Ramag
RX

Ramag

Ramag

Ramag – tablets that are prescribed for hypertension. Recommended for the prevention of cardiovascular disease, the treatment of kidney disease, heart failure, secondary prevention after a heart attack. Available in two dosages: 5 or 10 mg. Indications and application features are described in detail in the instructions.

Information

Indications for use (instruction): Ramag

Treatment of arterial hypertension.

Prevention of cardiovascular disease: reduction of cardiovascular morbidity and fatalities in patients with:

  • pronounced cardiovascular disease of atherothrombotic origin (the presence of a history of ischemic heart disease or stroke or peripheral vascular disease);
  • diabetes with at least one cardiovascular risk factor.

Treatment of kidney disease:

  • initial glomerular diabetic nephropathy, evidenced by the presence of microalbuminuria;
  • expressed glomerular diabetic nephropathy, as evidenced by the presence of macroproteinuria, in patients who have at least one cardiovascular risk factor;
  • expressed glomerular nondiabetic nephropathy, evidenced by the presence of macroproteinuria ≥ 3 g per day.

Treatment of heart failure, which is accompanied by clinical manifestations.

Secondary prophylaxis after acute myocardial infarction: reduction of deaths during the acute stage of myocardial infarction in patients with clinical signs of heart failure, provided treatment is started more than 48 hours after the occurrence of acute myocardial infarction.

How to use

Oral preparation.

Ramag is recommended to be taken daily at the same time. The drug can be taken before, during and after meals, since the use of food does not affect the bioavailability of the drug. Ramag tablets should be swallowed whole with water. They cannot be chewed or crushed.

If it is not possible to use the prescribed dose, ramipril should be used at the appropriate dosage.

Adults

Patients using diuretics. At the beginning of treatment with Ramag, arterial hypotension may occur, the development of which is more likely in patients receiving diuretics at the same time. In such cases, caution is advised, as these patients may have a decrease in BCC and/or electrolyte content.

If possible, it is advisable to discontinue diuretics 2–3 days before starting Ramag treatment.

In patients with hypertension that cannot be reversed with diuretics, treatment with Ramag should be started at a dose of 1.25 mg (use ramipril in the appropriate dosage). Kidney function and blood potassium levels should be carefully monitored. Subsequent dosage of Ramag should be adjusted according to the target blood pressure level.

Hypertension

The dose should be selected individually, depending on the patient's condition and the results of blood pressure control measurements. Ramag can be used as monotherapy or in combination with other classes of antihypertensive drugs.

Initial dose. Ramag treatment should be started gradually, starting with the recommended starting dose of 2.5 mg (use ramipril in the appropriate dosage) per day.

Patients with significant RAAS activation may experience a significant decrease in blood pressure after receiving the initial dose. For such patients, the recommended starting dose is 1.25 mg (ramipril should be used at the appropriate dose) and their treatment should be started under medical supervision.

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 of Ramag is 10 mg per day. Usually, the drug is taken 1 time a day.

Prevention of cardiovascular diseases

Initial dose. The recommended starting dose of Ramag is 2.5 mg (use ramipril in the appropriate dosage) once a day.

Dose titration and maintenance dose. Depending on the individual tolerability of the drug, the dose should be gradually increased. It is recommended that you double the dose after 1–2 weeks of treatment and then, after another 2–3 weeks, increase it to the target maintenance dose of 10 mg once a day.

Treatment of kidney disease

Patients with diabetes and microalbuminuria

Initial dose. The recommended starting dose of Ramag is 1.25 mg (use ramipril in the appropriate dosage) once a day.

Dose titration and maintenance dose. Depending on the individual tolerability of the drug in the subsequent treatment, the dose is increased. After 2 weeks of treatment, it is recommended to double the single daily dose to 2.5 mg (use ramipril in the appropriate dose) and then to 5 mg after another 2 weeks of treatment.

Patients with diabetes and at least one cardiovascular risk factor

Initial dose. The recommended starting dose of Ramag is 2.5 mg (use ramipril in the appropriate dosage) once a day.

Dose titration and maintenance dose. Depending on the individual tolerability of the drug in the subsequent treatment, the dose is increased. After 1–2 weeks of treatment, the daily dose of Ramag 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.

Patients with non-diabetic nephropathy, evidenced by the presence of macroproteinuria ≥ 3 g per day

Initial dose. The recommended starting dose of Ramag is 1.25 mg (use ramipril in the appropriate dosage) once a day.

Dose titration and maintenance dose. Depending on the individual tolerability of the patient, the drug is increased in subsequent treatment. After 2 weeks of treatment, it is recommended to double the single daily dose to 2.5 mg (use ramipril in the appropriate dose) and then to 5 mg after another 2 weeks of treatment.

Heart failure with clinical manifestations

Initial dose. For patients whose condition has stabilized after diuretic treatment, the recommended starting dose is 1.25 mg (ramipril administered at the appropriate dosage) per day.

Dose titration and maintenance dose. The Ramag dose is titrated 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 prophylaxis after acute myocardial infarction in the presence of heart failure

Initial dose. 48 hours after the onset of myocardial infarction, patients whose condition is clinically and hemodynamically stable are prescribed an initial dose of 2.5 mg (to use ramipril in the appropriate dosage) 2 times a day for 3 days. If the initial dose of 2.5 mg (use of ramipril in the appropriate dosage) is poorly tolerated, then the dose of 1.25 mg (use of ramipril in the appropriate dosage) should be given 2 times a day for 2 days with a further increase to 2.5 mg (use of ramipril at the appropriate dosage) and 5 mg 2 times a day. If the dose cannot be increased to 2.5 mg (ramipril administered at the appropriate dose) 2 times a day, treatment should be discontinued.

Dose titration and maintenance dose. Subsequently, the daily dose is increased by doubling it at intervals of 1-3 days until reaching the target maintenance dose of 5 mg 2 times a day.

Whenever possible, the maintenance daily dose is divided into 2 doses.

If the dose cannot be increased to 2.5 mg (ramipril administered at the appropriate dose) 2 times a day, treatment should be discontinued. Experience in treating patients with severe (New York Cardiac Association (NYHA) Class IV functional class) cardiac failure immediately after myocardial infarction is still insufficient. If, however, a decision is made to treat such patients with this drug, it is recommended that therapy be started at a dose of 1.25 mg (use ramipril at the appropriate dose) once a day and any increase should be performed 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 score:

  • if creatinine clearance is ≥60 ml/min, there is no need to adjust the starting dose (2.5 mg/day (use ramipril in the appropriate dose)) and the maximum daily dose is 10 mg;
  • if creatinine clearance is 30-60 ml/min, no initial dose adjustment (2.5 mg/day (use ramipril in appropriate dosage)) is required and maximum daily dose is − 5 mg;
  • if creatinine clearance is 10-30 ml/min, the initial daily dose is 1.25 mg/day (use ramipril in the appropriate dosage) and the maximum daily dose is 5 mg;
  • patients with hypertension who are on hemodialysis: in hemodialysis ramipril is excreted to a small extent; the starting dose is 1.25 mg (use ramipril in the appropriate dose) 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 with Ramag in patients with impaired liver function should be started under close medical supervision and the maximum daily dose in such cases should be 2.5 mg (use ramipril in the appropriate dosage).

Elderly patients. The initial dose should be lower, and subsequent dose titration should be performed more gradually in view of the higher likelihood of adverse effects, especially in very old and infirm patients. In such cases, a lower starting dose of 1.25 mg ramipril should be prescribed (ramipril should be used at the appropriate dosage).

Also see the above dosage information for patients receiving diuretics.

Children. Ramag is not recommended for use in children (up to 18 years of age) as there is insufficient data on the efficacy and safety of this drug for such patients.

Contraindications

Hypersensitivity to the active substance or to any of the excipients included in the preparation or to other ACE inhibitors. A history of angioneurotic edema (hereditary, idiopathic, or previously transmitted against the use of ACE inhibitors or angiotensin II receptor antagonists). Co-administration with sacubitrile / valsartan. Significant bilateral renal artery stenosis or renal artery stenosis in the presence of a single functioning kidney. Pregnancy and pregnancy planning. Ramipril should not be used in patients with hypotension or hemodynamically unstable conditions. Co-administration of Ramag with aliskiren containing contraindicated in patients with diabetes mellitus or renal dysfunction (GFR <60 ml/min / 1.73 m2). The concomitant use of ACE inhibitors and extracorporeal treatments that result in blood contact with negatively charged surfaces should be avoided.

Composition

Active ingredient: ramipril;

1 tablet contains ramipril 5 mg or 10 mg;

Excipients:

Tablets 5 mg: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch, sodium stearyl fumarate, pigment mixture PB24877 pink: lactose monohydrate, iron oxide red (E 172), iron oxide yellow (E 172);

Tablets 10 mg: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, starch pregelatinized, sodium stearyl fumarate.

Release form

10 tablets in a blister, 3 blisters in a carton.

Storage conditions

Store in the original package at a temperature not exceeding 25 °C. Keep out of the reach of children.

Manufacturer

Actavis Ltd., BLB 016, Bulebel Industrial Zone, Zeitung, ZTN3000, Malta.

Balkanpharma – Dupnitsa AD, ul. Samokov Highway 3, Dupnitsa, 2600, Bulgaria.

Registration certificate

No.464 dated 02.22.2019
Registration certificate (for a dosage of 10 mg): UA/13550/01/01
Registration certificate (for a dosage of 5 mg): UA/13550/01/02

Information on medicines is intended exclusively for doctors.