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APROVEL

isbesartan

 

QUALITATIVE AND QUANTITATIVE FORMULA

Aprovel 75 mg tablets

Each tablet contains 75 mg irbesartan.

Aprovel 150 mg tablets

Each tablet contains 150 mg irbesartan.

Aprovel 300 mg tablets

Each tablet contains 300 mg irbesartan.

 

PHARMACEUTICAL FORM

75 mg Tablet

White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.

150 mg Tablet

White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.

300 mg Tablet

White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.

 

CLINICAL PARTICULARS

Therapeutic indications

Treatment of essential hypertension. Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Aprovel reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation).

 

Posology and method of administration

The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Aprovel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.

 

In patients insufficiently controlled with 150 mg once daily, the dose of Aprovel can be increased to 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Aprovel (see Interaction with other medicinal products and other forms of interaction).

 

In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Aprovel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents as needed, to reach target blood pressure (see Pharmacodynamic properties).

Renal impairment: No dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.

Intravascular volume depletion: Volume and/or sodium depletion should be corrected prior to administration of Aprovel.

Hepatic impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.

Elderly patients: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.

Children: Safety and efficacy of Aprovel have not been established in children.

 

Contraindications

Hypersensitivity to any component of the product (see List of Excipients).

Second and third trimester of pregnancy (see Pregnancy and lactation).

Lactation (see Pregnancy and lactation)

 

Special warnings and special precautions for use

Intravascular volume depletion: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Aprovel.

 

Renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with drugs that affect the renin-angiotensin-aldosterone system. While this is not documented with Aprovel, a similar effect should be anticipated with angiotensin-II receptor antagonists.

 

Renal impairment and kidney transplantation: When Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Aprovel in patients with a recent kidney transplantation.

 

Hypertensive patients with type 2 diabetes and renal disease: The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects (see Pharmacodynamic properties).

 

Hyperkalema: As with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur during the treatment with Aprovel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended (see Interaction with other medicinal products and other forms of interaction).

 

Lithium: The combination of lithium and Aprovel is not recommended (see Interaction with other medicinal products and other forms of interaction).

 

Aortic and mitral valve stenosis, obstructive hvpertrophic cardiomyopathy: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

 

Primary aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Aprovel is not recommended.

 

General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

 

As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non- blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see Pharmacodynamic properties).

 

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