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Logo RENEZIDE TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

RENEZIDE TABLETS

COMPOSITION:
Each tablet contains:
  Hydrochlorothiazide 25 mg
  Triamterene 50 mg
PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Medicines acting on genito-urinary system: Diuretics.

PHARMACOLOGICAL ACTION:
Renezide tablets have an antihypertensive and diuretic action. The dominant action of the thiazides as a diuretic is to increase the renal excretion of sodium and chloride and an accompanying volume of water. Triamterene has no significant pharmacological actions other than those on the kidneys and exerts its effect directly on the distal part of the distal tubule. Diuresis is characterized by an increase in the excretion of sodium mostly accompanied by chloride as the anion. The combined effect of hydrochlorothiazide and triamterene on potassium excretion may be greatly modified by pharmacological means, and a sharp reduction in potassium output is then observed.

INDICATIONS:
Oedema associated with hepatic cirrhosis, nephrosis, mild to moderate congestive heart failure and corticosteroid therapy.
Mild to moderate hypertension.

CONTRA-INDICATIONS:
Renezide tablets should not be given to patients with hyperkalaemia or progressive renal failure, and should not be given with other potassium-sparing diuretics or potassium supplements. Hypersensitivity to any of the active ingredients.
Pregnancy and lactation.

WARNING:
It has been suggested that triamterene therapy should be withdrawn gradually in order to prevent a theoretical rebound loss of potassium.

DOSAGE AND DIRECTIONS FOR USE:
For OEDEMA the initial adult dose is one tablet twice daily after meals, which may be reduced to one tablet daily or even every second day when the oedema is under control.
The maximum dosage is four tablets daily.

For HYPERTENSION the starting adult dose is one tablet twice daily after meals, thereafter adjusting the dose to suit the needs of the patient.

Since thiazide diuretics enhance the effects of antihypertensive agents, the dose of the latter may need to be reduced if they are prescribed concurrently.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Hydrochlorothiazide:
Hydrochlorothiazide may cause a number of metabolic disturbances. It may cause hyperuricaemia and precipitate attacks of gout in some patients. Administration of hydrochlorothiazide may be associated with electrolyte imbalances including hypochloraemic alkalosis, hyponatraemia, and hypokalaemia.
The urinary excretion of calcium is reduced, and hypomagnesaemia has also occurred. There is some evidence to suggest that electrolyte imbalances during long-term treatment with thiazides may be associated with an increased incidence of cardiac arrhythmias.
Signs of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain and cramps and gastro-intestinal disturbances.
Other side-effects include anorexia, gastric irritation, nausea, vomiting, constipation, diarrhoea, headache, dizziness, postural hypotension, paraesthesia, impotence, and yellow vision.
Hypersensitivity reactions include skin rashes, photosensitivity, pulmonary oedema, and pneumonitis. Cholestatic jaundice, pancreatitis, and blood dyscrasias including thrombocytopenia and more rarely, granulocytopenia, leucopenia, and aplastic and haemolytic anaemia have been reported.

Triamterene:
Triamterene may cause nausea, vomiting, abdominal pain, diarrhoea or constipation, paraesthesia, thirst, dizziness, skin rash, pruritus, weakness, muscle cramps, and minor psychiatric or visual changes. Orthostatic hypotension and rises in blood-urea-nitrogen concentrations have been reported. Its potassium-sparing effect may lead to hyperkalaemia. Occasional abnormalities in liver-function tests have been reported.
Triamterene has also been reported to cause photosensitivity reactions, increases in uric acid concentrations and blood dyscrasias. Nephrolithiasis may occur in susceptible patients, and megaloblastic anaemia has been reported in patients with depleted folic acid stores such as those with hepatic cirrhosis.

Special Precautions:
Hydrochlorothiazide:
Hydrochlorothiazide may provoke hyperglycaemia and glycosuria in diabetic and other susceptible patients.
Hydrochlorothiazide may cause hypokalaemia which intensifies the effect of digitalis on cardiac muscle and administration of digitalis or its glycosides may have to be temporarily suspended.
Patients with severe coronary artery disease and cirrhosis of the liver are particularly at risk from hypokalaemia. Hyponatraemia may occur in patients with severe congestive heart failure who are very oedematous, particularly with large doses in conjunction with restricted salt in the diet.
Hydrochlorothiazide should be used with caution in patients with impaired hepatic function since they may increase the risk of hepatic encephalopathy. It should also be given with caution in renal impairment since they can further reduce renal function. It may precipitate attacks of gout in susceptible patients. All patients should be carefully observed for signs of fluid and electrolyte imbalance, especially in the presence of vomiting or during parenteral fluid therapy.
Hydrochlorothiazide may exacerbate or activate systemic lupus erythematosus in susceptible patients.
Hydrochlorothiazide crosses the placenta and there have been reports of neonatal jaundice, thrombocytopenia, and electrolyte imbalances following maternal treatment. Hydrochlorothiazide is excreted in the breast milk. Treatment with thiazide diuretics can inhibit lactation.

Triamterene:
Elderly patients, and patients with impaired renal function or diabetes mellitus are at particular risk of developing hyperkalaemia. It should be given with care to patients likely to develop acidosis, to patients with diabetes mellitus, and to those with impaired hepatic or renal function. Triamterene should be discontinued at least 3 days before glucose-tolerance tests are given to patients with diabetes mellitus because of the risks if patients are hyperkalaemic. Serum electrolytes and blood-urea-nitrogen should be estimated periodically.
Triamterene should be given with caution to patients with hyperuricaemia or gout, or a history of nephrolithiasis. Patients with depleted folic acid stores such as those with hepatic cirrhosis may be at increased risk of megaloblastic anaemia.

INTERACTIONS:
Hydrochlorothiazide:
Hydrochlorothiazide 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 effect of antihypertensive agents, while postural hypotension associated with thiazide diuretic therapy may be enhanced by concomitant ingestion of alcohol, barbiturates, or opioids. The potassium-depleting effect of thiazide diuretics may be enhanced by corticosteroids, corticotrophin, or carbenoxolone.
Concomitant administration of thiazide diuretics and lithium is not generally recommended as the association may lead to toxic blood concentrations of lithium. Blood-glucose concentrations should be monitored in patients taking anti-diabetic agents, since requirements may change. Hydrochlorothiazide may interfere with a number of diagnostic tests, including tests for parathyroid function; serum concentrations of protein-bound iodine may increase without signs of thyroid disturbance.

Triamterene:
Triamterene may interfere with the fluorescent measurement of quinidine, it may slightly colour the urine blue.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS SPECIFIC TREATMENT:
See “Side-effects and Special Precautions”. Treatment is symptomatic and supportive.

IDENTIFICATIONS:
Flat, bisected peach-coloured tablets with bevelled edges, engraved with mortar and pestle.

PRESENTATION:
Blister packs of 28 tablets and "Securitainers" of 250 tablets.

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

REGISTRATION NUMBER:
U/18.1/72

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13/08/1987

        M303A
        Tradepak P.E.

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