Ramizes 10 mg pills number 30

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer Farmak OJSC (Ukraine, Kiev)
Registration certificate UA/10982/01/04
The main medicament Ramizes
morion code 149215

Ramipril instruction manual

Composition:

active ingredient: ramipril; 1 tablet contains ramipril 1.25 mg, 2.5 mg, 5 mg, 10 mg;
auxiliary substances: tablets of 1.25 mg: sodium bicarbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch 1500, magnesium stearate;
tablets of 2.5 mg: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch 1500, magnesium stearate, iron oxide yellow (E 172);
tablets of 5 mg: sodium bicarbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch 1500, magnesium stearate, iron oxide yellow (E 172), iron oxide red (E 172);
tablets of 10 mg: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, starch pregelatinized 1500, magnesium stearate.

Dosage form.

Pills.

Pharmacotherapeutic group.

Angiotensin converting enzyme inhibitors. The code of automatic telephone exchange С09А А05.

Clinical characteristics.

Indications.

Arterial hypertension (as a monotherapy or in combination with other antihypertensive drugs, for example, diuretics or calcium antagonists).
Congestive heart failure (also in combination with diuretics).
Congestive heart failure, which occurred during the first few days after an acute myocardial infarction.
Nondiabetic or diabetic glomerular or initial nephropathy.
Reducing the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk (severe coronary heart disease (with or without a history of myocardial infarction), a history of history, a history of peripheral vascular disease, or diabetes mellitus with at least one an additional factor of cardiovascular risk (microalbuminuria, arterial hypertension, increased total cholesterol level, low level of high-density lipoprotein cholesterol, smoking)).

Contraindications.

  • Hypersensitivity to other ACE inhibitors or to any of the components of the drug;
  • angioedema in history;
  • stenosis of the renal artery (unilateral or bilateral);
  • hypotensive or hemodynamically unstable conditions;
  • primary hyperaldosteronism;
  • pregnancy, the period of breastfeeding;
  • childhood.

During the reception of Ramizes, dialysis or hemofiltration can not be performed using poly (acrylonitrile, sodium-2-methylsulfonate) membranes with high ultrafiltration activity (for example, "AN 69") and apheresis of LDL (low-density lipoprotein) using dextran sulfate from risk of developing severe anaphylactic shock.

Method of administration and dose.

Ramizes are taken regardless of the meal. Tablets should be swallowed whole, not chewing, washed down with plenty of water.

Treatment of arterial hypertension. The initial dose of the drug is usually 2.5 mg once a day. In the future, in case of insufficient antihypertensive effect, the dose of the drug is recommended to be increased by doubling it every 2-3 weeks.The usual maintenance dose is 2.5-5 mg per day. The maximum permissible daily intake for adults is 10 mg. An alternative to increasing the dose above 5 mg Ramizez per day may be an additional use, for example, a diuretic or a calcium antagonist.

Treatment of congestive heart failure. The initial dose is 1.25 mg once a day. With insufficient therapeutic effect, the daily dose can be increased, doubling it every 1-2 weeks. If the desired dose is 2.5 mg Ramizesa or higher, it can be taken as a single dose or divided into two doses. The maximum daily dose should not exceed 10 mg.

Treatment after acute myocardial infarction. The initial daily dose is 5 mg ( 2.5 mg in the morning and in the evening).With poor tolerance, this dose should be reduced to 2.5 mg per day (1.25 mg in the morning and evening for two days).

Then, depending on the reaction of the patient, the dose can be increased. Increase the dose is recommended by doubling it every 1-3 days.

In the future, the total daily dose, which was first divided into two, can be taken single-time. The maximum permissible daily dose is 10 mg of Ramizez.

The experience of treating patients with severe cardiac insufficiency (grade IV according to the NYHA - Yew York Heart Association) heart failure immediately after myocardial infarction is not enough. If it is decided to treat such patients with this remedy, it is recommended to begin therapy with the lowest effective daily dose (1.25 mg Ramizes once a day) and any increase in it should be done very carefully.

To reduce the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, the recommended initial dose of Ramizes is 2.5 mg once daily. The dose is gradually increased depending on the tolerability of the drug. It is recommended to double the dose in one week, and after three weeks to increase it to the usual maintenance dose - 10 mg once a day. The use of a dose of more than 10 mg once a day was not studied enough.

The use of patients with severe renal insufficiency and clearance of creatinine <36 ml / min was not studied enough.

Diabetic or nondiabetic nephropathy. The initial dose of the drug is 1.25 mg per day. Depending on the therapeutic effect, the daily dose may increase to a maintenance dose, which is 5 mg once a day. Doses over 5 mg once a day were not studied enough.

Special categories of patients.

Elderly patients. The initial dose is 1.25 mg per day.

Dosing for patients with renal insufficiency. If the creatinine clearance is 50 to 20 ml / min per 1.73 m2 body surface area, an initial daily dose of 1.25 mg Ramizes is usually used. The maximum allowable daily dose in this case is 5 mg Ramizes.

Patients with impaired liver function. In patients with impaired liver function, the maximum daily dose is 2.5 mg. Such patients in the early stages of Ramizes treatment require careful medical supervision.

Patients with incompletely compensated deficiency of fluid or salt in the body, patients with severe arterial hypertension, as well as patients for whom an antihypertensive reaction may pose a particular risk (for example, with clinically significant stenosis of coronary vessels or blood vessels supplying the brain): a reduced initial dose of 1.25 mg per day.

Patients who had previously been treated with diuretics. It is advisable to stop taking diuretics for 2-3 days or, depending on the duration of the diuretic, even earlier, before starting Ramises treatment, or at least reduce the dose of the diuretic. The initial daily dose is usually 1.25 mg.

In patients with arterial hypertension who are on hemodialysis: ramipril slightly gives in to dialysis. The initial dose is 1.25 mg per day, and the maximum daily dose is 5 mg; the drug should be used several hours after hemodialysis.

Adverse reactions.

Adverse reactions are classified by frequency of occurrence: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10000 to <1/1000), very rarely (from ≥1 / 100000 to <1/10000), the frequency is not determined (can not be determined from available data).

From the side of the cardiovascular system: often - arterial hypotension, orthostatic decrease in arterial pressure, syncope; infrequently - myocardial ischemia, including angina pectoris or myocardial infarction, tachycardia, arrhythmia, palpitations, peripheral edema, redness; rarely - stenosis of vessels, hypoperfusion, vasculitis; very rarely - a short-term ischemic attack, ischemic stroke; frequency is not defined - the Raynaud phenomenon.

On the part of the urinary system: infrequently - impaired renal function, including acute renal failure, increased urine output, worsening of background proteinuria, increased levels of urea and creatinine.

From the respiratory system: often - unproductive, irritating cough, bronchitis, sinusitis; infrequently - nasal congestion, bronchospasm, including exacerbation of asthma; rarely - dyspnoea.

From the digestive tract, liver and pancreas: often - inflammation in the oral cavity and gastrointestinal tract, digestive disorders, dyspepsia, diarrhea, nausea, vomiting; infrequent - increased levels of pancreatic enzymes, angioedema of the small intestine, including gastritis, constipation, dry mouth, increased levels of liver enzymes and / or conjugates of bilirubin; rarely - glossitis, a feeling of discomfort in the abdominal cavity, stomach pain, cholestatic jaundice, damage to the liver cells; frequency is not defined - aphthous stomatitis; in isolated cases - pancreatitis, impaired perception of odor and taste (eg, metallic taste); sometimes - a complete loss of taste, acute liver failure, cholestatic or cytolytic hepatitis - with a fatal outcome).

From the nervous system, the senses and the psyche: often - headache, dizziness; infrequently - vertigo, paresthesia, agevzia, dysgeusia, impaired vision, including blurred vision, decreased mood, anxiety, nervousness, anxiety, sleep disturbance, including somnolence; rarely - tremor, balance disorder, conjunctivitis, hearing impairment, ringing in the ears, confusion; frequency is not determined - cerebral ischemia, including ischemic stroke and transient ischemic attack, impaired psychomotor functions, burning sensation, parosmia, impaired attention.

Allergic and immunopathological reactions: the frequency is not determined - anaphylactic and anaphylactoid reactions, an increase in the level of antinuclear antibodies.

Reactions from the skin: often - rash, itching, urticaria; infrequently - angioedema, airway obstruction due to angioedema may have fatal consequences, pruritus, hyperhidrosis; rarely - exfoliative dermatitis, urticaria, onycholysis; very rarely photosensitivity reaction; frequency not defined - maculopapular rash, pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, exacerbation of psoriasis, psoriatic dermatitis, pemphigoid or lichenoidal exanthema or enanthema, allopecia.

Musculoskeletal disorders and disorders of connective tissue: often - muscle spasms, myalgia; infrequently - arthralgia.

Disorders of metabolism and nutrition: often - increased levels of potassium in the blood; infrequently - anorexia, decreased appetite; the frequency is not determined - a decrease in the level of sodium in the blood.

From the hemopoietic system and the lymphatic system: infrequently - eosinophilia; rarely - a decrease in the number of white cells (including neutropenia and agranulocytosis), a decrease in the number of red cells, a decrease in hemoglobin, a decrease in the number of platelets; frequency is not defined - bone marrow insufficiency, pancytopenia, hemolytic anemia.

Common disorders: often - pain in the chest, asthenia; infrequently - pyrexia; rarely - weakness, drowsiness, fatigue.

Disorders of reproductive function and mammary glands: infrequent - transient erectile dysfunction, impotence, decreased libido; frequency is not defined - gynecomastia.

Overdose.

Symptoms. Overdose can cause excessive expansion of peripheral vessels (with severe arterial hypotension, shock), bradycardia, electrolyte balance disturbance and kidney failure.

Treatment. General measures (gastric lavage, reception of activated carbon and sodium sulfate, if possible, during the first 30 minutes). In arterial hypotension, in addition to measures aimed at restoring fluid volume and salt balance, agonists of α1-adrenergic receptors (for example, norepinephrine, dopamine) should be used.

There is no data on the efficacy of forced diuresis, changes in urinary pH, hemofiltration or dialysis, in terms of accelerating the elimination of ramipril or ramiprilate.

Use during pregnancy or lactation.

Ramizes contraindicated in pregnancy. Before the beginning of its use, pregnancy should be excluded, as well as prevention of its onset, using an adequate method of contraception. If pregnancy occurred while taking Ramises, it should be immediately replaced with a drug that does not contain an ACE inhibitor.

Breastfeeding is a contraindication for the use of the drug.

Children.

Due to the lack of sufficient clinical experience, Ramizes can not be administered to children.

Features of application.

Ramises should be used under the constant supervision of a doctor.

In patients who were treated with ACE inhibitors, there were cases of angioedema, facial, extremities, lips, tongue, glottis or pharyngeal.

Urgent treatment of angioedema, which threatens life, involves the immediate administration of epinephrine (subcutaneously or slowly intravenously), in parallel with ECG monitoring and blood pressure. Recommended hospitalization, monitoring the patient for 12-24 hours minimum. You can write it out only after the symptoms have completely disappeared.

Patients who were treated with ACE had cases of angioedema. These patients complained of abdominal pain (with or without nausea or vomiting); In some cases, angioedema has also been observed. Symptoms of angioedema and intestinal edema disappeared after discontinuation of ACE inhibitors. There is no adequate therapeutic experience with Ramizes for children, patients with severe renal dysfunction (creatinine clearance below 20 mL / min at 1.73 m2 body surface area), and patients on dialysis.

Patients with increased activity of the renin-angiotensin system. In the treatment of patients with increased activity of the renin-angiotensin system, one should be especially cautious. Such patients have the risk of an unexpected and significant reduction in blood pressure and impairment of renal function as a result of ACE inhibition, especially when an ACE inhibitor or concomitant diuretic is prescribed for the first time or for the first time at a higher dose. At the beginning of treatment with the drug or with increasing the dose, you need to carefully monitor blood pressure until there is a threat of a sharp decline. Increased activity of the renin-angiotensin system can be expected, in particular, in patients with severe, especially malignant hypertension; in patients with heart failure, especially with severe, or one that has been treated with other drugs that can lower blood pressure; in patients with hemodynamically significant obstruction of inflow or outflow of blood from the left ventricle (for example, due to stenosis of the aorta or stenosis of the mitral valve or hypertrophic cardiomyopathy); in patients with hemodynamically significant stenosis of the renal artery. This category of patients in the initial phase of treatment needs special medical supervision. It may be necessary to stop the treatment initiated by diuretics: in patients who previously took diuretics. If discontinuance or reduction of the diuretic dose is not possible, strict medical supervision is necessary in the initial phase of treatment; in patients with a threat or violation of the water-electrolyte balance (as a result of insufficient intake of fluid or salt or, for example, due to diarrhea, vomiting or excessive sweating, in cases where compensation for lack of fluid and salt is insufficient).

It is recommended to correct the state of dehydration, hypovolemia or salt deficiency before treatment (however, for patients with heart failure such corrective measures should be carefully evaluated in terms of the possible risk of bulk overload). In clinically significant conditions, Ramisez treatment can be started or continued only if appropriate measures are simultaneously taken to prevent excessive blood pressure lowering and to reduce renal function.

Patients with liver disease. In patients with impaired liver function, the response to Ramizes treatment can be either increased or decreased. In addition, in patients with severe cirrhosis of the liver with edema and / or ascites, the activity of the renin-angiotensin system can be significantly increased. Therefore, during treatment of these patients it is necessary to be especially cautious.

Patients for whom a significant reduction in blood pressure presents a particular risk (eg, patients with hemodynamically significant stenosis of the coronary arteries or cerebral vessels), in the initial phase of treatment, special medical control is necessary.

The elderly. In the elderly response to ACE inhibitors may be more pronounced. At the beginning of treatment is recommended to estimate renal function. Monitoring of renal function. It is recommended to monitor renal function, especially in the first weeks of treatment with an ACE inhibitor. Especially careful control is needed for patients with heart failure; reduction in renal function; transplanted kidney; renovascular disease, including patients with hemodynamically significant unilateral renal artery stenosis. In the latter group of patients, even a slight increase in creatinine level in the blood serum may be indicative of a unilateral reduction of kidney function.

The combination with the methods of extracorporeal therapy. When receiving Ramizesa impossible to carry out procedures of extracorporeal therapies that result in contact of blood with negatively charged surfaces because of the risk of severe anaphylactic shock. Therefore, when using the drug should not conduct dialysis or hemofiltration using a poly (akrilonitrinovyh, sodium 2-metilsulfonatnyh) membranes with high ultrafiltration activity (e.g., «« AN 69 ") and the procedure apheresis LDL (low density lipoproteins) with dextran sulfate.

Hyperkalemia. In some patients treated with ACE inhibitors including ramipril observed hyperkalemia. The risk of hyperkalemia is higher in patients with renal insufficiency, persons older than 70 years with uncontrolled diabetes mellitus, those who received potassium salts, potassium-sparing diuretics, as well as other active substances which increase potassium levels, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis. If a combined use of these drugs is considered appropriate recommended regular monitoring of the level of potassium in serum.

Neutropenia / agranulocytosis. Cases of neutropenia / agranulocytosis, as well as thrombocytopenia and anemia are rare. There are reports about the possibility of bone marrow suppression. It is recommended to monitor the number of white blood cells to detect a possible leucopenia. It is necessary to carry out the bowl hemolytic monitoring patients with impaired renal function, with concomitant collagenosis (systemic lupus erythematosus or scleroderma), and in the initial phase of treatment or if the patient is taking other drugs, which can cause changes in the blood picture.

Cough. In some patients, the application of ACE inhibitors, cough occurs. Characteristically, the cough nonproductive, persistent and goes after the cessation of therapy. The probability of cough caused by ACE inhibitors should be considered in the differential diagnosis of cough.

The drug contains lactose, therefore it should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose syndrome malabsorption.

Ability to influence the reaction rate when driving or operating other machines.

Some side effects (e.g., some of the symptoms of lowering blood pressure, in particular, dizziness) may adversely affect the patient's ability to focus attention and psychomotor speed reactions, particularly at the beginning of treatment, or at the transition to the treatment by other drugs. After receiving the first dose or further dose escalation is not desirable to drive vehicles or work with other mechanisms for several hours.

The interaction with other drugs and other types of interactions.

Use with caution. Antihypertensive drugs (e.g. diuretics), and other drugs can lower blood pressure (e.g., nitrates, tricyclic antidepressants, anesthetics) should be expected to enhance the antihypertensive effect of ramipril. It recommended regularly monitor serum sodium concentration in patients who are treated simultaneously with diuretics.

Sympathomimetic vasoconstrictor may reduce blood pressure lowering effect Ramizesa. It is recommended to carefully monitor your blood pressure.

Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other drugs which may cause changes in hemogram, may increase the likelihood of hematological reactions while the use of ramipril.

Lithium salt. Excretion of lithium by the action of ACE inhibitors may decrease. Such a reduction can lead to an increase in the concentration of lithium in blood serum and improve lithium toxicity. In connection with this need to control the concentration of lithium. Antidiabetics (e.g., insulin and sulfonylurea derivatives). ACE inhibitors can enhance the effects of insulin. In some cases this may lead to hypoglycemic reactions in patients who are concurrently applied antidiabetics. At the beginning of treatment is recommended particularly careful monitoring of blood glucose levels.

Nonsteroidal anti-inflammatory drugs (NSAIDs). May weaken the effect of blood pressure reduction under the influence Ramizesa. Also, simultaneous treatment with ACE inhibitors and NSAIDs can cause increased risk of loss of kidney function and increase the level of potassium in serum.

Heparin. May increase the concentration of potassium in the blood serum.

Alcohol. Increases vasodilatation. Ramizes may increase the effects of alcohol.

Increased intake of salt can attenuate Ramizesa antihypertensive effect.

As a consequence of ACE inhibition increases the likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom. It is believed that this effect may also be observed with respect to other allergens.

Pharmacological properties.

Pharmacodynamics. Ramizes - antihypertensive drug, an ACE inhibitor. Suppressing synthesis of angiotensin II, the preparation reduces its vasoconstrictor effect and stimulating effect on the secretion of aldosterone. Increases in plasma renin activity and also inhibits the metabolism of bradykinin.

Ramipril causes a marked reduction in peripheral arterial resistance. In general, renal plasma flow and glomerular filtration rate does not change significantly. Introduction of ramipril to patients with hypertension leads to lower blood pressure in supine and standing, without a compensatory increase in heart rate. In most patients, the antihypertensive effect after oral administration of a single dose appears in 1-2 hours. The maximal effect of a single dose is usually achieved after 3-6 hours and typically lasts for 24 hours. The maximum antihypertensive effect of ramipril during prolonged observed after 3-4 weeks. When long-term therapy, it is stored for 2 years. In response to the abrupt cessation of administration of ramipril is no rapid and pronounced blood pressure rise.

In patients with symptomatic heart failure, whose treatment was started 3-10 days after an acute myocardial infarction ramipril reduced the risk of mortality by 27% compared with placebo. It was also revealed a decrease other risks, including the risk of sudden death (30%) and the risk of progression of the disease before the onset of severe / resistant heart failure (23%). In addition, a 26% decreased chance of later hospitalization due to heart failure.

Patients with non-diabetic or diabetic nephropathy ramipril reduces the rate of progression of renal failure and end-stage renal failure, and therefore - the need for dialysis or kidney transplantation. In patients with non-diabetic or diabetic nephropathy, the initial ramipril reduces the albumin excretion.

In patients who have an increased cardiovascular risk due to the presence of vascular disease or diabetes, ramipril reduces the frequency of occurrence of myocardial infarction, stroke or cardiovascular death. Furthermore, ramipril reduces the overall mortality and the appearance and revascularization, as well as delay the onset and progression of congestive heart failure. Ramipril reduces the risk of nephropathy in the overall group of patients and in patients with diabetes. Ramipril is also significantly reduced the incidence of microalbuminuria. Such effects have been observed in patients with both hypertension and with normotension.

Pharmacokinetics. Presystemic metabolism of ramipril to the active metabolite ramiprilat occurs in the liver. Besides such activation to form ramiprilat, ramipril undergoes glucuronidation and converted to ramipril diketopiperazine (ester). Ramiprilat also glyukuroniziruetsya and converted to ramiprilat diketopiperazine (acid).

Ramiprilata Bioavailability after oral administration of 2.5 and 5 mg of ramipril is about 45%. It was found that ramipril passes into breast milk.

Ramipril is rapidly absorbed after oral administration. Absorption of ramipril is not less than 56%. Ramipril with food showed no significant effect on absorption. Maximum plasma concentration of ramipril is achieved in 1 hour after oral administration. The half-life of ramipril is about 1 hr. The peak concentration of ramiprilat plasma occurs between 2 and 4 hours after oral administration of ramipril.

Reduced plasma concentrations of ramiprilat occurs in several phases. The half of the initial phase distribution and elimination is about 3 hours. After this comes a transition phase (with a half life of approximately 15 hours), and then - the final phase, during which the plasma concentration of ramiprilat is very low, with a half life of about 4-5 days.

The presence of the terminal phase is due to the slow dissociation of ramiprilat from the close but saturated due to the ACE.

Despite the long final elimination phase after a single dose of ramipril in the dose of 2.5 mg and higher steady state is achieved after approximately 4 days. Following multiple administration of an "effective" half-life, depending on the dose of 13-17 hours. dissociation time ramiprilata with ACE - 10.7 hours, indicating a high activity.

Binding of ramipril and ramiprilat with serum proteins is about 73% and 56%, respectively. In healthy volunteers aged 65-76 years ramipril and ramiprilat kinetics similar to that in healthy young volunteers. If the kidney excretion function ramiprilata reduced renal clearance ramiprilata creatinine clearance decreases proportionally. This causes an increase in plasma concentrations of ramiprilat, which decrease more slowly than in subjects with normal renal function. At high doses (10 mg) in reducing liver, ramipril ramiprilat transformation occurs later, the plasma concentration increases and ramipril ramiprilat excretion is slowed down. As well as in healthy volunteers and patients with hypertension,after oral administration of 5 mg ramipril 1 times a day for 2 weeks in patients with congestive heart failure, a significant accumulation of ramipril and ramiprilat not observed.

Pharmaceutical characteristics.

Basic physical and chemical properties.

1.25 mg Tablets: Tablets ploskotsilindricheskoy form white or almost white color with a chamfer, with a weak specific smell or odorless. On the surface of the tablets may be a slight marbling;
2.5 mg tablets: Tablets ploskotsilindricheskoy form of light yellow color with a facet and Valium, weak specific smell or odorless. On the surface of tablets allowed minor inclusions and marbling;
5 mg tablets: Tablets ploskotsilindricheskoy form a light pink color with the facet and Valium, weak specific smell or odorless. On the surface of tablets allowed minor inclusions and marbling;
10 mg tablets:ploskotsilindricheskoy tablet form, white or almost white color with a facet and Valium, weak specific smell or odorless. On the surface of the tablets may be a slight marbling.

Shelf life.

2 years. Tablets of 1.25 mg - 1 year 6 months. Do not use the product after the expiration date printed on the package.

Storage conditions.

Keep out of reach of children, protected from light at a temperature not higher than 25 ° C.

Packaging.

10 tablets in a blister pack. 1 or 3 blisters enclosed in a pack.

Category vacation.

On prescription.


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