Trandolapril

Mechanism-of-action classes: Angiotensin-converting Enzyme Inhibitors; Neprilysin Inhibitors.

• Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide.ICD-10: I10

• Trandolapril tablets are contraindicated in patients who are hypersensitive to this product, in patients with hereditary/idiopathic angioedema and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Do not co-administer aliskiren with trandolapril in patients with diabetes (see PRECAUTIONS, Drug Interactions ).contraindicated

Hypertension The recommended initial dosage of trandolapril tablets for patients not receiving a diuretic is 1 mg once daily in non-black patients and 2 mg in black patients. Dosage should be adjusted according to the blood pressure response. Generally, dosage adjustments should be made at intervals of at least 1 week. Most patients have required dosages of 2 to 4 mg once daily. There is little clinical experience with doses above 8 mg. Patients inadequately treated with once-daily dosing at 4 mg may be treated with twice-daily dosing. If blood pressure is not adequately controlled with trandolapril tablets monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of trandolapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with trandolapril tablets. (See WARNINGS . ) Then, if blood pressure is not controlled with trandolapril tablets alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 0.5 mg trandolapril tablets should be used with careful medical supervision for several hours until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response. (See WARNINGS , PRECAUTIONS and Drug Interactions .

Anaphylactoid and Possibly Related Reactions Presumably because angiotensin converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors, including trandolapril, may be subject to a variety of adverse reactions, some of them serious. Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions did not occur when ACE inhibitors were temporarily withheld, but they reappeared when the ACE inhibitors were inadver­tently readministered. Anaphylactoid Reactions During Membrane Exposure Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. Head and Neck Angioedema In controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors including trandolapril. Symptoms suggestive of angioedema or facial edema occurred in 0.13% of trandolapril-treated patients. Two of the four cases were life-threatening and resolved without treatment or with medication (corticosteroids).

The safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 received trandolapril. Nearly 200 hypertensive patients received trandolapril for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on trandolapril. Adverse events considered at least possibly related to treatment occurring in 1% of trandolapril-treated patients and more common on trandolapril 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 TRANDOLAPRIL (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) 0.4 (0) Headache and fatigue were all seen in more than 1% of trandolapril-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 trandolapril 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.

No data are available with respect to overdosage in humans. The oral LD 50 of trandolapril in mice was 4875 mg/Kg in males and 3990 mg/Kg in females. In rats, an oral dose of 5000 mg/Kg caused low mortality (1 male out of 5; 0 females). In dogs, an oral dose of 1000 mg/Kg did not cause mortality and abnormal clinical signs were not observed. In humans, the most likely clinical manifestation would be symptoms attributable to severe hypotension. Symptoms also expected with ACE inhibitors are hypotension, hyperkalemia, and renal failure. Laboratory determinations of serum levels of trandolapril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of trandolapril overdose. No data are available to suggest that physiological maneuvers (e.g., maneuvers to change the pH of the urine) might accelerate elimination of trandolapril and its metabolites. Trandolaprilat is removed by hemodialysis. Angiotensin II could presumably serve as a specific antagonist antidote in the setting of trandolapril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities.

• Jun 12, 2007ANDAANDA077522Lupin
• Jun 12, 2007ANDAANDA078438Aurobindo Pharma
• Jun 18, 2008ANDAANDA078508Epic Pharma
• May 5, 2010ANDAANDA079135Glenmark Pharms Ltd

1. 1Dyspnoea1426.9%
2. 2Fatigue1236.0%
3. 3Off Label Use1215.9%
4. 4Dizziness1165.7%
5. 5Diarrhoea1055.1%
6. 6Cough1014.9%
7. 7Asthenia974.7%
8. 8Drug Ineffective934.5%
9. 9Drug Interaction894.3%
10. 10Nausea894.3%
11. 11Toxicity To Various Agents874.2%
12. 12Hypotension803.9%
13. 13Hypertension793.8%
14. 14Headache703.4%
15. 15Arthralgia693.4%

The 10 most recently updated of 29 ClinicalTrials.gov registrations naming Trandolapril as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
  Not yet recruiting · Phase 4 · Interventional · 64 enrolled · Baylor Research Institute
  NCT07547878updated 2026-05-08
• The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission.
  Recruiting · Phase 4 · Interventional · 100 enrolled · Ziekenhuis Oost-Limburg
  NCT07513883updated 2026-04-07
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
  Not yet recruiting · Observational · 13,656 enrolled · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  NCT07262710updated 2025-12-04
• Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
  Recruiting · Observational · 180 enrolled · Beijing Friendship Hospital
  NCT05498675updated 2025-02-13
• Trandolapril 4 mg Tablet Under Non-Fasting Conditions
  Completed · Phase 1 · Interventional · 50 enrolled · Teva Pharmaceuticals USA
  NCT00840073updated 2024-08-20
• Trandolapril 4 mg Tablet Under Fasting Conditions
  Completed · Phase 1 · Interventional · 40 enrolled · Teva Pharmaceuticals USA
  NCT00840632updated 2024-08-20
• Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
  Recruiting · Phase 3 · Interventional · 20,000 enrolled · UMC Utrecht
  NCT02735707updated 2024-07-12
• Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
  Completed · Phase 4 · Interventional · 291 enrolled · University of Nebraska
  NCT01669434updated 2023-09-25
• NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
  Recruiting · Phase 4 · Interventional · 2,400 enrolled · Martin Huelsmann
  NCT02817360updated 2023-03-14
• ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
  Completed · Observational · 22,213 enrolled · University of Utah
  NCT04467931updated 2021-04-28

Frequently asked questions

How does Trandolapril work?

Mechanism-of-action classes: Angiotensin-converting Enzyme Inhibitors; Neprilysin Inhibitors.

What is Trandolapril used for?

According to FDA labeling, Trandolapril carries indications including: Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Trandolapril?

Trandolapril is classified as ACE inhibitors, plain, Angiotensin Converting Enzyme Inhibitor, Angiotensin-converting Enzyme Inhibitors, Neprilysin Inhibitors, Decreased Blood Pressure, Decreased Bradykinin Degradation, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasodilation.

What are the contraindications for Trandolapril?

Trandolapril labeling lists contraindications including: Trandolapril tablets are contraindicated in patients who are hypersensitive to this product, in patients with hereditary/idiopathic angioedema and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Do not co-administer aliskiren with trandolapril in patients with diabetes (see PRECAUTIONS, Drug Interactions ).. Always consult the full prescribing information and a clinician.