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Tarka
Generic Name: Trandolapril/Verapamil Hydrochloride
Drug Category: ACE Inhibitor/CCB
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 3 years.
| Approved Uses |
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Indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension. In using TARKA, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk. TARKA has not been evaluated in subjects with impaired hepatic and renal function. Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported. ACE inhibitors rarely have been associated with a syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death. Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors including trandolapril. Because of the trandolapril component. TARKA is contraindicated in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor. Patients receiving co-administration of an ACE inhibitor with an mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) or a neprilysin inhibitor (e.g., sacubitril) may be at increased risk for angioedema. Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. Trandolapril, as an ACE inhibitor, may cause excessive hypotension in patients with congestive heart failure. Because of the verapamil component, TARKA is contraindicated in:
Normal sinus rhythm is usually not affected, but in patients with sick sinus syndrome, verapamil may interfere with sinus node impulse generation and may induce sinus arrest or sinoatrial block. Atrioventricular block can occur in patients without preexisting conduction defects. Avoid use of aliskiren with TARKA in patients with renal impairment (GFR <60 ml/min). Trandolapril and trandolapril at concentrations increase in patients with impaired liver function. Do not co-administer aliskiren with TARKA in patients with diabetes. TARKA is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer TARKA within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor. In patients undergoing major surgery or during anesthesia with agents that produce hypotension, trandolapril will block angiotensin II formation secondary to compensatory renin release. Avoid co-administration of verapamil and ivabradine. Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. TARKA and lithium should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased. Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent clarithromycin. Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent erythromycin ethylsuccinate. Disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration. Concomitant therapy with flecainide and verapamil may result in additive negative inotropic effect and prolongation of atrioventricular conduction. Combined therapy of verapamil and quinidine in patients with hypertrophic cardiomyopathy should probably be avoided. Concomitant use of TARKA with other antihypertensive agents including diuretics, vasodilators, beta-adrenergic blockers, and alpha-antagonists may result in additive hypotensive effects. There are reports that verapamil may result in higher concentrations of the alpha-agonists prazosin and terazosin. Concomitant therapy with beta-adrenergic blockers and verapamil may result in additive negative effects on heart rate, atrioventricular conduction, and/or cardiac contractility. Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta adrenergic blocker) eye drops and oral verapamil. Trandolapril can attenuate potassium loss caused by thiazide diuretics and increase serum potassium when used alone. Use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), potassium supplements, or potassium containing salt substitutes concomitantly with ACE inhibitors can increase the risk of hyperkalemia. The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with verapamil has been associated with reports of myopathy/rhabdomyolysis. The antihypertensive effect of ACE inhibitors, including trandolapril may be attenuated by NSAIDs. Verapamil may increase carbamazepine concentrations during combined therapy. There have been reports that erythromycin and telithromycin may increase concentrations of verapamil. Phenobarbital therapy may increase verapamil clearance. Due to metabolism via the CYP enzyme system, there have been reports that verapamil may increase the concentrations of buspirone, midazolam, almotriptan and imipramine. When verapamil and colchicine are administered together, the potential inhibition of P-gp and/or CYP3A by verapamil may lead to increased exposure to colchicine. Verapamil therapy may inhibit the clearance and increase the plasma levels of theophylline. Due to metabolism via the CYP enzyme system, there have been reports that verapamil may increase the concentrations of buspirone, midazolam, almotriptan and imipramine. Concentrations of verapamil may be increased by the concomitant administration of protease inhibitors such as ritonavir, and reduced by the concomitant administration of sulfinpyrazone, or St John’s Wort. Concentrations of doxorubicin may be increased by the administration of verapamil. There have been reports that verapamil may elevate the concentrations of the oral antidiabetic glyburide. Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue TARKA as soon as possible. TARKA should not be administered to nursing mothers. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Initial therapy of hypertension. GoToSource |
| Adverse Events |
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Constipation and bradycardia (slow heart rate). GoToSource Atrioventricular block (first degree) and upper respiratory tract infection. GoToSource Urinary tract infection, cough, joint pain, dizziness and rash. GoToSource Hypotension (low blood pressure). GoToSource Liver injury, jaundice, pruritus (severe itching) and cholestasis (reduction or stoppage of bile flow). GoToSource Angioedema (swelling in deep layers of skin). GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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