Mavik (Oral)

Trandolapril is used by itself or with other medicines to treat high blood pressure (hypertension). High blood pressure puts extra strain on the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure can help lower the chances 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 helps relax the blood vessels. This lowers blood pressure and increases the flow of blood and oxygen to the heart.

Trandolapril is also used to treat congestive heart failure. It is sometimes used in certain patients after a heart attack. After a heart attack, some heart muscle can become damaged and weak. The heart muscle may continue to weaken over time, making it harder for the heart to pump blood. Trandolapril may be started within the first few days after a heart attack to improve survival rates. It can also help reduce the number of hospital visits for heart issues.

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

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood and urine 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 avoid getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

You should not use this medicine with sacubitril. Do not use this medicine and sacubitril/valsartan (Entresto®) within 36 hours of each other.

This medicine may cause serious allergic reactions, including anaphylaxis. This 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 using this medicine.

Call your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

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). Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or ongoing 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 if you have a fever, chills, or sore throat. These may be symptoms of an infection due to low white blood cells.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine, pale stools, nausea, vomiting, or yellow skin or eyes. These could be symptoms of a serious liver problem.

Hyperkalemia (high potassium in the blood) may occur while using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness in the legs. Ask your doctor before using any medicine, salt substitute, or supplement that contains potassium.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, facial, finger, or lower leg swelling, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine may be less effective in black patients. Black patients also have an increased risk of angioedema (swelling of the hands, arms, face, mouth, or throat).

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

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

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how trandolapril affects children. Its safety and effectiveness in children have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of trandolapril. However, older patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may change the dose, or other precautions may be needed. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential importance and do not include all possible interactions.

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

• Aliskiren
• Sacubitril

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

• Alteplase, Recombinant
• Amiloride
• Aspirin
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Candesartan
• Canrenoate
• Eplerenone
• Eprosartan
• Everolimus
• Furosemide
• Irbesartan
• Lithium
• Losartan
• Melphalan
• Mercaptopurine
• Olmesartan
• Potassium
• Potassium Citrate
• Potassium Phosphate
• Sirolimus
• Spironolactone
• Tacrolimus
• Telmisartan
• Triamterene
• Trimethoprim
• Valsartan

Using this medicine with any of the following medicines may increase the 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 take one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Bumetanide
• Bupivacaine
• Bupivacaine Liposome
• Capsaicin
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Gold Sodium Thiomalate
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Nesiritide
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with specific foods due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical conditions, especially:

• Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase the risk of this condition happening again.

• Collagen vascular disease (an autoimmune disease) along with kidney disease—Increased risk of blood problems.

• Diabetes or
• Kidney problems—Increased risk of potassium levels becoming too high.

• Diabetic patients who are also taking aliskiren (Tekturna®) or
• Hereditary or idiopathic angioedema or
• Patients with kidney problems who are also taking aliskiren (Tekturna®)—Should not be used in these patients.

• Electrolyte imbalance (e.g., high or low potassium or sodium levels) or
• Fluid imbalance (due to dehydration, vomiting, diarrhea) or
• Heart or blood vessel issues (e.g., aortic stenosis) or
• Kidney disease or
• Liver disease—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

More common

• Blurred vision
• confusion
• difficulty with breathing
• dizziness, faintness, or lightheadedness when standing up suddenly from a lying or sitting position
• fainting
• irregular heartbeat
• nausea
• nervousness
• numbness or tingling in the hands, feet, or lips
• stomach pain
• sweating
• unusual tiredness or weakness
• vomiting
• weakness or heaviness of the legs

Less common

• Chest pain or discomfort
• cool, sweaty skin
• difficulty with speaking
• double vision
• inability to move the arms, legs, or facial muscles
• muscle cramps in the hands, arms, feet, legs, or face
• numbness and tingling around the mouth
• seizures
• slow heartbeat
• stomach cramps
• tremor

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

More common

• Belching
• cough
• heartburn
• indigestion
• stomach discomfort or upset

Less common

• Burning feeling in the chest or stomach
• difficulty with moving
• joint pain
• muscle aches, pain, or stiffness
• swollen joints
• tenderness in the stomach area

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

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

In the U.S.

• Mavik

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: ACE Inhibitor

In addition to the use of trandolapril, 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. 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.

You may take this medicine with or without 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 (tablets): For high blood pressure: Adults—At first, 1 to 2 milligrams (mg) once a day. Your doctor may increase your dose to 2 to 4 mg per day. Children—Use and dose must be determined by your doctor. For treatment after a heart attack: Adults—At first, 1 milligram (mg) once a day. Your doctor may increase your dose to 4 mg per day taken as a single dose. 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.

• Which blood pressure medications cause coughing?