Active substanceLizinopril + HydrochlorothiazideLizinopril + Hydrochlorothiazide
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  • Co-Diroton
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  • Dosage form: & nbspPills.
    Composition:
    Co-Diroton 10 mg + 12.5 mg contains
    Active substances:
    10 mg of lisinopril in the form of 10.89 mg of lisinopril dihydrate and 12.5 mg of hydrochlorothiazide;
    Excipients:
    mannitol 50 mg, aluminum lacquer based on the dye of indigotine (E 132) 0.2 mg, pregelatinized starch 2.25 mg,
    corn starch 31 mg, calcium hydrophosphate dihydrate 136.8 mg, starch partially pregelatinized 2.25 mg,
    magnesium stearate 5 mg.
    Co-Diroton 20 mg + 12.5 mg contains
    Active substances:
    20 mg of lisinopril in the form of 21.77 mg of lisinopril dihydrate and 12.5 mg of hydrochlorothiazide;
    Excipients:
    mannitol 50 mg, aluminum lacquer based on the dye of indigotine (E 132) 0.2 mg, iron dye oxide yellow (E 172) 0.1 mg, pregelatinized starch 2.25 mg, corn starch 31 mg, calcium hydrophosphate dihydrate 136.7 mg,
    starch partially pregelatinized 2.25 mg, magnesium stearate 5 mg.
    Description:
    Tablets 10 mg + 12.5 mg:
    Round, flat-cylindrical, with a facet, light-blue color with a few impregnations of a darker color. The symbol C 43 is engraved on one side.

    Tablets 20 mg + 12.5 mg: Round, flat-cylindrical, with a facet, light green color with a few impregnations of a darker color. The symbol C 44 is engraved on one side.
    Pharmacotherapeutic group:hypotensive combined agent (angiotensin-converting enzyme inhibitor + diuretic).
    ATX: & nbsp

    C.09.B.A.03   Lizinopril in combination with diuretics

    Pharmacodynamics:
    Hypotensive combination. Has antihypertensive 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 (BP), 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 antihypertensive effect begins in about 6 hours and persists for 24 hours. The duration of the effect also depends on the size of the dose. The action takes about 1 hour. The maximum effect is determined in 6-7 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, stable action develops after 1-2 months.
    With a sharp withdrawal of the drug, there is no pronounced increase in blood pressure.
    In addition to reducing 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 antihypertensive properties; the hypotensive effect develops 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 persists for 6-12 hours. Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.
    Lysinopril and hydrochlorothiazide, if applied simultaneously, have an additive antihypertensive effect.
    Pharmacokinetics:Lisinopril
    After taking lisinopril, the maximum concentration in the blood serum is reached after 7 hours. It weakly binds to plasma proteins. The average degree of absorption of lisinopril is about 25%, with a significant interindividual variability (6-60%). Food does not affect the absorption of lisinopril. Lisinopril does not undergo metabolism and is excreted unchanged only by the kidneys. After repeated administration of an effective half-life of lisinopril is 12 hours. Renal dysfunction lisinopril slows down, but this delay becomes clinically significant only when the glomerular filtration rate is reduced below 30 ml / min. Elderly patients noted an average 2-fold higher level of the maximum drug concentration in the blood and AUC (area under the curve "in the plasma concentration - time") compared with patients younger. Lisinopril is excreted from the body by hemodialysis.
    It penetrates to a small extent through the blood-brain barrier.
    Hydrochlorothiazide does not undergo metabolism, but undergoes rapid excretion through the kidneys. The half-life of the drug ranges from 5.6 to 14.8 hours. At least 61% of ingested drug excreted unchanged within 24 hours. Hydrochlorothiazide penetrates the placental barrier, but does not penetrate the blood-brain barrier.

    Indications:Arterial hypertension (in patients who are shown combined therapy).
    Contraindications:Hypersensitivity to lisinopril, other ACE inhibitors or hydrochlorothiazide and excipients, angioedema (including angina angina associated with the use of ACE inhibitors), anuria, severe renal failure (creatinine clearance less than 30 ml / min). , hemodialysis using high-permeability membranes, hypercalcemia, hyponatremia, porphyria, precoma, hepatic coma, severe forms of diabetes mellitus, age under 18 years (efficacy and safety not established).
    Carefully:Aortic stenosis / hypertrophic cardiomyopathy, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney with progressive azotemia, post-transplant state. kidney failure, renal failure (QC more than 30 ml / min.), primary hyperaldosteronism, arterial hypotension, bone marrow hypoplasia, hyponatremia (increased risk of hypotension in patients on a low-salt or salt-free diet), hypovolemic conditions (including diarrhea, vomiting), connective tissue diseases (including systemic lupus erythematosus, scleroderma),diabetes, gout, depression of bone marrow hematopoiesis, hyperuricemia, hyperkalemia, coronary heart disease, cerebrovascular disease (including cerebrovascular insufficiency), severe chronic heart failure, liver failure, old age.
    Pregnancy and lactation:
    The use of lisinopril during pregnancy is contraindicated. When establishing a pregnancy, the drug should be stopped as soon as possible. Admission of ACE inhibitors in the II and III trimester of pregnancy has an adverse effect on the fetus (there may be a marked decrease in blood pressure, renal failure, hyperkalemia, hypoplasia of the skull bones, fetal death). Data on the negative effects of the drug on the fetus in case of application during the I trimester are not present. For newborns and infants who have undergone intrauterine exposure to ACE inhibitors, it is recommended to monitor for the timely detection of a marked decrease in blood pressure, oliguria, and hyperkalemia.
    During the treatment, the drug should be abolished breastfeeding.
    Dosing and Administration:
    Inside.
    For 1 tablet of the preparation Ko-Diroton, containing 10 mg of lisinopril + 12.5 mg of hydrochlorothiazide or 20 mg + 12.5 mg once a day. In the event that the proper therapeutic effect is not achieved within 2-4 weeks, the dose of the drug can be increased to 2 tablets of the drug Ko-Diroton, applied once a day.
    Dose for 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. The recommended initial dose of lisinopril in uncomplicated renal failure is 5-10 mg.
    Prior therapy with diuretics:
    Symptomatic arterial hypotension can occur after taking the initial dose of the drug. 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 starting treatment with the drug (see section SPECIAL INSTRUCTIONS).
    Side effects:

    The most common side effects: dizziness, headache. Other side effects:

    From the cardiovascular system: marked reduction of blood pressure, chest pain, rarely - orthostatic hypotension, tachycardia, bradycardia, the emergence of symptoms of heart failure, impaired atrioventricular conduction, myocardial infarction.

    From 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 central nervous system: lability of mood, violation of concentration, paresthesia, fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely - asthenic syndrome, confusion.

    From the respiratory system: dyspnea, dry cough, bronchospasm, apnea.

    On the part of the hematopoiesis system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decreased hemoglobin concentration, hematocrit, erythropenia).

    Allergic reactions: angioedema, swelling of the face, extremities, lips, tongue, epiglottis and / or larynxsection SPECIAL INSTRUCTIONS), skin rashes, itching, fever, vasculitis, positive reactions to antinuclear antibodies, increased ESR, eosinophilia.

    From the genitourinary system: uremia, oliguria / anuria, impaired renal function, acute renal failure, decreased potency.

    Laboratory indicators: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloraemia, hypercalcemia, hyperuricemia, hyperglycemia, elevated levels of urea and creatinine in blood plasma, hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance, increased activity of "liver" transaminases, especially in the presence of an anamnesis kidney disease, diabetes mellitus, and renovascular hypertension.

    Other: arthralgia, arthritis, myalgia, fever, impaired fetal development, exacerbation of gout.

    Overdose:
    Symptoms: marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.
    Treatment: symptomatic therapy, intravenous fluids, blood pressure control; therapy aimed at correcting dehydration and violations of the water-salt balance.Control of urea, creatinine and electrolytes% serum, as well as diuresis.
    Interaction:
    When used simultaneously with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes, containing potassium-a risk of hyperkalemia is increased, especially in patients with impaired renal function. Therefore, they can be jointly administered only on the basis of an individual decision of the 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 (NSAIDs) (indomethacin and others), estrogens - a decrease in the antihypertensive effect 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 gastrointestinal tract.
    The drug enhances the neurotoxicity of salicylates, weakens the effect of hypoglycemic drugs for oral administration, 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 strengthens the hypotensive effect of the drug. With the simultaneous administration of methyldopa, the risk of hemolysis increases.
    Special instructions:

    Symptomatic arterial hypotension

    Most often, a marked decrease in blood pressure occurs with a decrease in fluid volume caused by diuretic therapy, a reduction in the amount of salt in the diet, dialysis, diarrhea, or vomiting (see INTERACTIONS WITH OTHER DRUGS and ADVERSE EFFECTS). In patients with chronic heart failure with simultaneous renal insufficiency or without it, a marked decrease in blood pressure is possible. It is more often detected in patients with a severe class of chronic 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 arterial hypotension is not a contraindication for further administration of the drug.

    Before the start of treatment, if possible, the sodium concentration should be normalized and / or replace the lost volume of fluid, carefully monitor the effect of the initial 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 single-kidney artery 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 ACE inhibitors, including lisinopril, 6

    which can occur in any period 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 there was only edema of 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, appropriate therapy should be performed immediately (0.3-0.5 ml epinephrine (adrenaline) 1: 1000 sc) and / or measures to ensure airway patency.

    Patients who have had a history of angioedema, not associated with previous treatment with ACE inhibitors, may have an 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 (AN69®), which simultaneously take ACE inhibitors. In such cases, one should consider the possibility of using another type of membrane for dialysis or another antihypertensive agent.

    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 blood pressure, which is considered a consequence of this mechanism, can be eliminated by increasing the volume of circulating blood.

    Before surgery (including dentistry), an anesthesiologist should be warned 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, intake of potassium or drugs,(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 you need to adjust the dose of hypoglycemic agents for oral administration.

    Thiazide diuretics can reduce the secretion of calcium by the kidneys 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 period of treatment with the drug, regular monitoring in the blood plasma of potassium, glucose, urea, lipids is required.

    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 doing physical exercises, hot weather (the risk of dehydration and excessive blood pressure lowering due to a decrease in the volume of circulating blood).

    Effect on the ability to drive transp. cf. and fur:
    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.

    Form release / dosage:
    Tablets 10 mg + 12.5 mg. Tablets 20 mg + 12.5 mg.



    Packaging:For 10 tablets in a blister of PVC - aluminum foil. For 1 or 3 blisters in a cardboard box together with instructions for use.
    Storage conditions:
    At a temperature of no higher than 30 ° C. Keep out of the reach of children!

    Shelf life:
    2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003855/09
    Date of registration:21.05.2009
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Information update date: & nbsp05.01.2016
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