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ACE inhibitor Pregnancy: Not recommended in the first trimester and contraindicated during the second and third trimesters. Exposure in the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). Stop immediately when pregnancy is diagnosed and switch to alternative therapy; patients planning pregnancy should be changed to antihypertensives with established pregnancy safety. Breast-feeding: not recommended (no information available).

Trandolapril

Brand names: Gopten, Odrik

Trandolapril is an angiotensin-converting enzyme (ACE) inhibitor used in hypertension and in left ventricular dysfunction following myocardial infarction.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 0.5 mg initially (hypertension, adults not taking diuretics, without congestive heart failure and without renal or hepatic insufficiency); usual maintenance 1-2 mg
Route: oral
Frequency: once daily (single daily dose)
Max: 4 mg as a single daily dose
Hypertension: initial 0.5 mg once daily - a 0.5 mg dose will only achieve a therapeutic response in a minority of patients. Dosage should be doubled incrementally at intervals of 2 to 4 weeks based on patient response, up to a maximum of 4 mg as a single daily dose. Recommended maintenance dose range 1 to 2 mg as a single daily dose. If response is still unsatisfactory at 4 mg, consider combination therapy with diuretics and calcium channel blockers. Left ventricular dysfunction after acute myocardial infarction: treatment can start as early as the third day once necessary treatment conditions have been attained (stable haemodynamics, management of any residual ischaemia); initial dose must be low - 0.5 mg per day (24 hours) - increased progressively to a maximum of 4 mg daily as a single dose. Start in hospital under strict surveillance, particularly of blood pressure; forced titration may be temporarily suspended, for example in the event of symptomatic hypotension. Prior diuretic treatment: either discontinue the diuretic at least 72 hours before starting trandolapril and/or start with 0.5 mg daily, then adjust to response; if the diuretic must continue, medical supervision is necessary. Renovascular hypertension: initial 0.5 mg daily, adjusted according to blood pressure response. Cardiac failure (hypertensive patients with congestive heart failure, with or without renal insufficiency): start 0.5 mg once daily under close medical supervision in hospital. Hepatic impairment: in severely impaired liver function initiate 0.5 mg once daily under close medical supervision and adjust to therapeutic response. Elderly: normally no dose reduction needed and no dose adjustment necessary in those over 65 with age-normal renal function, but as some elderly are especially sensitive to ACE inhibitors it is recommended to start with low doses and monitor blood pressure response and kidney function; caution with concurrent diuretic treatment, congestive heart failure, or renal or hepatic insufficiency. Paediatric population: the medicinal product should not be given to children, as experience with treatment of children is insufficient (US label: safety and effectiveness in paediatric patients have not been established). Method of administration: oral use; may be taken before, during or after a meal.

Dose adjustments

Renal

The normal adult/elderly dose is recommended for creatinine clearance 30-70 ml/min, and no adjustment of the starting dose is needed above 30 ml/min. Creatinine clearance 0.2-0.5 ml/s (10-30 ml/min): initiate 0.5 mg daily, increasing if required to 1 mg daily as a single dose. Creatinine clearance below 0.2 ml/s (10 ml/min) and patients on haemodialysis: 0.5 mg daily as a single dose. Regular supervision of serum potassium and serum creatinine is necessary in these patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, other ACE inhibitors or any of the excipients
  • History of hypersensitivity including angioedema (e.g. Quincke's oedema) associated with prior administration of an ACE inhibitor
  • Hereditary or idiopathic angioedema
  • Second and third trimester of pregnancy
  • Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR below 60 ml/min/1.73 m2)
  • Concomitant use with sacubitril/valsartan therapy - trandolapril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan

Side effects

  • Hypotension (common); orthostatic hypotension, hot flushes (uncommon/rare)
  • Headache, dizziness (common); somnolence (uncommon)
  • Cough (common); upper respiratory tract inflammation and congestion (uncommon)
  • Nausea, diarrhoea, constipation, gastro-intestinal pain (uncommon)
  • Palpitations (uncommon); myocardial ischaemia, angina pectoris, cardiac failure, tachycardia, bradycardia (rare)
  • Hyperkalaemia; leucopenia, anaemia, platelet disorder (rare/not known)

Interactions

  • Dual blockade of the renin-angiotensin system (angiotensin receptor blockers, ACE inhibitors or aliskiren) - increased risk of hypotension, hyperkalaemia and changes in renal function including acute renal failure; in general avoid combined use and monitor blood pressure, renal function and electrolytes (US label; eMC section 4.5 not present in the fetched bundle)
  • Aliskiren - do not co-administer in patients with diabetes; avoid in patients with renal impairment (GFR below 60 mL/min)
  • Diuretics, especially recently instituted - excessive reduction of blood pressure after initiation; discontinue the diuretic, cautiously increase salt intake, or reduce the trandolapril starting dose
  • Sacubitril/valsartan - concomitant use contraindicated (eMC section 4.3)
  • Concurrent hypotensive treatments such as vasodilators (e.g. nitrates) and diuretics - assess carefully and reduce dose if possible in the event of hypotension post-myocardial infarction (eMC section 4.2)

Clinical monograph

How it works

Its active metabolite trandolaprilat inhibits ACE, reducing angiotensin II and aldosterone, thereby lowering vascular resistance and blood pressure.

Prescribing in practice

  • Contraindicated in pregnancy and in patients with a history of ACE inhibitor-associated angioedema.
  • Risk of hyperkalaemia and renal impairment, particularly with potassium-sparing agents, potassium supplements, NSAIDs or renal artery stenosis.
  • Initiate cautiously in volume-depleted patients because of the risk of symptomatic first-dose hypotension.

Monitoring

Check renal function and serum potassium before and after starting or changing the dose, along with blood pressure.

Counselling the patient

  • Report swelling of the face, lips, tongue or throat urgently.
  • A dry cough can develop; let your clinician know if it troubles you.
  • Avoid potassium-containing salt substitutes and tell your clinician if you may be pregnant.

Evidence & guidelines

ACE inhibitors improve survival after myocardial infarction with left ventricular dysfunction, as shown in the TRACE trial with trandolapril.

Reference: NICE NG136; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.