Trandolapril

Trandolapril is a prescription medication used to treat high blood pressure. If taken after a heart attack, trandolapril can also help improve survival and lower the risk of developing congestive heart failure. Trandolapril belongs to a group of drugs called angiotensin converting enzyme (ACE) inhibitors, which relax blood vessels to lower blood pressure and make the heart more efficient.

This medication comes in tablet form and is taken once or twice daily. It may be taken with or without food.

Common side effects of trandolapril include cough, indigestion, and muscle pain. Trandolapril can cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Trandolapril is a prescription medication used to treat high blood pressure. It is also used to improve survival and lower the risk of developing congestive heart failure after a heart attack.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Trandolapril may be found in some form under the following brand names:

• Mavik

• Tarka

Serious side effects have been reported. See "Drug Precautions" section

Common side effects include:

• cough
• dizziness
• diarrhea
• extremely low blood pressure
• indigestion
• muscle pain or cramps

This is not a complete list of trandolapril side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• potassium-sparing diuretics such as:
  • spironolactone (Aldactone)
  • triamterene (Dyrenium)
  • amiloride (Midamor)
• other diuretics such as:
  • furosemide (Lasix)
  • hydrochlorothiazide
  • torsemide (Demadex)
• aliskiren (Tekturna)
• angiotensin receptor blockers such as candesartan (Atacand), losartan (Cozaar), and telmisartan (Micardis, Twynsta)
• aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) such as:
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• lithium (Eskalith, Lithobid)
• potassium supplements
• injectable gold (sodium aurothiomalate)

This is not a complete list of trandolapril drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with trandolapril including:

• Hypotension: excessive perspiration and dehydration may lead to an excessive fall in blood pressure (hypotension). Vomiting or diarrhea may also lead to a fall in blood pressure.
• Decline in kidney function: Your doctor may need to perform tests to determine the stability of the function of your kidneys, especially in patients who already have kidney dysfunction.
• Hyperkalemia: Trandolapril may lead to increased levels of potassium, which could lead to side effects such as heart arrhythmias (irregular heartbeat) and nausea.
• Cough: Persistent dry cough has been reported with all ACE inhibitors, and will resolve after discontinuation of therapy.
• Valvular Stenosis: Those with aortic stenosis (stiffening of the main artery that carries blood away from the heart) might be at risk of decreased blood flow to the rest of the body.
• Angioedema: Tell your healthcare profession right away if you have signs or symptoms of angioedema, which include:
  • swelling of face, eyes, lips, tongue, larynx and extremities
  • difficulty in swallowing or breathing
  • hoarseness (having difficulty making sounds when trying to speak)
• Neutropenia: report any sign of infection such as sore throat or fever, which may be a sign of neutropenia (a decreased amount of white blood cells).
• Edema: report any sign of edema (increase in swelling of the arms or legs), which may be a sign of declining kidney dysfunction.
• Heart failure patients: caution is advised against rapid increases in exercise or physical activity for those who are being treated for heart failure.
• Intestinal Angioedema: Intestinal angioedema (swelling within the gut) has been reported in patients treated with ACE inhibitors. Report signs and symptoms of intestinal angioedema, including abdominal (stomach-area) pain, with or without nausea or vomiting.
• Liver failure: This is a rare occurrence. Nevertheless, report any signs or symptoms of hepatic failure, including:
  • yellowing of the skin or eyes
  • nausea
  • vomiting
  • fatigue
  • itching

Trandolapril can cause dizziness. Do not drive or operate heavy machinery until you know how trandolapril affects you.

Do not take trandolapril if you are hypersensitive to this product. Signs of a hypersensitivity reaction include:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• fainting
• rash

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of trandolapril, salt substitutes containing potassium should be avoided.

Before taking trandolapril, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• history of angioedema (swelling under the skin)
• have diabetes (high blood sugar) and you are taking aliskiren (Tekturna; also in Amturnide, Tekamlo, Tekturna HCT). Your doctor will probably tell you not to take trandolapril if you have diabetes and you are also taking aliskiren.
• have or have ever had heart or kidney disease or diabetes
• have liver disease
• are having surgery, including dental surgery. Inform the doctor or dentist that you are taking trandolapril.
• are using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these instructions carefully.
• pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Trandolapril is usually not recommended for use during pregnancy. See "FDA Warning" section.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Trandolapril falls into category D. It has been shown that use of trandolapril in pregnant women caused some babies to be born with problems. More specifically, it has been shown that use of drugs like trandolapril during the second and third trimesters of pregnancy harms the unborn baby’s kidneys and even increases the risk of death to the unborn baby. A more recent study showed that there may, in fact, also be an increased risk to the fetus if it is exposed to trandolapril during the first trimester.

However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Trandolapril has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from trandolapril, a choice should be made whether to stop nursing or to stop use of this medication. Determining the importance of the drug to the mother should be considered.

• Take trandolapril exactly as prescribed.
• Trandolapril comes in tablet form and is taken once or twice daily, with or without food.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of trandolapril at the same time.

Take trandolapril exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

High Blood Pressure: The recommended starting dosage of trandolapril 1mg or 2 mg once daily. If blood pressure is not adequately controlled with trandolapril alone, a diuretic may be added.

For people with congestive heart failure or left ventricular dysfunction following a heart attack: The recommended starting dose is 1 mg, once daily. Following the starting dose, your healthcare provider may gradually increase your dose toward a target dose of 4 mg, once daily.

Based on how your body responds to the medication and side effects you experience your healthcare provider may decide to increase or decrease your dose. The dose you receive is also based on the following factors:

• your age
• the medical condition you are being treated for
• other medical conditions you may have 
• other medications you are taking including diuretics

If you take too much trandolapril, call your healthcare provider or poison control center, or seek emergency medical attention right away.

• Store at controlled room temperature between 15º–30ºC (59º–86ºF).
• Keep this and all medications out of the reach of children.

Warning: Fetal Toxicity

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