ALTACE

Serious Warnings and Precautions When used in pregnancy, angiotensin converting enzyme (ACE) inhibitors can cause injury or even death of the developing fetus. When pregnancy is detected ALTACE should be discontinued as soon as possible (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).

General Cough A dry, persistent cough, which usually disappears only after withdrawal or lowering of the dose of ALTACE, has been reported. Such possibility should be considered as part of the differential diagnosis of cough (see ADVERSE REACTIONS).

g. g. operating a vehicle or machinery). Patient alertness ALTACE may lower the state of patient alertness and/or reactivity, particularly at the start of treatment (see ADVERSE REACTIONS). 73m2). Therefore, the use of ALTACE in combination with aliskiren-containing drugs is contraindicated in these patients (see CONTRAINDICATIONS).

The use of ALTACE in combination with an ARB is contraindicated in patients with diabetic nephropathy (see CONTRAINDICATIONS). Further, co-administration of ACE inhibitors, including ALTACE, with other agents blocking the RAS, such as ARBs or aliskiren-containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia (see DRUG INTERACTIONS).

Cardiovascular Aortic Stenosis There is concern, on theoretical grounds, that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction.

PrALTACE® Product Monograph Page 7 of 42 Hypotension Symptomatic hypotension has occurred after administration of ALTACE, usually after the first or second dose or when the dose was increased. , stenosis of the aortic valve) or in patients with hemodynamically relevant renal artery stenosis.

All patients should be cautioned about this potential excessive fall in BP and advised to consult their physician. Generally, it is recommended that dehydration, hypovolemia or salt depletion be corrected before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed against the risk of volume overload).

When these conditions have become clinically relevant, treatment with ALTACE must only be started or continued if appropriate steps are taken concurrently to prevent an excessive fall in BP and deterioration of renal function. In patients with ischemic heart disease or cerebrovascular disease, an excessive fall in BP could result in a myocardial infarction or cerebrovascular accident (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).