Indicated for:

Hypertension:

• The treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. 

Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction:

• For stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction.

Do not co-administer aliskiren with MAVIK in patients with diabetes.

Avoid use of aliskiren with MAVIK in patients with renal impairment (GFR <60 ml/min).

Following oral administration in patients with mild to moderate alcoholic cirrhosis, plasma concentrations of trandolapril and trandolaprilat were, respectively, 9-fold and 2-fold greater than in normal subjects, but inhibition of ACE activity was not affected. Lower doses should be considered in patients with hepatic insufficiency.

Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors including MAVIK. Intestinal angioedema has been reported in patients treated with ACE inhibitors ACE inhibitors cause a higher rate of angioedema in black than in non-black patients. Intestinal angioedema has been reported in patients treated with ACE inhibitors.

Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma.

ACE inhibitors rarely have been associated with a syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death.

Patients receiving coadministration of an ACE inhibitor with an mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) may be at increased risk for angioedema.

MAVIK is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer MAVIK within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.

Use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes concomitantly with ACE inhibitors can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, they should be used with caution and with appropriate monitoring of serum potassium.

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, MAVIK will block angiotensin II formation secondary to compensatory renin release.

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. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may experience an excessive reduction of blood pressure after initiation of therapy with MAVIK.

Concomitant use of ACE inhibitors and antidiabetic medicines (insulin or oral hypoglycemic agents) may cause an increased blood glucose lowering effect with greater risk of hypoglycemia.

Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including trandolapril, may result in deterioration of renal function, including possible acute renal failure.

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, MAVIK should be discontinued as soon as possible. MAVIK should not be administered to nursing mothers.

Radiolabeled trandolapril or its metabolites are secreted in rat milk. MAVIK should not be administered to nursing mothers.

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• Use in patients under the age of 18. GoToSource

• Diabetes mellitus, chronic renal insufficiency and atherosclerotic cardiovascular disease. GoToSource

• Arrhythmias. GoToSource

• Prevention of pain from sickle cell disease. GoToSource

• Cushing’s disease. GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Pruritus (severe itching), bullous eruptions (fluid-filled blisters), urticaria (hives) and hair loss. GoToSource

Agranulocytosis (low level of white blood cells). GoToSource

Cough and bronchitis. GoToSource

Thrombotic microangiopathy (disorder involving small blood vessels). GoToSource

Hypotension (low blood pressure) and hyperkalemia (high blood potassium level). GoToSource

Anemia. GoToSource

Fetal injury. GoToSource

Stomatitis (inflammation of the mouth and lips), pancreatitis (inflammation of the pancreas), cholestatic jaundice, mood and sleep disturbance and impotence. GoToSource

Lawsuits filed for angioedema, birth defects, kidney failure and hyperkalemia.