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

Logo LASIX® Retard
SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form):

LASIX® Retard
60 mg Capsules

COMPOSITION:
Each capsule contains 60 mg furosemide.

PHARMACOLOGICAL CLASSIFICATION:
A:18.1: Diuretics

PHARMACOLOGICAL ACTION:
LASIX® Retard 60 mg is an oral diuretic, antihypertensive agent. Furosemide inhibits reabsorption of sodium and water in the ascending loop of Henle but also in the proximal tubule and thus promotes diuresis.

Diuretic activity following a single dose commences after one hour, gradually increases and reaches a peak between four to six hours and tapers off during the next five to six hours.

LASIX® Retard 60 mg lowers pathologically raised blood pressure, but does not effect normal levels.

INDICATIONS:
LASIX® Retard 60 mg is indicated in conditions where prolonged diuresis is required. These conditions include oedema (cardiac, hepatic, renal, due to burns) particularly in elderly patients, and the management of mild to moderate hypertension, either alone, or as an adjuvant to other antihypertensive agents. LASIX® Retard 60 mg can also be used in other conditions in which diuretic therapy is indicated, such as toxaemia of pregnancy.

LASIX® Retard 60 mg is also indicated in oedema due to venous insufficiency and after thrombosis.

CONTRA-INDICATIONS:
Patients who are hypersensitive to furosemide or sulphonamides.

In renal failure with anuria.

LASIX® Retard 60 mg is contra-indicated if increasing azotaemia and oliguria occur during treatment of severe progressive renal disease. In these cases the drug should be discontinued. In hepatic coma, hypovolaemia, hypotension and in states of electrolyte depletion, therapy with LASIX® Retard 60 mg should not be instituted until the basic condition is corrected or improved.

LASIX® Retard 60 mg should only be used during pregnancy if strictly indicated (and then for a short period only) and should not be given to lactating women.

DOSAGE AND DIRECTIONS FOR USE:
Adults : For oedematous conditions 60 mg daily is the recommended initial dose. In mild cases 60 mg on alternative days may be sufficient.
In hypertension the recommended dose is 60 mg daily but in exceptional cases 60 mg to 120 mg or more may be required. The maximum dose depends on the individuals’response.
Children : Not suitable.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects of LASIX® Retard 60 mg therapy have been reported infrequently, but the following may occur:

1.        Various forms of dermatitis including urticaria, exfoliative dermatitis and pruritis, allergic reactions eg. skin rashes, interstitial nephritis, as well as paraesthesia, blurring of vision, postural hypotension, nausea, vomiting or diarrhoea may occur.

2.        Anaemia, leucopenia, aplastic anaemia, haemolytic anaemia and thrombocytopenia (with purpura) may occur. Rare cases of agranulocytosis, which responded to treatment, have occurred.

3.        Asymptomatic hyperuricaemia may occur and gout may be precipitated.

4.        Alterations in glucose tolerance test with abnormalities of the fasting and 2-hour postprandial sugar levels have been observed, and cases of precipitation of diabetes mellitus have been reported.

5.        LASIX® Retard 60 mg may lower serum calcium levels and cases of tetany have been reported.

6.        Excessive diuresis may result in dehydration and reduction of 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.

7.        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 natruretic effect of LASIX® Retard 60 mg, the sodium levels could be reduced especially if the oedema is reduced quickly. Electrolyte depletion presents as weakness, dizziness, lethargy, cramps in the legs, loss of appetite, vomiting and/or mental confusion, headache, feeling of pressure in the head, dryness of the mouth, visual impairment, dehydration.

8.        Animal experiments show no teratogenic effects, but the safety of furosemide in pregnancy in humans has not been established. LASIX® Retard 60 mg is therefore not recommended for use during the first and last three months of pregnancy.

9.        Nephrotoxicity associated with the use of cephalosporins may be potentiated when LASIX® Retard 60 mg is used in conjunction with cephalosporins. These medicines should thus not be used together.

10.        Other side effects which may present, include: acute pancreatitis, transient rise in creatinine, uric acid, cholesterol, triglyceride and urea levels, aggravation of obstructive uropathies, aggravation of metabolic alkalosis and nephrocalcinosis in premature infants and auditory disorders.

11.        Patients on LASIX® Retard 60 mg treatment should be warned of the possibility of reduced mental alertness with added care to be taken in road traffic and in the use of machinery.

12.        Symptoms of obstructed micturition may become manifest or may be aggravated.

13.        Hypersensitivity reactions including fever, interstitial nephritis and photosensitivity.

Interactions with other agents:
When cardiac glycoside is administered concurrently it should be remembered that potassium deficiency increases the sensitivity of the myocardium to digitalis. When glucocorticoid is administered during diuretic treatment the potassium-lowering effect of the steroid should be borne in mind.

Furosemide may potentiate the nephrotoxic effects of certain antibiotics (eg. aminoglycosides). Therefore, furosemide should be used with caution in patients with antibiotic induced renal impairment. It should be borne in mind that the ototoxicity of aminoglycoside antibiotics (eg. kanamycin, gentamicin, tobramycin) may be potentiated when furosemide is used concurrently. The hearing defects that result may be irreversible. Therefore, this drug combination should be restricted to vital indications.

Furosemide sometimes diminishes the potency of other drugs (eg. the effect of antidiabetics and of pressor amines) or potentiates their effect (eg. in the case of salicylates, theophylline, lithium and curaremimetic muscle relaxants).

The action of other hypotensive drugs may be potentiated by furosemide. Especially in combination with ACE-inhibitors a marked fall in blood pressure may be seen.

Certain non-steroidal anti-inflammatory agents (eg. acetylsalicylic acid; indomethacin) may antagonise the action of furosemide and may cause renal failure in case of pre-existing hypovolaemia.

Concurrent administration of furosemide and sucralfate should be avoided as sucralfate reduces the absorption of furosemide and hence weakens its effect.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
After the ingestion of an overdosage 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.

IDENTIFICATION:
LASIX® Retard 60 mg Capsules: A dark green and yellow opaque capsule.

PRESENTATION:
Bottles of 30 and 100.

STORAGE INSTRUCTIONS:
Store below 25°C. Store the packings well sealed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
J/18.1/5

NAME AND BUSINESS ADDRESS OF APPLICANT:
Noristan Limited
326 Marks Street, Waltloo, Pretoria

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1991

Hoechst Pharmaceuticals
Division of
Noristan Limited

        H21/01
Pro-Print

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