Trandolapril/Verapamil

DEA Class; Rx

Common Brand Names; Tarka

• ACE Inhibitors

ACE inhibitor and CCB; used qd for HTN; oral combination product contains immediate-release trandolapril and extended-release verapamil; has greater antihypertensive effects than either agent alone.

Indicated for the treatment of hypertension. Not indicated for initial therapy

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

Patients taking flibanserin

Verapamil

• Headache (1-12 %)
• Gingival hyperplasia (≤ 19%)
• Constipation (7-12%)
• Dizziness (4%)

• Dyspepsia (3%)
• Edema (2%)
• Fatigue (2%)
• Lethargy (3%)
• Pain (2%)
• Sleep disturbance (1%)
• Increased liver enzymes (1%)
• Pulmonary edema (2%)
• Flushing (1%)
• Hypotension (4%)
• Nausea (3%)

Trandolapril

• Syncope (6%)
• Bradycardia (1-5%)
• Stroke (3%)
• Gastritis (4%)
• Diarrhea (1%)
• Weakness (3%)
• Myalgia (5%)
• Hypotension (1-11%)
• Dizziness (1-23%)
• Increased uric acid (15%)
• Cough (2-35%)

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

Pregnancy Category: C (1st trimester); D (2nd and 3rd trimester)

Lactation: excreted in breast milk, use caution