Ifirmasta (Previously Irbesartan Krka)

Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Ifirmasta 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.

1). 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. 1). Special Populations Renal impairment No dose adjustment is necessary in patients with impaired renal function.

4). Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment. Elderly Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dose adjustment is not usually necessary for older people.

Paediatric population The safety and efficacy of Ifirmasta in children aged 0 to 18 has not been established. 2 but no recommendation on a posology can be made. Method of Administration For oral use.

5%). 5%). The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment. , uncommon) but in excess of placebo. The following table presents the adverse medicinal product reactions that were reported in placebo- controlled trials in which 1,965 hypertensive patients received irbesartan.

Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo. The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions additionally reported from post–marketing experience are also listed. These adverse reactions are derived from spontaneous reports.

4) Reproductive system and breast disorders: Uncommon: sexual dysfunction General disorders and administration site conditions: Common: fatigue Uncommon: chest pain Investigations: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.

4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. 3% of the patients in the placebo group. 7%) in irbesartan treated subjects. None of these increases were associated with identifiable clinical musculoskeletal events.

7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed. 9%). 5%) and elevated CK values in 2% of child recipients.

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 Ifirmasta.

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

While this is not documented with Ifirmasta, a similar effect should be anticipated with angiotensin-II receptor antagonists. Renal impairment and kidney transplantation When Ifirmasta 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 Ifirmasta 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.

1). Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).

1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

1. 6). 1).