Trandolapril Verapamil

Black Box Warnings

Trandolapril: Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

Contraindications

Hypersensitivity to either component

Second- or third-degree AV block (unless permanent pacemaker in place)

Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock

Concomitant use with aliskiren in patients with diabetes mellitus

Sick sinus syndrome (unless permanent pacemaker in place)

Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g. Wolff-Parkinson-White, Lown-Ganong-Levine syndromes)

Do not coadminister with aliskiren in patients with diabetes

History of angioedema

Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan

Severe left ventricular dysfunction

Cautions

Aortic stenosis, hypotension (initially or after dose increases) reported

Persistent progressive dermatologic reactions reported

Avoid taking with grapefruit juice

Use caution in heart failure or compromised ventricular function

Use caution in liver or renal impairment

Use caution and monitor closely if adminstered with concurrent beta blocker therapy

Excessive hypotension may occur if administered with concomitant diuretics, hypovolemia, hyponatremia

Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy

Avoid concomitant use of verapamil and quinidine in patients with hypertrophic cardiomyopathy; may cause significant hypotension

Hemodialysis with high flux membrane and low-density lipoprotein apharesis associated with anaphylactoid reactions

Avoid verapamil in patients with severe left ventricular dysfunction (e.g., ejection fraction < 30%, pulmonary wedge pressure above 20 mmHg, or severe symptoms of cardiac failure) and in patients with any degree of ventricular dysfunction if they are receiving a beta adrenergic blocker

ACE inhibitors may cause excessive hypotension in patients with congestive heart failure

Verapamil may produce a decrease in blood pressure below normal levels which may result in dizziness or symptomatic hypotension

ACE inhibitors rarely associated with syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death; mechanism of this syndrome is not understood; patients receiving ACE inhibitors who develop jaundice should discontinue therapy

Not for administration to patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter and a coexisting accessory AV pathway

Reduce dose if marked first-degree block or progressive development to second-or third-degree AV block; in rare instances, discontinuation of verapamil HCl and institution of appropriate therapy depending upon clinical situation may be necessary

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

Discontinue immediately if If laryngeal stridor or angioedema of the face, tongue or glottis occurs

Administration of other ACE inhibitors have been associated with 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; consider periodic monitoring of white blood cell counts in patients with collagen-vascular disease and/or renal disease

Acceleration of ventricular rate and/or ventricular fibrillation has been reported in patients with atrial flutter or atrial fibrillation and a coexisting accessory AV pathway

Trandolapril/verapamil is a prescription medication used to treat high blood pressure, medically known as hypertension.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Trandolapril & Verapamil is part of the drug class:

• ACE inhibitors and calcium channel blockers

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the enzyme CYP3A4 such as  some macrolide antibiotics (clarithromycin, telithromycin, erythromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delavirdine, and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• anti-arrhythmic (irregular heartbeat) medications such as disopyramide (Norpace), flecainide (Tambocor), and quinidine
• medications that treat high blood pressure such vasodilators, angiotensin-converting enzyme inhibitors (ACEIs), diuretics, beta blockers, and angiotensin receptor blockers (ARBs)
• lithium
• theophylline
• digoxin (Lanoxin)
• cimetidine (Tagamet)
• simvastatin (Zocor)
• atorvastatin (Lipitor)
• colchicine (Colchrys)
• the immunosuppressant medications cyclosporine (Neoral, Gengraf, Sandimmune), tacrolimus (Prograf), and sirolimus (Rapamune)
• antidepressants such as buspirone (Buspar) and imipramine (Tofranil)
• midazolam (Versed)

This is not a complete list of trandolapril/verapamil drug interactions. Ask your doctor or pharmacist for more information.

 

If you take too much trandolapril/verapamil, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If trandolapril/verapamil is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.