Tritace pills 5mg №28

Indications

- essential hypertension;

- chronic heart failure (as part of combination therapy, in particular in combination with diuretics);

- diabetic or non-diabetic nephropathy preclinical and clinically pronounced stages, including with severe proteinuria, especially when combined with arterial hypertension;

- reducing the risk of myocardial infarction, stroke or cardiovascular mortality in patients with high cardiovascular risk: in patients with confirmed coronary artery disease, myocardial infarction with or without history, including patients who have undergone percutaneous transluminal coronary angioplasty, aorto-coronary chromic, and coronary angioplasty; in patients with a history of stroke; in patients with occlusive lesions of peripheral arteries; in patients with diabetes mellitus with at least one additional risk factor (microalbuminuria, arterial hypertension, increase in plasma concentrations of total cholesterol, decrease in plasma concentrations of cholesterol-HDL, smoking).

- heart failure that developed during the first few days (from 2 to 9 days) after acute myocardial infarction.

Dosage and administration

Tablets must be swallowed whole (do not chew), and drink plenty of water (1/2 cup) of water, regardless of the meal (that is, pills can be taken both before and during or after meals).The dose is selected depending on the therapeutic effect and tolerability of the drug to patients.

Treatment with Tritace ^® is usually long, and its duration in each case is determined by the doctor.

Unless otherwise prescribed, the following dosing regimens are recommended for normal kidney and liver function.

With essential hypertension

Typically, the initial dose is 2.5 mg 1 time per day in the morning (in this case, Tritace pills can be used^® 2.5 mg or 1/2 pill 5 mg with risk). If, when taking the drug in this dose for 3 weeks or more, it is not possible to normalize blood pressure, the dose may be increased to 5 mg / day. With insufficient effectiveness of the dose of 5 mg in 2-3 weeks, it can be doubled to the maximum recommended daily dose of 10 mg / day.

As an alternative to increasing the dose to 10 mg per day with insufficient hypotensive efficacy of a daily dose of 5 mg, other antihypertensive drugs, in particular diuretics or slow Calcium channel blockers, can be added to the treatment.

In chronic heart failure

The recommended initial dose is 1.25 mg 1 time / day (in this case, you can use 1/2 pill of Tritace^® 2.5 mg with risk). Depending on the response to the patient's therapy, the dose may increase. It is recommended to double the dose at intervals of 1-2 weeks. If a daily dose of 2.5 mg or more is required, it can be given once a day or divided into 2 doses.

The maximum recommended daily dose is 10 mg.

With diabetic or non-diabetic nephropathy

The recommended initial dose is 1.25 mg 1 time / day (in this case, you can use 1/2 pill of Tritace^® 2.5 mg with risk). The dose may be increased to 5 mg 1 time / day. In these conditions, doses higher than 5 mg 1 time per day have not been studied enough in controlled clinical trials.

To reduce the risk of myocardial infarction, stroke or cardiovascular mortality in patients with high cardiovascular risk

The recommended initial dose is 2.5 mg 1 time per day (in this case, Tritace pills can be used^® 2.5 mg or 1/2 pill 5 mg with risk).

Depending on the patient's tolerance of the drug, the dose can be gradually increased. It is recommended to double the dose after 1 week of treatment, and in the next 3 weeks of treatment to increase it to the usual maintenance dose of 10 mg 1 time / day.

Doses in excess of 10 mg are not well understood in controlled clinical trials.

The use of the drug in patients with QA less than 0.6 ml / sec has not been studied enough.

In heart failure, which developed during the first few days (from 2 to 9 days) after acute myocardial infarction

The recommended initial dose is 5 mg / day, divided into two single doses of 2.5 mg, which are taken one in the morning and the second in the evening (in this case, you can use Tritace tablets^® 2.5 mg or 1/2 pill 5 mg with risk). If the patient does not tolerate this initial dose (there is an excessive decrease in blood pressure), then it is recommended that he give 1.25 mg 2 times a day for two days (in this case 1/2 pills of Tritace can be used^® 2.5 mg with risk).

Then, depending on the response of the patient, the dose may be increased. It is recommended that the dose with its increase doubled with an interval of 1-3 days. Later, the total daily dose, which was initially divided into two doses, can be given once.

The maximum recommended dose is 10 mg.

Currently, the experience of treating patients with severe heart failure (III-IV functional class according to the NYHA classification), which arose immediately after an acute myocardial infarction, is insufficient. If such patients decide on treatment with Tritace^®It is recommended that treatment should be started with the lowest possible dose - 1.25 mg 1 time / day (in this case 1/2 pills of Tritace can be used^® 2.5 mg with risk) and extreme care should be taken with each dose increase.

Use in selected patient groups

Patients with impaired renal function

At QC from 50 to 20 ml / min The initial daily dose is usually 1.25 mg (in this case, you can use 1/2 pills of Tritace^® 2.5 mg with risk). The maximum allowable daily dose of 5 mg

Patients with incompletely corrected loss of fluid and electrolytes, patients with severe arterial hypertension, as well as patients for whom excessive blood pressure reduction presents a certain risk (for example, in severe atherosclerotic lesions of the coronary and cerebral arteries)

The initial dose is reduced to 1.25 mg / day (in this case, you can use 1/2 pill Tritace^® 2.5 mg with risk).

Patients with prior diuretic therapy

It is necessary, if possible, to cancel diuretics in 2-3 days (depending on the duration of action of diuretics) before starting treatment with Tritace^® or at least reduce the dose of diuretics taken. Treatment of such patients should be started with the lowest dose, equal to 1.25 mg Ramipril (in this case, you can use 1/2 tablet^® 2.5 mg with risk), taken 1 time / day in the morning. After taking the first dose and every time after increasing the dose of ramipril and (or) "loop" diuretics, patients should be under medical supervision for at least 8 hours to avoid an uncontrolled hypotensive reaction.

Elderly patients (over 65)

The initial dose is reduced to 1.25 mg / day (in this case, you can use 1/2 pills of Tritace^® 2.5 mg with risk).

Patients with impaired liver function

The reaction of blood pressure to receive the drug Tritace^® can both increase (due to slowing down the removal of ramiprilat) or decrease (due to slowing down the transformation of the low-active ramipril into the active ramiprilat). Therefore, at the beginning of treatment requires careful medical observation. The maximum permissible daily dose is 2.5 mg (in this case, you can use pills Tritace^® 2.5 mg or 1/2 pill 5 mg with risk).

Adverse effects

The following undesirable effects are given in accordance with the following gradations of the frequency of their occurrence: very often (≥10%), often (≥1%, but <10%), sometimes (≥0.1%, but <1%), rarely (≥0.01 %, but <0.1%), very rarely (<0.01%, including isolated cases), the frequency is unknown (according to the available data it is impossible to establish the frequency of occurrence).

Since the cardiovascular system: often - an excessive decrease in blood pressure, impaired orthostatic regulation of vascular tone (orthostatic hypotension), syncopal conditions; sometimes - myocardial ischemia, including the development of an attack of stenocardia or myocardial infarction, tachycardia, arrhythmias (appearance or amplification), palpitations, peripheral edema, flushing of the skin of the face; rarely - the occurrence or enhancement of circulatory disorders on the background of stenotic vascular lesions, vasculitis; frequency is unknown - Raynaud's syndrome.

From the side of the central nervous system: often - headache, feeling of "lightness" in the head; sometimes - dizziness, agevziya (loss of taste sensitivity), dysgeusia (violation of taste sensitivity), depressed mood, anxiety, nervousness, restlessness, sleep disorders, including drowsiness; rarely - tremor, imbalance, confusion; frequency is unknown - cerebral ischemia, including ischemic stroke and transient cerebral circulation disturbance, impaired psychomotor reactions, paresthesia (burning sensation), parosmia (impaired sense of smell), impaired attention.

Side of the organ of vision: sometimes visual disturbances, including blurred images; rarely - conjunctivitis.

From the organ of hearing: rarely - hearing loss, ringing in the ears.

On the part of the respiratory system: often - dry cough (worse at night and lying down), bronchitis, sinusitis, shortness of breath; sometimes - bronchospasm, including the weighting of the course of asthma, nasal congestion.

From the digestive system: often - inflammatory reactions in the stomach and intestines, indigestion, abdominal discomfort, dyspepsia , diarrhea, nausea, vomiting; sometimes - pancreatitis, incl. fatal (cases of pancreatitis with a fatal outcome when taking ACE inhibitors were extremely rare), increased activity of pancreatic enzymes in the blood plasma, intestinal angioedema, abdominal pain, gastritis, constipation, dry oral mucosa; rarely - glossitis; unknown frequency - aphthous stomatitis (inflammatory reaction of the oral mucosa).

From the hepatobiliary system: sometimes - increased activity of liver enzymes and concentration of conjugated bilirubin in the blood plasma; rarely - cholestatic jaundice, hepatocellular lesions; frequency is unknown - acute liver failure, cholestatic or cytolytic hepatitis (death was rarely observed).

From the kidneys and urinary tract: sometimes - impaired renal function, including the development of acute renal failure , an increase in the excretion of urine, an increase in pre-existing proteinuria, an increase in the concentration of urea and creatinine in the blood.

From the reproductive system and mammary glands: sometimes - transient impotence due to erectile dysfunction, decreased libido; frequency unknown: gynecomastia.

From the hemopoietic system: sometimes - eosinophilia; rarely - leukopenia, including neutropenia and agranulocytosis, a decrease in the number of erythrocytes in peripheral blood, a decrease in the concentration of hemoglobin, thrombocytopenia; frequency is unknown - oppression of bone marrow hematopoiesis, pancytopenia, hemolytic anemia.

From the skin and mucous membranes: often - skin rash (in particular maculopapular); sometimes - angioedema, incl. fatal (laryngeal edema can cause airway obstruction, resulting in death), pruritus, hyperhidrosis; rarely - exfoliative dermatitis, urticaria, oniholysis; very rarely - photosensitivity reactions; frequency is unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, worsening of the course of psoriasis, psoriasis-like dermatitis, pemphigoid or lichenoid (desiccous) exanthema or enanthema, alopecia.

From the musculoskeletal system: often - muscle cramps, myalgia; sometimes arthralgia.

Metabolic disorders, nutrition and laboratory parameters: often - increased concentration of potassium in the blood; sometimes - anorexia, loss of appetite; frequency unknown - decrease in sodium concentration in the blood.

On the part of the immune system: unknown frequency - anaphylactic or anaphylactoid reactions (when ACE is inhibited, the number of anaphylactic or anaphylactoid reactions to insect poisons increases), an increase in the concentration of antinuclear antibodies.

General violations: often - chest pain, feeling tired; sometimes - fever; rarely - asthenia (weakness).

Contraindications

- angioedema (hereditary or idiopathic, and also after taking ACE inhibitors) in history - the risk of rapid development of angioedema;

- hemodynamically significant renal artery stenosis (bilateral or unilateral in the case of a single kidney);

- arterial hypotension (systolic blood pressure less than 90 mm Hg. Art.) Or conditions with unstable hemodynamic parameters;

- hemodynamically significant aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy;

- primary hyper aldosteronism;

- severe renal failure (CC less than 20 ml / min with a body surface of 1.73 m²) (experience in clinical use is insufficient);

- hemodialysis (experience with clinical use is insufficient);

- pregnancy;

- lactation period;

- nephropathy, the treatment of which is carried out by the SCS, NSAIDs , immunomodulators and / or other cytotoxic agents (clinical experience is insufficient);

- chronic heart failure in the stage of decompensation (experience of clinical use is insufficient);

- age up to 18 years (experience of clinical use is insufficient);

- hemodialysis or hemofiltration using some membranes with a negatively charged surface, such as high-flow polyacrylonitrile membranes (risk of hypersensitivity reactions);

- apheresis of low-density lipoproteins using dextran sulfate (risk of hypersensitivity reactions);

- hyposensitization therapy in case of hypersensitivity reactions to the poisons of insects, such as bees, wasps;

- hypersensitivity to ramipril, other ACE inhibitors, or to any of the components of the drug.

Additional contraindications when using the drug Tritace^® in the acute stage of myocardial infarction:

- severe heart failure (functional class IV according to the NYHA classification);

- unstable angina;

- life-threatening ventricular arrhythmias;

- pulmonary heart.

WITH caution

- conditions in which an excessive decrease in blood pressure is particularly dangerous (with atherosclerotic lesions of the coronary and cerebral arteries);

- conditions accompanied by an increase in the activity of the renin-angiotensin-aldosterone system (RAAS), in which, when ACE is inhibited, there is a risk of a sharp decrease in blood pressure with deterioration of renal function (marked arterial hypertension, especially malignant arterial hypertension; chronic heart failure, especially severe or due to which other hypotensive drugs are taken, hemodynamically significant unilateral stenosis of the renal artery (if both kidneys are present); taking diuretics; disturbances of water and electrolyte balance as a result of inadequate intake of liquid and salt, diarrhea, vomiting, excessive sweating);

- dysfunction of the liver (lack of experience in the application: it is possible to both strengthen and weaken the effects of ramipril

- in patients with cirrhosis of the liver with ascites and edema, a significant activation of the RAAS is possible (see above, States accompanied by an increase in the activity of the RAAS);

- renal dysfunction (CC more than 20 ml / min with a body surface of 1.73 m²) due to the risk of hyperkalemia and leukopenia);

- condition after kidney transplantation;

- Systemic diseases of the connective tissue, incl. systemic lupus erythematosus, scleroderma, concomitant therapy with drugs that can cause changes in the pattern of peripheral blood (possibly inhibition of bone marrow hematopoiesis, the development of neutropenia or agranulocytosis);

- diabetes mellitus (risk of hyperkalemia);

- old age (risk of increased hypotensive action);

- hyperkalemia.

Use during pregnancy and lactation

Ramipril is contraindicated during pregnancy, because can have an adverse effect on the fetus: impaired development of the kidneys of the fetus, lowering blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnios, contracture of the limbs, deformation of the skull bones, hypoplasia of the lungs.

Therefore, before taking the drug in women of childbearing age pregnancy should be excluded.

If a woman is planning a pregnancy, the treatment with ACE inhibitors should be stopped.

In case of pregnancy during the treatment with Tritace^®, should, as soon as possible, stop taking it and transfer the patient to the reception of other drugs, with the use of which the risk to the child will be minimal.

If treatment with tritace^® necessary during breastfeeding, breastfeeding should be discontinued.

Application for violations of the liver

WITH caution use in case of marked impaired liver function.

Application for violations of kidney function

Use with caution in marked impaired renal function.

The drug is contraindicated in severe renal failure (CC less than 20 ml / min with a body surface of 1.73 m²), with hemodialysis.

Use in children

Contraindication: age up to 18 years (experience of clinical use is insufficient).

Use in elderly patients

Elderly patients (over 65 years) - the initial dose is reduced to 1.25 mg / day (in this case, 1/2 pills of Tritace can be used^® 2.5 mg with risk).

special instructions

Before starting treatment with Tritace^® it is necessary to eliminate hyponatremia and hypovolemia. In patients who have previously taken diuretics, it is necessary to cancel them or, at least, to reduce their dose 2-3 days before starting to receive the drug Tritace^® (in this case, the condition of patients with chronic heart failure should be carefully monitored, due to the possibility of their decompensation due to an increase in BCC).

After taking the first dose of the drug, as well as increasing its dose and / or dose of diuretics (especially "loop"), it is necessary to ensure close medical observation of the patient for at least 8 hours in order to take appropriate measures in the event of an excessive decrease in blood pressure.

If the drug Tritace^® used for the first time or in a high dose in patients with increased activity of the RAAS, they should be carefully monitored for blood pressure, especially at the beginning of treatment, since these patients have an increased risk of an excessive decrease in blood pressure.

For malignant hypertension and heart failure, especially in the acute stage of myocardial infarction, treatment with Tritace^® should begin only in a hospital.

In patients with chronic heart failure, taking the drug can lead to the development of a pronounced decrease in blood pressure, which in some cases is accompanied by oliguria or azotemia and rarely by the development of acute renal failure.

Care should be taken when treating older patients, since they may be particularly sensitive to ACE inhibitors; in the initial phase of treatment, it is recommended to monitor indicators of renal function.

In patients for whom a decrease in blood pressure may pose a certain risk (for example, in patients with atherosclerotic narrowing of the coronary or cerebral arteries), treatment should begin under strict medical supervision.

Caution should be exercised during physical exertion and / or hot weather due to the risk of sweating and dehydration with the development of arterial hypotension, due to a decrease in the BCC and a decrease in the concentration of sodium in the blood.

During treatment with Tritace^® not recommended to drink alcohol.

Transient hypotension is not a contraindication to continue treatment after stabilization of blood pressure. In the case of recurrence of severe hypotension, reduce the dose or discontinue the drug.

In patients treated with ACE inhibitors, there have been cases of angioedema of the face, limbs, lips, tongue, pharynx, or larynx. In the event of swelling in the face (lips, eyelids) or tongue, or a violation of swallowing or breathing, the patient should immediately stop taking the drug. Angioedema, localized in the area of ​​the tongue, pharynx, or larynx (possible symptoms: impaired swallowing or breathing) can be life-threatening and requires urgent measures for its relief: direct injection 0.3-0.5 mg or IV drip 0.1 mg (under the control of blood pressure, heart rate and ECG) followed by the use of corticosteroids (IV, IV, or orally); It is also recommended in / in the introduction of antihistamines (histamine H antagonists₁- and H₂receptors), and in case of insufficiency of inactivators of the enzyme C₁β-esterase, you can consider the need to introduce in addition to epinephrine inhibitors of the enzyme C₁esterase.The patient should be hospitalized, and monitoring should be carried out until the relief of symptoms, but not less than 24 hours.

In patients treated with ACE inhibitors, there were cases of intestinal angioedema, which was manifested by abdominal pains with nausea and vomiting or without them; in some cases, angioedema of the face was also observed simultaneously. When a patient with the above described symptoms appears in patients with ACE inhibitors, when a differential diagnosis is made, the possibility of developing intestinal angioedema in them should also be considered.

Treatment aimed at desensitization to the poison of insects (bees, wasps), and the simultaneous use of ACE inhibitors can initiate anaphylactic and anaphylactoid reactions (for example, reduction of blood pressure, shortness of breath, vomiting, allergic skin reactions), which can sometimes be life-threatening. During treatment with ACE inhibitors, hypersensitivity reactions to insect venom (for example, bees, wasps) develop faster and are more difficult. If it is necessary to conduct desensitization to the poison of insects, then the ACE inhibitor should be temporarily replaced by an appropriate drug of another class.

When using ACE inhibitors, life-threatening, rapidly developing anaphylactoid reactions have been described, sometimes up to the development of shock during hemodialysis or plasma filtration using certain high-flow membranes (for example, polyacrylonitrile membranes) (see also the instructions of the membrane manufacturers).It is necessary to avoid sharing Tritace^® and such membranes, for example, for urgent hemodialysis or hemofiltration. In this case, it is preferable to use other membranes or exclude the use of ACE inhibitors. Similar reactions were observed with the apheresis of low-density lipoproteins using dextran sulfate. Therefore, this method should not be used in patients receiving ACE inhibitors.

In patients with impaired liver function reaction to treatment with Tritace^® may be either reinforced or weakened. In addition, in patients with severe cirrhosis of the liver with edema and / or ascites, a significant activation of the RAAS is possible, therefore, special care should be taken in treating these patients.

Before surgery (including dental) it is necessary to warn the surgeon / anesthesiologist about the use of ACE inhibitors.

It is recommended to carefully monitor newborns who have been exposed to prenatal effects of ACE inhibitors to detect arterial hypotension, oliguria and hyperkalemia. In oliguria, it is necessary to maintain blood pressure and renal perfusion by injecting appropriate fluids and vasoconstrictor agents. Newborns have a risk of oliguria and neurological disorders, possibly due to a decrease in renal and cerebral blood flow due to a decrease in blood pressure caused by ACE inhibitors.

Control of laboratory parameters before and during treatment with Tritace^® (up to 1 time per month in the first 3-6 months of treatment)

Monitoring kidney function (determination of serum creatinine concentrations)

In the treatment of ACE inhibitors in the first weeks of treatment and subsequently recommended to monitor renal function. Especially careful monitoring is required for patients with acute and chronic heart failure, impaired renal function, after kidney transplantation, patients with renovascular diseases, including patients with hemodynamically significant unilateral renal artery stenosis in the presence of two kidneys (in these patients even a slight increase in serum creatinine may be indicator of decreased renal function).

Electrolyte concentration control

Regular monitoring of serum potassium is recommended. Especially careful monitoring of serum potassium concentration is required for patients with impaired renal function, significant impairment of water and electrolyte balance, and chronic heart failure.

Monitoring of hematological parameters (concentration of hemoglobin, the number of leukocytes, erythrocytes, platelets, leukocyte formula)

It is recommended to monitor the indicators of the complete blood count to detect possible leukopenia. More regular monitoring is recommended at the beginning of treatment and in patients with impaired renal function,as well as in patients with diseases of the connective tissue or in patients receiving at the same time other drugs that can change the pattern of peripheral blood (see the section on Interaction with Other Drugs). Control of the number of leukocytes is necessary for the early detection of leukopenia, which is especially important in patients with an increased risk of its development, as well as at the first signs of infection. If neutropenia is detected (the number of neutrophils is less than 2000 / μl), treatment with ACE inhibitors is required.

When symptoms arise due to leukopenia (for example, fever, swollen lymph nodes, tonsillitis), urgent monitoring of the peripheral blood pattern is necessary. In case of signs of bleeding (the smallest petechiae, red-brown eruptions on the skin and mucous membranes), it is also necessary to control the number of platelets in the peripheral blood.

Determination of liver enzyme activity, blood bilirubin concentration

When jaundice or significant increase in liver enzymes occurs, treatment with Tritace^® should stop and provide medical observation of the patient.

Influence on ability to drive motor transport and control mechanisms

During the treatment with the drug Tritace^® it is necessary to refrain from engaging in potentially hazardous activities, including driving, requiring increased concentration and psychomotor speed, becauseagainst the background of his intake, dizziness may appear, a decrease in the speed of psychomotor reactions, attention, especially after taking the first dose,

Overdose

Symptoms: excessive peripheral vasodilation with the development of a pronounced decrease in blood pressure, shock; bradycardia, water and electrolyte disorders, acute renal failure, stupor.

Treatment: gastric lavage, taking adsorbents, sodium sulfate (if possible during the first 30 minutes). In the case of a pronounced decrease in blood pressure, the administration of alpha can be added to the therapy for replenishing the blood volume rate and restoring electrolyte balance.₁-adrenergic agonists (norepinephrine, dopamine) and angiotensin II (angiotensinamide). In the case of bradycardia refractory to a drug treatment, it may be necessary to install a temporary artificial pacemaker. In case of overdose, it is necessary to monitor serum concentrations of creatinine and electrolytes.

Drug interaction

Contraindications

The use of certain high-flow membranes with a negatively charged surface (for example, polyacrylonitrile membranes) during hemodialysis or hemofiltration and the use of dextran sulfate for the apheresis of low-density lipoproteins increases the risk of developing severe Anaphylactic reactions .

Not recommended combinations

With potassium salts, potassium-sparing diuretics (for example, amiloride, triamterene, spironolactone), a more pronounced increase in the concentration of potassium in sy