Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland
Treatment of essential hypertension in adults.
Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
The usual recommended initial and maintenance dose is 150 mg once daily. Irprestan 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 Irprestan can be increased to 300 mg, or other anti-hypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with irbesartan (see section 4.5).
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 irbesartan 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 sections 4.3, 4.4, 4.5 and 5.1).
No dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4).
No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
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.
The safety and efficacy of irbesartan in children aged 0 to 18 has not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food.
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
No specific information is available on the treatment of overdose with irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdose. Irbesartan is not removed by haemodialysis.
2 years.
This medicinal product does not require any special storage conditions.
Blister packs (PVC/PVdC-Alu blisters).
Tablet containers (HDPE) with desiccant and LDPE cap.
Pack sizes:
Blisters: 14, 28, 30, 56, 84, 90, 98 tablets
Tablet containers: 30, 60, 250 tablets.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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