Tritace is an antihypertensive preparation, an ACE inhibitor. Ramiprilat, the active metabolite of ramipril, is a long-acting ACE inhibitor. In plasma and tissues, this enzyme catalyzes the conversion of angiotensin I to angiotensin II (active vasoconstrictor) and the breakdown of the active vasodilator bradykinin.
Hypersensitivity to ramipril or other ACE inhibitors, history of angioedema during therapy with ACE inhibitors, hereditary or idiopathic angioedema, bilateral renal artery stenosis, arterial stenosis of a solitary kidney, condition after kidney transplantation, hemodynamically significant aortic or mitral stenosis, HOCM, primary hyperaldosteronism, pregnancy, lactation.
With caution. Severe lesions of the coronary and cerebral arteries (danger of reducing blood flow with an excessive decrease in blood pressure), unstable angina pectoris, severe ventricular arrhythmias, end-stage CHF, decompensated cor pulmonale, diseases requiring the appointment of corticosteroids and immunosuppressants (lack of clinical experience) - incl. h. with systemic connective tissue diseases, renal and / or liver failure, hyperkalemia, hyponatremia (including against the background of diuretics and a diet with restriction of Na + intake), conditions accompanied by a decrease in BCC (including diarrhea, vomiting), elderly age, age 18 years (safety and efficacy have not been studied).
The following undesirable effects are given in accordance with the following gradations of the frequency of their occurrence: very often (≥10%), often (≥1%,
From the side of the cardiovascular system: often - an excessive decrease in blood pressure, a violation of the orthostatic regulation of vascular tone (orthostatic hypotension), syncope; sometimes - myocardial ischemia, including the development of an attack of angina pectoris or myocardial infarction, tachycardia, arrhythmias (appearance or intensification), palpitations, peripheral edema, flushing of the skin of the face; rarely - the occurrence or intensification of circulatory disorders against the background of stenosing vascular lesions, vasculitis; frequency unknown - Raynaud's syndrome.
From the side of the central nervous system: often - headache, feeling of "lightness" in the head; sometimes - dizziness, ageusia (loss of taste sensitivity), dysgeusia (violation of taste sensitivity), depressed mood, anxiety, nervousness, restlessness, sleep disturbances, including drowsiness; rarely - tremor, imbalance, confusion; the frequency is unknown - cerebral ischemia, including ischemic stroke and transient cerebrovascular accident, impaired psychomotor reactions, paresthesia (burning sensation), parosmia (impaired odor perception), impaired attention.
Sides of the organ of vision: sometimes - visual disturbances, including vagueness of the image; rarely - conjunctivitis.
On the part of the organ of hearing: rarely - hearing impairment, ringing in the ears.
From the respiratory system: often - dry cough (aggravated at night and in the supine position), 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, discomfort in the abdomen, dyspepsia, diarrhea, nausea, vomiting; sometimes - pancreatitis, incl. fatal (cases of fatal pancreatitis when taking ACE inhibitors were extremely rare), 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 hepatobiliary system: sometimes - an increase in the activity of liver enzymes and the concentration of conjugated bilirubin in the blood plasma; rarely - cholestatic jaundice, hepatocellular lesions; the frequency is unknown - acute liver failure, cholestatic or cytolytic hepatitis (lethal outcome was extremely rare).
From the side of the kidneys and urinary tract: sometimes - a violation of kidney function, including the development of acute renal failure, an increase in the amount 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 hemoglobin concentration, thrombocytopenia; frequency is unknown - oppression of bone marrow hematopoiesis, pancytopenia, hemolytic anemia.
On the part of the skin and mucous membranes: often - skin rash (in particular maculopapular); sometimes - angioedema, incl. fatal (laryngeal edema can cause airway obstruction leading to death), pruritus, hyperhidrosis; rarely - exfoliative dermatitis, urticaria, onycholysis; very rarely - photosensitivity reactions; frequency unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, worsening of psoriasis, psoriasis-like dermatitis, pemphigoid or lichenoid (lichen-like) exanthema or enanthema, alopecia.
From the musculoskeletal system: often - muscle cramps, myalgia; sometimes - arthralgia.
Metabolism, nutrition and laboratory disorders: often - an increase in the concentration of potassium in the blood; sometimes - anorexia, loss of appetite; the frequency is unknown - a decrease in the concentration of sodium in the blood.
On the part of the immune system: the frequency is unknown - anaphylactic or anaphylactoid reactions (with ACE inhibition, the number of anaphylactic or anaphylactoid reactions to insect venom increases), an increase in the concentration of antinuclear antibodies.
General disorders: often - chest pain, feeling tired; sometimes - an increase in body temperature; rarely - asthenia (weakness).
Interaction
With the simultaneous use of potassium salts, potassium-sparing diuretics (for example, amiloride, triamterene, spironolactone) with Tritace, hyperkalemia is observed (control of the potassium content in the blood serum is necessary).
Simultaneous use of Tritace with antihypertensive agents (in particular, diuretics) and other preparations that reduce blood pressure leads to an increase in the effect of ramipril.
With simultaneous use with hypnotics, opioids and analgesics, a sharp decrease in blood pressure is possible.
Vasopressor sympathomimetic preparations (epinephrine) and estrogens can cause a weakening of the action of ramipril.
With the simultaneous use of Tritace with allopurinol, procainamide, cytostatic agents, immunosuppressants, systemic corticosteroids and other preparations that can change the blood picture, a decrease in the number of leukocytes in the blood is possible.
With simultaneous use with lithium preparations, an increase in plasma lithium concentration is possible, which leads to an increase in the cardio- and neurotic effects of lithium.
With the simultaneous use of Tritace with oral hypoglycemic agents (sulfonylurea derivatives, biguanides), insulin, hypoglycemia increases. NSAIDs (indomethacin, acetylsalicylic acid) may reduce the effectiveness of ramipril.
With simultaneous use with heparin, an increase in the concentration of potassium in the blood serum is possible.
Table salt reduces the effectiveness of ramipril.
Ethanol enhances the hypotensive effect of ramipril.
How to take, course of administration 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 decrease in blood pressure, diuretic preparations are additionally prescribed. CHF: initial dose - 1.25 mg / day; if necessary, increase the dose to 2.5 mg for 1-2 weeks.
In the treatment of patients who have had a myocardial infarction, the initial dose is 2.5 mg 2 times a day (with poor tolerance, 1.25 mg is taken during the first 2 days).
Renal failure (CC 30-60 ml / min), age over 65 years, diabetes mellitus: initial dose - 1.25 mg, maintenance dose - 2.5 mg; the maximum dose is 5 mg / day.
Overdose
Symptoms: pronounced decrease in blood pressure, shock, severe bradycardia, disturbances in water and electrolyte balance, acute renal failure, stupor.
Treatment: gastric lavage, intake of adsorbents, sodium sulfate (if possible, within the first 30 minutes). In the event of the development of arterial hypotension, the administration of alpha 1-adrenergic stimulants (norepinephrine, dopamine) and angiotensin II (angiotensinamide) can be added to therapy to replenish bcc and restore salt balance.
Storage conditions
At temperatures up to 25 °C
Best before date
5 years