Trandolapril and Verapamil

Name: Trandolapril and Verapamil

What is the most important information I should know about trandolapril and verapamil?

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant.

If you have diabetes, do not use trandolapril and verapamil together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

How should I take trandolapril and verapamil?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Trandolapril and verapamil works best if you take it with food.

Your blood pressure will need to be checked often.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking trandolapril and verapamil. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

If you need surgery, tell the surgeon ahead of time that you are using trandolapril and verapamil. You may need to stop using the medicine for a short time.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking trandolapril and verapamil?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

If you also take disopyramide, avoid taking it within 48 hours before or 24 hours after you take trandolapril and verapamil.

Do not use potassium supplements or salt substitutes while you are taking trandolapril and verapamil, unless your doctor has told you to.

Precautions While Using trandolapril and verapamil

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

Using trandolapril and verapamil 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 trandolapril and verapamil, 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 trandolapril and verapamil and call your doctor right away.

Check with your doctor right away if you become sick while taking trandolapril and verapamil, 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.

trandolapril and verapamil 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 trandolapril and verapamil.

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 trandolapril and verapamil. 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 trandolapril and verapamil. trandolapril and verapamil 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.

What are some things I need to know or do while I take Trandolapril and Verapamil?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how trandolapril and verapamil affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • If you have high blood sugar (diabetes), this medicine may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • Low white blood cell counts have happened with captopril, a drug like this one. This may lead to more chance of getting an infection. Most of the time, this has happened in people with kidney problems, mainly if they have certain other health problems. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • If you are taking trandolapril and verapamil and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • Take good care of your teeth. See a dentist often.
  • Talk with your doctor before you drink alcohol.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • A very bad reaction called angioedema has happened with this medicine. Sometimes, this has been deadly. The chance of angioedema may be higher in black patients. Talk with the doctor.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking trandolapril and verapamil with your other drugs.

Clinical Studies

In controlled clinical trials, once daily doses of Trandolapril and Verapamil hydrochloride extended-release tablets, trandolapril 4 mg/verapamil HCl extended-release 240 mg or trandolapril 2 mg/verapamil HCl extended release 180 mg, decreased placebo-corrected seated pressure (systolic/diastolic) 24 hours after dosing by about 7 to 12/6 to 8 mmHg. Each of the components of Trandolapril and Verapamil hydrochloride extended-release tablets added to the antihypertensive effect. Treatment effects were consistent across age groups (<65, ≥65 years), and gender (male, female).

Blood pressure reductions were significantly greater for the Trandolapril and Verapamil hydrochloride extended-release tablet 4 mg/240 mg combination than for either of the components used alone.

The antihypertensive effects of Trandolapril and Verapamil hydrochloride extended-release tablets have continued during therapy for at least 1 year.

Dosing Adult

Note: Not for initial therapy; dose is individualized; may be substituted for individual components in patients currently maintained on both agents separately.

Hypertension: Oral: Trandolapril 1 to 4 mg/verapamil 180 to 240 mg once daily.

Dosing Renal Impairment

CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

CrCl <30 mL/minute: Dosage adjustment recommended; use with caution.

Hemodialysis: Dosage adjustment recommended; use with caution.

ALERT U.S. Boxed Warning

Fetal toxicity:

When pregnancy is detected, discontinue trandolapril/verapamil as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Other Comments

Administration advice: Take with food.

Monitoring:
-Cardiovascular: PR interval
-Hepatic: Liver function periodically
-Renal: Kidney function periodically
-Hematologic: Consider periodic WBC monitoring in patients with collagen-vascular disease and/or renal disease.

Patient advice:
-Female patients of childbearing age should be told about the consequences of exposure to this drug during pregnancy. Patients should be asked to report pregnancies as soon as possible.
-Advise patients to report any signs of infection (e.g., sore throat, fever). If infection is suspected, WBCs should be performed immediately.
-Advise patients to use caution when driving or operating machinery until the response to initial treatment has been determined.

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