Trandolapril oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of trandolapril.
Drugs List
Therapeutic Indications
Uses
Hypertension - mild to moderate
Left ventricular dysfunction after myocardial infarction
Dosage
Adults
Hypertension
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.
Elderly
(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.
Dialysis
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.
Contraindications
Children under 18 years
Within 36 hours of discontinuing a sacubitril containing product
Breastfeeding
Galactosaemia
Haemodialysis with high flux membranes
Hereditary angioneurotic oedema
Idiopathic angioneurotic oedema
Pregnancy
Renal artery stenosis
Precautions and Warnings
Desensitisation therapy
Immunosuppression
Aortic stenosis
Atherosclerosis
Cerebral ischaemia
Collagen vascular disease
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hyperkalaemia
Hypertrophic cardiomyopathy
Hyponatraemia
Hypovolaemia
Ischaemic heart disease
Lactose intolerance
Left ventricular outflow obstruction
Peripheral vascular disease
Renal impairment
Renovascular disorder
Scleroderma
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
Pregnancy
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal pain
Acute renal failure
Agranulocytosis
Alopecia
Anaemia
Angina pectoris
Angioneurotic oedema
Arrhythmias
Arthralgia
Asthenia
Atrioventricular block
Blood urea increased
Blurred vision
Bronchitis
Bronchospasm
Cardiac arrest
Cardiac failure
Cerebral haemorrhage
Cholestatic jaundice
Confusion
Constipation
Cough
Decrease in haemoglobin and haematocrit
Depression
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Dyspnoea
Eosinophilia
Epistaxis
Erectile dysfunction
Erythema multiforme
Fatigue
Fever
Flushing
Glossitis
Haemolytic anaemia
Headache
Hepatitis
Hyperhidrosis
Hyperkalaemia
Hypersensitivity reactions
Hyperuricaemia
Hypoglycaemia
Hypotension
Ileus
Impaired vision
Increase in antinuclear antibodies (ANA)
Increases in hepatic enzymes
Insomnia
Leukopenia
Malaise
Migraine
Muscle spasm
Myalgia
Myocardial infarction
Myoclonus
Nausea
Nervousness
Neutropenia
Pain
Palpitations
Pancreatitis
Pancytopenia
Peripheral oedema
Peripheral vascular disorders
Pollakiuria
Proteinuria
Pruritus
Psoriasis like symptoms
Rash
Reduced libido
Reduced platelet count
Renal impairment
Rhinitis
Serum bilirubin increased
Serum creatinine increased
Sinusitis
Sleep disturbances
Somnolence
Stevens-Johnson syndrome
Syncope
Tachycardia
Tinnitus
Toxic epidermal necrolysis
Transient ischaemic attack
Upper respiratory symptoms
Urticaria
Vertigo
Vomiting
White blood cell count decreased
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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.
https://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON046451
Last accessed: May 21, 2013.
MHRA Drug Safety Update: Volume 1, Issue 5, December 2007
https://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON2033216
Last accessed: May 21, 2013.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Trandolapril. Last revised: December 27, 2007.
Last accessed: May 21, 2013.
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