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

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

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

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

COMPOSITION:
Each 1 mL contains 10 mg
furosemide as the sodium salt.

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Diuretics.

PHARMACOLOGICAL ACTION:
Furosemide is a loop diuretic acting primarily by inhibiting electrolyte and fluid reabsorption in the thick ascending limb of Henie, as well as in the proximal tubule. It is up to 99% protein bound, has a half life of about 1.5 hours and has a duration of action in the range of 4 to 6 hours. It is excreted mainly in the urine and bile. Loop diuretics increase the excretion of potassium, titratable acid, ammonia, calcium and magnesium. The concentration of uric acid in plasma is increased. In patients with pulmonary oedema, furosemide increases systemic venous capacitance, thereby decreasing left ventricular filling pressure. Furosemide crossed the placental barrier and is excreted in milk.

INDICATIONS:
Furosemide is indicated for the treatment of oedema of cardiac, hepatic or renal origin.
Acute pulmonary oedema.
Cerebral oedema.
Forced diuresis.

CONTRA-INDICATIONS:
Patients who are hypersensitive to furosemide or sulphonamides.
It should not be given in anuria or in renal failure due to nephrotoxic drugs nor in renal failure associated with hepatic coma.
Furosemide should not be given in pre-comatose states associated with hepatic cirrhosis. Furosemide should be used with caution in pregnancy.
Furosemide crosses the placental barrier and is excreted in milk. Safety in lactation has not been established.
It should be used with caution in jaundiced infants.

WARNINGS:
Fluid and electrolyte imbalance should be monitored especially in the presence of vomiting or during parenteral fluid therapy.

DOSAGE AND DIRECTIONS FOR USE:
The recommended adult intramuscular or intravenous dose is 20-50 mg, repeated if necessary after not less than 2 hours.
The usual paediatric dose is 0,5 to 1,5 mg/kg body mass.
Intravenous injection should be given slowly. The rate must not exceed 4 mg per minute.
Pulmonary oedema:
Initial dose 40 mg intravenously given slowly.
If necessary, the injection may be repeated after approximately 60 minutes.
The dose may be increased to 80 mg, given slowly intravenously.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effect associated with furosemide therapy is fluid and electrolyte imbalance including hyponatraemia, hypokalaemia, and hypochloraemic alkalosis, particularly after large doses or prolonged administration. Other side-effects are relatively uncommon, and include allergy, nausea, diarrhoea, blurred vision, yellow vision, dizziness, headache, pancreatitis, photosensitivity, skin rashes, and hypotension. Skin rashes and photosensitivity reactions may be severe and hypersensitivity reactions including interstitial nephritis occur less frequently. Bone marrow depression may occur less frequently. Agranulocytosis, thrombocytopenia, and leucopenia have been reported. Hepatic dysfunction, cholestatic jaundice, and paraesthesia have also been reported. Tinnitus and deafness may occur less frequently and more particular during rapid high-dose parenteral furosemide therapy. Deafness may be permanent in some cases, particularly if furosemide has been given to patients taking other ototoxic medicine.
Furosemide may provoke hyperglycaemia and glycosuria. It may cause hyperuricaemia and precipitate attacks of gout in some patients.
Pancreatitis is common at high doses. Cholestatic jaundice has been reported. Furosemide increases the urinary excretion of calcium.
Renal stone formation has been reported when furosemide has been used to treat preterm infants .
It should be used with care in patients with prostatic hypertrophy or impairment of micturition. Furosemide may enhance the nephrotoxicity of cephalosporin antibiotics such as cephalothin and of aminoglycoside antibiotics.
Concurrent administration of phenytoin or indomethacin may reduce the clinical effects of furosemide.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
Treatment is symptomatic and supportive.
After the ingestion of an overdose, there is some danger of dehydration and electrolyte depletion due to excessive diuresis.
The excessively rapid mobilization of oedema may lead to malaise and asthenia.
Rapid changes in the pressure-flow relationships in the cardiovascular system may even in the presence of an expanded extracellular fluid volume, give rise to symptoms usually associated with hypovolemia. In intensive long-term therapy, the diuretic-induced renal loss of sodium chloride may lead to extracellular fluid depletion, with or without hyponatremia. The condition usually responds to discontinuation of the diuretic agent and the liberalization of sodium chloride intake in the diet.

IDENTIFICATION:
A clear, colourless to almost colourless solution, in 2 mL or 5 mL amber glass, type 1, ampoules.

PRESENTATION:
2 mL amber glass, type 1, ampoules packed in boxes of 10 and 100.
5 mL amber glass, type 1, ampoules packed in boxes of 10.

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

REGISTRATION NUMBERS:
20 mg/2 mL:         32/18.1/0194
50 mg/5 mL:         29/18.1/0664

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MICRO HEALTHCARE (Pty) Ltd
10 Lindley Street
BETHLEHEM
9701
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1997

New addition to this site: September 2005
Source: Pharmaceutical Industry
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