Cosmos Pharmaceutical Limited | Induric® Tablets
Cosmos Limited is one of the leading manufacturers of pharmaceutical products in Kenya and East Africa. Through our specialized Human Health and Animal Health.
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Induric® Tablets

PRESENTATION:

Induric® Tablets 2.5mg: White, circular, biconvex tablet plain on both sides. Each tablet contains: Indapamide Hemihydrate equivalent to Indapamide USP 2.5mg, Lactose and other excipients.

CLINICAL PHARMACOLOGY:

Indapamide is a non- thiazide sulphonamide with an indole ring, belonging to the diuretic family. At the dose of 2.5mg per day of Indapamide exerts a prolonged antihypertensive activity in hypertensive human subjects. Dose-effect studies have demonstrated that, at the dose of 2.5mg per day, the antihypertensive effect is maximal and the diuretic effect is subclinical. As this antihypertensive dose of 2.5mg per day, Indapamide reduces vascular hyper reactivity to noradrenaline in hypertensive patients and decreases total peripheral resistance and arteriolar resistance. The implication of an extrarenal mechanism of action in the antihypertensive effect is demonstrated by maintenance of its antihypertensive efficacy in functionally anepheric hypertensive patients. The vascular mechanism of action of Indapamide involves: ¨A reduction in the contractility of vascular smooth muscle due to a modification of transmembrane ion exchanges, essentially calcium. ¨Vasodilation due to stimulation of the synthesis of prostaglandin PGE 2 and the vasodilator and platelet antiaggregant prostacyclin PGI 2. ¨Potentiation of the vasodilator action of bradykinin. It has also been demonstrated that in the short, medium and long term, in hypertensive patients, Indapamide: ¨Reduces left ventricular hypertrophy ¨Does not appear to alter lipid metabolism: triglycerides, LDL-cholesterol & HDL Cholesterol; ¨Does not appear to alter glucose metabolism, even in diabetic hypertensive patients. Normalisation of blood pressure and a significant reduction in micro albuminuria have been observed after prolonged administration of Indapamide in diabetic hypertensive subjects. The co-prescription of Indapamide with other antihypertensives (beta-blockers, calcium channel blockers or angiotensin converting enzyme inhibitors) results in improved control of hypertension with an increased percentage of responders compared to that observed with single-agent therapy. Pharmacokinetics: Indapamide is rapidly and completely absorbed from the gastrointestinal tract. 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 (b phase) of indapamide is approximately 15-18 hours.

PRESENTATION: Induric® Tablets 2.5mg: White, circular, biconvex tablet plain on both sides. Each tablet contains: Indapamide Hemihydrate equivalent to Indapamide USP 2.5mg, Lactose and other excipients.

CLINICAL PHARMACOLOGY:

Indapamide is a non- thiazide sulphonamide with an indole ring, belonging to the diuretic family. At the dose of 2.5mg per day of Indapamide exerts a prolonged antihypertensive activity in hypertensive human subjects. Dose-effect studies have demonstrated that, at the dose of 2.5mg per day, the antihypertensive effect is maximal and the diuretic effect is subclinical. As this antihypertensive dose of 2.5mg per day, Indapamide reduces vascular hyper reactivity to noradrenaline in hypertensive patients and decreases total peripheral resistance and arteriolar resistance. The implication of an extrarenal mechanism of action in the antihypertensive effect is demonstrated by maintenance of its antihypertensive efficacy in functionally anepheric hypertensive patients. The vascular mechanism of action of Indapamide involves: ¨A reduction in the contractility of vascular smooth muscle due to a modification of transmembrane ion exchanges, essentially calcium. ¨Vasodilation due to stimulation of the synthesis of prostaglandin PGE 2 and the vasodilator and platelet antiaggregant prostacyclin PGI 2. ¨Potentiation of the vasodilator action of bradykinin. It has also been demonstrated that in the short, medium and long term, in hypertensive patients, Indapamide: ¨Reduces left ventricular hypertrophy ¨Does not appear to alter lipid metabolism: triglycerides, LDL-cholesterol & HDL Cholesterol; ¨Does not appear to alter glucose metabolism, even in diabetic hypertensive patients. Normalisation of blood pressure and a significant reduction in micro albuminuria have been observed after prolonged administration of Indapamide in diabetic hypertensive subjects. The co-prescription of Indapamide with other antihypertensives (beta-blockers, calcium channel blockers or angiotensin converting enzyme inhibitors) results in improved control of hypertension with an increased percentage of responders compared to that observed with single-agent therapy.

Pharmacokinetics:

Indapamide is rapidly and completely absorbed from the gastrointestinal tract. 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 (b phase) of indapamide is approximately 15-18 hours.

USES: For the treatment of essential hypertension. Indapamide may be used as sole therapy or combined with other antihypertensive agents.For the treatment of essential hypertension. Indapamide may be used as sole therapy or combined with other antihypertensive agents.

DOSAGE AND ADMINISTRATION:

One tablet each day, preferably in the morning. The tablets can be taken with or without food. They should be swallowed whole with water.

CONTRA-INDICATIONS AND WARNINGS:

Hypersensitivity to sulfonamides; severe renal failure; hepatic encephalopathy or severe hepatic failure; hypokalemia. Precautions: Pregnancy; lactation; monitoring of K+ and uric serum levels is recommended especially in subjects with predisposition or a sensitivity to hypokalemia and in patients with gout. Although no allergic manifestations have been reported during clinical trials, patients with a history of allergy to sulfonamides derivatives should be closely monitored. Adverse Effects: Drug combinations to be avoided; lithium; nonantiarrhymic drugs causing wave burst arrhythmia such erythromycin, halofantrine, pentamidine, terfenadine and vincamine. Overdosage: Consult your doctor or pharmacist immediately. Interactions: Diuretic-induced hypokalaemia may enhance the toxicity of digitalis glycosides and may also increase the risk of arrhythmias with drugs that prolong the QT interval, such as astemizole, terfenadine, halofantrine, pimozide, and sotalol. These thiazides may enhance the neuromuscular blocking action of competitive neuromuscular blockers, such as atracurium, probably by their hypokalaemic effect. The potassium-depleting effect of diuretics may be enhanced by corticosteroids, corticotrpin, beta2 agonists such as salbutamol, carbenoxolone, amphotericin B, or reboxetine. Diuretics may enhance the effect of other antihypertensives, particularly the first dose hypotension that occurs with alpha blockers or ACE inhibitors. Orthostatic hypotension associated with diuretics may be enhanced by alcohol, barbiturates, or opiods. The antihypertensive effects of diuretics may be antagonized by drugs that cause fluid retention, such as corticosteroids, NSAIDs, or carbenoxolone; diuretics may enhance the nephrotoxicity of NSAIDs. Thiazides have been reported to diminish the response to pressor amines, such as noradrenaline, but the clinical significance of this effect is uncertain. Thiazides should not usually be used with lithium since the association may lead to toxic blood concentrations of lithium. Other drugs for which increased toxicity has been reported when given with thiazides include allopurinol and tetracyclines. Thiazides may alter the requirements for hypoglycaemics in diabetic patients.

PHARMACEUTICAL PRECAUTIONS:

Store in a dry place below 30°C. Protect from light. Keep all medicines out of the reach of children.

LEGAL CATEGORY: Prescription Only Medicine (POM)

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