ALTACE (ramipril) is indicated for:

• Essential Hypertension: ALTACE is indicated in the treatment of essential hypertension. It may be used alone or in association with thiazide diuretics.

  
  

  ALTACE should normally be used in patients in whom treatment with a diuretic or a beta blocker was found ineffective or has been associated with unacceptable adverse effects.

  
  

  ALTACE can also be tried as an initial agent in those patients in whom use of diuretics and/or beta blockers are contraindicated or in patients with medical conditions in which these drugs frequently cause serious adverse effects.

  
  

  The safety and efficacy of ALTACE in renovascular hypertension have not been established and therefore, its use in this condition is not recommended.

  
  

  The safety and efficacy of concurrent use of ALTACE with antihypertensive agents other than thiazide diuretics have not been established.
  

• Treatment Following Acute Myocardial Infarction: ALTACE is indicated following acute myocardial infarction in clinically stable patients with signs of left ventricular dysfunction to improve survival and reduce hospitalizations for heart failure.
  

  Sufficient experience in the treatment of patients with severe (NYHA class IV) heart failure immediately after myocardial infarction is not yet available (see Warnings and Precautions, Cardiovascular, Hypotension).

• Management of Patients at Increased Risk of Cardiovascular Events: ALTACE may be used to reduce the risk of myocardial infarction, stroke or cardiovascular death in patients over 55 years of age who are at high risk of cardiovascular events because of a history of coronary artery disease, stroke, peripheral artery disease, or diabetes that is accompanied by at least one other cardiovascular risk factor such as hypertension, elevated total cholesterol levels, low high density lipoprotein levels, cigarette smoking, or documented microalbuminuria.

Angioedema has been reported in patients with ACE inhibitors including ALTACE. Angioedema associated with laryngeal involvement may be fatal. If laryngeal stridor or angioedema of the face, extremities, lips, tongue, or glottis occurs, ALTACE should be discontinued immediately, the patient treated appropriately in accordance with accepted medical care, and carefully observed until the swelling disappears. In instances where swelling is confined to the face and lips, the condition generally resolves without treatment, although antihistamines may be useful in relieving symptoms. Where there is involvement of tongue, glottis, or larynx, likely to cause airway obstruction, appropriate therapy (including, but not limited to 0.3 to 0.5 ml of subcutaneous epinephrine solution 1:1000) should be administered promptly (see Adverse Reactions, Clinical Trial Adverse Drug Reactions, Essential Hypertension; Less Common Clinical Trial Adverse Drug Reactions (<1%)

Angioedema—Intestinal

Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases facial angioedema also occurred. The intestinal angioedema symptoms resolved after stopping the ACE inhibitor.

Anaphylactoid Reactions During Membrane Exposure

Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes [e.g. polyacrylonitrile (PAN)] and treated concomitantly with an ACE inhibitor. Dialysis should be stopped immediately if symptoms such as nausea, abdominal cramps, burning, angioedema, shortness of breath and severe hypotension occur. Symptoms are not relieved by antihistamines. In these patients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agents.

Anaphylactoid Reactions During LDL Apheresis

Rarely, patients receiving ACE inhibitors during low density lipoprotein apheresis with dextran sulfate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding the ACE inhibitor therapy prior to each apheresis.

Anaphylactoid Reactions During Desensitization

There have been isolated reports of patients experiencing sustained life threatening anaphylactoid reactions while receiving ACE inhibitors during desensitization treatment with hymenoptera (e.g. bees, wasps) venoma. In the same patients, these reactions have been avoided when ACE inhibitors were temporarily withheld for at least 24 hours, but they have reappeared upon inadvertent rechallenge.