Aprovasc Warnings

Hypotension - Patients with volume depletion: Irbesartan has rarely been associated with hypotension in hypertensive patients who have no other concomitant condition. Symptomatic hypotension may occur, such as with ACE inhibitors, in patients with sodium/volume depletion and in those under intensive treatment with diuretics and/or salt restriction or in hemodialysis. The depletion of volume and/or sodium should be corrected before starting treatment with Irbesartan/Amlodipine (Aprovasc) or the start of treatment with the lowest possible dose should be considered.
Hypoglycemia: Irbesartan can cause hypoglycemia, particularly in patients being treated for diabetes. Therefore, it may be necessary to adjust the dose of the diabetes medication of repaglinide or insulin (see Adverse Reactions).
Fetal/Neonatal Morbidity and Mortality: Although there is no experience with irbesartan in pregnant women, it has been reported that exposure of the pregnancy product to ACE inhibitors, administered to pregnant women during the second and third quarters of pregnancy, causes injuries and death of the fetus. Therefore, as any other drug acting directly on the renin-angiotensin-aldosterone system, Irbesartan/Amlodipine (Aprovasc) should not be administered during pregnancy. When pregnancy is detected during treatment, Irbesartan/Amlodipine (Aprovasc) should be discontinued as soon as possible.
Patients with heart failure: Patients with heart failure must be treated cautiously. In a large-scale, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA class III and IV heart failure of non-ischemic origin, the use of amlodipine is associated with an increase in reports of pulmonary oedema despite there having been no significant difference in the frequency of cases in which the heart failure worsened when compared with the placebo (see Pharmacology: Pharmacokinetics and Pharmacodynamics under Actions). Calcium-channel blockers, including amlodipine, must be used with caution in patients with congestive heart failure, since they can increase the risk of future cardiovascular problems, events and mortality.
Hepatic impairment: For amlodipine: As is the case with other calcium antagonists, the half-life of Amlodipine is increased and the AUC values are greater in patients with abnormal liver function and dose recommendations have not been established for this group.
Therefore, amlodipine must be initiated in the lowest possible dose range and should be used with caution, both as initial treatment and on increasing the dose in these patients. A slow dose adjustment and careful monitoring of patients with severe liver failure may be necessary.
Elderly patients: In elderly patients, the dose must be increased carefully (see Dosage & Administration).
Patients with renal failure: Amlodipine may be used in these patients at normal doses. The changes in amlodipine concentration in plasma are not correlated with the severity of the kidney failure. Amlodipine is not capable of being dialysed.
Hypertensive crisis: The safety and efficacy of Irbesartan/Amlodipine (Aprovasc) in the treatment of hypertensive crisis has not been established.