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LIXAMIDE TABLETS

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME
(and dosage form):

LIXAMIDE TABLETS

COMPOSITION:
Each tablet contains 2,5 mg indapamide.

PHARMACOLOGICAL CLASSIFICATION:
A 7.1 Hypotensive medicines.

PHARMACOLOGICAL ACTION:
Indapamide is an antihypertensive diuretic. Its antihypertensive mechanism of action is not clearly understood but possibly involves both renal and extra-renal effects. The diuretic effect (reduction of extracellular fluid and blood volume) probably contributes only minimally since blood pressure is decreased at doses well below the effective diuretic dose. The antihypertensive effect possibly results from reduction of peripheral vascular resistance.
A reduction in left ventricular mass in hypertensive patients has been shown to be associated with prolonged use of indapamide.
Pharmacokinetics
Indapamide is rapidly absorbed after oral administration. Peak blood levels are reached within 2 hours and peak antihypertensive effect after a single dose is reached after approximately 24 hours. The onset of antihypertensive action after multiple doses occurs within 1 to 2 weeks and time to peak effect is 8 to 12 weeks. Indapamide undergoes extensive hepatic biotransformation and only 7% remains unchanged in the urine. The elimination half-life in whole blood is approximately 14 hours. Indapamide binds to plasma proteins (71-79%) and elastin in vascular smooth muscle.

INDICATIONS:
LIXAMIDE tablets are indicated in the management of mild to moderate hypertension.

CONTRA-INDICATIONS:
Severe hepatic function impairment.
Hypersensitivity to indapamide.
Safety in pregnancy and lactating mothers has not been established.

WARNINGS:
Elderly patients may be more sensitive to the hypotensive and electrolyte effects of LIXAMIDE tablets and are more likely to have aged-related renal function impairment. The risk-benefit should be considered in patients presenting the following medical problems: anuria or severe renal function impairment, diabetes mellitus, a history of gout, hyperuricaemia, hepatic function impairment and sympathectomy.

DOSAGE AND DIRECTIONS FOR USE:

Adults:	One tablet containing 2,5 mg indapamide to be taken in the morning. LIXAMIDE tablets may be used in conjunction with other agents for the management of hypertension.
Children:	Appropriate studies on the age effects relationship of indapamide in children have not been performed and hence a dosage has not been established.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects
Incidence less frequent requiring medical attention: allergic reaction (skin rash, itching, hives), electrolyte imbalance, specifically hypernaturaemia (dryness of mouth, increased thirst, unusual tiredness or weakness), hypochloraemic alkalosis, or hypokalaemia (irregular heartbeat, mood or mental changes, muscle cramps or pain, nausea or vomiting, weak pulse). Electrolyte imbalance is dose related, with hypokalaemia occurring fairly frequently, but is usually not symptomatic.
Incidence less frequent requiring medical attention only if they continue or are bothersome: diarrhoea, headache, loss of appetite, orthostatic hypotension as a result of volume depletion (dizziness or light-headedness, especially when getting up from a lying or sitting position); trouble sleeping; upset stomach.
Special precautions
Patients sensitive to other sulphonamide-type medications may be sensitive to LIXAMIDE tablets.
The following medications may interact with LIXAMIDE tablets: amiodarone, coumarin or indandione-derivative anticoagulants, digitalis glycosides, other antihypertensives, non-depolarising neuromuscular blocking agents and sympathomimetics. Concurrent use with lithium is not recommended.
Laboratory tests values may change in patients taking LIXAMIDE tablets, specifically decreased serum concentrations of calcium and protein-bound iodine (slightly), and potassium and sodium (but usually within normal limits); increased serum concentrations of uric acid (but usually with in normal limits); and increased plasma renin activity.
Recommended patient monitoring includes determination of the concentrations of blood glucose and urea nitrogen, and serum uric acid and electrolytes.
Treatment with LIXAMIDE tablets may require concurrent administration of potassium supplements or potassium-sparing diuretics in patients considered at higher risk of developing hypokalaemia. However, caution should the exercise as the loss of potassium is usually not clinically significant and supplementation may lead to the development of hyperkalaemia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage: Refer to side-effects and special precautions.
Treatment: Immediate evacuation of the stomach followed by supportive, symptomatic treatment and monitoring of serum electrolyte concentrations and renal function.

IDENTIFICATION:
White round tablets with sharp edges.

PRESENTATION:
Cartons containing 30 or 600 blister-packed tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
31/7.1/0097

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Xeragen Laboratories (Pty) Ltd.
Units 8-11 Glen Park Industrial
1 Highdale Road,
Glen Anil
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 2001

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New addition to this site: February 2004
Source: Pharmaceutical Industry
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