Tritace, pills 5mg, 28pcs

Composition

1 tablet contains:

ramipril 5 mg.

Auxiliary substances:  

hypromellose,

pregelatinized starch,

microcrystalline cellulose,

sodium stearyl fumarate,

red iron oxide dye.

Pharmacological action

Tritac is an antihypertensive drug, an ACE inhibitor. Ramiprilate, the active metabolite of ramipril, is a long-acting ACE inhibitor. In blood plasma and tissues, this enzyme catalyzes the conversion of angiotensin I to angiotensin II (an active vasoconstrictor) and cleavage of the active vasodilator bradykinin.

A decrease in angiotensin II production and an increase in bradykinin activity leads to vasodilation and contributes to the cardioprotective and endothelioprotective effects of ramipril. Angiotensin II stimulates the release of aldosterone, and ramipril causes a decrease in aldosterone secretion.

Taking ramipril leads to a significant decrease in OPSS, generally without causing changes in renal blood flow and glomerular filtration rate.

Taking ramipril causes a decrease in blood pressure both in the supine and standing positions without a compensatory increase in heart rate. The antihypertensive effect begins 1-2 hours after ingestion of a single dose of the drug and persists for 24 hours.

The maximum antihypertensive effect of Tritac usually develops by 3-4 weeks of continuous use of the drug and is maintained for a long time. Sudden discontinuation of the drug does not lead to a rapid and significant increase in blood pressure.

The use of the drug reduces mortality (including sudden death), the risk of developing severe heart failure, and reduces the number of hospitalizations of patients with clinical signs of chronic heart failure after acute myocardial infarction.

In patients with diabetic and non-diabetic clinically expressed nephropathy, the drug reduces the rate of progression of renal failure, and in the preclinical stage of diabetic and non-diabetic nephropathy, ramipril reduces albuminuria. The drug has a positive effect on carbohydrate metabolism and lipid profile, causes a decrease in pronounced hypertrophy of the myocardium and vascular wall.

Indications

• Arterial hypertension.
• Chronic heart failure (as part of combination therapy), including those that developed during the first few days after acute myocardial infarction.
• Diabetic nephropathy and nephropathy against the background of chronic diffuse kidney diseases (chronic glomerulonephritis with pronounced proteinuria) – preclinical and clinically pronounced stages.
• To prevent the development of myocardial infarction, stroke, or “coronary death” in patients with coronary heart disease, with an increased risk of cardiovascular diseases, including patients who have had a myocardial infarction, percutaneous transluminal coronary angioplasty, and coronary artery bypass grafting.

Contraindications

Hypersensitivity to ramipril or other ACE inhibitors, a history of angioedema during ACE inhibitor therapy, hereditary or idiopathic angioedema, bilateral renal artery stenosis, stenosis of the artery of a single kidney, condition after kidney transplantation, hemodynamically significant aortic or mitral stenosis, HOCMP, primary hyperaldosteronism, pregnancy, lactation.

With caution. Severe lesions of the coronary and cerebral arteries (risk of reduced blood flow due to excessive blood pressure reduction), unstable angina, severe ventricular arrhythmias, end – stage CHF, decompensated “pulmonary” heart, diseases requiring the use of corticosteroids and immunosuppressants (lack of clinical experience) – including systemic connective tissue diseases, renal and/or liver failure, hyperkalemia, hyponatremia (including on the background of diuretics and a diet with restricted Na+ intake), conditions accompanied by a decrease in BCC (including diarrhea, vomiting), elderly age, age 18 years (safety and efficacy of use have not been studied).

Side effects

The undesirable effects listed below are given according to the following frequency gradations: very common (≥10%), common (≥1%,

From the cardiovascular system: often-excessive decrease in blood pressure, violation of orthostatic regulation of vascular tone (orthostatic hypotension), syncopal states; sometimes-myocardial ischemia, including the development of an attack of angina or myocardial infarction, tachycardia, arrhythmias (appearance or increase), palpitations, peripheral edema, flushes of blood to the skin of the face; rarely-occurrence or increase of circulatory disorders against the background of stenosing vascular lesions, vasculitis; frequency unknown-Raynaud’s syndrome.

From the central nervous system: often – headache, a feeling of “lightness” in the head; sometimes – dizziness, ageusia (loss of taste sensitivity), dysgeusia (violation of taste sensitivity), depressed mood, anxiety, nervousness, motor restlessness, sleep disorders, including drowsiness; rarely – tremor, balance disorders, confusion; frequency unknown – cerebral ischemia, including ischemic stroke and transient cerebrovascular accident, violation of psychomotor reactions, paresthesia (sensation of pain). burning sensation), parosmia (impaired perception of odors), impaired attention.

Sides of the visual organ: sometimes-visual disorders, including blurred images; rarely-conjunctivitis.

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

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

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

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

From the side of the kidneys and urinary tract: sometimes-impaired renal function, including the development of acute renal failure, increased urinary excretion, increased pre-existing proteinuria, increased urea and creatinine concentrations in the blood.

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

From the hematopoietic system: sometimes – eosinophilia; rarely-leukopenia, including neutropenia and agranulocytosis, a decrease in the number of red blood cells in the peripheral blood, a decrease in the concentration of hemoglobin, thrombocytopenia; frequency unknown – inhibition of bone marrow hematopoiesis, pancytopenia, hemolytic anemia.

From the skin and mucous membranes: often – skin rash (in particular maculopapular); sometimes – angioedema, including with a fatal outcome (laryngeal edema can cause airway obstruction leading to death), pruritus, hyperhidrosis; rarely – exfoliative dermatitis, urticaria, onycholysis; very rarely – photosensitization reactions; frequency unknown – toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravation, psoriasis-like dermatitis, pemphigoid or lichenoid (lichen-like) exanthema or enanthema, alopecia. Musculoskeletal disorders: often-muscle cramps, myalgia; sometimes-arthralgia.

Disorders of metabolism, nutrition and laboratory parameters: often-an increase in the concentration of potassium in the blood; sometimes-anorexia, decreased appetite; frequency unknown-a decrease in the concentration of sodium in the blood.

From the immune system: the frequency is unknown – anaphylactic or anaphylactoid reactions (with ACE inhibition, the number of anaphylactic or anaphylactoid reactions to insect poisons increases), an increase in the concentration of antinuclear antibodies.

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

Interaction

When potassium salts, potassium-sparing diuretics (for example, amiloride, triamterene, spironolactone) are used simultaneously with Tritac, hyperkalemia is observed (monitoring of the potassium content in the blood serum is necessary).

Simultaneous use of Tritac with antihypertensive agents (in particular, diuretics) and other drugs that reduce blood pressure, leads to an increase in the effect of ramipril.

When used concomitantly with sleeping pills, opioids and analgesics, a sharp decrease in blood pressure is possible.

Vasopressor sympathomimetic drugs (epinephrine) and estrogens can cause a weakening of the effect of ramipril.

With the simultaneous use of Tritac with allopurinol, procainamide, cytostatic agents, immunosuppressants, systemic corticosteroids and other drugs that can change the blood picture, it is possible to reduce the number of white blood cells in the blood.

When used concomitantly with lithium preparations, it is possible to increase the concentration of lithium in plasma, which leads to an increase in the cardio – and neurotic effects of lithium.

With the simultaneous use of Tritac with oral hypoglycemic agents (sulfonylureas, biguanides), insulin, hypoglycemia increases. NSAIDs (Indometacin, acetylsalicylic acid) may reduce the effectiveness of ramipril.

When used concomitantly with heparin, it is possible to increase the concentration of potassium in the blood serum.

Table salt reduces the effectiveness of ramipril.

Ethanol enhances the hypotensive effect of ramipril.

How to take, course of use and dosage

Arterial hypertension: inside, the initial dose is 2.5 mg, once, in the morning, on an empty stomach or 2 times a day. In case of insufficient hypotensive effect, the dose is gradually increased every 2-3 weeks. The maximum daily dose is 10 mg, the maintenance dose is 2.5-5 mg.

In the absence of an optimal reduction in blood pressure, diuretic drugs are additionally prescribed. CHF: the initial dose is 1.25 mg / day; if necessary, increase the dose to 2.5 mg for 1-2 weeks.

In the treatment of patients who have suffered a myocardial infarction, the initial dose is 2.5 mg 2 times a day (if poorly tolerated during the first 2 days, take 1.25 mg).

Renal insufficiency (creatinine clearance 30-60 ml / min), age over 65 years, diabetes mellitus: initial dose-1.25 mg, maintenance dose-2.5 mg; maximum dose-5 mg / day.

Overdose

Symptoms: marked decrease in blood pressure, shock, severe bradycardia, impaired water-electrolyte balance, acute renal failure, stupor.

Treatment: gastric lavage, intake of adsorbents, sodium sulfate (if possible during the first 30 minutes). If arterial hypotension develops, the use of alpha-1-adrenostimulants (norepinephrine, dopamine) and angiotensin II (angiotensinamide) may be added to therapy to replenish BCC and restore salt balance.

Special instructions

After taking the first dose, as well as with an increase in the dosage of diuretics and/or ramipril, patients should be under medical supervision for 8 hours to avoid the development of an uncontrolled hypotensive reaction. In patients with CHF, taking the drug can lead to the development of severe arterial hypotension, which in some cases is accompanied by oliguria or azotemia, and rarely-the development of acute renal failure.

The lower limit of systolic blood pressure for treatment in the early stages of myocardial infarction is considered to be 100 mm Hg. Patients with malignant arterial hypertension or concomitant decompensated CHF should begin treatment in a hospital setting. Before and during therapy with ACE inhibitors, it is necessary to count the total number of white blood cells and determine the leukocyte formula (up to 1 time per month in the first 3-6 months of treatment in patients with an increased risk of neutropenia – with impaired renal function, systemic connective tissue diseases or receiving high doses, as well as at the first signs of infection). If neutropenia is confirmed (the number of neutrophils is less than 2 thousand/µl), ACE inhibitor therapy should be discontinued.

Before and during treatment, it is necessary to monitor blood pressure, kidney function (creatinine, urea), K+ and other electrolytes in plasma, Hb, and the activity of” liver ” enzymes in the blood. Caution should be exercised when prescribing the drug to patients on a low-salt or salt-free diet (increased risk of hypotension). Symptomatic hypotension may occur in patients with reduced BCC (due to diuretic therapy), salt restriction, dialysis, diarrhea, and vomiting.

Transient hypotension is not a contraindication for continuing treatment after BP stabilization. In case of repeated occurrence of severe hypotension, the dose should be reduced or the drug should be discontinued. The use of AN69 dialysis membranes in combination with ACE inhibitors is not recommended (due to the possibility of developing anaphylactoid reactions in patients). If there is a history of angioedema that is not associated with the use of ACE inhibitors, then such patients still have an increased risk of developing it when taking it.

Safety and efficacy in pediatric practice: newborns who have been exposed to intrauterine ACE inhibitors should be closely monitored for hypotension, oliguria, and hyperkalemia. With oliguria, it is necessary to maintain blood pressure and renal perfusion by introducing appropriate fluids and vasoconstrictor drugs.

Newborns and children are at risk of oliguria and neurological disorders, possibly due to reduced renal and cerebral blood flow due to a decrease in blood pressure caused by ACE inhibitors (received by pregnant women and after childbirth); lower initial doses and careful monitoring are recommended.

Caution should be exercised when exercising or in hot weather because of the risk of dehydration and hypotension due to reduced fluid volume. It is not recommended to use ethanol. Before surgery (including dentistry), the surgeon/anesthesiologist should be warned about the use of ACE inhibitors.

During the treatment period, care should be taken when driving vehicles and doing other activities. potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (dizziness may occur, especially after the initial dose of an ACE inhibitor in patients taking diuretic drugs).

Form of production

Pills.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Ramipril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Kidney damage, Prevention of heart attacks and strokes, Diabetic nephropathy, Heart failure, Hypertension