Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Treatment of hypertension.
Treatment of symptomatic heart failure.
Short term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction.
Treatment of renal disease in hypertensive patients with Type 2 diabetes mellitus and incipient nephropathy (see section 5.1).
The dose should be individualised according to patient profile and blood pressure response (see section 4.4).
Dapril may be used as monotherapy or in combination with other classes of antihypertensive medicinal products (see sections 4.3, 4.4, 4.5 and 5.1).
In patients with hypertension the usual recommended starting dose is 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose.
A starting dose of 2.5 – 5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of renal impairment (see Table 1 below).
The usual effective maintenance dosage is 20 mg administered in a single daily dose. In general, if the desired therapeutic effect cannot be achieved in a period of 2 to 4 weeks on a certain dose level, the dose can be further increased. The maximum dose used in long-term, controlled clinical trials was 80 mg/day.
Symptomatic hypotension may occur following initiation of therapy with Dapril. This is more likely in patients who are being treated currently with diuretics. Caution is recommended therefore, since these patients may be volume and/or salt depleted. If possible the diuretic should be discontinued 2 to 3 days before beginning therapy with Dapril. In hypertensive patients in whom the diuretic cannot be discontinued, therapy with Dapril should be initiated with a 5 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Dapril should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed (see sections 4.4 and 4.5).
Use in Hypertensive Paediatric Patients aged 6-16 years:
The recommended initial dose is 2.5 mg once daily in patients 20 to <50 kg, and 5 mg once daily in patients ≥50 kg. The dosage should be individually adjusted to a maximum of 20 mg daily in patients weighing 20 to <50 kg, and 40 mg in patients ≥50 kg. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in paediatric patients (see section 5.1).
In children with decreased renal function, a lower starting dose or increased dosing interval should be considered.
Dosage in patients with renal impairment should be based on creatinine clearance as outlined in Table 1 below.
Table 1. Dosage Adjustment in Renal Impairment:
| Creatinine clearance (ml/min) | Starting dose (mg/day) |
|---|---|
| Less than 10 ml/minute (including patients on dialysis) | 2.5 mg* |
| 10–30 ml/minute | 2.5–5 mg |
| 31–80 ml/minute | 5–10 mg |
* Dosage and/or frequency of administration should be adjusted depending on the blood pressure response.
The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
In patients with symptomatic heart failure, Dapril should be used as adjunctive therapy to diuretics and, where appropriate, digitalis or beta-blockers. Dapril may be initiated at a starting dose of 2.5 mg once a day, which should be administered under medical supervision to determine the initial effect on the blood pressure. The dose of Dapril should be increased:
Dose adjustment should be based on the clinical response of individual patients.
Patients at high risk of symptomatic hypotension e.g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia, or patients who have been receiving vigorous diuretic therapy should have these conditions corrected, if possible, prior to therapy with Dapril. Renal function and serum potassium should be monitored (see section 4.4).
Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers. Intravenous or transdermal glyceryl trinitrate may be used together with Dapril.
Treatment with Dapril may be started within 24 hours of the onset of symptoms. Treatment should not be started if systolic blood pressure is lower than 100 mm Hg. The first dose of Dapril is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Patients with a low systolic blood pressure (120 mm Hg or less) when treatment is started or during the first 3 days after the infarction should be given a lower dose – 2.5 mg orally (see section 4.4).
In cases of renal impairment (creatinine clearance < 80 ml/minute), the initial Dapril dosage should be adjusted according to the patient’s creatinine clearance (see Table 1).
The maintenance dose is 10 mg once daily. If hypotension occurs (systolic blood pressure less than or equal to 100 mm Hg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure less than 90 mm Hg for more than 1 hour) Dapril should be withdrawn.
Treatment should continue for 6 weeks and then the patient should be re-evaluated. Patients who develop symptoms of heart failure should continue with Dapril (see section 4.2).
In hypertensive patients with type 2 diabetes mellitus and incipient nephropathy, the dose is 10 mg Dapril once daily which can be increased to 20 mg once daily, if necessary, to achieve a sitting diastolic blood pressure below 90 mm Hg.
In cases of renal impairment (creatinine clearance < 80 ml/minute), the initial Dapril dosage should be adjusted according to the patient’s creatinine clearance (see Table 1).
There is limited efficacy and safety experience in hypertensive children >6 years old, but no experience in other indications (see section 5.1). Lisinopril is not recommended in children in other indications than hypertension.
Lisinopril is not recommended in children below the age of 6, or in children with severe renal impairment (GFR <30 ml/min/1.73 m²) (see section 5.2).
In clinical studies, there was no age-related change in the efficacy or safety profile of the drug. When advanced age is associated with decrease in renal function, however, the guidelines set out in Table 1 should be used to determine the starting dose of Dapril. Thereafter, the dosage should be adjusted according to the blood pressure response.
There is no experience regarding the administration of Dapril in patients with recent kidney transplantation. Treatment with Dapril is therefore not recommended.
Tablets should be swallowed whole, with a little water if required. They can be taken with or without food.
Dapril should be administered orally in a single daily dose. As with all other medications taken once daily, Dapril should be taken at approximately the same time each day. The absorption of Dapril tablets is not affected by food.
Limited data are available for overdose in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
The recommended treatment of overdosage is intravenous infusion of normal saline solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. If ingestion is recent, take measures aimed at eliminating lisinopril (e.g. emesis, gastric lavage, administration of absorbents and sodium sulphate). Lisinopril may be removed from the general circulation by haemodialysis (see section 4.4). Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored frequently.
48 months.
This medicinal product does not require any special storage conditions.
PVC/PVDC-Aluminium blisters of ten tablets. Packs of ten (all strengths), thirty tablets (all stregths) and twenty tablets (20 mg), with a patient information leaflet are available.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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