Composition, form of production and packaging
Tablets 1 tab.
lisinopril (in the form of dihydrate) 20 mg
hydrochlorothiazide 12.5 mg
14 pcs. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Hypotensive combination. Has hypotensive and diuretic effect.
Lisinopril
The ACE inhibitor reduces the formation of angiotensin II from angiotensin I. Reducing angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces the overall peripheral vascular resistance, arterial 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 more than veins. Some effects are explained by the effect on tissue renin-angiotensin systems. With prolonged use, the severity of myocardial hypertrophy and the walls of arteries of resistive type decreases. Improves the blood supply of the ischemic myocardium. ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure. The hypotensive effect begins approximately 6 hours later and persists for 24 hours. The duration of the effect also depends on the amount of the dose. The onset of action is after 1 hour. The maximum effect is determined after 6-7 hours. In arterial hypertension, the effect is observed in the first days after the start of treatment, stable effect develops in 1-2 months.
With a sharp withdrawal of the drug, there is no pronounced increase in blood pressure.
In addition to lowering blood pressure, lisinopril reduces albuminuria. In patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium.
Lizinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not increase the incidence of hypoglycemia.
Hydrochlorothiazide
A thiazide diuretic whose diuretic effect is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron;delays the excretion of calcium ions, uric acid. Has hypotensive properties; the hypotensive effect develops due to the expansion of arterioles. Virtually no effect on normal blood pressure. Diuretic effect occurs in 1-2 hours, reaches a maximum after 4 hours and lasts for 6-12 hours. The hypotensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.
Lizinopril and hydrochlorothiazide, if applied simultaneously, have an additive antihypertensive effect.
INDICATIONS
- Arterial hypertension (in patients who are shown combined therapy).
DOSING MODE
Inside, 1 tablet Rileys-sanovel plus 1 time a day, regardless of food intake. The maximum dose is 2 tablets once a day.
Dose in renal failure: in patients with QC from 30 and less than 80 ml / min, the drug can be used only after adjusting the dose of individual components of the drug.
Prior therapy with diuretics: symptomatic hypotension may occur after taking the first dose of the drug. Therefore, you should stop taking diuretics 2-3 days before starting treatment with the drug.
SIDE EFFECT
The most common side effects: dizziness, headache.
Other side effects:
From the cardiovascular system: a marked decrease in blood pressure, chest pain, rarely - orthostatic hypotension, tachycardia, bradycardia, the onset of symptoms of heart failure, violation of atrioventricular conduction, myocardial infarction.
On the part of the digestive tract: nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, taste change, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.
From the skin: urticaria, increased sweating, photosensitivity, skin itching, hair loss.
From the side of the nervous system: lability of mood, impaired concentration, paresthesia, fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely - asthenic syndrome, confusion. On the part of the respiratory system: dyspnea, bronchospasm, apnea.
On the part of the hematopoiesis system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, hematocrit, erythrocytopenia).
Allergic reactions: angioedema, facial edema, extremities, lips, tongue, epiglottis and / or larynx, skin rashes, itching, fever, vasculitis, positive responses to antinuclear antibodies, increased ESR, eosinophilia.
On the part of the genitourinary system: uremia, oliguria / anuria, impaired renal function, acute renal failure, decreased potency.
Laboratory indices: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloraemia, hypercalcemia, hyperuricemia, hyperglycemia, increased urea and creatinine levels in the blood plasma, hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance, increased activity of "liver" transaminases, especially when the presence of a history of kidney disease, diabetes and renovascular hypertension.
Other: dry cough, arthralgia, arthritis, myalgia, fever, impaired fetal development, exacerbation of gout.
CONTRAINDICATIONS
anuria;
- severe renal failure (CC less than 30 ml / min), angioedema (including in the history of the use of ACE inhibitors), hemodialysis using high-flow membranes;
- hypercalcemia;
- hyponatremia, porphyria;
- Prekoma;
- hepatic coma ;,
- severe forms of diabetes mellitus;
- age under 18 years (effectiveness and safety not established);
- Hypersensitivity to the drug, other ACE inhibitors and sulfonamide derivatives.
With caution: aortic stenosis / hypertrophic cardiomyopathy, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney with progressive azotemia, condition after kidney transplantation, renal failure (creatinine clearance more than 30 ml / min), primary hyperaldosteronism, arterial hypotension, hyponatremia (increased risk of development arterial hypotension in patients on a low-salt or salt-free diet), hypovolemic conditions (including diarrhea, vomiting), connective tissue diseases (systemic lupus erythematosus, scleroderma), diabetes mellitus, gout, oppression of bone marrow hematopoiesis, hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular diseases (including cerebral circulatory insufficiency), severe chronic heart failure, hepatic insufficiency, elderly age.
PREGNANCY AND LACTATION
It is not recommended to use the drug during pregnancy. If pregnancy occurs, the drug should be stopped as soon as possible (thiazide diuretics penetrate the blood-brain barrier), except in cases that are dangerous for the mother's life. Admission of ACE inhibitors in the II and III trimesters of pregnancy has an adverse effect on the fetus (there may be a marked decrease in blood pressure, kidney failure, hyperkalemia, skull hypoplasia, fetal death). Data on the negative effects of the drug on the fetus in the case of application of the drug during the I trimester are not present. It is not recommended to prescribe diuretics relative to healthy pregnant women due to the risk of fetal and newborn jaundice, and probably other side effects described for adults, as well as thrombocytopenia of the mother. Diuretic therapy does not prevent the development of pregnancy toxicity.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure (QC less than 30 ml / min), with hemodialysis using high-flow membranes.
With caution: condition after kidney transplant, kidney failure (creatinine clearance more than 30 ml / min).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution in case of liver failure.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
APPLICATION IN ELDERLY PATIENTS
Use with caution in old age.
SPECIAL INSTRUCTIONS
Symptomatic hypotension
Most often, a marked decrease in blood pressure occurs when the volume of fluid is reduced, caused by diuretic therapy, a decrease in the amount of salt in the diet, dialysis, diarrhea, or vomiting. In patients with chronic heart failure with simultaneous renal failure or without it, a marked decrease in blood pressure is possible. It is more often detected in patients with a severe degree 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. Similar rules should be adhered to when assigning patients with coronary heart disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.
Transient hypotensive reaction is not a contraindication for taking the next dose of the drug.
Before the start of treatment, if possible, normalize the sodium concentration and / or replenish the lost volume of fluid, carefully monitor the effect of the first dose of the drug on the patient.
Impaired renal function
In patients with chronic heart failure, a marked decrease in blood pressure after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. Cases of acute renal failure are noted. In patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney receiving ACE inhibitors, there was an increase in urea and serum creatinine, usually reversible after discontinuation of treatment. It was more common in patients with renal insufficiency.
Hypersensitivity / Angioedema
Angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx was rarely seen in patients treated with an ACE inhibitor, including lisinopril, which may occur at any time of treatment. In this case, treatment with lisinopril should be stopped as soon as possible and for the patient to establish an observation until the symptoms regress completely. In cases where the edema appeared only on the face and lips, the condition usually passes without treatment, however, it is possible to prescribe antihistamines.
Angioedema with edema of the larynx can be fatal. When the tongue, epiglottis or larynx are covered, airway obstruction can occur, therefore, an appropriate therapy (0.3-0.5 ml of epinephrine (adrenaline) 1: 1000 subcutaneously) and / or measures to ensure airway patency should be performed immediately.
Patients who have had an angioedema in their history and who have not been associated with previous treatments with ACE inhibitors may be at increased risk of developing it during treatment with an ACE inhibitor.
Cough
When an ACE inhibitor was used, a cough was noted. Cough is dry, prolonged, which disappears after discontinuing treatment with an ACE inhibitor. With a differential diagnosis of cough, one must also consider a cough caused by the use of an ACE inhibitor.
Patients on hemodialysis
Anaphylactic reaction was noted in patients undergoing hemodialysis using dialysis membranes with high permeability, which simultaneously take ACE inhibitors. In such cases it is necessary to consider the possibility of using another 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.
The pronounced decrease in arterial pressure, which is considered a consequence of this mechanism, can be eliminated by increasing the volume of circulating blood.
Before surgery (including dentistry), it is necessary to alert the surgeon / anesthesiologist about the use of ACE inhibitors.
Potassium in the serum
In some cases, hyperkalemia was noted.
Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, the use of potassium drugs or drugs that cause an increase in the potassium concentration in the blood (eg, heparin), especially in patients with impaired renal function.
In patients who have a risk of symptomatic hypotension (on a low-salt or salt-free diet) with or without hyponatremia, as well as in patients who received high doses of diuretics, the above conditions must be compensated before the start of treatment (loss of fluid and salts).
Metabolic and endocrine effects
Thiazide diuretics can influence glucose tolerance, so it is necessary to adjust the dosage of hypoglycemic drugs.
Thiazide diuretics can reduce the secretion of calcium in the urine and cause hypercalcemia. Expressed hypercalcemia may be a symptom of latent hyperparathyroidism. It is recommended to stop treatment with thiazide diuretics before the parathyroid gland function test.
During the treatment with the drug, regular monitoring of the blood plasma of potassium, glucose, urea, lipids and creatinine is necessary.
During the period of treatment it is not recommended to drink alcoholic beverages, since alcohol enhances the hypotensive effect of the drug.
Care should be taken when performing physical exercises, hot weather (the risk of dehydration and excessive reduction in blood pressure due to a decrease in the volume of circulating blood).
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, one should refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, since dizziness is possible, especially at the beginning of the course of treatment.
OVERDOSE
Symptoms: marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.
Treatment: symptomatic therapy, intravenous fluid administration, blood pressure control, therapy aimed at correction of dehydration and water-salt balance disorders. Control of urea, creatinine and electrolytes in blood serum, as well as diuresis.
DRUG INTERACTION
When used simultaneously with potassium-sparing diuretics (spiroeolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium - the risk of hyperkalemia increases, especially in patients with impaired renal function. Therefore, they can be jointly administered only on the basis of an individual decision of the treating physician with regular monitoring of potassium level in the serum and kidney function.
With simultaneous use with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol - strengthening of the hypotensive effect. When used simultaneously with non-steroidal anti-inflammatory drugs (indomethacin, etc.), estrogens reduce hypotensive action of lisinopril. With simultaneous use with lithium preparations - slowing the excretion of lithium from the body (increased cardiotoxic and neurotoxic action of lithium). With simultaneous use with antacids and colestyramine - reduced absorption in the digestive tract.
The drug enhances the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic drugs, norepinephrine, epinephrine and antidotal drugs, increases the effects (including side effects) of cardiac glycosides, the action of peripheral muscle relaxants, reduces the excretion of quinidine.
Reduces the effect of oral contraceptives. Ethanol enhances the hypotensive effect of the drug. With the simultaneous administration of methyldopa, the risk of hemolysis increases.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In a dry place at a temperature of no higher than 25 В° C. Keep out of the reach of children! Shelf life - 5 years.
