Aprovasc Special Precautions

Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS): The dual blockade of the renin angiotensin aldosterone system with the combination of Irbesartan/Amlodipine (Aprovasc) with angiotensin-converting enzyme inhibitors (ACEIs) or with aliskiren is not recommended since there is an increased risk of hypotension, hyperkalemia, and changes in renal function compared to monotherapy.
The use of Irbesartan/Amlodipine (Aprovasc) in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (Glomerular Filtration Rate (GFR) <60 ml/min/1.73m²).
The use of lrbesartan/Amlodipine (Aprovasc) in combination with ACE inhibitors is contraindicated in patients with diabetic nephropathy.
The use of lrbesartan/Amlodipine (Aprovasc) in patients with psoriasis or with a history of psoriasis should be weighed carefully as it may exacerbate psoriasis.
General: Changes in the renal function of susceptible individuals can be expected as a consequence of the inhibition of the renin-angiotensin-aldosterone system. In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system (hypertensive patients with stenosis of the renal artery of 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 elevation 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.
Lithium: The concomitant use of angiotensin II receptor blockers and calcium channel blockers may reduce renal lithium clearance and the increase of serum levels that may reach toxic levels. Lithium levels should be monitored in patients who are receiving APROVASC.
Effects on ability to drive: For irbesartan: The effect of irbesartan on the ability to drive and use machines has not been investigated, despite the fact that, based on its pharmacodynamic properties, it is unlikely that irbesartan will have an effect on the ability to drive or operate machines. The patient must bear in mind that those being treated for hypertension may occasionally experience dizziness or tiredness.
For amlodipine: Amlodipine may have a mild or moderate effect on the ability to drive and use machines. If patients taking amlodipine experience dizziness, headache, fatigue or nausea. The reaction speed may be affected. Caution is advised especially when starting treatment.
Use in Children: Safety and efficacy in pediatric patients have not been established.
Use in the Elderly: In elderly patients, with volume depletion (including those on therapy with diuretics), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, can cause a deterioration of renal function, including a possible acute renal failure. These effects are usually reversible. Renal function should be monitored in patients receiving periodic treatment with Irbesartan and NSAIDs. The antihypertensive effect of angiotensin II receptor antagonists can be attenuated by NSAIDs including selective COX-2 inhibitors. In patients receiving Irbesartan in clinical studies no overall differences were observed in terms of efficacy and safety in older patients (65 years or older) or in younger patients.