Indicated for:

Hypertension:

• The treatment of hypertension, to lower blood pressure. ALTACE may be used alone or in combination with thiazide diuretics

Reduction in the Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes:

• For patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. ALTACE can be used in addition to other needed treatment (such as antihypertensive, antiplatelet, or lipid-lowering therapy).

Heart Failure Post-Myocardial Infarction:

• For the treatment of post-myocardial infarction patients who have shown signs of congestive heart failure, the recommended starting dose of ALTACE is 2.5 mg twice daily (5 mg per day). A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily. After one week at the starting dose, increase dose (if tolerated) toward a target dose of 5 mg twice daily, with dosage increases being about 3 weeks apart.

After the initial dose of ALTACE, observe the patient under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. If possible, reduce the dose of any concomitant diuretic as this may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of ALTACE does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

ALTACE is contraindicated:

• In combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ALTACE within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor
• Do not co-administer ALTACE with aliskiren
• In patients with diabetes

Avoid concomitant use of aliskiren with ALTACE in patients with renal impairment (GFR <60 mL/min/1.73 m²).

Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors. Angioedema associated with laryngeal edema can be fatal.

Rarely, ACE inhibitors, including ALTACE, have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death.

In patients with severe congestive heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including ALTACE, may be associated with oliguria or progressive azotemia and rarely with acute renal failure or death.

ALTACE can cause symptomatic hypotension, after either the initial dose or a later dose when the dosage has been increased.

In rare instances, treatment with ACE inhibitors may be associated with mild reductions in red blood cell count and hemoglobin content, blood cell or platelet counts. In isolated cases, agranulocytosis, pancytopenia, and bone marrow depression may occur.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on ALTACE and other agents that affect the RAS.

In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on ALTACE and other agents that affect the RAS.

Concomitant use of telmisartan and ramipril is not recommended.

Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with ALTACE.

Concomitant administration of ALTACE with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium.

Patients taking concomitant mammalian target of rapamycin (mTOR) inhibitor (e.g. temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.

ACE inhibitors during therapy with lithium; therefore, frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including ALTACE.

When pregnancy is detected, discontinue ALTACE as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Ingestion of a single 10 mg oral dose of ALTACE resulted in undetectable amounts of ramipril and its metabolites in breast milk. However, because multiple doses may produce low milk concentrations that are not predictable from a single dose, do not use ALTACE in nursing mothers.

GoToSource

• Use in patients under the age of 18. GoToSource

• Dosage greater than 20 mg daily. GoToSource

• Diabetic neuropathy. GoToSource

• Rheumatoid arthritis. GoToSource

• Migraines. GoToSource

• Bartter syndrome. GoToSource

• Type I autosomal dominant polycystic kidney disease. GoToSource 

• Inhibit functional matrix metalloproteinase activity in crohn’s disease fistulas. GoToSource

• Reduction of proteinuria in children after renal transplantation. GoToSource

• Use with metformin for metabolic syndrome. GoToSource

Hyponatraemia (low sodium level). GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Generalized pustular psoriasis. GoToSource

Hyperkalemia (high potassium levels). GoToSource

Hypotension and bone marrow suppression. GoToSource  

Birth defects. GoToSource 

Telangiectasia (dilated blood vessels on the skin or mucosal surface). GoToSource

Dry cough. GoToSource

Lawsuits filed for birth defects, kidney failure and angioedema.