Trandolapril/verapamil Generic Name & Formulations
Legal Class
Rx
General Description
Trandolapril, verapamil HCl (ext-rel); 2mg/180mg, 1mg/240mg, 2mg/240mg, 4mg/240mg; tabs.
Pharmacological Class
ACE inhibitor + diphenylalkylamine calcium channel blocker (CCB).
How Supplied
Contact supplier
Manufacturer
Trandolapril/verapamil Indications
Indications
Hypertension (not for initial therapy).
Trandolapril/verapamil Dosage and Administration
Adult
Titrate individual components. Take with food. ≥18yrs: 1 tab daily.
Children
<18yrs: not established.
Trandolapril/verapamil Contraindications
Contraindications
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 flibanserin (discontinue trandolapril/verapamil ≥2 weeks prior to starting; do not give trandolapril/verapamil within 2 days of discontinuing flibanserin). Concomitant aliskiren in patients with diabetes. Concomitant neprilysin inhibitor (eg, sacubitril); do not give within 36 hours of switching to or from sacubitril/valsartan.
Trandolapril/verapamil Boxed Warnings
Boxed Warning
Fetal toxicity.
Trandolapril/verapamil Warnings/Precautions
Warnings/Precautions
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: avoid. Nursing mothers: not recommended.
Trandolapril/verapamil Pharmacokinetics
See Literature
Trandolapril/verapamil Interactions
Interactions
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, flibanserin. 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.
Trandolapril/verapamil Adverse Reactions
Adverse Reactions
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.
Trandolapril/verapamil Clinical Trials
See Literature
Trandolapril/verapamil Note
Notes
Formerly known under the brand name Tarka.
Trandolapril/verapamil Patient Counseling
See Literature