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What is Mavik (trandolapril)?
Blood pressure is dependent on the degree of narrowing of the arteries and veins; the narrower the arteries and veins, the higher the blood pressure. Angiotensin II is a chemical substance made in the body that causes the muscles in the walls of arteries and veins to contract, narrowing the arteries and veins and thereby elevating blood pressure. Angiotensin II is formed by ACE.
Mavik is an inhibitor of ACE and blocks the formation of angiotensin II thereby lowering blood pressure. The drop in blood pressure also means the heart doesn't have to work as hard because the pressure it must pump blood against is less. The efficiency of a failing heart improves, and the output of blood from the heart increases. Thus, ACE inhibitors such as Mavik in addition to high blood pressure, are also useful in treating heart failure.
Common side effects of Mavik include:
- sexual dysfunction, and
- abnormal liver tests.
Serious side effects of Mavik include:
- impaired kidney function (especially in patients with severe heart failure or pre-existing kidney disease),
- low white blood cell counts and increased risk of infection (rare), and
- hypersensitivity reactions and angioedema (swelling of face, lips, tongue, throat).
Combining Mavik with potassium supplements, potassium containing salt substitutes, or potassium-conserving diuretics can lead to dangerously high blood levels of potassium.
Mavik taken at the same time as aluminum- or magnesium-based antacids decreases its absorption into the body.
Mavik can cause an increase in the amount of lithium in the body and increase the effects of lithium toxicity.
What are the important side effects of Mavik (trandolapril)?
Trandolapril is generally well tolerated. The most common side effects are:
- sexual dysfunction, and
- abnormal liver tests.
Impairment of kidney function has been reported with ACE inhibitors, especially in patients with severe heart failure or pre-existing kidney disease. In rare instances, low white blood cell counts have been reported with the use of trandolapril. Low white blood cells increase the risk of infections. Trandolapril may cause hypersensitivity reactions and angioedema (swelling of face, lips, tongue, throat).
Mavik (trandolapril) side effects list for healthcare professionals
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
|Occurring at 1% or greater|
(N=832) % Incidence (% Discontinuance)
(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)|
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
|Placebo-Controlled (TRACE) Mortality Study|
|Elevated serum uric acid||15||13|
|PICA or CABG||7.3||6.1|
|Cardiogenic shock||3.8||< 2|
|Intermittent claudication||3.8||< 2|
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
Central Nervous System
Pruritus, rash, pemphigus.
Eye, Ear, Nose, Throat
Epistaxis, throat inflammation, upper respiratory tract infection.
Emotional, Mental, Sexual States
Decreased leukocytes, decreased neutrophils.
Metabolism And Endocrine
Increased liver enzymes including SGPT (ALT).
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
Central Nervous System
Emotional, Mental, Sexual States
Metabolism And Endocrine
Increased SGOT (AST).
Renal And Urinary
Clinical Laboratory Test Findings
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.
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.
Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.
What drugs interact with Mavik (trandolapril)?
Dual Blockade Of The Renin-Angiotensin System (RAS)
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Mavik and other agents that affect the RAS.
Do not co-administer aliskiren with Mavik in patients with diabetes. Avoid use of aliskiren with Mavik in patients with renal impairment (GFR <60 ml/min).
Concomitant Diuretic Therapy
As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may experience an excessive reduction of blood pressure after initiation of therapy with Mavik. The possibility of exacerbation of hypotensive effects with Mavik may be minimized by either discontinuing the diuretic or cautiously increasing salt intake prior to initiation of treatment with Mavik. If it is not possible to discontinue the diuretic, the starting dose of trandolapril should be reduced.
Agents Increasing Serum Potassium
Trandolapril can attenuate potassium loss caused by thiazide diuretics and increase serum potassium when used alone. Use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes concomitantly with ACE inhibitors can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, they should be used with caution and with appropriate monitoring of serum potassium.
Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including trandolapril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving trandolapril and NSAID therapy.
The antihypertensive effect of ACE inhibitors, including trandolapril may be attenuated by NSAIDs.
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including Mavik.
Mammalian Target of Rapamycin (mTOR) Inhibitors
Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.
Patients taking concomitant neprilysin inhibitors (e.g., sacubitril) may be at increased risk for angioedema.
The hypotensive effect of certain inhalation anesthetics may be enhanced by ACE inhibitors including trandolapril.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies were conducted with oral trandolapril administered by gavage to mice (78 weeks) and rats (104 and 106 weeks). No evidence of carcinogenic potential was seen in mice dosed up to 25 mg/kg/day (85 mg/m²/day) or rats dosed up to 8 mg/kg/day (60 mg/m²/day). These doses are 313 and 32 times (mice), and 100 and 23 times (rats) the maximum recommended human daily dose (MRHDD) of 4 mg based on body-weight and body-surfacearea, respectively assuming a 50 kg individual.
The genotoxic potential of trandolapril was evaluated in the microbial mutagenicity (Ames) test, the point mutation and chromosome aberration assays in Chinese hamster V79 cells, and the micronucleus test in mice. There was no evidence of mutagenic or clastogenic potential in these in vitro and in vivo assays.
Reproduction studies in rats did not show any impairment of fertility at doses up to 100 mg/kg/day (710 mg/m²/day) of trandolapril, or 1250 and 260 times the MRHDD on the basis of body-weight and body-surface-area, respectively.
Radiolabeled trandolapril or its metabolites are secreted in rat milk. Mavik should not be administered to nursing mothers.
In placebo-controlled studies of Mavik, 31.1% of patients were 60 years and older, 20.1% were 65 years and older, and 2.3% were 75 years and older. No overall differences in effectiveness or safety were observed between these patients and younger patients. (Greater sensitivity of some older individual patients cannot be ruled out).
Neonates With A History Of In Utero Exposure To Mavik
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
The safety and effectiveness of Mavik in pediatric patients have not been established.
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Related Disease Conditions
High Blood Pressure (Hypertension)
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
Portal hypertension is most commonly caused by cirrhosis, a disease that results from scarring of the liver. Other causes of portal hypertension include blood clots in the portal vein, blockages of the veins that carry the blood from the liver to the heart, and a parasitic infection called schistosomiasis. Symptoms of portal hypertension include varices (enlarged veins), vomiting blood, blood in the stool, black and tarry stool, ascites (abnormal fluid collection within the peritoneum, the sac that contains the intestines within the abdominal cavity), confusion and lethargy, splenomegaly or enlargement of the spleen, and decreased white blood cell counts.
Hypertension-Related Kidney Disease
Second Source WebMD Medical Reference
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Hypertensive Kidney Disease
High blood pressure can damage the kidneys and is one of the leading causes of kidney failure (end-stage renal kidney disease). Kidney damage, like hypertension, can be unnoticeable and detected only through medical tests. If you have kidney disease, you should control your blood pressure. Other treatment options include prescription medications.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Pseudotumor Cerebri (intracranial hypertension) is a condition where there is an increase in pressure of fluid surrounding the brain and spinal cord (cerebrospinal fluid or CSF) mimicing a brain tumor. The cause is unknown. The most common symptom is headache but also include eye-pain, vision loss and double vision. Pseudotumor cerebri is diagnosed with MRI or CAT scans and treated by discontinuing offending medications (if applicable), weight loss and diuretic medications. The condition can also be helped by repeated drainage of spinal fluid using the lumbar puncture.
Preeclampsia (Pregnancy Induced Hypertension)
Preeclampsia is related to increased blood pressure and protein in the mother's urine. Preeclampsia typically begins after the 20th week of pregnancy. When preeclampsia causes seizures, it is termed "eclampsia" and is the second leading cause of maternal death of in the US. Preeclampsia is the leading cause of fetal complications. Risk factors for preeclampsia include high blood pressure, obesity, multiple births, and women with preexisting medical conditions such as diabetes, kidney disease, rheumatoid arthritis, lupus, or scleroderma. Pregnancy planning and lifestyle changes may reduce the risk of preeclampsia during pregnancy.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.