Pronunciation:

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

Brand Names:

• Tarka

Dosage Forms:

• Tablet, Extended Release

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, trandolapril/verapamil hydrochloride should be discontinued as soon as possible .

ACE inhibitors can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Classifications:

Therapeutic—

ACE Inhibitor/Calcium Channel Blocker Combination

Pharmacologic—

ACE Inhibitor

Chemical—

Verapamil

Uses of This Medicine:

Trandolapril and verapamil combination belongs to the class of medicines called high blood pressure medicines (antihypertensives). It 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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

The exact way in which this medicine works is not known. Trandolapril is a type of medicine known as an angiotensin-converting enzyme (ACE) inhibitor. It blocks an enzyme in the body that is necessary in producing a substance that causes blood vessels to tighten. Verapamil is a type of medicine known as a calcium channel blocker. Calcium channel blocking agents affect the movement of calcium into the cells of the heart and blood vessels. The actions of both medicines relax blood vessels, lower 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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of trandolapril and verapamil in children with use in other age groups.

Older adults—

Although this medicine has not been shown to cause different side effects or problems in older people than it does in younger adults, blood levels of trandolapril and verapamil may be increased in the elderly. Elderly people also may be more sensitive to the effects of this medicine.

Pregnancy—

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies 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.
3rd Trimester	D	Studies 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—

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.

• Dofetilide
• Ranolazine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Bee-sting allergy treatments or
• Dialysis treatments—Increased risk of serious allergic reaction occurring

• Dehydration—Lowering effects on blood pressure may be increased

• Type 2 diabetes mellitus—Increased risk of potassium levels in the body becoming too high

• Duchenne's muscular dystrophy—Verapamil may make this condition worse

• Heart disease or
• Hypotension (low blood pressure)—Further lowering of blood pressure may make problems resulting from these conditions worse

• Kidney disease or
• Liver disease—Effects may be increased because of slower removal of the medicine from the body

• Scleroderma or
• Systemic lupus erythematosus (SLE) (or history of)—Increased risk of blood problems with ACE inhibitors

• Previous reaction to any ACE inhibitor involving hoarseness; swelling of face, mouth, hands, or feet; or sudden trouble in breathing—Reaction is more likely to occur again with ACE inhibitors

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor, at the same time each day. Do not take more of it and do not take it more often than directed.

Swallow the tablets whole, without breaking, crushing, or chewing them.

Take this medicine with food or milk.

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 a day.
    • 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly, to check for unwanted effects, and to change the dosage if needed.

If you think that you may have become pregnant, check with your doctor immediately. Use of this medicine, especially during the second and third trimesters (after the first 3 months) of pregnancy, may cause serious injury or even death to the unborn child.

Do not take any other medicines, especially potassium supplements, or salt substitutes that contain potassium unless approved or prescribed by your doctor.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially 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 experience these effects.

Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection resulting from low white blood cell counts.

Check with your doctor immediately if you notice difficult breathing or swelling of the face, arms, or legs. These could be symptoms of a serious allergic reaction.

Check with your doctor if you become sick while taking this medicine, especially with severe or continuing vomiting or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water which can result in low blood pressure. Use extra care during exercise or hot weather.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

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

Swelling of face, mouth, hands, or feet

trouble in swallowing or breathing (sudden) accompanied by hoarseness

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Chest pain

cough (with mucus)

dark urine, yellow eyes or skin, or pain in right side

lightheadedness or fainting

fever, chills, or sore throat

general feeling of discomfort or illness

shortness of breath

slow heartbeat

wheezing

Signs and symptoms of too much potassium in the body

Confusion

irregular heartbeat

nervousness

numbness or tingling in hands, feet, or lips

weakness or heaviness of legs

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 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.