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Anti-hypertensive, diuretic agent.

Each tablet contains 2.5 mg indapamide hemihydrate.

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 proteins 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 extensively metabolised with only 7% of the unchanged product found in the urine during the 48 hours following administration. Elimination half-life (13 phase) of indapamide is approximately 15 to 18 hours.

The mechanism whereby indapamide exerts its action in the control of hypertension has not been completely elucidated; both renal and extrarenal actions may be involved. The renal site of action is the promixal part of the distal tubule and the ascending part of Henle's loop. Sodium and chloride ions are excreted in approximately equivalent amounts. The increased delivery of sodium to the distal tubular exchange site results in increased potassium excretion.

The proposed extrarenal mechanisms of antihypertensive action of indapamide may include a reduction in peripheral arterial resistance and normalisation of vascular hyper-reactivity.

Whilst indapamide given at 2.5 mg daily produces minimal diuresis with serum potassium and uric acid usually remaining within the range of normal values, occasional patients may develop hypokalaemia or hyperuricaemia.

At the dosage recommended for hypertension indapamide does not usually adversely influence triglycerides, LDL cholesterol or the LDL-HDL cholesterol ratio. Indapamide does not appear to adversely affect glucose tolerance.

Management of essential hypertension. It may be tried as a sole therapeutic agent in the treatment of mild to moderate hypertension. Normally indapamide is used as the initial agent in multiple drug regimens.

Anuria, progressive and severe oliguria, hepatic coma, known hypersensitivity to indapamide or to other sulphonamide derivatives.

Electrolyte changes observed with indapamide become significant at doses above 2.5 mg/day. As doses above 2.5 mg only increases the diuretic effect and electrolyte disturbances consequent to diuresis without any further anti hypertensive effect. The maximum recommended dose of indapamide is 2.5 mg administered as one tablet daily.

Hypokalaemia may occur at all doses. Symptoms of hypokalaemia include weakness, cramps, and cardiac dysrrhythmias. Hypokalaemia is a particular hazard in digitalised patients; dangerous of fatal arrhythmias may be precipitated.

Caution should be observed when the drug is administered to patients with severe renal impairment since the drug is excreted primarily by the renal route.

Hyperuricaemia may occur during administration of indapamide. Rarely, gout has been reported. Blood uric acid levels should be monitored, particularly in patients with a history of gout who should continue to receive appropriate treatment.

Patients receiving indapamide should be carefully observed and serum electrolytes monitored for signs and symptoms of fluid or electrolyte imbalance; namely hyponatraemia, hypochloraemia and hypokalaemia. Blood urea nitrogen and uric acid should also be assessed during therapy. Hypokalaemia will be more common in association with concomitant steroid or ACTH therapy and with inadequate electrolyte intake. The serum potassium should be determined at regular intervals and potassium supplementation instituted when indicated (see Warnings).

The signs of electrolyte imbalance are: dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscle fatigue, hypotension, oliguria, gastrointestinal disturbances such as nausea and vomiting, tachycardia and ECG changes.

Special caution should be used in treating patients with severe hepatic disease to avoid metabolic alkalosis in cases of potassium depletion which may precipitate episodes of hepatic encephalopathy.

Orthostatic hypotension may occur and may be potentiated by alcohol, barbiturates, narcotics of concurrent therapy with other antihypertensives.

When indapamide is given with other nondiuretic antihypertensive agents, the effects on blood pressure are additive.

Sulphonamide derivatives have been reported to exacerbate or activate systemic lupus erythematosus. These possibilities should be kept in mind with the use of indapamide although no case has been reported to date.

Although indapamide 2.5 mg daily can safely be administered to hypertensive patients with impaired renal function, the treatment should be discontinued if increasing azotaemia and oliguria occur. 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.

Use in Pregnancy: Risk Category: C

Indapamide, being a loop diuretic, enters the fetal circulation and may cause electrolyte disturbances.

Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics like frusemide and bumetanide are probably also associated with the risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose.

There is no information on the use of indapamide in pregnancy. Whilst animal studies have not suggested any teratogenic effect, indapamide is not recommended for administration to pregnant women unless the expected benefit outweighs the potential risk.

Use in Lactation:
It is not known whether indapamide is excreted in breast milk. It is therefore not recommended that the drug be given to lactating women as the possible effect on the newborn is unknown.

Use in Children:
Safety and effectiveness have not been established.

The following values represent the maximum variations from pre-treatment values in occasional patients at some stage during but not necessarily throughout treatment. Blood uric acid up 8.6%, blood glucose up 6%, BUN up 5.7%, blood creatinine up 3.6%.

No interactions have been reported between indapamide and oral hypoglycaemic agents, anticoagulants, uricosurics and anti-inflammatory agents.

It is recommended that the drug not be used in combination with a diuretic agent since the combination may produce hypokalaemia and hyperuricaemia.

It is recommended not to be used in combination with antiarrhythmics such as quinidine derivatives, cardiac glycosides, corticoids or laxatives, in case of hypokalaemia.

Adverse Reactions:
The most severe and common adverse effect is the electrolyte imbalance. Electrolyte changes reported include: hypokalaemia 14.2% (requiring K+ supplementation 6%, with clinical symptoms 1.2%); hypochloraemia 9.4%; hyponatraemia 3.1%.

Central nervous system (8.1 %), Incidence >1 % <3%:
asthenia, headache, dizziness, vertigo. Incidence <1% drowsiness, sleepiness, insomnia, weakness, lethargy, visual disturbance.

Gastrointestinal (2.6%). Incidence <1%:

nausea/anorexia, dryness of mouth, gastralgia, vomiting, diarrhoea, constipation.

Musculoskeletal (1.4%). Incidence >1 % <3%:
muscle cramps. Incidence <1%: joint pain, back pain, weakness of legs.

Cardiovascular (1 %). Incidence <1 %:

orthostatic hypotension, tachycardia, ECG changes (nonspecific ST-T changes, U waves, left ventricular strain).

Urogenital (0.5%). Incidence <1%:

impotence, modification of libido, polyuria.

Dermatological (0.5%). Incidence <1%:

rash, pruritus.


Endocrine (0.2%). Incidence <1%:


Other (0.5%). Incidence <1%:

tinnitus, malaise/ fainting, sweating.

Dosage and Administration:
Adults. 1 tablet (2.5 mg indapamide) daily to be taken in the morning. The action of indapamide is progressive and whilst the optimum reduction in blood pressure is usually seen after 4 weeks, some further small but useful reduction in blood pressure may be observed over the following 4 to 6 weeks. A larger dose than 2.5 mg daily is not recommended as there is little additional antihypertensive effect, whilst the diuretic effect becomes more prominent.

A single daily tablet of indapamide may effectively be combined with another antihypertensive agent such as beta-blockers, methyldopa, clonidine, prazosin and other adrenergic blocking agents.

Indapamide has slight but significant carry-over hypotensive effect lasting up to 1 or 2 weeks after the cessation of therapy.

Symptoms. There have been no reports of overdosage. Based on the pharmacological activities of indapamide, overdosage may lead to excessive diuresis with electrolyte depletion. In cirrhotic patients, overdosage might precipitate hepatic coma.

Treatment. There is no specific antidote. Treatment is symptomatic and supportive. Discontinue drug. Induce emesis or perform gastric lavage. Correct dehydrate, electrolyte imbalance, hepatic coma and hypotension by established procedures.

2.5 mg tablet: pink film coated, marked "IE" 2.5 on one side, "G" on the reverse.

Pack Sizes:

Blister Packs of 90's.

Storage Conditions:
Store at room temperature. Protect from moisture, freezing and excessive heat. Below 30C.











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