Medical Editor: John P. Cunha, DO, FACOEP
What Is Mavik?
Mavik (trandolapril) is an ACE (angiotensin converting enzyme) inhibitor used to treat high blood pressure (hypertension), and to improve survival after a heart attack. Mavik is available in generic form.
What Are Side Effects of Mavik?
Common side effects of Mavik include:
- dizziness,
- drowsiness,
- lightheadedness,
- diarrhea,
- dry cough, or
- blurred vision as your body adjusts to the medication.
Other side effects of Mavik include:
- cold symptoms (stuffy nose, sneezing, sore throat),
- muscle pain,
- headache,
- sleep problems (insomnia),
- upset stomach,
- diarrhea,
- constipation, or
- skin itching or rash.
Tell your doctor if you have unlikely but serious side effects of Mavik including:
- fainting,
- decreased sexual ability,
- symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat),
- changes in the amount of urine, or
- signs of infection (e.g., fever, chills, persistent sore throat).
Dosage for Mavik
To treat hypertension, the recommended initial dosage of Mavik for patients not receiving a diuretic is 1 or 2 mg once daily. Most patients require dosages of 2 to 4 mg once daily. Following a heart attack, the recommended starting dose is 1 mg, once daily, adjusted toward a target dose of 4 mg, once daily.
What Drugs, Substances, or Supplements Interact with Mavik?
Mavik may interact with gold injections to treat arthritis, lithium, potassium supplements, salt substitutes that contain potassium, or diuretics (water pills). Tell your doctor all medications and supplements you use.
Mavik During Pregnancy or Breastfeeding
Mavik is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Mavik (trandolapril) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
QUESTION
Salt and sodium are the same. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- upper stomach pain, and jaundice (yellowing of the skin or eyes);
- chest pain, pounding heartbeats or fluttering in your chest;
- high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
- low white blood cell counts--fever, chills, feeling light-headed, mouth sores, skin sores, sore throat, cough, trouble breathing; or
- lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus.
Common side effects may include:
- cough;
- dizziness; or
- diarrhea.
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.
SLIDESHOW
How to Lower Blood Pressure: Exercise Tips See SlideshowSIDE EFFECTS
The safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 received MAVIK. Nearly 200 hypertensive patients received MAVIK for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on MAVIK. Adverse events considered at least possibly related to treatment occurring in 1% of MAVIK-treated patients and more common on MAVIK than placebo, pooled for all doses, are shown below, together with the frequency of discontinuation of treatment because of these events.
ADVERSE EVENTS IN PLACEBO-CONTROLLED HYPERTENSION
TRIALS
| Occurring at 1% or greater | ||
| MAVIK (N=832) % Incidence (% Discontinuance) |
PLACEBO (N=237) % Incidence (% Discontinuance) |
|
| Cough | 1.9 (0.1) | 0.4 (0.4) |
| Dizziness | 1.3 (0.2) | 0.4 (0.4) |
| Diarrhea | 1.0 (0.0) | 0.4 (0.0) |
Headache and fatigue were all seen in more than 1% of MAVIK-treated patients but were more frequently seen on placebo. Adverse events were not usually persistent or difficult to manage.
Left Ventricular Dysfunction Post Myocardial Infarction
Adverse reactions related to MAVIK occurring at a rate greater than that observed in placebo-treated patients with left ventricular dysfunction, are shown below. The incidences represent the experiences from the TRACE study. The follow-up time was between 24 and 50 months for this study.
Percentage of Patients with Adverse Events Greater
Than Placebo
| Placebo-Controlled (TRACE) Mortality Study | ||
| Adverse Event | Trandolapril N=876 |
Placebo N=873 |
| Cough | 35 | 22 |
| Dizziness | 23 | 17 |
| Hypotension | 11 | 6.8 |
| Elevated serum uric acid | 15 | 13 |
| Elevated BUN | 9.0 | 7.6 |
| PICA or CABG | 7.3 | 6.1 |
| Dyspepsia | 6.4 | 6.0 |
| Syncope | 5.9 | 3.3 |
| Hyperkalemia | 5.3 | 2.8 |
| Bradycardia | 4.7 | 4.4 |
| Hypocalcemia | 4.7 | 3.9 |
| Myalgia | 4.7 | 3.1 |
| Elevated creatinine | 4.7 | 2.4 |
| Gastritis | 4.2 | 3.6 |
| Cardiogenic shock | 3.8 | < 2 |
| Intermittent claudication | 3.8 | < 2 |
| Stroke | 3.3 | 3.2 |
| Asthenia | 3.3 | 2.6 |
Clinical adverse experiences possibly or probably related or of uncertain relationship to therapy occurring in 0.3% to 1.0% (except as noted) of the patients treated with MAVIK (with or without concomitant calcium ion antagonist or diuretic) in controlled or uncontrolled trials (N=1134) and less frequent, clinically significant events seen in clinical trials or post-marketing experience include (listed by body system):
General Body Function
Chest pain.
Cardiovascular
AV first degree block, bradycardia, edema, flushing, and palpitations.
Central Nervous System
Drowsiness, insomnia, paresthesia, vertigo.
Dermatologic
Pruritus, rash, pemphigus.
Eye, Ear, Nose, Throat
Epistaxis, throat inflammation, upper respiratory tract infection.
Emotional, Mental, Sexual States
Anxiety, impotence, decreased libido.
Gastrointestinal
Abdominal distention, abdominal pain/cramps, constipation, dyspepsia, diarrhea, vomiting, nausea.
Hemopoietic
Decreased leukocytes, decreased neutrophils.
Metabolism And Endocrine
Increased liver enzymes including SGPT (ALT).
Musculoskeletal System
Extremity pain, muscle cramps, gout.
Pulmonary
Dyspnea.
Postmarketing
The following adverse reactions were identified during post approval use of MAVIK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Body Function
Malaise, fever.
Cardiovascular
Myocardial infarction, myocardial ischemia, angina pectoris, cardiac failure, ventricular tachycardia, tachycardia, transient ischemic attack, arrhythmia.
Central Nervous System
Cerebral hemorrhage.
Dermatologic
Alopecia, sweating, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Emotional, Mental, Sexual States
Hallucination, depression.
Gastrointestinal
Dry mouth, pancreatitis, jaundice and hepatitis.
Hemopoietic
Agranulocytosis, pancytopenia.
Metabolism And Endocrine
Increased SGOT (AST).
Pulmonary
Bronchitis.
Renal And Urinary
Renal failure.
Clinical Laboratory Test Findings
Hematology
Thrombocytopenia.
Serum Electrolytes
Hyponatremia.
Creatinine And Blood Urea Nitrogen
Increases in creatinine levels occurred in 1.1% of patients receiving MAVIK alone and 7.3% of patients treated with MAVIK, a calcium ion antagonist and a diuretic. Increases in blood urea nitrogen levels occurred in 0.6% of patients receiving MAVIK alone and 1.4% of patients receiving MAVIK, a calcium ion antagonist, and a diuretic. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis. (see PRECAUTIONS and WARNINGS.)
Liver Function Tests
Occasional elevation of transaminases at the rate of 3X upper normals occurred in 0.8% of patients and persistent increase in bilirubin occurred in 0.2% of patients. Discontinuation for elevated liver enzymes occurred in 0.2% of patients.
Other
Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.
Read the entire FDA prescribing information for Mavik (Trandolapril)
© Mavik Patient Information is supplied by Cerner Multum, Inc. and Mavik Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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