Irbetan 300

Irbetan 300

Irbetan 300

201912-0043 • 2364 Views • Box of 5 blisters x 10 film coated tablets.
COMPOSITION

Active ingredient

Irbesartan 300 mg

 

Irbesartan is indicated for the treatment of essential hypertension. Irbesatan may be used alone or in combination with other antihypertensives

It is also indicated for the treatment of renal disease with hypertension and type 2 diabetes mellitus.

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration: 

For oral use, it may be taken with or without food.

Posology

The usual recommended initial and maintenance dose is 150 mg once daily.

In patients insufficiently controlled with maintenance dose, the dose of irbesartan can be increased to 300 mg and other antihypertensive agents can be added.

In hypertensive type 2 diabetic patients, therapy should be titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. 

Elderly, renal impairment and mild and moderate hepatic impairment: No dosage adjustment is necessary in patients with renal impairment.  A lower starting dose (75 mg) should be considered for patients undergoing hemodialysis and in the elderly over 75 years. There is no clinical experience in patients with severe hepatic impairment.

 

CONTRAINDICATIONS

Hypersensitivity to irbesartan or to any of the excipients of this medicine

Pregnancy and breastfeeding.

 

WARNINGS AND PRECAUTIONS

- 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, diarrhea or vomiting. Such conditions should be corrected before the administration of Irbesartan.

- 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 medicinal products that affect the renin-angiotensin-aldosterone system.

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

- Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy.

- Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.

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 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, azotemia, oliguria, or rarely acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

 

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date

 

Box of 5 blisters x 10 film coated tablets.

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