Indapamide Tablets 2.5mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Indapamide Tablets 2.5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg of indapamide hemihydrate
3 PHARMACEUTICAL FORM
Film-coated tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of essential hypertension. Indapamide Tablets 2.5mg may be used as sole therapy or combined with other antihypertensive agents.
4.2. Posology and Method of Administration
Adults: The dosage is one tablet, containing 2.5mg indapamide hemihydrate, daily, to be taken in the morning.
The action of indapamide is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of therapy. A larger dose than 2.5mg indapamide daily is not recommended as there is no appreciable additional antihypertensive effect, but a diuretic effect may become apparent. If a single daily tablet of indapamide does not achieve a sufficient reduction in blood pressure, another antihypertensive agent may be added; those which have been used in combination with indapamide include beta-blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents. The co-administration of indapamide hemihydrate with diuretics which may cause hypokalaemia is not recommended.
There is no evidence of rebound hypertension on withdrawal of indapamide.
Elderly: There are no significant changes in the pharmacokinetics of indapamide in the elderly. Numerous clinical studies have shown that it can be used without problems and indeed has a particular benefit on systolic blood pressure in the elderly.
Children: There is no experience of the use of this drug in children.
Route of administration Oral.
4.3. Contra-Indications
Indapamide Tablets 2.5mg are not recommended in patients with recent cerebrovascular accident, severe hepatic failure or a known history of allergy to sulphonamide derivatives.
Studies in functionally anephric patients for one month undergoing chronic haemodialysis, have not shown evidence of drug accumulation despite the fact that indapamide is not dialysable.
Although indapamide 2.5mg daily (one tablet) can be safely administered to hypertensive patients with impaired renal function, the treatment should be discontinued if there are signs of increasing renal insufficiency.
4.4. Special Warnings and Special Precautions for Use
Blood potassium and urate levels should be closely monitored in patients predisposed or sensitive to hypokaliaemia (cardiac patients treated with glycosides, elderly, or patients suffering from hyperaldosteronism); in patients suffering from gout.
In case of an aggravation of pre-existing renal insufficiency, it is recommended to interrupt the treatment with Indapamide Tablets 2.5mg.
In patients with hyperparathyroidism, the treatment with Indapamide Tablets 2.5mg should be interrupted on the occurrence of hypercalcemia.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
The concomitant administration of the following medicaments with Indapamide Tablets 2.5mg is not recommended:
Diuretics (risk of electrolyte imbalance)
Antiarrhythmics such as quinidine derivatives, cardiac glycosides, corticoids or laxatives in case of hypokalaemia
Lithium (increase in blood levels due to a diminished urinary excretion of lithium)
4.6. Pregnancy and Lactation
Pregnancy: No teratological effects have been seen in animals but because animal reproduction studies are not always predictive of human response, Indapamide Tablets 2.5mg should be used during pregnancy only if clearly needed.
Nursing mothers: It is not known if Indapamide Tablets 2.5mg is excreted in human milk. Because most drugs are excreted in human milk, if use of Indapamide Tablets 2.5mg is deemed essential, the patient should stop nursing.
4.7. Effects on Ability to Drive and Use Machines
No evidence of any adverse effect on mental alertness.
4.8. Undesirable Effects
Hypokalaemia, headache, dizziness, fatigue, muscular cramps, nausea, anorexia, diarrhoea, constipation, dyspepsia, and cutaneous rash may occur as a result of treatment with Indapamide Tablets 2.5mg. There have been some rare reports of orthostatic hypotension, palpitations, increase in liver enzymes, blood dyscrasia including thrombocytopenia,
hyponatremia, metabolic alkalosis, hyperglycaemia, increase in blood urate levels, paresthesia, erythema multiforme, epidermal necrolysis, photosensitivity, impotence, renal insufficiency and reversible acute myopia. At the dosage recommended for hypertension, indapamide does not usually adversely influence plasma triglycerides, LDL cholesterol or the LDL-HDL cholesterol ratio. Indapamide does not appear to adversely affect glucose tolerance when used in patients with diabetes and also in non diabetics.
4.9. Overdose
Symptoms of overdosage would be those associated with a diuretic effect: electrolyte disturbances, hypotension and muscular weakness.
Treatment would be symptomatic, directed at correcting the elctrolyte abnormalities and gastric lavage or emesis should be considered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Indapamide, an indole derivative of chlorosulfonamide has an antihypertensive action causing a drop in systolic, diastolic and mean blood pressure. This antihypertensive action is maximal at a dose of 2.5mg 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 2.5mg per day is demonstrated as a decrease in vascular hyperreactivity and a reduction in total peripheral and anteriolar 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 trans-membrane ionic influx, essentially calcium, and the stimulation of synthesis of the vasodilatory hypotensive prostaglandin PGE2.
5.2. Pharmacokinetic Properties
Indapamide is rapidly and completely absorbed after oral administration. Peak blood levels are obtained after 1 to 2 hours.
Indapamide is concentrated in the erythrocytes and is 79% bound to plasma protein and to erythrocytes. It is taken up by the vascular wall in smooth vascular muscle according to its high lipid solubility. 70% of a single oral dose is eliminated by the kidneys and 23% by the gastrointestinal tract. Indapamide is metabolised to a marked degree with 7% of the unchanged product found in the urine during the 48 hours following administration. Elimination half life ( P phase) of indapamide is approximately 15 - 18 hours.
5.3. Pre-clinical Safety Data
Not applicable
6.1 List of excipients
Lactose EP Maize starch EP Magnesium stearate EP Talc EP Povidone EP
Coating:
Glycerol EP White beeswax EP Sodium laurylsulphate EP Methylhydroxy-propylcellulose EP Polyoxyethylene glycol 6000 EP Titanium dioxide (E171) EP Purified water EP Ethyl alcohol HSE
6.2. Incompatibilities
None known
6.3. Shelf-Life
The shelf life of this product is five years.
6.4. Special Precautions for Storage
Store below 30°C.
6.5. Nature and Contents of Container
Indapamide Tablets 2.5mg are presented in pack sizes of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 tablets presented in PVC/aluminium blister strips packaged together with a patient information leaflet into a cardboard carton, or PVdC coated PVC/Aluminium blisters (60g/m PVdC on 250pm PVC/20pm Al).
6.6.
Instructions for Use, Handling and Disposal
Indapamide Tablets 2.5mg are for oral use only.
7 MARKETING AUTHORISATION HOLDER
Norton Healthcare Limited
Albert Basin
Royal Docks
London
E16 2QJ
8 MARKETING AUTHORISATION NUMBER(S)
PL 00530/0508
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/12/1995
10 DATE OF REVISION OF THE TEXT
28/07/2000