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

Logo FUROSEMIDE-FRESENIUS 250 mg/25 mL

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

FUROSEMIDE-FRESENIUS 250 mg/25 mL
(Injection)

COMPOSITION:
Each 25 mL ampoule contains 250 mg
furosemide

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Diuretics.

PHARMACOLOGICAL ACTION:
Furosemide is a high-ceiling diuretic acting primarily by inhibiting electrolyte re-absorption in the thick ascending limb of Henle, but also in the proximal tubule. It is approximately 98% protein bound, has a half life of about 92 minutes and is short but rapid acting. It is excreted mainly by the kidneys, and to a much lesser extent by the liver or in the faeces.

INDICATIONS:
Oliguria in acute or chronic renal failure, chronic renal insufficiency.

CONTRA-INDICATIONS:
Hypersensitivity to furosemide or sulphonamides (cross-sensitivity exists between sulphonamides and furosemide). Pregnancy and lactation.
Furosemide should not be given in anuria or in renal failure due to nephrotoxic or hepatotoxic drugs nor in renal failure associated with hepatic coma.
Furosemide should not be given to patients with Addison’s disease or pre-existing hypercalcaemia.

WARNINGS:
Fluid and electrolyte imbalance should be monitored during therapy. Except as a single trial dose in acute anuria in the absence of obstruction, furosemide should be avoided in anuric patients. Caution should be exercised in patients with impaired hepatic function or renal impairment.

DOSAGE AND DIRECTIONS FOR USE:
The rate of infusion should never exceed 4 mg/minute.
Oliguria in acute or chronic renal failure:
250 mg Furosemide diluted to 250 mL in a suitable diluent infused over one hour (suitable diluents include dextrose 5%, ringers lactate, sodium chloride 0,9% or dextrose 10% or 20% in water.)
If urine output is insufficient within an hour, this dose may be followed by 500 mg furosemide added to an infusion fluid, the volume of which must be governed by the patient's state of hydration, and infused over 2 hours. If urine output is still not satisfactory within 1 hour of the end of the second infusion, a third dose of 1 g furosemide may be infused over 4 hours.
In oliguria or anuric patients with significant fluid overload, the injection may be given directly into the vein at an administration rate never to exceed 4 mg/minute.
The effective dose (up to 1 g) may be given daily. Dosage is then adjusted according to patient's response.
Patients not responding to 1 g furosemide probably require dialysis.
Furosemide should never be infused together with other medication in the same intravenous fluid.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Fluid and electrolyte imbalance including hyponatraemia, hypokalaemia and hypochloraemic alkalosis, dehydration, hypotension and hypovolemic shock, particularly after large doses or prolonged administration. Signs of electrolyte imbalance include headache, hypertension and muscle cramps.
Other side-effects include allergy, nausea, diarrhoea, blurred vision, yellow vision, dizziness, headache, pancreatitis, jaundice, photosensitivity, skin rashes and hypotension. Hypersensitivity reactions including interstitial nephritis occur infrequently.
Bone marrow depression may occur: agranulocytosis, thrombocytopenia and leucopenia have been reported.
Hepatic dysfunction, cholestatic jaundice and paraesthesia have also been reported.
Tinnitis and deafness may occur during rapid high-dose therapy (faster than 4 mg/minute). Deafness may be permanent, particularly in patients with impaired renal function or when administered concomitantly with ototoxic medication.
Hyperglycaemia and glycosuria, hyperuricaemia (with precipitated attacks of gout) and an increased excretion of calcium may occur.
Renal stone formation has been reported in pre-term infants.
Precautions:
Caution should be exercised in patients with diabetes or gout. Patients on restricted sodium intake are particularly susceptible to excessive dehydration and hypotension.
Care should be taken in patients with prostatic hypertrophy or impairment of micturition. Furosemide may enhance the nephrotoxicity of cephalosporin and aminoglycoside antibiotics as well as the ototoxicity of aminoglycoside antibiotics. Concurrent administration of phenytoin or indomethacin may reduce the clinical effects of furosemide. Digitalis glycoside toxicity may be enhanced as well as the effect of muscle relaxants such as tubocurarine. The effect of other antihypertensive agents may be enhanced.
Care should be taken in patients receiving potassium-depleting steroids. The response of pressor amines eg. nor-adrenaline, has been reported to be diminished.
Patients sensitive to sulphonamides may develop allergic dermatological and vasculitic reactions to furosemide.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "side-effects and special precautions".
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear colourless solution in 25 mL amber ampoules.

PRESENTATION:
25 mL amber ampoules packed in boxes of 10.

STORAGE INSTRUCTIONS:
Protect from light.
Store below 25°C
Keep out of reach of children.

REGISTRATION NUMBER
Z/18.1/139

NAME AND BUSINESS ADDRESS OF APPLICANT:
BODENE (PTY) LIMITED trading as Intramed, 6 Gibaud Road
Port Elizabeth, 6001, South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
08/06/1992

        12-150/08-02
        Pro-Print

Updated on this site: March 2005
Source: State Hospital Pharmacy

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