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Trandolapril and verapamil (Oral route)

Pronunciation:

tran-DOE-la-pril, ver-AP-a-mil hye-droe-KLOR-ide

Brand Names:

  • Tarka

Dosage Forms:

  • Tablet, Extended Release

Warnings:

Oral route(Tablet, Extended Release)

Discontinue treatment with trandolapril/verapamil hydrochloride as soon as possible when pregnancy is detected, since fetal toxicity, including injury and death to the developing fetus, can be caused by drugs that act directly on the renin-angiotensin system .

Classifications:

Therapeutic—

ACE Inhibitor/Calcium Channel Blocker Combination

Pharmacologic—

ACE Inhibitor

Chemical—

Verapamil

Uses of This Medicine:

Trandolapril and verapamil combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering pressure reduces the risk of strokes and heart attacks.

Trandolapril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, trandolapril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Verapamil is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels, lowers blood pressure, and increase the supply of blood and oxygen to the heart.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of trandolapril and verapamil combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trandolapril and verapamil combination in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aliskiren
  • Dofetilide
  • Lomitapide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Adenosine
  • Afatinib
  • Alprenolol
  • Alteplase, Recombinant
  • Amiloride
  • Amiodarone
  • Atazanavir
  • Atenolol
  • Atorvastatin
  • Azathioprine
  • Azilsartan
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bosutinib
  • Bucindolol
  • Bupivacaine
  • Bupivacaine Liposome
  • Candesartan Cilexetil
  • Canrenoate
  • Carbamazepine
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Clarithromycin
  • Clonidine
  • Clopidogrel
  • Clozapine
  • Cobicistat
  • Colchicine
  • Crizotinib
  • Cyclobenzaprine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dantrolene
  • Digoxin
  • Dilevalol
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Eplerenone
  • Eprosartan
  • Erythromycin
  • Eslicarbazepine Acetate
  • Esmolol
  • Everolimus
  • Fentanyl
  • Fingolimod
  • Hydrocodone
  • Ibrutinib
  • Ifosfamide
  • Irbesartan
  • Ivabradine
  • Ketoconazole
  • Labetalol
  • Levobunolol
  • Losartan
  • Lovastatin
  • Lurasidone
  • Mepindolol
  • Mepivacaine
  • Metipranolol
  • Metoprolol
  • Mitotane
  • Nadolol
  • Nebivolol
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Pindolol
  • Piperaquine
  • Pixantrone
  • Potassium
  • Primidone
  • Propranolol
  • Ranolazine
  • Simeprevir
  • Simvastatin
  • Sotalol
  • Spironolactone
  • Talinolol
  • Telmisartan
  • Tertatolol
  • Timolol
  • Tizanidine
  • Tolvaptan
  • Trabectedin
  • Triamterene
  • Valsartan
  • Vilazodone
  • Vincristine
  • Vincristine Sulfate Liposome

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Aspirin
  • Azosemide
  • Bemetizide
  • Bendroflumethiazide
  • Benzthiazide
  • Bromfenac
  • Bufexamac
  • Bumetanide
  • Bupivacaine
  • Bupivacaine Liposome
  • Buspirone
  • Buthiazide
  • Capsaicin
  • Celecoxib
  • Chlorothiazide
  • Chlorthalidone
  • Choline Salicylate
  • Clonixin
  • Clopamide
  • Cyclopenthiazide
  • Cyclosporine
  • Cyclothiazide
  • Dalfopristin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Digitoxin
  • Dipyrone
  • Dutasteride
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Flecainide
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Fosphenytoin
  • Furosemide
  • Gold Sodium Thiomalate
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Ibuprofen
  • Ibuprofen Lysine
  • Indapamide
  • Indinavir
  • Indomethacin
  • Itraconazole
  • Ketoprofen
  • Ketorolac
  • Lithium
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Methyclothiazide
  • Metolazone
  • Midazolam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Nevirapine
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxcarbazepine
  • Oxyphenbutazone
  • Pancuronium
  • Parecoxib
  • Phenobarbital
  • Phenylbutazone
  • Phenytoin
  • Piketoprofen
  • Piretanide
  • Piroxicam
  • Polythiazide
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Quinethazone
  • Quinidine
  • Quinupristin
  • Rifapentine
  • Ritonavir
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sirolimus
  • Sodium Salicylate
  • St John's Wort
  • Sulindac
  • Tedisamil
  • Telithromycin
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Trichlormethiazide
  • Tubocurarine
  • Valdecoxib
  • Vecuronium
  • Xipamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs) with other ACE inhibitors, history of—May increase the risk of this condition occurring again.
  • AV block, without a pacemaker or
  • Cardiogenic shock (shock caused by heart attack) or
  • Diabetic patients who are also taking aliskiren (Tekturna®) or
  • Heart disease (e.g., left ventricular dysfunction), severe or
  • Heart rhythm problems (e.g., atrial flutter, atrial fibrillation, Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) or
  • Hypotension (low blood pressure) or
  • Sick sinus syndrome (abnormal heart rhythm), without a pacemaker—Should not be used in patients with these conditions.
  • Collagen vascular disease (an autoimmune disease) together with kidney disease—Increased risk of blood problems.
  • Congestive heart failure—Use may lead to kidney problems.
  • Diabetes or
  • Kidney problems—Increased risk of potassium levels in the body becoming too high.
  • Duchenne's muscular dystrophy (muscle problem) or
  • Electrolyte imbalance (e.g., low levels of potassium, salt or sodium in the body) or
  • Fluid imbalance (due to excessive perspiration, vomiting, diarrhea) or
  • Heart disease (e.g., hypertrophic cardiomyopathy) or
  • Heart rhythm problems (e.g., prolonged PR interval) or
  • Kidney disease or
  • Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Take this medicine at the same time each day.

Swallow the extended-release tablets whole. Do not break, crush, or chew them.

Take this medicine with food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For high blood pressure:
      • Adults—1 or 2 tablets per day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, stop using this medicine and call your doctor right away.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Check with your doctor right away if you have any symptoms of liver problems, such as dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor if you have a fever, chills, or sore throat. These may be symptoms of an infection resulting from low white blood cell countss.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Do not use supplements or salt substitutes containing potassium or without first checking with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine could affect surgery or medical procedures.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
Chest pain
chills
cough (with mucus)
dark urine
fever
general feeling of discomfort or illness
lightheadedness or fainting
pain in the right side of the abdomen or stomach
shortness of breath
slow heartbeat
sore throat
swelling of the face, mouth, hands, or feet
trouble in swallowing or breathing (sudden) accompanied by hoarseness
wheezing
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare
Constipation
cough (dry, continuing)
diarrhea
dizziness
itching
joint pain or pain in the arms or legs
nausea
unusual tiredness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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