Diroton 10mg tablets 28 (Lisinopril)
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Active substance: lisinopril dihydrate 10.89 mg, which corresponds to the content of lisinopril 10 mg.
Excipients : Magnesium stearate, talc, mannitol, corn starch, calcium hydrogen phosphate dihydrate.
Diroton is an ACE inhibitor.
Reduces the formation of angiotensin II from angiotensin I. A decrease in the content of angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces OPSS, blood pressure, preload, pressure in the pulmonary capillaries, causes an increase in minute volume of blood and increased myocardial tolerance to stress in patients with chronic heart failure. Dilates arteries to a greater extent than veins. Some effects are explained by the effects on tissue renin-angiotensin systems. With prolonged use, hypertrophy of the myocardium and the walls of the arteries of the resistive type decreases. Improves blood supply to ischemic myocardium.
ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow down the progression of left ventricular dysfunction in patients who have had myocardial infarction without clinical manifestations of heart failure.
The onset of action of the drug - after 1 hour, reaches a maximum after 6-7 hours and persists for 24 h. The duration of the effect also depends on the amount of the dose taken. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months. With abrupt cancellation of the drug did not observe a pronounced increase in blood pressure.
Diroton reduces albuminuria. In patients with hyperglycemia, it helps to normalize the function of the damaged glomerular endothelium. Does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not lead to an increase in cases of hypoglycemia.
Indications for use
- essential and renovascular arterial hypertension (in the form of monotherapy or in combination with other antihypertensive drugs);
- chronic heart failure (as part of combination therapy);
- early treatment of acute myocardial infarction (in patients with stable hemodynamic indicators in the first 24 hours for the prevention of left ventricular dysfunction and heart failure);
- diabetic nephropathy (in order to reduce albuminuria in patients with type 1 diabetes mellitus with normal blood pressure and in patients with mellitus type 2 diabetes with arterial hypertension).
- hypersensitivity to lisinopril and other components of the drug;
- angioedema in the anamnesis (including associated with the use of ACE inhibitors);
- idiopathic angioedema;
- hereditary edema of Quincke;
- the period of breastfeeding;
- age up to 18 years (efficacy and safety have not been established);
- simultaneous use with aliskiren and preparations containing aliskiren in patients with diabetes mellitus and / or moderate or severe renal impairment (GFR less than 60 ml / min / 1.73 m 2 surface area of the body);
- simultaneous use with angiotensin II receptor antagonists (ARA II) in patients with diabetic nephropathy;
- simultaneous use with inhibitors of neutral endopeptidase (for example, with drugs containing sacubitril) due to the high risk of developing angioedema.
With caution: aortic stenosis, hypertrophic obstructive cardiomyopathy, mitral stenosis, bilateral renal artery stenosis, stenosis of the artery of a single kidney, condition after kidney transplantation, renal failure (QC less than 30 ml / min), primary hyperaldosteronism, arterial hypotension, inhibition of bone marrow hematopoiesis, immunosuppressive therapy, simultaneous use of allopurinol or procainamide, or a combination of these complicating factors (risk of neutropenia and agranulocytosis), hyponatremia (increased risk of arterial hypotension in patients on a low-salt or salt-free diet), hypovolemic conditions (including diarrhea, vomiting), systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), diabetes mellitus, gout, hyperuricemia, hyperkalemia, coronary heart disease, cerebrovascular diseases (including cerebral circulation failure), chronic heart failure, hemodialysis using high-permeability dialysis membranes (AN69) ® ), advanced age (over 65 years), simultaneous use with potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt, simultaneous use with lithium preparations, burdened allergic history, simultaneous desensitization with an allergen from Hymenoptera venom, simultaneous apheresis of low-density lipoproteins (LDL-apheresis) using dextran sulfate, use during major surgical interventions or during general anesthesia, the use in patients of the Negroid race.
Dosage and Administration
The drug is taken orally 1 time / day, in the morning, with all indications, before or after meals, always at about the same time of day.
Use in essential hypertension: patients who do not receive other antihypertensive drugs are prescribed 10 mg 1 time / day. The usual daily maintenance dose is 20 mg. The maximum daily dose is 40 mg. The full effect usually develops after 2-4 weeks from the start of treatment, which should be taken into account when increasing the dose. With insufficient clinical effect, it is possible to combine the drug with other antihypertensive drugs. If the patient received preliminary treatment with diuretics, then their reception should be discontinued 2-3 days before the start of the use of Diroton. If it is impossible to cancel diuretics, then the initial dose of Diroton should not exceed 5 mg / day. In this case, after taking the first dose, medical supervision is recommended for several hours (maximum action is achieved after about 6 hours), because a pronounced decrease in blood pressure may develop.
Use in renovascular hypertension and conditions with increased activity of renin-angiotensin-aldosterone systems: it is advisable to prescribe a lower initial dose - 2.5-5 mg / day under enhanced medical supervision (control of blood pressure, kidney function, potassium concentration in the blood serum). The maintenance dose should be determined depending on the dynamics of blood pressure.
Use in chronic heart failure: the initial dose is 2.5 mg 1 time / day, which can be increased to the usual maintenance daily dose of 5-20 mg. The daily dose should not exceed 20 mg.
Use in acute myocardial infarction: as part of combination therapy on the first day, 5 mg is prescribed, then - 5 mg every other day, 10 mg - after two days and then 10 mg 1 time / day. In patients with acute myocardial infarction, the drug should be used for at least 6 weeks. At the beginning of treatment or in during the first 3 days after acute myocardial infarction in patients with low systolic blood pressure (?120 mm Hg), the drug should be prescribed at a dose of 2.5 mg. In case of a decrease in blood pressure (systolic blood pressure of ≥100 mm Hg) while taking Diroton, the daily dose of 5 mg can be temporarily reduced to 2.5 mg. In the case of a prolonged pronounced decrease in blood pressure (systolic blood pressure) while taking Diroton, the daily dose of 5 mg can be temporarily reduced to 2.5 mg. In the case of a prolonged pronounced decrease in blood pressure (systolic blood pressure)
In patients with insulin-dependent diabetes mellitus, Diroton is used at a dose of 10 mg 1 time / day. If necessary, the dose can be increased to 20 mg 1 time / day in order to achieve diastolic blood pressure values below 75 mm Hg. in a sitting position. Patients with non-insulin-dependent diabetes mellitus are prescribed the drug in the same dose, in order to achieve diastolic blood pressure values below 90 mm Hg. in a sitting position.
Due to the fact that lisinopril is excreted by the kidneys, the initial dose should be determined depending on the creatinine clearance, then, in accordance with the reaction, a maintenance dose should be established in conditions of frequent control of renal function, potassium concentration and serum sodium concentration: Creatinine clearance (ml / min) Initial dose 30-70 5-10 mg 10-30 2.5-5 mg Less than 10 (including patients on hemodialysis) 2.5 mg
During treatment with lisinopril, the following adverse drug reactions (NLR) have been reported. NLR is presented by system-organ classes in accordance with the MedDRA classification and with the frequency of occurrence: very often - 1/10 of the appointments (≥10%), often - 1/100 of the appointments (≥1%, but <10%), infrequently - 1/1000 of the appointments (≥0.1%, but <1%), rarely - 1/10,000 of the appointments (≥0.01%, but <0.1%), very rarely - less than 1/10,000 of the appointments (<0.01%), the frequency is unknown - it is impossible to estimate on the basis of available data.
Within each frequency group, adverse reactions are presented in descending order of severity.
On the part of the hematopoietic system: very rarely - inhibition of bone marrow hematopoiesis, agranulocytosis, leukopenia, neutropenia, thrombocytopenia, hemolytic anemia, anemia, lymphadenopathy.
On the part of the immune system: very rarely - autoimmune disorders; frequency unknown - anaphylactic/anaphylactoid reaction.
From the endocrine system: rarely - syndrome of inadequate secretion of antidiuretic hormone.
From the side of metabolism and nutrition: very rarely - hypoglycemia.
Mental disorders: infrequently - mood changes, sleep disturbances, hallucinations; rarely - mental disorders; the frequency is unknown - depression.
From the nervous system: often - dizziness, headache; infrequently - vertigo, paresthesia, dysgeusia; rarely - confusion, drowsiness, muscle cramps, back pain, parosmia (impaired sense of smell); frequency unknown - fainting.
From the cardiovascular system: often - a pronounced decrease in blood pressure, orthostatic hypotension and related symptoms; infrequently - myocardial infarction (due to a pronounced decrease in blood pressure in high-risk groups of patients), tachycardia, heart palpitations, acute cerebral circulation disorder (due to a pronounced decrease in blood pressure in groups of high-risk patients), Raynaud's syndrome.
From the respiratory system: often - cough; infrequently - chest pain, rhinitis; very rarely - bronchospasm, allergic alveolitis / eosinophilic pneumonia, sinusitis.
From the digestive system: often - diarrhea, vomiting; infrequently - abdominal pain, nausea, digestive disorders; rarely - dry mouth; very rarely - pancreatitis, anorexia, angioedema of the intestine.
From the liver and biliary tract: very rarely - liver failure, hepatic cell hepatitis or cholestatic, jaundice.
From the skin and subcutaneous tissues: infrequently - skin rash, skin itching; rarely - psoriasis, urticaria, alopecia, hypersensitivity / angioedema of the face, hands and feet, lips, tongue, glottis and / or larynx; very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus vulgaris, hyperhidrosis, pseudolymphoma of the skin *.
From the musculoskeletal system: rarely - pain in the limbs.
From the outside urinary system: often - impaired renal function; rarely - acute renal failure, uremia; very rarely - oliguria / anuria.
From the genitals and mammary gland: infrequently - impotence; rarely - gynecomastia, sexual dysfunction.
General disorders and disorders at the injection site: infrequently - increased fatigue, asthenia.
Laboratory and instrumental data: infrequently - an increase in the concentration of urea and creatinine in the blood serum, hyperkalemia, increased activity of liver enzymes; rarely - a decrease in hemoglobin and hematocrit, hyperbilirubinemia, hyponatremia.
* A symptom complex has been reported, which may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia/arthritis, positive reaction antinuclear antibodies (AHA), increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, skin rash, photosensitivity or other changes in the skin.
The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life - 3 years. Do not use after the expiry date which is stated on the carton.
- Dosage form
- 10 mg
- Number of tablets
- INN Russian