Aprovasc Special Precautions

Special warnings: Hypotension: Volume-Depleted Patients: Irbesartan has been rarely associated with hypotension in hypertensive patients without other co-morbid conditions. As with ACE inhibitors, symptomatic hypotension may be expected to occur in sodium/volume-depleted patients such as those treated vigorously with diuretics and/or salt restriction, or on hemodialysis. Volume and sodium-depletion should be corrected before initiating therapy with Aprovasc or a lower starting dose should be considered.
Fetal/neonatal morbidity and mortality: Although there is no experience with irbesartan in pregnant women, in utero exposure to ACE inhibitors given to pregnant women during the second and third trimesters of gestation has been reported to cause injury and death to the developing fetus. Thus, as for any drug that also acts directly on the renin-angiotensin-aldosterone system, Aprovasc should not be used during pregnancy. If pregnancy is detected during therapy, Aprovasc should be discontinued as soon as possible.
Patients with heart failure: In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischemic etiology, amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the incidence of worsening heart failure as compared to placebo (see Pharmacology: Pharmacodynamics under Actions).
Hepatic impairment: As with other calcium antagonists, amlodipine's half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Aprovasc should therefore be administered with caution in these patients.
Hypertensive crisis: The safety and efficacy of Aprovasc in hypertensive crisis has not been established.
General precautions: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system (hypertensive patients with renal artery stenosis in one or both kidneys, or patients with severe congestive heart failure), treatment with other drugs that affect this system has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. The possibility of a similar effect occurring with the use of an angiotensin II receptor antagonist, including irbesartan, cannot be excluded.
Use in Children: Safety and efficacy in pediatric patients have not been established.
Use in the Elderly: Among patients who received irbesartan in clinical studies, no overall differences in efficacy or safety were observed between older patients (65 years or older) and younger patients.