Hypertension
Congestive heart failure
Treatment of patients who, within the first few days after an acute myocardial infarction, have demonstrated clinical signs of congestive heart failure.
Prevention of myocardial infarction, stroke, or cardiovascular death, and reduction of the need for revascularization procedures in patients with an increased cardiovascular risk, such as those with coronary heart disease (with or without a history of myocardial infarction), a history of stroke, or a history of peripheral vascular disease.
Prevention of myocardial infarction, stroke, or cardiovascular death in diabetic patients.
Prevention of progressive renal failure in patients with persistent proteinuria exceeding 1 g/day.
The dosage is based on the desired effect and the patient's tolerance. Acecard® is usually a long-term therapy, and the doctor determines the duration of treatment individually for each patient.
Treatment of hypertension:
The recommended initial dose is 2.5 mg once daily. Depending on the response, the dose may be doubled at intervals of 2 to 3 weeks.
The usual maintenance dose is 2.5 to 5 mg daily, with a maximum dose of 10 mg daily.
Treatment of congestive heart failure:
The recommended initial dose is 1.25 mg once daily. Depending on the response, the dose may be doubled at intervals of 1 to 2 weeks.
The maximum daily dose is 10 mg. If the required daily dose is 2.5 mg or more, it may be taken as a single dose or divided into two separate doses.
Treatment after myocardial infarction:
The recommended initial dose is 5 mg daily, divided into two doses of 2.5 mg each, taken in the morning and evening.
If this dose is not well tolerated, 1.25 mg should be taken twice daily for two days.
The dose may then be doubled at intervals of 1 to 3 days, depending on the response.
As treatment progresses, the total daily dose may be taken as a single dose.
The maximum daily dose is 10 mg.
Sufficient experience is still lacking in the treatment of patients with severe (NYHA-IV) heart failure immediately after myocardial infarction. If treatment is given, it should start with 1.25 mg once daily and be increased with particular caution.
Prevention of myocardial infarction, stroke, or cardiovascular death:
The recommended initial dose is 2.5 mg once daily.
Depending on tolerance, the dose is gradually increased by doubling it after one week. Three weeks later, it should be doubled again to the usual maintenance dose of 10 mg.
Prevention of progressive renal failure:
The recommended initial dose is 1.25 mg once daily, which may be doubled at intervals of 2 to 3 weeks, depending on tolerance.
Special considerations:
In patients pre-treated with a diuretic, consideration should be given to discontinuing the diuretic for at least 2 to 3 days before starting Acecard® or at least reducing the diuretic dose. The initial dose in such patients is generally 1.25 mg.
In cases of impaired liver or renal function, response to treatment may be increased or reduced. Treatment should therefore be initiated under close medical supervision.
The maximum daily dose is 2.5 mg.
The tablets must be swallowed whole, without chewing, with a sufficient amount of liquid (approximately half a glass). They may be taken before, during, or after a meal.
Ramiprilat, the active metabolite of Ramipril, is a potent and long-acting angiotensin-converting enzyme (ACE) inhibitor.
Administration of Acecard® leads to vasodilation and, particularly in hypertensive patients, a reduction in blood pressure. The blood pressure-lowering effect of a single dose occurs within 1–2 hours after intake, reaches its peak within 3–6 hours, and usually lasts 24 hours.
Acecard® is also effective in the treatment of congestive heart failure. Furthermore, in patients showing clinical signs of congestive heart failure after an acute myocardial infarction, Acecard® has been shown to reduce mortality risk, including the risk of sudden death, progression to severe or resistant heart failure, and heart failure-related hospitalization.
When administered as a preventive measure, Acecard® significantly reduces the incidence of myocardial infarction, stroke, and cardiovascular deaths in patients with increased cardiovascular risk due to vascular diseases (e.g., coronary heart disease, a history of stroke, or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (e.g., microalbuminuria, hypertension, elevated total cholesterol, low high-density lipoprotein cholesterol levels, or smoking).
Additionally, Acecard® reduces overall mortality, lowers the need for revascularization procedures, and delays the onset and progression of congestive heart failure. In both diabetic and non-diabetic patients, it significantly reduces the occurrence of microalbuminuria and lowers the risk of developing nephropathy. These effects are observed in both hypertensive and normotensive patients.
Acecard® must not be used in patients with:
Hypersensitivity to Ramipril, any other ACE inhibitor, or any excipients.
A history of angioneurotic edema.
Hemodynamically relevant renal artery stenosis, either bilateral or unilateral in a single kidney.
Low blood pressure or an unstable circulatory condition (risk of hypotension and renal failure).
Due to the risk of severe, rapid-onset, and allergy-like (anaphylactoid) reactions, ACE inhibitors must not be used with extracorporeal treatments involving blood contact with negatively charged surfaces.
Acecard® must not be taken during pregnancy.
If treatment with Acecard® is necessary during lactation, breastfeeding must be discontinued to prevent the infant from ingesting small amounts of Ramipril through breast milk.
Extracorporeal treatments involving blood contact with negatively charged surfaces may trigger severe anaphylactoid reactions.
Concomitant use of potassium salts or potassium-sparing diuretics (e.g., spironolactone) may cause an increase in serum potassium levels. Close monitoring of serum potassium is required.
ACE inhibitors may enhance the effects of antidiabetic agents (e.g., insulin or sulfonylureas), potentially leading to excessive reductions in blood sugar levels (hypoglycemia).
An excessive drop in blood pressure may occur, particularly after the initial dose or an increased dose of Acecard® or an additional diuretic. In some cases, this may lead to shock.
Uncommon side effects include increased serum urea and serum creatinine levels (especially when used with diuretics), impaired renal function, and, in rare cases, acute renal failure.
A persistent, dry, non-productive cough may occur, which may worsen at night or while lying down. This is more common in women and non-smokers.
Other uncommon side effects include nausea, elevated liver enzymes, increased bilirubin levels, and jaundice due to bile excretion impairment.
Store in a cool, dry place below 30°C.
Protect from light.
Keep out of reach of children.
To be dispensed only with a prescription from a registered physician.
