ODRIK Hard capsule Ref.[110103] Active ingredients: Trandolapril

For oral use

Posology

Adults

Hypertension

The starting dose is 1 mg once daily as a single dose. The daily dose can be adjusted according to patient response up to a maximum 4 mg given as a single daily dose.

Left ventricular dysfunction after myocardial infarction

Following a myocardial infarction, therapy may be initiated as early as the third day.

Treatment should be initiated as a daily dose of 0.5 mg. The dose should be progressively increased to a maximum of 4 mg as a single daily dose.

Depending upon the tolerability such as symptomatic hypotension, this forced titration can be temporarily suspended.

In the event of hypotension, all concomitant hypotensive therapies such as vasodilators, including nitrates and diuretics must be carefully checked and if possible, their dose reduced.

The dose of Odrik should be lowered only if the previous measures are not effective or not feasible. Please see Section 5.2 for special instructions pertaining toolder patients, gender-specific differences and patients with renal and hepatic impairment.

Special Populations

Older People

The dose in older people is the same as in adults. There is no need to reduce the dose in older people with normal renal and hepatic function. Caution in older people with concomitant use of diuretics, congestive heart failure or renal or hepatic insufficiency. The dose should be titrated according to the need for the control of blood pressure.

Paediatric Population

The safety and efficacy of Odrik in children has not been establishedand therefore use in this age group is not recommended.

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. In these patents, therapy should be started at a dose of 0.5mg to 1mg trandolapril once daily under close medical supervision.

Renal impairment

For patients with a creatinine clearance of 30 to 70 mL/minute, the usual adult and older people doses are recommended.

Patients with a creatinine clearance below 30 mL/min are recommended to be given a reduced trandolapril starting dose (i.e. starting dose of 0.5mg) and then to be titrated up to the desired effect over time. In these patents, therapy should be under close medical supervision.

Patients with a creatinine clearance larger than 30mL/min do not require a starting dose adjustment.

Dialysis

It is not known for certain if trandolapril or trandolaprilat are removed by dialysis. However, it would be expected that dialysis could remove the active moiety, trandolaprilat, from the circulation, resulting in a possible loss of control of blood pressure. Therefore careful monitoring of the patient’s blood pressure during dialysis is required and the dosage of trandolapril adjusted if needed.

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. Treatment with trandolapril should therefore be initiated at a dose of 0.5mg once daily under close medical supervision.

Prior diuretic treatment

In patients who are at risk from a stimulated renin-angiotensin (e.g., patients with water and sodium depletion), the diuretic should be discontinued two or three days before beginning therapy with 0.5mg trandolapril to reduce the likelihood of symptomatic hypotension. The diuretic may be resumed later if required. If diuretic treatment is continued, plasma creatinine levels should be monitored.

Food

The absorption of Odrik is not affected by food.

In clinical trials, doses of up to 16 mg have been administered and were well tolerated. There is no experience of overdosage. In the event of overdosage following recent ingestion, consideration should be given to emptying the stomach contents. Blood pressure should be monitored and if hypotension develops, volume expansion should be considered.

Symptoms

Symptoms expected with ACE inhibitors 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 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 should be 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 should be considered. Bradycardia or severe vaso-vagale reactions should be treated with atropine. Pacemaker therapy should be considered. It is unknown if trandolaprilat can be eliminated from the body by haemodialysis.

Treatment

After ingestion of an overdose of trandolapril tablets, total intestinal lavage should be considered. Blood pressure should be monitored and if hypotension develops, volume expansion should be considered. There is no specific antidote for trandolapril overdose.

4 years.

Do not store above 25°C. Store in the original package.

PVC/PVDC/Aluminium blister strips containing 7, 28 or 56 capsules.

Not all pack sizes may be marketed.

No special requirements.