Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Generics [UK] Ltd. t/a Mylan, Station Close, Potters Bar, Herts EN6 1TL, U.K.
Mild or moderate arterial hypertension.
Left ventricular dysfunction after acute myocardial infarction.
For adults not taking diuretics, without congestive heart failure and without renal or hepatic insufficiency, the recommended initial dosage is 0.5 mg as a single daily dose. 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.
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.
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). The initial dose must be low (see section 4.4), particularly if the patient exhibits normal or low blood pressure at the initiation of therapy. Initial treatment should be 0.5 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.
Treatment should be started in hospital under strict surveillance, particularly of blood pressure (see section 4.4).
In the event of hypotension, all concurrent hypotensive treatments (see sections 4.3, 4.4, 4.5 and 5.1) (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.
In the event of prior diuretic treatment, special precautions must be taken:
It is recommended either to discontinue the diuretic treatment at least 72 hours before the trandolapril treatment is begun and/or start with 0.5 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.
Initial treatment should be 0.5 mg daily. The dose should be adjusted according to the blood pressure response.
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. In these patients, therapy should be started at a dose of 0.5 mg trandolapril once daily under close medical supervision in hospital.
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.
At a creatinine clearance of 0.2–0.5 ml/s (10-30 ml/min), treatment should be initiated with a daily dose of 0.5 mg. If required, the dose can be increased to 1 mg daily as a single dose. At a creatinine clearance below 0.2 ml/s (10 ml/min) and for patients in haemodialysis the dose is 0.5 mg daily as a single dose. For these patients regular supervision of serum potassium and serum creatinine is necessary.
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. Treatment with trandolapril should therefore be initiated at a dose of 0.5 mg once daily under close medical supervision and adjusted according to therapeutic response (see sections 4.4 and 5.2).
The medicinal product should not be given to children, as experience with treatment of children is insufficient.
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.
Caution must be exercised in older patients with concurrent diuretic treatment (see sections 4.4, 4.5 and 5.1), congestive heart failure or renal or hepatic insufficiency. The dose should be adjusted according to the blood pressure response.
For oral use.
Trandolapril may be taken before, during or after a meal.
The highest doses used in clinical studies are 32 mg (single doses given to healthy volunteers) and 16 mg (repeated doses to hypertensive patients), respectively.
Symptoms of overdose are severe hypotension, shock, stupor, bradycardia, electrolyte disturbance and renal failure.
After ingestion of an overdose the patient should be monitored closely, preferably in an intensive care unit. Serum electrolytes and serum creatinine are to be measured frequently. Therapeutic procedures depend on the severity of the symptoms. If the ingestion is recent, take measures aimed at eliminating trandolapril (e.g. emesis, gastric lavage, administration of absorbents and sodium sulfate).
In the event of symptomatic hypotension the patient is placed in the shock position and treatment with physiological salt solution or other forms of plasma expansion should be initiated as soon as possible. Treatment with angiotensin II may be considered in a referral centre. Bradycardia or severe vasovagal reactions should be treated with atropine. Pacemaker therapy should be considered.
It is not known whether trandolaprilat can be eliminated from the body by haemodialysis to a clinically significant degree.
There is no specific antidote for trandolapril overdose.
Shelf life: 3 years.
Store below 25°C.
Store in the original package.
Blister (PVC/PE/PVDC/Al).
0.5 mg, 1 mg, 2 mg and 4 mg: 14, 20, 28, 30, 50, 56, 84, 90 and 100 capsules.
Not all pack sizes may be marketed.
No special requirements.
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