Summary of content

Irbesartan

Visa No.: VD-35369-21

Product: Irbesartan Stada 150 mg

API: Irbesartan

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 513/QÐ-QLD_01/09/2021_170BS

INDICATIONS

Irbesartan is indicated in adults for:

Treatment of essential hypertension
Treatment of renal disease in patients with hypertension and type 2 diabetes, as part of an antihypertensive treatment regimen.

DOSAGE AND ADMINISTRATION

Method of administration: Oral use

Dosage

The recommended initial and maintenance dose is 150 mg once daily, taken with or without food. Irbesartan 150 mg once daily generally provides effective blood pressure control over 24 hours compared with 75 mg.
However, a starting dose of 75 mg may be considered, particularly in patients undergoing hemodialysis or patients over 75 years of age.
In patients whose blood pressure is not adequately controlled with irbesartan 150 mg once daily, the dose may be increased to 300 mg once daily, or another antihypertensive agent may be added.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with irbesartan.
In patients with hypertension and type 2 diabetes, treatment should be initiated at 150 mg once daily and titrated to 300 mg once daily as the preferred maintenance dose for renal protection.
The renal protective effect of irbesartan in these patients has been demonstrated in studies where irbesartan was used in combination with other antihypertensive agents, as needed, to achieve target blood pressure.

Special Populations

Renal impairment No dose adjustment is required in patients with renal impairment. A lower starting dose of 75 mg should be considered in patients undergoing hemodialysis.

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

Elderly patients: Dose adjustment is generally not required in elderly patients.
However, initiation of therapy with a 75 mg dose should be considered in patients over 75 years of age.

Pediatric population: The safety and efficacy of irbesartan in children aged 0–18 years have not been established.

CONTRAINDICATIONS

Hypersensitivity to irbesartan or to any excipient of the product.
Second and third trimesters of pregnancy.
Concomitant use of irbesartan with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 mL/min/1.73 m²).

WARNINGS AND PRECAUTIONS

This medicine should be used only under medical prescription.
Read the instructions carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.