A-Z Drug Facts > Trandolapril/Verapamil Hydrochloride

Trandolapril / Verapamil Hydrochloride

Pronouncation: (tran-DOE-lah-prill/veh-RAP-uh-mill HIGH-droe-KLOR-ide)
Class: Antihypertensive combination

Trade Names:
Tarka
- Tablets 1 mg trandolapril and 240 mg verapamil
- Tablets 2 mg trandolapril and 180 mg verapamil
- Tablets 2 mg trandolapril and 240 mg verapamil
- Tablets 4 mg trandolapril and 240 mg verapamil

Pharmacology

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Trandolapril

Reduces formation of the vasopressor hormone angiotensin II by inhibiting angiotensin-converting enzyme (ACE), resulting in decreased BP and reduced sodium reabsorption and potassium retention.

Verapamil

Inhibits movement of calcium ions across cell membrane, resulting in depression of mechanical contraction of myocardial and vascular smooth muscle and depression of both impulse formation (automaticity) and conduction velocity.

Indications and Usage

Treatment of hypertension.

Contraindications

Patients with severe left ventricular dysfunction; hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock; sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker); atrial flutter or atrial fibrillation and an accessory bypass tract (eg, Wolff-Parkinson-White syndrome); history of angioedema related to previous treatment with an ACE inhibitor; hypersensitivity to any component of the product; second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker.

Dosage and Administration

The fixed combination is not indicated for initial therapy. The combination may be substituted for the titrated components.

Adults

PO The recommended dose range of trandolapril for hypertension is 1 to 4 mg/day in a single dose or 2 divided doses. The recommended dose range of sustained-release verapamil is 120 to 480 mg/day in a single dose or 2 divided doses. For convenience, patients receiving trandolapril (up to 8 mg) and verapamil (up to 240 mg) in separate tablets administered every day may instead substitute Tarka containing the same component doses.

Storage/Stability

Store tablets at controlled room temperature (59° to 77°F). Keep container tightly closed.

Drug Interactions

Trandolapril Agents increasing serum potassium (eg, potassium-sparing diuretics [amiloride, spironolactone, triamterene]; potassium supplements, potassium-containing salt substitutes)

Risk of hyperkalemia may be increased.

Diuretics

Increased risk of excessive reduction in BP.

Thiazide diuretics (eg, hydrochlorothiazide)

Potassium loss caused by thiazides may be attenuated.

Verapamil Beta-blockers (eg, propranolol)

Additive negative effects on heart rate, AV conduction, and/or cardiac contractility.

Carbamazepine, cyclosporine, digitalis, theophylline

Serum levels may be elevated by verapamil, resulting in toxicity of these agents.

Disopyramide

Do not administer within 48 h before or 24 h after verapamil.

Flecainide

Additive effects on myocardial contractility, AV conduction, repolarization, negative inotropic effect, and prolongation of AV conduction.

Lithium

Increased sensitivity to the effects of lithium and increased lithium serum levels, resulting in toxicity.

Neuromuscular blocking agents (curare-like and depolarizing)

Activity may be potentiated.

Phenobarbital

May increase verapamil Cl.

Quinidine

Increased risk of hypotension in patients with hypertrophic cardiomyopathy. Verapamil may counteract the effects of quinidine on AV conduction.

Rifampin

Bioavailability of verapamil may be reduced, decreasing the therapeutic effect.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

First degree AV block; bradycardia; chest pain; angina; second degree AV block; bundle branch block; edema; hypotension; MI; palpitation; premature ventricular contractions; nonspecific ST-T changes; near syncope; tachycardia; hypotension.

Verapamil

CHF/pulmonary edema; third degree AV block; syncope.

CNS

Dizziness; drowsiness; hypesthesia; insomnia; loss of balance; paresthesia; vertigo; anxiety; abnormal mentation; malaise; weakness; headaches; fatigue.

Trandolapril

Decreased libido.

Verapamil

Cerebrovascular accident; confusion; psychotic symptoms; shakiness; somnolence.

Dermatologic

Pruritus; rash.

Verapamil

Ecchymosis; bruising; exanthema; hair loss; hyperkeratosis; maculae; sweating; urticaria; Stevens-Johnson syndrome; erythema multiforme.

EENT

Epistaxis; tinnitus; blurred vision.

GI

Constipation; diarrhea; nausea; dyspepsia; dry mouth.

Trandolapril

Pancreatitis.

Verapamil

Gingival hyperplasia; reversible, nonobstructive paralytic ileus.

Genitourinary

Endometriosis; impotence; hematuria; nocturia; polyuria; proteinuria.

Verapamil

Gynecomastia; galactorrhea/hyperprolactinemia; increased urination; spotty menstruation.

Hematologic

Decreased leukocytes; decreased neutrophils; decreased platelets; decreased WBC.

Hepatic

Increased liver enzymes (ALT, AST, alkaline phosphatase).

Metabolic

Gout (increased uric acid).

Respiratory

Bronchitis; cough; dyspnea; upper respiratory tract infection.

Miscellaneous

Flushing; arthralgias/myalgias; angioedema; back and joint pain.

Precautions

Warnings When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.

Pregnancy

Category D (second and third trimester). Category C (first trimester). ACE inhibitors (eg, trandolapril) can cause injury or death to fetus if used during second or third trimester. When pregnancy is detected, discontinue as soon as possible.

Lactation

Trandolapril

Not established.

Verapamil

Excreted in breast milk.

Children

Safety and efficacy not established.

Elderly

Greater sensitivity compared with younger patients should be considered.

Hepatic effects

Trandolapril

ACE inhibitors rarely have been associated with a syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death.

Verapamil

Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported.

Hepatic/Renal impairment

Use with caution.

Angioedema

ACE inhibitors including trandolapril may cause angioedema of the face, extremities, lips, tongue, glottis, and larynx.

Cardiac conduction

Verapamil may be associated with a variety of cardiac conduction abnormalities including first-, second-, or third-degree AV block; bradycardia; asystole; severe hypotension; nodal escape rhythms, PR prolongation and ventricular tachycardia in patients with atrial flutter/fibrillation and Wolff-Parkinson-White syndrome caused by antigrade conduction.

Heart failure

Verapamil should be avoided in patients with severe left ventricular dysfunction or any degree of ventricular dysfunction if receiving a beta-adrenergic blocker.

Hypertrophic cardiomyopathy

Serious adverse effects where seen in patients with hypertrophic cardiomyopathy who received verapamil.

Hypotension

Trandolapril

May cause excessive hypotension in patients with CHF or salt or volume depletion.

Verapamil

Hypotension may occur during initial therapy or with dosage increases and is more likely in patients taking beta-blockers.

Neutropenia/Agranulocytosis

May occur with trandolapril; risk appears greatest in patients with renal dysfunction, heart failure, or immunosuppression.

Neuromuscular transmission

It may be necessary to reduce the dose of verapamil in patients with attenuated neuromuscular transmission.

Overdosage

Symptoms

Trandolapril

Severe hypotension

Verapamil

Pronounced hypotension, bradycardia and conduction system abnormalities, symptoms secondary to hypoperfusion (eg, metabolic acidosis, hyperglycemia, hyperkalemia, renal dysfunction, convulsions)

Patient Information

• Advise patient to take 1 or 2 times daily as prescribed and to take each dose with food.
• Advise patient to try to take each dose at about the same time each day.
• Inform patient that drug controls but does not cure hypertension and to continue taking drug as prescribed even when BP is not elevated.
• Caution patient not to change the dose or stop taking unless advised by health care provider.
• Instruct patient to continue taking other BP medications as prescribed by health care provider.
• Instruct patient in BP and pulse measurement skills.
• Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted. Also, advise patient to take record of BP and pulse to each follow-up visit.
• Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
• Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
• Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP, resulting in lightheadedness or fainting.
• Emphasize to hypertensive patient importance of other modalities on BP: weight control, regular exercise, smoking cessation, and moderate intake of alcohol and salt.
• Instruct patient to stop taking the drug and immediately report any of the following symptoms to health care provider: fainting; swelling of the face, lips, eyelids, or tongue; difficulty breathing; yellowing of the skin or eyes.
• Instruct patient to inform health care provider if a persistent cough or bothersome constipation develop while taking this medication.

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