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

Logo PURESIS® TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

PURESIS® TABLETS

COMPOSITION:
Each tablet contains 40 mg
Furosemide.

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Diuretics

PHARMACOLOGICAL ACTION:
Puresis exerts its diuretic action by virtue of its saluretic properties. Experimental evidence has proved that Furosemide acts by reducing the reabsorption of sodium and water at the levels of the proximal convoluted tubule, ascending limb of Henle's loop and the distal convoluted tubule.
Puresis thus acts throughout the tubule, and it is today believed that the action of Furosemide on the loop of Henle is the most important action on the nephron. In situations where other methods of treatment fail to induce diuresis, it is often possible with Puresis, to increase the excretion of sodium and water, even when the glomerular filtration rate is markedly impaired.
Puresis lowers pathologically raised blood pressure levels, but does not affect normal values.
With Puresis administration, the onset of action is rapid, usually within half-an-hour. Peak action is usually achieved after 2 hours, and the duration of action of the drug is 4 –5 hours.

INDICATIONS:
(a) Ascites due to cirrhosis of the liver, mechanical obstruction or cardiac failure.
(b) To prevent oliguria from progressing to complete anuria.
(c) Cardiac oedema.
(d) Hypertension of mild to moderate degree.
(e) Oedema occurring during the last three months of pregnancy – pre-eclamptic toxaemia and eclampsia. (See warnings).

CONTRA-INDICATIONS:
Patients who exhibit hypersensitivity to furosemide. In hepatic coma and in states of electrolyte depletion. Puresis is contra-indicated if increasing azotaemia and oliguria occur during treatment of severe progressive renal disease.
Lactating women.

WARNING:
In pregnancy, Puresis should be administered with great caution and only in carefully selected cases, for short periods of time. Concomitant therapy with cephaloridine may result in nephrotoxicity.

DOSAGE AND DIRECTIONS FOR USE:
Adults –        Initial dose:         One to three tablets.
  Maintenance dose:         Half to one tablet daily.
  or:         As prescribed by the physician.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
(i) Various forms of dermatitis including urticaria and exfoliative dermatitis, pruritus, paraesthesia, blurring of vision, yellow vision, dizziness, pancreatitis, photosensitivity, postural hypotension, headache, nausea, vomiting or diarrhoea may occur.
(ii) Anaemia, leucopenia, aplastic anaemia and thrombocytopenia (with purpura) may occur. Agranulocytosis has occurred.
(iii) Asymptomatic hyperuricaemia can occur and gout may be precipitated.
(iv) Alterations in glucose tolerance tests with abnormalities of the fasting and 2-hour post-prandial sugar have been observed, and cases of precipitation of diabetes mellitus have been reported.
(v) Puresis may lower the serum calcium levels and cases of tetany have been reported.
(vi) Excessive diuresis may result in dehydration and deduction in blood volume with circulatory collapse and the possibility of vascular thrombosis and embolism, particularly in elderly patients. The excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity. Care should be taken in patients receiving potassium depleting steroids.
(vii) Electrolyte disturbance –Hypokalaemia may be reduced with a potassium-rich diet. If it already exists before the commencement of treatment –which is particularly likely to occur in cases of cirrhosis – the serum potassium should be restored to normal by potassium supplements and, if necessary, by the administration of sodium and chloride. Because of its strong natriuretic effect, Puresis may cause a decrease in the sodium level, particularly when the oedema is corrected rapidly.
Electrolyte depletion may manifest itself by weakness, dizziness, lethargy, leg cramps, anorexia, vomiting and/or mental confusion.
Hepatic dysfunction, cholestatic jaundice and paraesthesia have been reported. Tinnitus and deafness may occur in particular during rapid high-dose parenteral furosemide therapy. Deafness may be permanent particularly if furosemide has been given to patients taking ototoxic medication.
Puresis 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. Puresis may enhance the nephrotoxicity of cephalosporin antibiotics such as cephalothin and of aminoglycoside antibiotics. It can also enhance the ototoxicity of aminoglycoside antibiotics. Concurrent administration of phenytoin or indomethacin may reduce the clinical effects of Puresis.
Puresis should be used with caution in patients with impaired hepatic function since it may increase the risk of hepatic encephalopathy. It should be used with caution in patients with renal impairment. Puresis may enhance the toxicity of digitalis glycosides by depleting serum-potassium concentrations. It may enhance the neuromuscular blocking action of competitive muscle relaxants, such as tubocurarine. It may enhance the effects of antihypertensive agents. The potassium-depleting effect of furosemide may be enhanced by corticosteroids, corticotrophin, or carbenoxolone.
Concomitant administration of Puresis and lithium is generally not recommended since the association may lead to toxic blood concentrations of lithium. Blood-glucose concentrations should be monitored in patients taking antidiabetic agents as requirements may change.
The use of Puresis in patients suffering from acute forms of porphyria, especially variegate porphyria, and to a lesser extent acute intermittent porphyria and hereditary coproporphyria is contentious, and Puresis should thus be used with caution in these patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects" above. Treatment is symptomatic and supportive.

IDENTIFICATION:
Flat, white to off-white, bisected tablets with bevelled edges and engraved "F1" on one side and mortar and pestle on the other side.

PRESENTATION:
Packs of 30 and 250 tablets

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

REGISTRATION NUMBER:
H/18.1/185

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8/75
                        G881
                A & S PRINTERS

Updated on this site: May 2000
Current: September 2004
Source: Community Pharmacy

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