Safety Labeling Changes Approved By FDA CDER
Ramipril is an ACE inhibitor indicated for the treatment of hypertension.
It may be used alone or in combination with thiazide diuretics. The most common
adverse reactions include headache, dizziness, fatigue, and cough.
Aliskiren is an orally active renin
antagonist given in patients with hypertension
with elevated plasma renin levels.
Physicians are advised not
to co-administer Aliskiren with Ramipril in patients with diabetes or in
patients with renal impairment (GFR < 60 mL/min/1.73 m2).
Dual blockade of the Renin
Angiotensin Aldosterone System (RAAS) with ACE inhibitors and Aliskiren is
associated with increased risks of hypotension, hyperkalemia, and changes in
renal function (including acute renal failure) compared to monotherapy.
Physicians should closely
monitor blood pressure, renal functions and electrolytes in patients on
Ramipril and other agents that affect the RAAS.
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