Iruzid pills 10 mg + 12.5 mg N30
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Active ingredients
Hydrochlorothiazide + Lisinopril
Release form
Pills
Composition
Lisinopril 10 mg hydrochlorothiazide 12.5 mg adjuvants: mannitol 22 mg, calcium phosphate dihydrate 44 mg, corn starch 10.27 mg, pregelatinized starch 10 mg, indigo carmine 0.4 mg, magnesium stearate 0.83 mg.
Pharmacological effect
An antihypertensive combination preparation containing an ACE inhibitor (lisinopril) and a diuretic (hydrochlorothiazide). It has antihypertensive and diuretic effect. Lysinopril 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 prostaglandin synthesis. Reduces the OPSS, blood pressure, preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and increased tolerance to stress in patients with chronic heart failure. Expands arteries to a greater extent than veins. Some effects are attributed to effects on tissue renin-angiotensin systems. Improves blood supply to ischemic myocardium. With prolonged use, hypertrophy of the myocardium and arterial walls of the resistive type is reduced. The use of ACE inhibitors in patients with heart failure leads to an increase in life expectancy; in patients undergoing myocardial infarction without clinical manifestations of heart failure - to slow the progression of left ventricular dysfunction. The antihypertensive effect is observed 6 hours after taking the drug and persists for 24 hours. The duration of action also depends on the dose. The onset of action of the drug - after 1 h. The maximum effect is observed after 6-7 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, a stable action develops after 1-2 months. BP lisinopril reduces albuminuria. In patients with hyperglycemia, it helps normalize the function of the damaged glomerular endothelium. Lysinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not lead to an increase in hypoglycaemia. magnesium, water in the distal nephron; delays the excretion of calcium ions, uric acid.It has an antihypertensive effect due to the expansion of arterioles. Virtually no effect on normal blood pressure. The diuretic effect develops after 1-2 hours, reaches a maximum after 4 hours and lasts 6-12 hours. The antihypertensive effect appears after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect. In the combination, lisinopril and hydrochlorothiazide have an additive antihypertensive effect.
Pharmacokinetics
Lisinopril Absorption Absorption - 30%. Bioavailability of lisinopril is 29%. Cmax in plasma is reached in approximately 6–8 hours. Food intake does not affect the absorption of lisinopril. DistributionInferiorly bound to plasma proteins. Lizinopril slightly penetrates the BBB and the placental barrier. Metabolism Lysinopril does not biotransform in the body. Excretion Lysinopril is excreted unchanged with the urine. T1 / 2–12 h. followed by a terminal distant β-phase (about 30 hours). Hydrochlorothiazide Absorption After ingestion is absorbed by 60-80%. Cmax in plasma is reached in approximately 1.5-3 hours. Changes in absorption under the influence of food do not have clinical significance. DistributionHydrochlorothiazide accumulates in erythrocytes. In the phase of elimination, its concentration in erythrocytes is 3-9 times greater than in plasma. Plasma protein binding of 40-70%. Metabolism and elimination Hydrochlorothiazide is metabolized to a very small extent. Excretion of hydrochlorothiazide from plasma has a two-phase character: T1 / 2 in the initial α-phase is 2 hours, in the terminal β-phase - about 10 hours with urine; 50-75% of the ingested dose - unchanged.
Indications
- arterial hypertension (in patients for whom combination therapy is indicated).
Contraindications
- anuria; - renal failure of a severe degree (CC <30 ml / min); - angioedema (including a history of the use of ACE inhibitors); - hemodialysis using high-flow membranes; - hypercalcemia; - hyponatremia; - porphyria; - precoma, hepatic coma; - diabetes mellitus (severe forms); - age up to 18 years (efficacy and safety not established); - hypersensitivity to the drug, other ACE inhibitors and sulfonamides derived. With caution, you should prescribe the drug for aortic stenosis,ardiomiopatii, bilateral renal artery stenosis,arterial stenosis of the only kidney with progressive azotemia, in the state after kidney transplantation, renal failure (CC more than 30 ml / min), primary hyperaldosteronism, arterial hypotension, bone marrow hypoplasia, hyponatremia (increased risk of arterial hypotension in patients with low salt or no pain diet), in hypovolemic conditions (including in diarrhea, vomiting), connective tissue diseases (systemic lupus erythematosus, scleroderma), diabetes, bone marrow suppression th hematopoiesis, gout, hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular disease (including at cerebrovascular insufficiency), severe chronic heart failure, liver failure, elderly patients.
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Use during pregnancy and lactation
The use of lisinopril during pregnancy is contraindicated. If pregnancy is established, treatment with Iruzid should be stopped as soon as possible. Acceptance of ACE inhibitors in the second and third trimesters of pregnancy has an adverse effect on the fetus (a pronounced decrease in blood pressure, renal failure, hyperkalemia, hypoplasia of the skull, fetal death) are possible. There is no data on the negative effect of the drug on the fetus in the case of use in the first trimester of pregnancy. For newborns and infants who have undergone intrauterine effects of ACE inhibitors, it is recommended to conduct careful monitoring to timely detect a pronounced decrease in blood pressure, oliguria, hyperkalemia. During the period of treatment with Iruzid, breastfeeding should be canceled.
Dosage and administration
The drug is prescribed inside 1 tab. (10 mg + 12.5 mg or 20 mg + 12.5 mg) 1 time / day.If necessary, the dose can be increased to 20 mg + 25 mg 1 time / day. Patients with renal insufficiency with QC of 30 and less than 80 ml / min Iruzid can be used only after selecting the dose of individual components of the drug. The recommended initial dose of lisinopril for uncomplicated renal failure is 5–10 mg / day. Prior diuretic therapy After receiving the initial dose of Iruzide, symptomatic hypotension may occur. Such cases are more common in patients who have had a loss of fluid and electrolytes due to previous treatment with diuretics. Therefore, you should stop taking diuretics 2-3 days before the start of treatment with Iruzid.
Side effects
The most frequently observed were dizziness, headache. From the side of the cardiovascular system: marked decrease in blood pressure, chest pain; rarely - orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, impaired AV conduction, myocardial infarction. From the digestive system: nausea, vomiting, abdominal pain, dry mouth, dyspepsia, anorexia, change in taste, pancreatitis, hepatocellular or cholestatic hepatitis, jaundice. From the side of the central nervous system and peripheral nervous system: increased fatigue, mood lability, impaired concentration, paresthesia, drowsiness, jerky muscle twitching of limbs and gu b; rarely - asthenic syndrome, confusion of consciousness. On the part of the respiratory system: dry cough, dyspnea, bronchospasm, apnea. On the skin: increased sweating, hair loss, photosensitization. On the hemopoietic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anesthesia. decrease in hemoglobin, decrease in hematocrit, erythrocytopenia). On the part of the urogenital system: uremia, oliguria / anuria, impaired renal function, acute renal failure, reduced potency. Allergic reactions: angionev otics of the face, extremities, lips, tongue, epiglottis and / or larynx, skin rash, pruritus, urticaria, fever, vasculitis, positive results for antinuclear antibodies, increased ESR, eosinophilia. Laboratory indicators: hyperkalemia and / or hypokalemia, hyponatremia hypomagnesemia, hypochloremia, hypercalcemia, hyperuricemia,hyperglycemia, hypercholesterolemia, hypertriglyceridemia, reduced glucose tolerance, increased urea and plasma creatinine levels, hyperbilirubinemia, increased liver transaminase activity, especially with a history of kidney disease, diabetes mellitus, and renovascular hypertension. gout, fever. Effect on the fetus: impaired fetal development.
Overdose
Symptoms: pronounced decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, irritability. Treatment: symptomatic therapy is carried out, intravenous fluids, blood pressure control, therapy aimed at correcting dehydration (fluid injections) and disorders of water - salt balance. It should be monitored urea, creatinine and electrolytes in the serum, as well as diuresis.
Interaction with other drugs
With simultaneous use of Iruzid with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium, the risk of hyperkalemia increases, especially in patients with impaired renal function. Therefore, if it is necessary to use this combination, the control of potassium in the blood serum and kidney function is shown. With simultaneous use of Iruzid with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants and ethanol, an increased antihypertensive effect is noted. simultaneous use of Iruzid with lithium preparations slows down the elimination of lithium from the body, which leads to an increase in cardioto systolic and neurotoxic effects of lithium. If used concurrently with antacids and Kolestiramin, the absorption of Iruzid from the gastrointestinal tract is reduced. Simultaneous use increases the neurotoxicity of salicylates. Simultaneously, Iruzid reduces the effect of oral hypoglycemic drugs, norepinephrine, epinephrine and perfume patterns, which is used in an inaccurate pattern. (including side) cardiac glycosides,the action of peripheral muscle relaxants. With simultaneous use, Iruzid reduces the excretion of quinidine. With simultaneous use reduces the effect of oral contraceptives. With simultaneous use with methyldopa, the risk of hemolysis increases. Ethanol enhances the hypotensive effect of the drug.
special instructions
Symptomatic hypotension It should be borne in mind that a decrease in blood pressure occurs with a decrease in BCC, caused by diuretic therapy, a decrease in the amount of salt in food, dialysis, diarrhea or vomiting. In patients with chronic heart failure with simultaneous renal failure or without it, a pronounced decrease in blood pressure, which is more often detected in patients with severe forms of heart failure, as a result of the use of large doses of diuretics, hyponatremia or impaired renal function. In such patients, treatment should begin under the strict supervision of a physician. Such tactics should be followed when administering Iruzid to patients with coronary artery disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to a myocardial infarction or stroke. A transient hypotensive reaction is not a contraindication for taking the next dose of the drug. Before the start of treatment, sodium concentration should be normalized and / or replenish the lost volume of fluid, carefully control the effect of the initial dose of the drug on the patient. Violation of the kidney function in patients with chronic echnoy deficiency marked reduction of blood pressure after the start of treatment with ACE inhibitors may lead to further deterioration of renal function. Cases of acute renal failure were noted. In patients with bilateral renal artery stenosis or arterial stenosis of a single kidney who received ACE inhibitors, there was an increase in serum urea and creatinine, usually reversible after discontinuation of treatment (it was more common in patients with renal insufficiency). Increased sensitivity / Angioedema of patients taking ACE inhibitors, including lisinopril, rarely developed angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx , And its development is possible at any time during treatment.In this case, treatment should be stopped as soon as possible and monitoring should be established until the symptoms are fully regressed. However, in cases where edema occurred only on the face and lips, and the condition returned to normal without treatment, antihistamine medications may be prescribed. When angioedema spreads to the tongue, epiglottis and / or larynx, an obstruction of the respiratory tract can occur, therefore appropriate therapy should be performed immediately -0.5 ml of a solution of epinephrine / adrenaline / 1: 1000 n / a) and / or measures to ensure the airway patency. In patients with a history of which there was already angioedema, not related to the previous treatment By using an ACE inhibitor, the risk of its development during treatment with an ACE inhibitor may be increased. Cough When using an ACE inhibitor, there was a cough (dry, long-lasting, which disappears after stopping the ACE inhibitor). In differential diagnosis of cough, cough caused by the use of an ACE inhibitor should be considered. Patients on hemodialysis Consider that anaphylactic reaction may develop in patients who are simultaneously taking ACE inhibitors and are on hemodialysis using dialysis membranes with high permeability. In such cases, you should consider using a different type of membrane for dialysis or another antihypertensive drug. Surgery / General Anesthesia When using drugs that reduce blood pressure in patients with extensive surgery or during general anesthesia, lisinopril can block the formation of angiotensin II. A pronounced decrease in blood pressure, which is considered a consequence of this mechanism, can be eliminated by an increase in the BCC. Before surgical intervention (including dentistry) it is necessary to warn the surgeon / anesthe iologa APF.Kaly on the application of the inhibitors in some cases, the serum was observed hyperkalemia. Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, taking potassium drugs or drugs that increase the concentration of potassium in the blood (for example, heparin), especially in patients with impaired renal function. Patients who are at risk of developing symptomatic hypotension and are on a low-salt or salt-free diet with / without hyponatremia, as well as in patients who received high doses of diuretics,The above conditions should be compensated before starting treatment (loss of fluid and salt). Metabolic and endocrine effects Thiazide diuretics can affect glucose tolerance, therefore it is necessary to adjust the doses of hypoglycemic drugs taken simultaneously with Iruzide. Severe hypercalcemia can be a symptom of latent hyperparathyroidism. It is recommended to stop treatment with thiazide diuretics before conducting a test to assess the function of the parathyroid glands. During the treatment period with Iruzid, regular monitoring of the level of potassium, glucose, urea, and lipids in the blood plasma is necessary. Alcohol enhances the hypotensive effect of the drug. Care should be taken when exercising, hot weather, because there is a risk of dehydration and excessive blood pressure reduction due to a decrease in the BCC. Impact on the ability to drive vehicles and machinery dizziness is possible, especially at the beginning of the course of treatment.