic syndrome) and/or where intravenous administration has taken place too rapidly.
    • Occasionally, reactions of the skin and mucous membranes may occur, such as itching, urticaria, other rashes or bullous lesions, erythema multiforme, exfoliative dermatitis or purpura. Severe anaphylactic and anaphylactoid reactions with e.g., circulatory collapse (shock) are rare.
    • In rare cases, fever, inflammation of the blood vessels or kidneys (vasculitis or interstitial nephritis), eosinophilia or disturbances of sensation (paraesthesiae) may occur, as may, occasionally, photosensitivity.
    • Occasionally, a decrease in the number of platelets (thrombopenia), or rarely in the number of white blood cells (leucopenia) may develop, as may in isolated cases, a decrease in the numbers of red blood cells (haemolytic or aplastic anaemia) or the absence of certain white blood cells (agranulocytosis).
    • Bone marrow depression has been reported as a rare complication and necessitates withdrawal of treatment.
    • In premature infants, kidney stones containing calcium (nephrolithiasis) may develop and calcium salts may be deposited in the renal tissue (nephrocalcinosis).
    • Furosemide administered in premature infants during the first weeks of life may increase the risk of persistence of Botallo’s duct.
    • Local reactions e.g., pain, may occur at the injection site after intramuscular injection.
    • Some adverse effects (e.g., changes in blood picture, severe anaphylactic reactions, or severe bullous skin reactions) may under certain circumstances become life-threatening, it is essential that, if sudden or severe reactions do occur, you inform a doctor at once.
  • Some adverse effects may impair the ability to concentrate and react. Therefore, constitute a risk in situations where these abilities are of particular importance (e.g., operating a vehicle or machinery).

 

PRESENTATION :

Furosemide Injection 20 mg/2 ml         Box, 10 ampoules @ 2 ml         Reg. No. GKL1902360343A1

 

STORAGE :

STORE BELOW 30°C, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by : 

BERNOFARM

Sidoarjo – Indonesia