Trandolapril-Verapamil

Trandolapril-Verapamil is a combination medication used for the treatment of hypertension (high blood pressure).

• Trandolapril-Verapamil is available under the following different brand names: Tarka

Common side effects of Trandolapril-Verapamil include:

• dizziness as your body adjusts to the medication
• dry cough
• slow heartbeat
• constipation
• nausea
• headache
• runny or stuffy nose
• sore throat
• constipation
• diarrhea
• back pain
• joint pain
• Serious side effects of Trandolapril-Verapamil include:
• swelling of the ankles or feet
• unusual tiredness
• shortness of breath
• symptoms of high potassium blood levels (such as muscle weakness and irregular heartbeat)
• fast heartbeat
• fainting

Rare side effects of Trandolapril-Verapamil include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 2 mg/180 mg
• 1 mg/240 mg
• 2 mg/240 mg
• 4 mg/240 mg
• Combines an immediate-release formulation of an angiotensin-converting enzyme (ACE) inhibitor, trandolapril, and a slow-release formulation of a calcium channel blocker, verapamil hydrochloride

Hypertension

Adult dosage

• Not indicated for the initial therapy
• Usual dose: Trandolapril 1-4 mg/verapamil HCl ER 180-240 mg orally once a day
• For convenience, patients receiving trandolapril (up to 8 mg) and verapamil (up to 240 mg) in separate tablets, administered once a day, may instead receive tablets of a combination containing the same component doses
• Clinical trials with combination have explored only once-a-day dosing

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Trandolapril-Verapamil has severe interactions with the following drugs:
  • aliskiren
  • dantrolene
  • fezolinetant
  • flibanserin
  • lomitapide
  • lonafarnib
  • pimozide
  • protein a column
• Trandolapril-Verapamil has serious interactions with at least 135 other drugs.
• Trandolapril-Verapamil has moderate interactions with at least 375 other drugs.
• Trandolapril-Verapamil has minor interactions with at least 127 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to either component
• Second- or third-degree AV block (unless a permanent pacemaker is in place)
• Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock
• Concomitant use of aliskiren in patients with diabetes mellitus; do not coadminister Trandolapril-Verapamil with aliskiren in patients with diabetes
• Sick sinus syndrome (unless a permanent pacemaker is in place)
• Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (eg, Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome)
• History of angioedema
  • Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hours of switching to or from sacubitril/valsartan
  • Severe left ventricular dysfunction
  • Patients taking flibanserin

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Trandolapril-Verapamil?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Trandolapril-Verapamil?”

Cautions

• Aortic stenosis, hypotension (initially or after dose increases) reported
• Persistent progressive dermatologic reactions reported
• Avoid taking Trandolapril-Verapamil with grapefruit juice
• Use caution in patients with heart failure or compromised ventricular function
• Use caution in cases of liver or renal impairment
• Use caution and monitor closely if administered with concurrent beta-blocker therapy
• Excessive hypotension may occur if administered with concomitant diuretics; hypovolemia and hyponatremia reported
• Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren is 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 apheresis associated with anaphylactoid reactions
• Avoid verapamil in patients with severe left ventricular dysfunction (eg, ejection fraction less than 30%, pulmonary wedge pressure above 20 mmHg, or severe symptoms of cardiac failure) and 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 cause a decrease in blood pressure below normal levels, which may result in dizziness or symptomatic hypotension
• ACE inhibitors are rarely associated with the syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death; the 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, it may be necessary to discontinue verapamil HCl and initiate appropriate therapy depending upon the clinical situation
• 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 laryngeal stridor or angioedema of the face, tongue, or glottis occurs
• Administration of other ACE inhibitors has 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
• Drug interaction overview
  • Concomitant administration of moderate CYP3A4 inhibitor such as verapamil with flibanserin significantly increases flibanserin concentrations, which can lead to severe hypotension and syncope; concomitant use is contraindicated at least 2 weeks before starting flibanserin; do not administer therapy within 2 days of discontinuing flibanserin

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during the 1st trimester; use in life-threatening emergencies when no safer drug is available during the 2nd and 3rd trimesters
• Lactation
  • Excreted in breast milk; use caution