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Trandolapril oral

Updated 2 Feb 2023 | ACE inhibitors


Oral formulations of trandolapril.

Drugs List

  • trandolapril 1mg capsules
  • trandolapril 2mg capsules
  • trandolapril 4mg capsules
  • trandolapril 500microgram capsules
  • Therapeutic Indications


    Hypertension - mild to moderate
    Left ventricular dysfunction after myocardial infarction



    Patients not taking diuretics, without congestive heart failure, renal or hepatic insufficiency

    Initially 500 micrograms once daily. Dosage should be doubled at intervals of 2 to 4 weeks, according to patient response, up to a maximum of 4 mg as a single daily dose. The usual maintenance dose range is 1 to 2 mg as a single dose daily.
    If the patient response is not satisfactory at a daily dose of 4 mg, combination therapy should be considered.

    Patients with congestive heart failure (with or without associated renal impairment)
    Initially 500 micrograms once daily administered under close medical supervision in hospital. Symptomatic hypotension has been observed in such patients after administration of ACE inhibitors.

    Left ventricular dysfunction after myocardial infarction
    Treatment may start 3 days after myocardial infarction, at an initial dose of 500 micrograms once daily. Dosage can be progressively increased up to a maximum of 4 mg as a single daily dose. Forced titration can be temporarily suspended depending upon the tolerability such as symptomatic hypotension.


    (See Dosage; Adult).

    Use with caution in elderly patients with concomitant diuretics, congestive heart failure or renal or hepatic impairment. Dose should be titrated according to the need to control blood pressure.

    Patients with Renal Impairment

    Severe renal impairment (creatinine clearance below 10 ml/minute)
    Initially 500micrograms once daily, with a maximum daily dose not exceeding 2 mg. Therapy should be under close medical supervision.

    It is not proven that trandolapril or trandolaprilat are removed by dialysis, although it is expected that the active moiety, trandolaprilat, is removed from the circulation. This would result in a loss of blood pressure control. Blood pressure should be monitored carefully during dialysis, and the dosage of trandolapril adjusted if required.

    Patients with Hepatic Impairment

    Severe hepatic impairment
    Treatment should be initiated at 500micrograms once daily. Therapy should be under close medical supervision.

    Additional Dosage Information

    If symptomatic hypotension develops during titration, the dose should not be further increased. Adjunctive treatment dosages should be reduced, and if this is not effective the trandolapril dose should be reduced.

    Prior diuretic treatment in patients at risk from stimulated renin-angiotensin system (e.g. water and sodium depleted patients)
    Discontinue diuretic therapy 2 to 3 days before commencing trandolapril therapy at 500 micrograms once daily initially, to reduce the likelihood of symptomatic hypotension. The diuretic may be reintroduced later if required.


    Children under 18 years
    Within 36 hours of discontinuing a sacubitril containing product
    Haemodialysis with high flux membranes
    Hereditary angioneurotic oedema
    Idiopathic angioneurotic oedema
    Renal artery stenosis

    Precautions and Warnings

    Desensitisation therapy
    Aortic stenosis
    Cerebral ischaemia
    Collagen vascular disease
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Hypertrophic cardiomyopathy
    Ischaemic heart disease
    Lactose intolerance
    Left ventricular outflow obstruction
    Peripheral vascular disease
    Renal impairment
    Renovascular disorder
    Severe hepatic impairment
    Systemic lupus erythematosus
    Uncontrolled cardiac failure

    Anaesthetist should be made aware patient is taking this medication
    Anaphylactoid reactions possible with haemofiltration or LDL apheresis
    Anaphylactoid reactions possible with highly permeable dialysis membranes
    Anaphylaxis possible with concomitant hyposensitisation to wasp/bee venom
    Advise ability to drive/operate machinery may be affected by side effects
    Afro-Caribbean or black patients may show reduced response
    Consider stopping diuretic 2-3 days prior to therapy if appropriate
    Correct existing water and electrolyte disturbances before administration
    Exclude renovascular disorder before treatment
    Contains lactose
    Place patient in supine position if severe hypotension occurs
    Evaluate renal function before and during treatment
    Exclude pregnancy prior to initiation of treatment
    Monitor serum electrolytes before and during treatment
    Consider monitoring urine protein levels in collagen vascular disease
    Consider monitoring white blood cell counts in collagen vascular disease
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor hepatic function frequently in patients with hepatic impairment
    Monitor patients with renovascular disease
    Higher incidence of angioedema in black patients
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    May cause hyperkalaemia
    Discontinue temporarily in LDL apheresis or desensitisation therapy
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if angioedema occurs
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Advise patient not to take NSAIDs unless advised by clinician
    Avoid antacids within 2 hours of dose
    Advise patient to moderate alcohol intake during treatment
    Advise on problems of salt substitutes/high intake of potassium-rich food
    Female: Ensure adequate contraception during treatment

    Trandolapril should be initiated under specialist supervision and with careful clinical monitoring in those with severe heart failure or in those:- receiving multiple or high dose diuretic therapy (e.g. more than 80mg of furosemide daily or its equivalent).

    Pregnancy and Lactation


    Trandolapril is contraindicated during pregnancy.

    There are insufficient data on trandolapril in pregnancy; however, exposure to ACE inhibitors in mid or late pregnancy have been associated with hypoxia, hypocalvaria, renal tubular dysgenesis, and severe neonatal hypotension. Intrauterine growth retardation (IUGR) or prematurity may also be observed.

    ACE inhibitors are contraindicated during the second and third trimesters of pregnancy as exposure during these trimesters is known to induce human foetal toxicity (renal dysfunction, oligohydramnios, pulmonary hypoplasia, patent ductus arteriosus, delay in skull ossification, neonatal toxicity and even death). Severe and sometimes fatal anuria in the foetus and in the newborn have been observed and is thought to be caused by the compromise of the foetal renal system. Foetal renal failure resulting from in utero exposure to ACE inhibitors has been reported where dialysis has been required shortly after birth. Evidence of a risk of teratogenicity after first trimester exposure is conflicting, however, the MHRA recommends that a risk cannot be excluded. Recent data published does associate first trimester ACE inhibitor exposure with congenital CNS and cardiovascular defects. Unless treatment with an ACE inhibitor is considered absolutely essential, women who are planning to become pregnant should be switched to an alternative drug with an established safety record. If exposure has occurred in the first trimester a detailed ultrasound diagnosis is advisable. Exposure to an ACE inhibitor during pregnancy is not an indication for either invasive diagnostic procedures or termination of pregnancy. In cases involving long term prenatal therapy in the second and/ or third trimesters, the foetus should be monitored for the potential development of oligohydramnios, and foetal growth should be assessed with detailed ultrasound scans (Schaefer, 2007).

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Trandolapril is contraindicated during breastfeeding.

    It is unknown whether trandolapril is excreted into breast milk, however its molecular weight is low enough that excretion would be excreted.

    The MHRA has stated that although ACE inhibitors are not generally recommended for use by breastfeeding mothers they are not absolutely contraindicated and may be prescribed if treatment is considered essential. The MHRA state that ACE inhibitors should not be used by breastfeeding mothers in the first few weeks after delivery because of possible profound neonatal hypotension particularly in preterm infants. If ACE inhibitor therapy is considered essential for the mother the use of captopril, enalapril or quinapril may be considered when the infant is older. The infant should be carefully followed up for signs of hypotension should ACE inhibitor treatment be deemed necessary.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Acute renal failure
    Angina pectoris
    Angioneurotic oedema
    Atrioventricular block
    Blood urea increased
    Blurred vision
    Cardiac arrest
    Cardiac failure
    Cerebral haemorrhage
    Cholestatic jaundice
    Decrease in haemoglobin and haematocrit
    Dry mouth
    Erectile dysfunction
    Erythema multiforme
    Haemolytic anaemia
    Hypersensitivity reactions
    Impaired vision
    Increase in antinuclear antibodies (ANA)
    Increases in hepatic enzymes
    Muscle spasm
    Myocardial infarction
    Peripheral oedema
    Peripheral vascular disorders
    Psoriasis like symptoms
    Reduced libido
    Reduced platelet count
    Renal impairment
    Serum bilirubin increased
    Serum creatinine increased
    Sleep disturbances
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Transient ischaemic attack
    Upper respiratory symptoms
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: May 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Gopten. Abbott Healthcare Products Limited. Revised September 2012.

    Summary of Product Characteristics: Trandolapril 0.5mg capsules. Actavis UK Ltd. Revised October 2012.

    Summary of Product Characteristics: Trandolapril 1mg capsules. Actavis UK Ltd. Revised October 2012.

    Summary of Product Characteristics: Trandolapril 2mg capsules. Actavis UK Ltd. Revised October 2012.

    Summary of Product Characteristics: Trandolapril 4mg capsules. Actavis UK Ltd. Revised October 2012.

    MHRA Drug Safety Update: Volume 2, Issue 10, May 2009.
    Last accessed: May 21, 2013.

    MHRA Drug Safety Update: Volume 1, Issue 5, December 2007
    Last accessed: May 21, 2013.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Trandolapril. Last revised: December 27, 2007.
    Last accessed: May 21, 2013.

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