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TRANDOLAPRIL is a brand name for Trandolapril. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Mild or moderate hypertension. • Left ventricular dysfunction after acute myocardial infarction.
Verbatim from this product's MHRA label. Tap a section to expand.
5 mg as a single daily dose. 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.
The recommended maintenance dose range is 1 to 2 mg as a single daily dose. If the patient response is still unsatisfactory at a dose of 4 mg trandolapril, combination therapy should be considered with diuretics and calcium channels blockers.
Left ventricular dysfunction after acute myocardial infarction:
After an acute myocardial infarction, treatment can be started as early as the third day once necessary treatment conditions have been attained (stable haemodynamics and management of any residual ischaemia). 4), particularly if the patient exhibits normal or low blood pressure at the initiation of therapy.
5 mg per day (24 hours). The dose may be increased progressively to a maximum of 4 mg daily as a single dose. This forced titration may be temporarily suspended, for example in the event of symptomatic hypotension. 4). 1) (for example vasodilators such as nitrates, diuretics) must be assessed carefully and if possible, their dose reduced.
The dose of trandolapril should be reduced only if these precautions are insufficient or cannot be effected. 5 mg daily. In that case the dose must be adjusted in accordance with the patient’s response. If the diuretic treatment must necessarily continue, medical supervision is necessary.
5 mg daily. The dose should be adjusted according to the blood pressure response. Cardiac failure In hypertensive patients who also have congestive heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed after treatment with ACE inhibitors.
5 mg trandolapril once daily under close medical supervision in hospital.
Renal impairment:
The normal dose for adults and older people is recommended to patients with a creatinine clearance between 30-70 ml/min. It is not necessary to adjust the starting dose in patients with a creatinine clearance above 30 ml/min. 5 mg. If required, the dose can be increased to 1 mg daily as a single dose.
The following table displays adverse reactions reported in hypertension (n=2,520) and post- myocardial infarction (n=876) clinical trials and from post-marketing experience with trandolapril. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness, when the seriousness could be assessed.
Undesirable side effects are listed below using the following convention:
Very common (≥ 1/10) Common (≥1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data). Infections and infestations Uncommon Rare Upper respiratory tract infection.
Urinary tract infection, bronchitis, pharyngitis. Blood and lymphatic system disorders Rare Not known Leucopenia, anaemia, platelet disorder, white blood cell disorder. Agranulocytosis, pancytopenia, platelet count decreased, haemoglobin decreased, haematocrit decreased.
Immune system disorders Rare Hypersensitivity. Metabolism and nutrition disorders Rare Hyperglycaemia, hyponatraemia, hypercholesterolaemia, hyperlipidaemia, Not known hyperuricaemia, gout, anorexia, increased appetite, enzyme abnormality.
Hyperkalaemia Psychiatric disorders Uncommon Rare Insomnia, libido decreased. Hallucination, depression, sleep disorder, anxiety, agitation, apathy, nervousness. Nervous system disorders Common Uncommon Rare Not known Headache, dizziness.
Somnolence. Cerebrovascular accident, syncope, myoclonus, paraesthesia, migraine, migraine without aura, dysgeusia. Transient ischaemic attack, cerebral haemorrhage, balance disorder. Eye disorders Rare Blepharitis, conjunctival oedema, visual impairment, eye disorder Ear and labyrinth disorders Uncommon Rare Vertigo Tinnitus Cardiac disorders Uncommon Rare Not known Palpitations Myocardial infarction, myocardial ischaemia, angina pectoris, cardiac failure, ventricular tachycardia, tachycardia, bradycardia Atrioventricular block, cardiac arrest, arrhythmia, electrocardiogram abnormal Vascular disorders Common Uncommon Rare Not known Hypotension* Hot flushes Hypertension, angiopathy, orthostatic hypotension, peripheral vascular disorder, varicose vein Cerebrovascular infarction Respiratory, thoracic and mediastinal disorders Common Uncommon Cough.
Risk of hypotension and/or renal insufficiency In patients with uncomplicated hypertension, symptomatic hypotension has been observed in rare cases after the first dose or after an increased dose. Marked activation of the renin-angiotensin- aldosterone system occurs under certain conditions, especially in the event of severe fluid and sodium depletion (low salt diet, prolonged diuretic treatment, dialysis, diarrhoea or vomiting), renal artery stenosis, heart failure and cirrhosis of the liver with oedema and/or ascites.
The ACE inhibitor’s suppression of the renin-angiotensin-aldosterone system may cause severe arterial hypotension and/or functional renal insufficiency, especially at the first dosage, when the dose is increased and during the first two weeks of treatment.
g. acute myocardial infarction, cerebrovascular infarction). In such risk patients, including those with angina pectoris, ischaemic heart disease or cerebrovascular disorders, trandolapril treatment should be initiated under close medical supervision in low doses, with careful dose adjustment.
In the event of prior diuretic treatment, in some patients particularly if this treatment has been recently instituted, the fall in blood pressure on initiation of treatment with trandolapril may be excessive. 5). Fluid and salt depletion should be remedied before initiating trandolapril treatment.
If the patient develops arterial hypotension or renal insufficiency during treatment, dose reduction or suspension of the treatment with trandolapril and/or diuretics may be necessary. A case of arterial hypotension occurring after the initial dose does not exclude subsequent treatment with trandolapril provided the dose is adjusted carefully.
If symptomatic hypotension occurs, the patient should be placed in a supine position and, if necessary, receive an intravenous infusion of physiological saline. Intravenous atropine may be necessary if there is associated bradycardia.
• Hypersensitivity to the active substance, other ACE inhibitors or any of the excipients. g. Quincke's oedema) associated with prior administration of an ACE inhibitor. • Hereditary or idiopathic angioedema. 6). 1). • Concomitant use with sacubitril/valsartan therapy.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg daily as a single dose. For these patients regular supervision of serum potassium and serum creatinine is necessary.
Hepatic impairment:
In patients with severely impaired liver function, a decrease in the metabolic clearance of the parent compound, trandolapril and the active metabolite trandolaprilat results in a large increase in plasma trandolapril levels and to a lesser extent, an increase in trandolaprilat levels.
2).
Paediatric population:
The medicinal product should not be given to children, as experience with treatment of children is insufficient.
Elderly:
Normally no dose reduction is needed. Pharmacokinetic studies of hypertensive patients over 65 who have normal kidney function for their age indicate that dose adjustment is not necessary. As some elderly patients may, however, be especially sensitive to ACE inhibitors, it is recommended initially to use low doses and to monitor the blood pressure response and the kidney function.
1), congestive heart failure or renal or hepatic insufficiency. The dose should be adjusted according to the blood pressure response. Method of administration For oral use. Trandolapril may be taken before, during or after a meal.
Upper respiratory tract inflammation, upper respiratory tract congestion Rare Not unknown Dyspnoea, epistaxis, pharyngeal inflammation, oropharyngeal pain, productive cough, respiratory disorder, throat irritation, rhinorrhoea. Bronchospasm.
Gastrointestinal disorders Uncommon Rare Not known Nausea, diarrhoea, constipation, gastro-intestinal pain, gastro-intestinal disorder Haematemesis, gastritis, vomiting, abdominal pain, dyspepsia, dry mouth, flatulence. Ileus, pancreatitis Hepatobiliary disorders Rare Very rare Not known Hepatitis, hyperbilirubinaemia Cholestasis Jaundice, liver function test abnormal, transaminases increased Skin and subcutaneous tissue disorders Uncommon Rare Very rare Not known Pruritus, skin rash Angioedema, hyperhidrosis, psoriasis, eczema, acne, dry skin, skin disorder Dermatitis Urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia.
Musculoskeletal and connective tissue disorders Uncommon Rare Back pain, muscle spasms, pain in extremity Myalgia, arthralgia, bone pain, osteoarthritis Renal and urinary disorders Rare Not known Renal failure, azotaemia, polyuria, pollakiuria Blood creatinine increased, blood urea increased, proteinuria Reproductive system and breast disorders Uncommon Erectile dysfunction Congenital, familial and genetic disorders Rare Congenital arterial malformation, ichthyosis General disorders and administration site conditions Common Asthenia Uncommon Rare Not known Malaise, chest pain, oedema peripheral, feeling abnormal Oedema, fatigue Pyrexia Investigations Very rare Not known Raised potassium blood levels, gamma- glutamyl transferase, raised lipase, raised immunoglobulin.
Increased serum urea, increased serum creatinine, reduced platelet count, increased liver function tests (including ASAT and ALAT), blood alkaline phosphatase increased, blood lactate dehydrogenase increased, laboratory test abnormal.
Injury, poisoning and procedural complications Rare Injury *Hypotension has a common frequency in patients with left ventricular dysfunction following myocardial infarction from the TRACE clinical study (n=876). However, it has an uncommon frequency in those patients from hypertension clinical trials (n=2,520).
Undesirable effects reported for ACE inhibitors as a class (frequency not given):
Blood and lymphatic system disorders: Haemolytic anaemia, eosinophilia and/or increased ANA (anti-nuclear antibody) Nervous system disorders Confusional state Eye disorders Vision blurred Respiratory, thoracic and mediastinal disorders: Sinusitis, rhinitis, glossitis Gastrointestinal disorders: Intestinal angioedema.
Skin and subcutaneous tissue disorders:
Erythema multiforme, psoriasis-like efflorescences Congenital, familial and genetic disorders Haemolytic anaemia with a congenital deficiency concerning G-6 PDH (glucose-6- phosphate dehydrogenase). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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Patients with renovascular hypertension Treatment of renovascular hypertension is carried out by revascularisation. However, ACE inhibitors may be of use until revascularisation can be effected, or if such a procedure is not to be carried out.
The risk of severe arterial hypotension and renal insufficiency is increased when patients with prior unilateral or bilateral renal artery stenosis are treated with an ACE inhibitor. Diuretics may further increase the risk. Loss of renal function may occur with only small changes in the serum creatinine, even in patients with unilateral renal artery stenosis.
For these patients treatment should be initiated in the hospital under close medical supervision with low doses and careful dose adjustment. Diuretic treatment should be discontinued, and renal function and serum potassium monitored during the early weeks of treatment.
Assessment of renal function Evaluation of the patient should include assessment of renal function prior to initiation of therapy and during treatment. Proteinuria may occur if renal impairment is present prior to therapy or relatively high doses are used.
2). In patients with renal insufficiency it is recommended that renal function and serum potassium be monitored closely during the early weeks of treatment and subsequently as appropriate. Some hypertensive patients without previously diagnosed renal disease may develop increases in serum urea nitrogen and serum creatinine when trandolapril is given concurrently with diuretics.
Proteinuria may occur. In patients with renal insufficiency, congestive heart failure or unilateral or bilateral renal artery stenosis, in the single kidney as well as after renal transplantation, there is a risk of impairment of renal function.
If recognised early, such impairment of renal function is reversible upon discontinuation of therapy. Additionally, in patients with renal insufficiency, the risk of hyperkalaemia should be considered and the patient’s electrolyte status checked regularly.
Kidney transplantation There is no experience regarding the administration of trandolapril in patients with a recent kidney transplantation. Treatment with trandolapril is therefore not recommended. Patients with impaired liver function As trandolapril is a prodrug metabolised to its active form in the liver, particular caution and close monitoring should be applied to patients with impaired liver function.
Hepatic failure Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood.
Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up. Hypersensitivity/Angioedema Cases of oedema in the face, lips, tongue, glottis and/or larynx as well as the extremities have been reported in patients treated with an ACE inhibitor, including trandolapril.
Angio oedema may occur particularly during the early weeks of treatment. Seldom does it develop only after prolonged treatment with an ACE inhibitor. In such cases the trandolapril treatment should be discontinued immediately, and the patient monitored until the oedema disappears.
When the oedema is localised to include only the face, it generally disappears without treatment, although antihistamines have been useful in relieving symptoms. The combination of facial and glottis oedema may be life-threatening. Swelling of the tongue, glottis or larynx […]