INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo INTRAMED FUROSEMIDE INJECTION 20 mg/2 mL
INTRAMED FUROSEMIDE INJECTION 50 mg/5 mL

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

INTRAMED FUROSEMIDE INJECTION 20 mg/2 mL
INTRAMED FUROSEMIDE INJECTION 50 mg/5 mL

COMPOSITION:
Each 1 mL contains 10 mg
furosemide

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Diuretics.

PHARMACOLOGICAL ACTION:
Furosemide is a high-ceiling diuretic acting primarily by inhibiting electrolyte and fluid reabsorption in the thick ascending limb of the Loop of Henle as well as in the proximal tubule. It is approximately 90% protein bound, has a half life of about 1 - 2 hours and has a duration of action in the range of 3 - 6 hours. It is excreted mainly by the kidneys and liver and the remainder in the faeces. The excretion of potassium, titratible acid, ammonia, calcium and magnesium are enhanced and the concentration of uric acid in plasma is increased.
In patients with pulmonary oedema, venous capacitance is increased, thereby decreasing left ventricular filling pressure.

INDICATIONS:
Cardiac oedema: All forms of cardiac oedema in conjunction with adequate glycoside therapy.
Ascites due to cirrhosis of the liver, mechanical obstruction or cardiac failure.
Renal oedema (in nephrotic syndrome usually in conjunction with ACTH or corticosteroids).
Pulmonary oedema.
Cerebral oedema.
Forced diuresis e.g. management of barbiturate poisoning.
Burns: to reduce local oedema and to prevent oliguria from progressing to complete anuria.

CONTRA-INDICATIONS:
Patients who are hypersensitive to furosemide or sulphonamides.
Increased azotaemia and oliguria occurring during treatment of severe progressive renal disease – the drug should be discontinued. In hepatic coma and in states of electrolyte depletion, hypovolaemia and hypotension, therapy with Furosemide Injection should not be instituted until the basic condition is corrected or improved.
Lactating women.

WARNINGS:
Fluid and electrolyte imbalance should be monitored during therapy.

DOSAGE AND DIRECTIONS FOR USE:
Intravenous or intramuscular administration of furosemide is indicated in all cases where intestinal absorption is impaired or prompt diuresis is required. The rapid and powerful effect produced by intravenous injection may result in a transitory fall in plasma volume.
Intravenous injection should be given slowly (over 1 to 2 minutes).

The recommended adult dose by this route is 20 to 40 mg, repeated if necessary after not less than 2 hours. The usual pediatric dose is 1 mg/kg.

Pulmonary oedema: Initial dose 40 mg intravenously. If necessary, the injection may be repeated after approximately 60 to 90 minutes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
With parenteral use of furosemide in high doses reversible deafness and tinnitus have been reported when the infusion is faster than 4 mg per minute. Permanent deafness may develop in patients with impaired renal function.
Various forms of skin reactions including rashes, urticaria, exfoliative dermatitis, paraesthesia, pruritis, purpura, photosensitivity and erythema multiforme may occur.
Nausea, vomiting, diarrhoea, blurred vision, dizziness, headache, pancreatitis, muscle spasm, cramps, hypotension and allergic reactions may occur.
Furosemide should be used with care in patients with prostatic hypertrophy or impairment of micturition.
Anaemia, leucopenia, agranulocytosis, aplastic anaemia and thrombocytopenia (with purpura) may occur.
Asymptomatic hyperuricaemia may occur and gout may be precipitated.
Alterations in glucose tolerance tests with abnormalities of the fasting and 2-hour postprandial sugar levels have been observed, and cases of precipitation of diabetes mellitus have been reported.
Furosemide increases urinary excretion of calcium, may lower serum calcium levels and cases of tetany have been reported.
Excessive diuresis may result in dehydration and reduction in blood volume, with circulatory collapse and with the possibility of vascular thrombosis and embolism, particularly in elderly patients. Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity. Care should also be taken in patients receiving potassium-depleting steroids.
Electrolyte disturbances: Hypokalaemia may be counteracted with a potassium-rich diet. If a deficiency state exists - especially in cirrhosis - the serum potassium must first be restored by potassium supplementation, and if necessary, sodium and chloride. Because of the strong natriuretic effect of Furosemide injection, the sodium levels could be reduced especially if the oedema is reduced quickly. Magnesium depletion may develop. Electrolyte depletion may present as weakness, dizziness, lethargy, cramps in the legs, loss of appetite, vomiting and/or mental confusion.
The safety of furosemide in pregnancy has not been established.
Nephrotoxicity associated with the use of cephalosporins and aminoglycosides may be potentiated when furosemide is used in conjunction with cephalosporins and aminoglycosides. These medicines should thus not be used together.
Liver damage or dysfunction as well as reversible renal failure have been reported. Furosemide should be used with caution in patients with impaired hepatic or renal function, or with diabetes mellitus or adrenal disease.
Furosemide may enhance the neuromuscular blocking action of non-depolarising muscle relaxants, such as tubocurarine, as well as the effects of guanethidine, methyldopa and rauwolfia alkaloids.
Postural hypotension associated with Furosemide may be enhanced by concomitant ingestion of alcohol, barbiturates or narcotics.
Concomitant administration of furosemide and lithium may lead to toxic blood concentrations of lithium.
Cross sensitivity may occur with furosemide and sulfonamides.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
After the ingestion of an overdose there is some danger of dehydration and electrolyte depletion due to excessive diuresis.
The guiding principle of treatment is water and electrolyte replacement in accordance with urine output (with monitoring of carbohydrate metabolism if necessary). If difficulty in micturition is proved or suspected as in cases of prostatic hypertrophy or impairment of consciousness, care must be taken to ensure a free outflow of urine from the bladder.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear colourless solution in 2 mL amber ampoules and 5 mL clear ampoules.

PRESENTATION:
2 mL amber or 5 mL clear ampoules packed in containers of 10.

STORAGE INSTRUCTIONS:
Protect from light. Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Intramed Furosemide Injection 20 mg/2 mL: K/18.1/207
Intramed Furosemide Injection 50 mg/5 mL: Z/18.1/138

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (Pty) Ltd
6 Gibaud Road
6001 Port Elizabeth

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1992 12-156/4-96
KOHLER C&P P.E. 

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004