trandolapril 4 mg tablet

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Medication name

Generic name:
Trandolapril - oral

Pronunciation
(tran-DOL-a-pril)

Brand name(s)
Mavik

Warning

Trandolapril can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away.

Uses

Trandolapril is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is also used to treat heart failure and to improve survival after a heart attack. Trandolapril belongs to a class of drugs known as ACE inhibitors. It works by relaxing blood vessels so blood can flow more easily.

Other uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for kidney disease and to help protect the kidneys from harm due to diabetes.

How to use

Read the Patient Information Leaflet if available from your pharmacist before you start taking trandolapril and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. The dosage is based on your medical condition and response to treatment.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

For the treatment of high blood pressure, it may take 1 week before you get the full benefit of this drug. For the treatment of heart failure, it may take several weeks to months before you get the full benefit of this drug.

Tell your doctor if your condition does not get better or if it gets worse (for example, your blood pressure readings remain high or increase).

Side effects

Dizziness, lightheadedness, or tiredness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)
  • fainting

Although trandolapril may be used to prevent kidney problems or treat people who have kidney problems, it may also rarely cause kidney problems or make them worse. Your doctor will check your kidney function while you are taking this medication. Tell your doctor right away if you have any signs of kidney problems such as a change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Get medical help right away if you have any symptoms of liver damage, including:

  • nausea/vomiting that doesn't stop
  • loss of appetite
  • stomach/abdominal pain
  • yellowing eyes/skin
  • dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking trandolapril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (such as captopril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema)
  • blood filtering procedures (such as LDL apheresis, dialysis)
  • high level of potassium in the blood
  • liver disease

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Severe sweating, diarrhea, or vomiting may cause dehydration and cause you to feel lightheaded. Tell your doctor if you have severe diarrhea or vomiting. To prevent dehydration, drink plenty of fluids unless your doctor tells you not to.

This medication may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness and high potassium levels.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using trandolapril. Trandolapril may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Warning section.

It is unknown if trandolapril passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • aliskiren
  • gold injections
  • lithium
  • sacubitril
  • certain drugs that weaken the immune system/increase the risk of infection (such as everolimus, sirolimus)
  • drugs that may increase the level of potassium in the blood (such as ARBs including losartan/valsartan, birth control pills containing drospirenone)

Some products have ingredients that could raise your blood pressure or worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

A very serious reaction may occur if you are getting injections for bee/wasp sting allergy (desensitization) and are also taking trandolapril. Make sure all your doctors know which medicines you are using.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: unusually fast or slow heartbeat, severe dizziness, or fainting.

Notes

Do not share this medication with others.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.

Lab and/or medical tests (such as kidney function, potassium levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Check your blood pressure and pulse (heart rate) regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised May 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.