(and dosage form):
Each sustained release tablet contains 1,5 mg Indapamide
A 7.1 Vasodilators, Hypotensive Medicine.
Indapamide, [N-(3-sulphamoyl-4-chlorobenzamido) 2-methyl indoline] is an indole derivative of chlorosulphonamide with an antihypertensive action. It has an extra-renal antihypertensive action resulting in a decrease in vascular hyperreactivity and a reduction in total peripheral and arteriolar resistance. This 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. there is also a direct renal diuretic action.
Prolonged use of Indapamide has been shown to be associated with a reduction in left ventricular mass in hypertensive patients.
Indapamide is completely absorbed after oral administration. Peak blood levels are reached after 12 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 lipophilic 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 localises in smooth vascular muscle.
NATRILIX SR (1,5 mg Indapamide) is indicated in the management of mild to moderate hypertension.
Hypersensitivity to the active ingredient or other sulphonamide type medications.
Severe hepatic insufficiency.
Severe renal failure with creatinine clearance <36 mL/min.
Safety in pregnancy has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Adults: One tablet daily, preferably in the morning. In more severe cases, NATRILIX SR (1,5 mg Indapamide) 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, diarrhoea and postural hypotension.
Electrolyte imbalances including hypochloraemic alkalosis, hyponatraemia, hypokalaemia and hyperuricaemia; hypersensitivity reactions which include skin rashes, pulmonary oedema, pneumonitis, cholestatic jaundice, pancreatitis and blood dyscrasias including thrombocytopaenia and less frequently, granulocytopaenia, leucopaenia, aplastic anaemia and haemolytic anaemia have been reported.
Indapamide given at 1,5 mg daily usually produces no significant diuresis.
Serum potassium should be monitored in patients prone or sensitive to hypokalaemia (such as patients treated concomitantly with steroids, digitalis or laxative drugs). Uric acids should be monitored, particularly in patients with a history of gout, who should continue to receive appropriate treatment.
Indapamide 1,5 mg (one tablet) daily can be administered to hypertensive patients with mild to moderately impaired renal function. However, the treatment should be discontinued if increasing azotemia or oliguria occur.
The co-administration of NATRILIX SR (1,5 mg Indapamide) with other 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 tablets, containing 3 blisters with 10 tablets each.
Store below 30°C in a dry place.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SERVIER LABORATORIES SOUTH AFRICA (PTY) LTD.
Rivonia Gate South, 381 Rivonia Boulevard, Rivonia, 2128.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Updated on this site: May 2004
Current: November 2005
Source: Community Pharmacy
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