$32.00
Manufacturer: Slovenia
Indicated for:
- Treatment of arterial hypertension.
- Prevention of cardiovascular disease: reducing the incidence of cardiovascular disease and mortality in patients with:
- severe cardiovascular diseases of atherothrombotic origin (history of coronary heart disease or stroke or peripheral vascular disease);
- diabetes mellitus, which have at least one cardiovascular risk factor.
- Treatment of kidney disease:
- initial glomerular diabetic nephropathy, as evidenced by the presence of microalbuminuria;
- severe glomerular diabetic nephropathy, as evidenced by the presence of macroproteinuria, in patients with at least one cardiovascular risk factor;
- severe glomerular non-diabetic nephropathy, as evidenced by the presence of macroproteinuria ≥ 3 g per day.
- Treatment of heart failure, accompanied by clinical manifestations.
- Secondary prevention after acute myocardial infarction: reduction of mortality in the acute stage of myocardial infarction in patients with clinical signs of heart failure when starting treatment more than 48 hours after the onset of acute myocardial infarction.
Description
Ampril (Ramipril) tablets 5 mg. Instructions
Ingredients
active ingredient: ramipril;
1 tablet contains ramipril 5 mg;
excipients: sodium bicarbonate, lactose, sodium croscarmellose, corn starch, sodium stearyl fumarate, Pigment blend PB 24899 Pink (contains lactose, iron oxide yellow (E172), iron oxide red (E172)).
Dosage form
Pills.
Basic physical and chemical properties: oval, flat tablets without a shell, pink.
Pharmacotherapeutic group
Drugs acting on the renin-angiotensin system. ACE inhibitors. Ramipril. ATX code C09A A05.
Pharmacodynamics
Ramipril refers to prodrugs, after absorption it decomposes in the liver with the formation of ramiprilat. Ramiprilat is a potent long-acting ACE inhibitor. ACE catalyses the conversion of angiotensin I to the vasoconstrictor, angiotensin II. ACE is an analog of kininase, an enzyme that catalyses the breakdown of bradykinin. Inhibition of ACE activity leads to a decrease in the concentration of angiotensin II, an increase in plasma renin activity, an increase in the action of bradykinin and a decrease in aldosterone secretion. The latter can cause an increase in the level of potassium in the blood serum.
In patients with arterial hypertension, the antihypertensive and hemodynamic effects of ramipril are due to the expansion of resistant vessels and a decrease in total peripheral vascular resistance, resulting in a gradual decrease in blood pressure. The heart rate basically does not change. During long-term treatment, there is a decrease in left ventricular hypertrophy without affecting heart function. The hypotensive effect after taking a single dose appears 1-2 hours after administration, reaches a maximum within 3-6 hours and usually lasts for 24 hours. Ramipril is also an effective drug for the treatment of congestive heart failure. In patients with clinical signs of chronic heart failure after acute myocardial infarction, it reduces the risk of sudden death,
According to published data, ramipril significantly reduces the incidence of myocardial infarction, stroke and reduces mortality from cardiovascular diseases in patients at increased risk due to cardiovascular diseases (for example, active stage coronary heart disease, previous stroke or peripheral vascular disease) or due to for diabetes who have at least one additional risk factor (microalbuminuria, hypertension, elevated total cholesterol, low high-density lipoprotein, smoking). The drug also reduces overall mortality and the need for revascularization and delays the onset and progression of heart failure. In patients with diabetes.
Indications
- Treatment of arterial hypertension.
- Prevention of cardiovascular disease: reducing the incidence of cardiovascular disease and mortality in patients with:
- severe cardiovascular diseases of atherothrombotic origin (history of coronary heart disease or stroke or peripheral vascular disease);
- diabetes mellitus, which have at least one cardiovascular risk factor.
- Treatment of kidney disease:
- initial glomerular diabetic nephropathy, as evidenced by the presence of microalbuminuria;
- severe glomerular diabetic nephropathy, as evidenced by the presence of macroproteinuria, in patients with at least one cardiovascular risk factor;
- severe glomerular non-diabetic nephropathy, as evidenced by the presence of macroproteinuria ≥ 3 g per day.
- Treatment of heart failure, accompanied by clinical manifestations.
- Secondary prevention after acute myocardial infarction: reduction of mortality in the acute stage of myocardial infarction in patients with clinical signs of heart failure when starting treatment more than 48 hours after the onset of acute myocardial infarction.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients that make up Ampril (Ramipril) tablets 5 mg. , or other ACE inhibitors (angiotensin-converting enzyme).
- A history of angioedema (hereditary, idiopathic, or previously transferred to the background of the use of ACE inhibitors or angiotensin II receptor antagonists).
- Significant bilateral renal artery stenosis or renal artery stenosis in the presence of a single kidney.
- Pregnant women or women planning to become pregnant.
- Ampril (Ramipril) tablets 5 mg. should not be used in patients with arterial hypotension or hemodynamically unstable conditions.
- It should not be used together with preparations containing aliskiren in patients with diabetes mellitus or moderate or severe renal insufficiency (GFR <60 ml/min).
- The simultaneous use of ACE inhibitors and extracorporeal therapies that lead to blood contact with negatively charged surfaces should be avoided, since such use can lead to severe anaphylactic reactions. Such extracorporeal therapies include dialysis or hemofiltration using certain high fluid permeability membranes (eg polyacrylonitrile) and low density lipoprotein apheresis using dextran sulfate.
Dosage and administration
The dosage and period of treatment depends on the patient’s condition, the need for concomitant treatment and is always determined by the doctor.
Ampril (Ramipril) tablets 5 mg. is recommended to be taken daily at the same time. Ampril (Ramipril) tablets 5 mg. can be taken before, during and after meals, since food intake does not affect the bioavailability of the drug. Tablets should be swallowed whole with water (approximately ½ cup). They must not be chewed or crushed.
Adults.
Patients taking diuretics. At the beginning of treatment, arterial hypotension may occur, the development of which is more likely in patients who simultaneously receive diuretics. In such cases, it is recommended to exercise caution, since these patients may have a decrease in BCC and / or the amount of electrolytes.
It is advisable to stop the use of the diuretic 2-3 days before the start of treatment with ramipril, if possible.
In patients with arterial hypertension who cannot stop the diuretic, treatment with ramipril should be started with a dose of 1.25 mg. Kidney function and blood potassium levels should be closely monitored. Further dosing should be adjusted depending on the target blood pressure level.
Arterial hypertension.
The dose should be selected individually, depending on the characteristics of the patient’s condition and the results of control measurements of blood pressure. Ramipril can be used as monotherapy or in combination with other classes of antihypertensive drugs.
starting dose. Treatment with the drug should be started gradually, starting with the recommended initial dose of 2.5 mg per day.
In patients with significant activation of renin-angiotensin after taking the initial dose, a significant decrease in blood pressure may occur. For such patients, the recommended dose is 1.25 mg, and their treatment should be started under control.
Dose titration and maintenance dose. The dose can be doubled every 2-4 weeks until the target blood pressure level is reached, the maximum dose is 10 mg per day. As a rule, the drug should be taken once a day.
Prevention of cardiovascular diseases.
starting dose . The recommended initial dose of the drug is 2.5 mg 1 time per day.
Dose titration and maintenance dose. Depending on the individual tolerability of the drug, the dose should be gradually increased. It is recommended to double the dose after 1-2 weeks of treatment, and then – after 2-3 weeks – increase it to the target maintenance dose of 10 mg 1 time per day.
See the information above regarding the dosing of the drug for patients receiving diuretics.
Treatment of kidney disease.
In patients with diabetes mellitus and microalbuminuria.
starting dose. The recommended starting dose is 1.25 mg once daily.
Dose titration and maintenance dose. Depending on the individual tolerability of the drug during further treatment, the dose should be increased. After 2 weeks of treatment, a single dose is recommended to be doubled to 2.5 mg, and then to 5 mg after 2 weeks of treatment.
In patients with diabetes mellitus and at least one cardiovascular risk factor.
starting dose. The recommended initial dose of the drug is 2.5 mg 1 time per day.
Dose titration and maintenance dose. Depending on the individual tolerability of the drug during further treatment, the dose should be increased. After 1-2 weeks of treatment, the daily dose of the drug is recommended to be doubled to 5 mg, and then to 10 mg after 2-3 weeks of treatment. The target daily dose is 10 mg.
In patients with non-diabetic nephropathy, as evidenced by the presence of macroproteinuria ≥ 3 g / day.
starting dose. The recommended starting dose is 1.25 mg once daily.
Dose titration and maintenance dose. Depending on the patient’s individual tolerance of the drug during further treatment, the dose should be increased. After 2 weeks of treatment, a single dose is recommended to be doubled to 2.5 mg, and then to 5 mg after 2 weeks of treatment.
Heart failure with clinical manifestations.
starting dose. For patients whose condition has stabilized after treatment with diuretics, the recommended initial dose is 1.25 mg per day.
Dose titration and maintenance dose. Titrate the dose by doubling it every 1-2 weeks until a maximum daily dose of 10 mg is reached. It is advisable to divide the dose into 2 doses.
Secondary prevention after acute myocardial infarction in the presence of heart failure.
starting dose. 48 hours after the onset of myocardial infarction in patients who are clinically and hemodynamically stable, prescribe an initial dose of 2.5 mg 2 times a day for 3 days. If the initial dose of 2.5 mg is poorly tolerated, a dose of 1.25 mg 2 times a day for 2 days should be used, followed by an increase to 2.5 mg and 5 mg 2 times a day. If the dose can be increased to 2.5 mg 2 times a day, treatment should be discontinued.
See the above information regarding the dosing of the drug for patients receiving diuretics.
Dose titration and maintenance dose. In the future, increase the daily dose by doubling it with an interval of 1-3 days until the target maintenance dose of 5 mg 2 times a day is reached.
When possible, divide the maintenance dose into 2 divided doses.
If the dose can be increased to 2.5 mg 2 times a day, treatment should be discontinued. There is still insufficient experience in the treatment of patients with severe (NYHA Class IV) heart failure immediately after myocardial infarction. If, nevertheless, a decision is made to treat such patients with this drug, it is recommended to start therapy with a dose of 1.25 mg 1 time per day and to carry out any increase with extreme caution.
Special categories of patients.
Patients with impaired renal function. The daily dose for patients with impaired renal function depends on the creatinine clearance (see section “Pharmacological properties”):
- if creatinine clearance ≥ 60 ml / min, there is no need to adjust the initial dose (2.5 mg / day), and the maximum daily dose is 10 mg;
- if creatinine clearance is 30-60 ml / min, there is no need to adjust the initial dose (2.5 mg / day), and the maximum daily dose is 5 mg;
- if creatinine clearance is 10-30 ml / min, the initial daily dose is 1.25 mg / day, and the maximum daily dose is 5 mg;
- patients with arterial hypertension on hemodialysis: with hemodialysis, ramipril is slightly excreted; the initial dose is 1.25 mg, and the maximum daily dose is 5 mg, the drug should be taken a few hours after the hemodialysis session.
Patients with impaired liver function. Treatment of patients with impaired liver function should be started under close supervision, and the maximum daily dose in such cases should be 2.5 mg.
Elderly patients. The initial dose should be lower, and further dose titration should be carried out more gradually, given the high likelihood of side effects, especially in very old and frail patients. In such cases, a lower initial dose of 1.25 mg ramipril should be prescribed.
Recent Reviews