Mavik

DRUG DESCRIPTION

Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S, 3aR, 7aS)-1-[(S)-N-[(S)-1-Carboxy-3phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its empirical formula is C24H34N2O5 and its structural formula is

MAVIK® (trandolapril) Structural Formula Illustration

M.W. = 430.54
Melting Point = 125°C

Trandolapril is a white or almost white powder that is soluble ( > 100 mg/mL) in chloroform, dichloromethane, and methanol. MAVIK tablets contain 1 mg, 2 mg, or 4 mg of trandolapril for oral administration. Each tablet also contains corn starch, croscarmellose sodium, hypromellose, iron oxide, lactose monohydrate, povidone, sodium stearyl fumarate.

What are the possible side effects of trandolapril (Mavik)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • urinating more or less than usual, or not at all;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding;
  • tired feeling, muscle weakness, and pounding or uneven heartbeats;
  • ...

Read All Potential Side Effects and See Pictures of Mavik »

What are the precautions when taking trandolapril (Mavik)?

Before taking trandolapril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (e.g., benazepril, captopril); or if you have any other allergies (including exposure to certain membranes used for blood filtering). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood...

Read All Potential Precautions of Mavik »


Mavik Consumer (continued)

SIDE EFFECTS: You may experience dizziness, light-headedness, diarrhea, dry cough or blurred vision as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: fainting, decreased sexual ability.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: change in the amount of urine, signs of infection (e.g., fever, chills, persistent sore throat).

This drug may rarely cause serious (possibly fatal) liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing eyes or skin, dark urine, stomach/abdominal pain, persistent fatigue, persistent nausea.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.

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 (e.g., benazepril, captopril); or if you have any other allergies (including exposure to certain membranes used for blood filtering). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood levels of potassium, severe dehydration (and loss of electrolytes such as sodium), blood vessel disease (e.g., collagen vascular diseases such as lupus, scleroderma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and light-headedness due to lowering of your blood pressure, get up slowly when rising from a seated or lying position. Serious loss of body fluids can also lower your blood pressure and worsen dizziness. Drink adequate fluids to prevent from becoming dehydrated. If you are on restricted fluid intake, consult your doctor for further instructions. Be careful not to become too overheated during exercise which can lead to excessive sweating. Consult your doctor if you experience severe vomiting or diarrhea.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive its effects, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Mavik Patient Information Including Side Effects

Brand Names: Mavik

Generic Name: trandolapril (Pronunciation: tran DOE la pril)

  • What is trandolapril (Mavik)?
  • What are the possible side effects of trandolapril (Mavik)?
  • What is the most important information I should know about trandolapril (Mavik)?
  • What should I discuss with my healthcare provider before taking trandolapril (Mavik)?
  • How should I take trandolapril (Mavik)?
  • What happens if I miss a dose (Mavik)?
  • What happens if I overdose (Mavik)?
  • What should I avoid while taking trandolapril (Mavik)?
  • What other drugs will affect trandolapril (Mavik)?
  • Where can I get more information?

What is trandolapril (Mavik)?

Trandolapril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme.

Trandolapril is used to treat high blood pressure (hypertension), and to improve survival after a heart attack.

Trandolapril may also be used for other purposes not listed in this medication guide.

What are the possible side effects of trandolapril (Mavik)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • urinating more or less than usual, or not at all;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding;
  • tired feeling, muscle weakness, and pounding or uneven heartbeats;
  • chest pain; or
  • swelling, rapid weight gain.

Less serious side effects may include:

  • cough;
  • muscle pain;
  • dizziness, drowsiness, headache;
  • sleep problems (insomnia);
  • nausea, upset stomach; or
  • mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about trandolapril (Mavik)?

Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Trandolapril could cause birth defects in the baby if you take the medication during pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of trandolapril.

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

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking trandolapril. Drink plenty of water each day while you are taking this medication.

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