(and dosage form):
Each tablet contains:
The Potassium Chloride is incorporated into a specially formulated slow-release core.
A 18.1 Diuretics
Lenurex-K is a diuretic which reduces the reabsorption of electrolytes from the renal tubules, thereby increasing the excretion of sodium, potassium and chloride ions, and consequently of water. It also slightly increases bicarbonate excretion without appreciable alteration of the acid-base balance or the pH of the urine, it has a lowering effect on the blood pressure and enhances the action of other hypotensive agents.
Cyclopenthiazide is absorbed from the gastro-intestinal tract, distributed throughout the extracellular space and diffuses across the placenta.
Diuresis occurs in about two hours, reaches a maximum in about four hours, and lasts for about twelve hours. Tolerance does not develop and therapeutic efficacy is maintained when it is administered over long periods, but patients may not respond if their glomerular filtration-rate is markedly reduced. This medicine contains potassium chloride. It has not been proven that this dosage will necessarily prevent a significant potassium loss or correct an existing deficiency of potassium.
Oedema due to sodium and water retention. In patients with diabetes insipidus, cyclopenthiazide decreased urinary volume and may therefore be of value in the management of the disease. Essential hypertension: preferably in combination with other antihypertensive agents.
Patients with an established hypersensitivity towards the drug. Severe renal and/or hepatic insufficiency.
DOSAGE AND DIRECTIONS FOR USE:
For the treatment of oedema:
The average daily dose is 2 tablets daily, preferably taken in the morning.
In the treatment of hypertension:
The usual dose is 2 tablets daily.
1 to 2 tablets daily or every second or third day.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects which occur occasionally include allergies, skin rashes epigastric pain, anorexia, gastric irritation, nausea, vomiting, diarrhoea, constipation, photosensitivity, erythema multiforme (the Stevens-Johnson syndrome) dizziness, headache, weakness, inflammation of the salivary glands and paraesthesias. Acute pancreatitis has been reported following prolonged administration. Intestinal ulceration has also been reported.
Toxic effects such as hypochloraemic alkalosis, jaundice, and blood dyscrasias including agranulocytosis, aplastic anaemia, thrombocytopenia, and leucopenia have occasionally occurred. Orthostatic hypotension which may be accentuated by alcohol, barbiturates or narcotics has occurred. In patients with severe congestive heart failure who are very oedematous, a low-salt syndrome may occur, particularly with large doses. Low salt diets should therefore be relaxed during treatment.
Cyclopenthiazide may provoke hyperglycaemia and glycosuria in diabetic and other susceptible patients. It may cause hyperuricaemia and precipitate attacks of gout in some patients.
The urinary excretion of calcium is reduced.
The patient should be carefully observed for signs of fluid and electrolyte imbalance. Cyclopenthiazide should be used with caution in patients with impaired hepatic or renal function or with diabetes mellitus.
Borderline renal and/or hepatic insufficiency may be aggravated. Blood glucose concentrations should be monitored in patients taking antidiabetic agents.
Serum concentrations of protein bound iodine may increase without signs of thyroid toxicity.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypochloraemic alkalosis and dehydration. Treatment of overdosage is symptomatic.
CONDITIONS OF REGISTRATION:
The product may be advertised to the profession only.
Yellow sugar coated, biconvex tablet.
Packs of 28, 56, 100 and 500 tablets.
Store below 25°C.
Keep container tightly closed.
KEEP OUT OF THE REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
Republic of South Africa
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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