Trandolapril

Do not co-administer with trandolapril in patients with diabetes. Avoid use in patients with renal impairment (GFR <60 mL/min) due to increased risks of hypotension, hyperkalemia, and acute renal failure.

Potassium-sparing diuretic increases risk of hyperkalemia when used with trandolapril; requires caution and appropriate serum potassium monitoring.

Dual blockade of RAS associated with increased risks of hypotension, hyperkalemia, and acute renal failure compared to monotherapy.

Increased serum lithium levels and symptoms of lithium toxicity reported with concomitant ACE inhibitor therapy. Risk further increased if diuretic also used.

Co-administration with trandolapril may result in deterioration of renal function including possible acute renal failure, especially in elderly, volume-depleted, or renal-impaired patients.

Concomitant use with trandolapril increases risk of hyperkalemia and requires caution with appropriate serum potassium monitoring.

Potassium-sparing diuretic increases risk of hyperkalemia when used with trandolapril; requires caution and appropriate serum potassium monitoring.

Upon discontinuation of any verapamil-containing regime including trandolapril and verapamil hydrochloride extended-release tablets, the patient should be reassessed to avoid underdigitalization. No clinically significant pharmacokinetic interaction has been found between trandolapril (or its metabolites) and digoxin. Trandolapril and verapamil hydrochloride extended-release tablets and lithium should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended.

Closely monitor blood pressure, renal function and electrolytes in patients on trandolapril and other agents that affect the RAS. Avoid use of aliskiren with trandolapril in patients with renal impairment (GFR <60 ml/min). Concomitant Diuretic Therapy 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 trandolapril.

Potassium-sparing diuretic increases risk of hyperkalemia when used with trandolapril; requires caution and appropriate serum potassium monitoring.

Concomitant use may cause increased blood glucose lowering effect with greater risk of hypoglycemia.

May cause excessive reduction of blood pressure after initiation of trandolapril therapy, especially with recently instituted diuretic therapy.

Concomitant use may cause increased blood glucose lowering effect with greater risk of hypoglycemia.

Can increase risk of hyperkalemia when used concomitantly with trandolapril. Use with caution and monitor serum potassium.

Mammalian Target of Rapamycin (mTOR) Inhibitors Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see Warnings – Head and Neck Angioedema).

Coadministration led to 44% increase in trandolapril Cmax but no difference in trandolaprilat pharmacokinetics or ACE inhibition.

Trandolapril did not affect plasma concentration of oral digoxin; no clinically significant interaction observed.

Coadministration increased renal clearance of trandolaprilat by 25% but no effect on furosemide or trandolaprilat pharmacokinetics or ACE inhibition.

Table 3: No observed clinically important drug interactions of Veltassa Angiotensin-converting enzyme (ACE) inhibitors Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril Angiotensin II receptor blockers (ARB) Azilsartan, candesartan, irbesartan, losartan, olmesartan, valsartan β-adrenoceptor blockers (β-blocker) Metoprolol Loop diuretics Furosemide, bumetanide, torasemide Mineralocorticoid receptor antagonists (MRA) Eplerenone, finerenone, spironolactone Neprilysin inhibitors Sacubitril Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Canagliflozin, dapagliflozin, empagliflozin Antibiotics Trimethoprim, amoxicillin, cephalexin Anticoagulants Warfarin, apixaban, rivaroxaban Anti-parathyroid agents and Thyroid preparations Cinacalcet Antithrombotic agents Clopidogrel, acetylsalicylic acid Blood glucose lowering drugs Glipizide Calcium channel blockers Amlodipine, verapamil Immunosuppressants Tacrolimus Others Lithium, allopurinol, atorvastatin, digoxin, phenytoin, riboflavin, sevelamer