Generic Name and Formulations:
Trandolapril, verapamil HCl (ext-rel); 2mg/180mg, 1mg/240mg, 2mg/240mg, 4mg/240mg; tabs.
Indications for TARKA:
Hypertension (not for initial therapy).
Titrate individual components. Take with food. ≥18yrs: 1 tab daily.
<18yrs: not established.
History of ACEI-associated angioedema. Severe left ventricular dysfunction. Hypotension. Cardiogenic shock. Sick sinus syndrome, 2nd- or 3rd-degree AV block, unless paced. Atrial flutter or fibrillation and an accessory bypass tract. Concomitant aliskiren in patients with diabetes. Concomitant neprilysin inhibitor (eg, sacubitril); do not give within 36 hours of switching to or from sacubitril/valsartan.
Fetal toxicity may develop; discontinue if pregnancy is detected. Renal or hepatic impairment. Salt/volume depletion. CHF. Avoid in ventricular dysfunction on a β-blocker. Control mild heart failure (eg, with digitalis, diuretics). Cerebrovascular or ischemic heart disease. Renal artery stenosis. Dialysis (esp. high-flux membrane). Hypertrophic cardiomyopathy. AV conduction or neuromuscular transmission disorders. Surgery. Diabetes. Monitor WBCs in renal or collagen-vascular disease. Monitor BP, electrolytes, renal and liver function. Discontinue if laryngeal edema, angioedema, or jaundice develops. Black patients may have higher risk of angioedema than non-black patients. Neonates. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.
See Contraindications. For trandolapril: increased risk of angioedema with concomitant neprilysin inhibitor or mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus). Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). Excessive hypotension with diuretics. Hyperkalemia with K+ supplements, K+-sparing diuretics, salt substitutes. Potentiates antidiabetic agents. May be antagonized by, and renal toxicity potentiated by NSAIDs, including selective COX-2 inhibitors (monitor renal function in elderly and/or volume-depleted). Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare. For verapamil: Potentiates alcohol, β-blockers, other antihypertensives, digitalis, ivabradine (avoid), lithium, theophylline, neuromuscular blockers, flecainide, carbamazepine, cyclosporine, sirolimus, tacrolimus, doxorubicin, tranquilizers/antidepressants (eg, buspirone, midazolam, almotriptan, imipramine), colchicine, dabigatran. Potentiated by grapefruit juice. Avoid disopyramide; quinidine in cardiomyopathy. Potentiated by CYP3A4 inhibitors (eg, erythromycin, ritonavir); antagonized by CYP3A4 inducers (eg, rifampin, St. John's wort). May potentiate statins; limit simvastatin dose to 10mg/day or lovastatin to 40mg/day. May need to reduce initial and maintenance dose for other CYP3A4 substrates (eg, atorvastatin). Inhalation anesthetics may potentiate cardiac depression. May increase bleeding with aspirin. Monitor theophylline, lithium levels.
ACE inhibitor + diphenylalkylamine calcium channel blocker (CCB).
Cough, AV block, constipation, dizziness, elevated liver enzymes, fatigue, chest pain, bradycardia, hypotension, joint pain, GI upset, bronchitis, dyspnea, pain in extremities, paralytic ileus; rare: hepatic failure.
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