(and dosage form):
Each tablet contains 2,5 mg indapamide [N-(3-sulphamoyl-4-chlorobenzamido) 2-methyl indoline].
A 7.1 Hypotensive drug.
Indapamide, an indole derivative of chlorosulphonamide, has an antihypertensive action causing a drop in systolic, diastolic and mean blood pressure. This antihypertensive action is maximal at a dose of 2,5 mg per day and the diuretic effect is slight, usually without clinical manifestation.
At higher doses, the diuretic effect becomes more prominent. The extra-renal antihypertensive action of 2,5 mg per day is demonstrated as a decrease in vascular hyperreactivity and a reduction in total peripheral and arteriolar resistance. The extra-renal mechanism of action has also been demonstrated by the maintenance of antihypertensive effect in functionally anephric patients. The extra-renal action is thought to be due to the inhibition of transmembrane ionic influx, essentially calcic, and the stimulation of synthesis of the vasodilatory hypotensive prostaglandin PGE2.
Prolonged use of indapamide has been shown to be associated with a reduction in left ventricular mass in hypertensive patients.
Indapamide is rapidly and completely absorbed after oral administration. Peak blood levels are reached after 1 to 2 hours. Indapamide is extensively metabolised and only 5-7% is found unchanged in the urine. The elimination half-life is 14-18 hours. Indapamide is 79% bound to plasma protein. The methyl-indoline portion of the molecule gives indapamide its lopiphilic character, and indapamide's lipid solubility is 5 to 8 times that of the thiazides. It is as a result of this characteristic that indapamide localizes in smooth vascular muscle.
NATRILIX (indapamide) is indicated in the management of mild to moderate hypertension.
Severe hepatic insufficiency.
Safety in pregnancy has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Adults: Maximum dose is 2,5 mg per day. The dosage is one tablet containing 2,5 mg indapamide hemihydrate, daily, to be taken in the morning with breakfast. In more severe cases, NATRILIX can be combined with other categories of antihypertensive agents.
Children: There is no experience of the use of this drug in children.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include giddiness, headaches, anorexia, gastric irritation, nausea, vomiting, constipation and diarrhoea.
Indapamide given at 2,5 mg daily produces minimal diuresis. However, hyperuricaemia and hypokalaemia may occur and potassium supplementation may be required.
Serum potassium should be monitored in patients prone or sensitive to hypokalaemia (such as patients treated concomitantly with steroids, digitalis or laxative drugs). Uric acid should be monitored, particularly in patients with a history of gout, who should continue to receive the appropriate treatment.
Indapamide 2,5 mg (one tablet) daily can be administered to hypertensive patients with impaired renal function, and to those undergoing chronic haemodialysis, as there is no evidence of drug accumulation. However, the treatment should be discontinued if increasing azotemia or oliguria occur.
The co-administration of NATRILIX with diuretics, which may cause hypokalaemia, is not recommended.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
These could include: allergies, skin rashes, epigastric pain, nausea, photosensitivity, dizziness, weakness and paraesthesia.
Treatment is supportive and symptomatic.
White bi-convex, film coated tablets.
Blister packs of 30 and 600 tablets.
Store below 25°C in a dry place.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SERVIER LABORATORIES SOUTH AFRICA (PTY) LTD.
1st Floor, Rivonia Gate, 381 Rivonia Boulevard, Rivonia, 2128.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1995 810
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