Active substanceRamipril + HydrochlorothiazideRamipril + Hydrochlorothiazide
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  • Ramazid H
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  • Hartil®-D
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  • Dosage form: & nbsppills
    Composition:

    each tablet contains active ingredients: 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide or 5 mg of ramipril and 25 mg of hydrochlorothiazide, respectively. Excipients: lactose monohydrate, hypromellose, crospovidone, microcrystalline cellulose, sodium stearyl fumarate.

    Description:

    Tablets 2.5 mg + 12.5 mg: White oval tablets with bevel, with a risk on both sides, on one side of the tablet - engraving "2.5" and "12.5" on opposite sides of the risks.

    Tablets 5 mg + 25 mg: White oval pills with a bevel, with a risk on both sides, on one side of the tablet - engraving "5" and "25" on different sides-from the risks.

    Pharmacotherapeutic group:hypotensive combined agent (ACE inhibitor + diuretic)
    ATX: & nbsp

    C.09.B.A   ACE inhibitors in combination with diuretics

    C.09.B.A.05   Ramipril in combination with diuretics

    Pharmacodynamics:

    Tablets of ramipril / hydrochlorothiazide have antihypertensive and diuretic effects. Ramipril and hydrochlorothiazide are used alone or together in the treatment of high blood pressure (BP).The antihypertensive effects of both components are complementary, almost additive, and the hypokalemic effect of hydrochlorothiazide is reduced by ramipril.

    Ramipril

    Ramiprilate, an active metabolite of ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I- (synonyms: angiotensin-converting enzyme, kininase II). This enzyme catalyzes the conversion of angiotensin I by tissues to the active angiotensin II vasoconstrictor, as well as the breakdown of the active bradykinin vasodilator. Reducing the amount of angiotensin II and suppressing the decay of bradykinin leads to vasodilation.

    Since angiotensin II also stimulates the release of aldosterone, ramiprilate leads to a decrease in the release of aldosterone.

    The use of ramipril leads to a marked decrease in peripheral vascular resistance. Usually, there are no significant changes in the rate of renal blood flow and glomerular filtration.

    The intake of ramipril tablets by patients with hypertension reduces blood pressure in a standing and lying position without compensatory increase in the heart rate (heart rate). In most patients, the antihypertensive effect is manifested after 1-2 hours after taking one dose.The degree of severity of the effect reaches a maximum after 3-6 hours after administration. As a rule, the antihypertensive effect of a single dose is maintained for 24 hours. With prolonged treatment with ramipril, the maximum antihypertensive effect is usually achieved in 2-4 weeks. It is shown that with long-term therapy, the antihypertensive effect can be maintained for 2 years. A sharp discontinuation of ramipril does not lead to a rapid and excessive increase in blood pressure.

    Hydrochlorothiazide

    Hydrochlorothiazide is a thiazide diuretic. Suppresses the reabsorption of sodium and chlorine ions in the distal part of the nephron. Reinforced renal excretion of these ions is accompanied by increased urination (due to osmotic binding of water). The excretion of potassium and magnesium ions increases, and uric acid is delayed. High doses lead to increased elimination of bicarbonate, and long-term intake delays excretion of calcium ions.

    Possible mechanisms of antihypertensive action include: a change in the sodium balance, a decrease in the volume of extracellular fluid and plasma, a change in the resistance of renal vessels, or a decrease in reactions to noradrenaline and angiotensin II.

    Excretion of electrolytes and water begins approximately 2 hours after administration, the maximum effect is achieved in 3-6 hours and persists for 6-12 hours. Antihypertensive effect is achieved in 3-4 days of treatment and lasts for 1 week after completion of the drug. With long-term treatment, a decrease in blood pressure is achieved with the use of smaller doses than those necessary for a diuretic effect. Decrease in blood pressure is accompanied by a slight increase in the rate of glomerular filtration, vascular resistance of the renal bed and the activity of renin in the blood plasma.

    The administration of single high doses of hydrochlorothiazide leads to a decrease in plasma volume, glomerular filtration rate, renal blood flow and average blood pressure. With prolonged administration of small doses, the volume of blood plasma remains reduced, while the minute volume and the rate of glomerular filtration return to the initial level preceding the initiation of treatment. Mean arterial pressure and systemic vascular resistance remain reduced.

    Thiazide diuretics can interfere with the production of breast milk.

    Pharmacokinetics:

    Ramipril

    After oral administration ramipril quickly absorbed.Judging by radioactivity determined in the urine after ingestion of labeled ramipril (excretion by the kidney is only one of several ways), at least 56% of the drug is absorbed. Simultaneous food intake does not affect suction.

    Ramipril is a prodrug that undergoes metabolism during "first passage" through the liver, resulting in the formation (due to hydrolysis, mainly in the liver) of the only active metabolite ramiprilate. In addition to transforming into an active metabolite, ramiprilate, ramipril conjugated with glucuronic acid and converted into a diketopiperazine ester of ramipril. Ramiprilate is also conjugated with glucuronic acid and converted to diketopiperazine-ramiprilate (acid). Thanks to the activation / metabolism of ramipril, bioavailability after ingestion is approximately 20%. After oral administration of 2.5-5 mg of ramipril, the bioavailability of ramiprilata is approximately 45% of the bioavailability recorded after intravenous administration of the same dose of ramipril.

    The concentration of ramipril in the blood plasma reaches its maximum value (Stach) within 1 hour after ingestion.A ramiprilate ram in the blood plasma is achieved within 2-4 hours after taking ramipril inside. The period of pblvovedeniya (T1 / 2) ramipril is approximately 1 hour. After intravenous administration, the volume of distribution of ramipril is approximately 90 liters (1.2 liters / kg), and ramiprilate is 500 liters (6.7 liters / kg). The association with blood plasma proteins is approximately 73% and 56%, respectively, for ramipril and ramiprilate. Experiments on lactating animals have shown that ramipril is excreted in breast milk.

    The decrease in the concentration of ramiprilate in blood plasma has a multiphase nature. The initial distribution and elimination phase is characterized by T1 / 2, which is approximately 3 hours. Then an intermediate phase (T1 / 2 approximately 15 hours) followed by a final phase during which the plasma ramiprilate concentrations are very low (T1 / 2 - 4-5 days). This final phase is due to the slow dissociation of ramiprilate from the strong, but saturated complexes with ACE. Despite the duration of the elimination phase, the equilibrium concentration of ramipril is reached in about 4 days with a daily intake of 2.5 mg or more of ramipril. Effective T1 / 2 (parameter related to the choice of dose) is 13-17 hours after taking several doses.

    After ingestion of 10 mg of labeled ramipril, about 40% of the radioactivity is released through the intestine and 60% - by the kidneys. After intravenous administration of ramipril, approximately 50-60% of the dose is determined in the urine (in the form of ramipril and its metabolites); apparently, about 50% is excreted bypassing the kidneys. After intravenous administration of ramiprilata, approximately 70% of the substance and its metabolites are detected in the urine, which implies that about 30% of ramiprilate is excreted bypassing the kidneys. Within 24 hours after ingestion of 5 mg of ramipril by patients with a catheter that removes the resulting bile, found equal amounts of excretion of ramipril and its metabolites by kidney and bile. Approximately 80-90% of the metabolites released by the kidneys and bile were represented by ramiprilate and preparations for its further metabolism. The share of glucuronide and diketopiperazine derivative of ramipril accounted for about 10-20%, and nonmetabolized ramipril was approximately 2% of the total amount of ramipril.

    The pharmacokinetics of ramipril and ramiprilate in healthy volunteers depends little on age (no differences between young people and those aged 65 to 75 years).

    In patients with impaired renal function, excretion of ramiprilata by the kidneys decreases. The renal clearance of ramiprilate is proportional to the creatinine clearance (CC) and correlates with it. Due to this, the concentration of ramiprilate in the blood plasma is higher, and its elimination is carried out for a longer time than in patients with normal renal function.

    If ramipril is administered in high doses (10 mg), a violation of liver function slows the activation of ramipril (transformation into ramiprilate) and leads to an increase in its concentration in the blood plasma. Elimination of ramiprilate slows down.

    In adults with arterial hypertension and chronic heart failure, there is no significant accumulation of ramipril and ramiprilate after ingestion of ramipril (5 mg once daily for 2 weeks).

    Hydrochlorothiazide

    Approximately 70% of hydrochlorothiazide is absorbed after ingestion, and its bioavailability is also 70%. After ingestion of 12.5 mg of hydrochlorothiazide, the concentration in the blood plasma reaches a maximum (70 ng / ml) for 1.5-4 hours; 25 mg hydrochlorothiazide concentration in blood plasma reaches a maximum (142 ng / ml) after 2-5 hours; 50 mg hydrochlorothiazide concentration in plasma reaches a maximum (260 ng / ml) after 2-4 hours.Approximately 40% of hydrochlorothiazide binds to blood plasma proteins. Hydrochlorothiazide in small amounts is excreted in breast milk.

    Almost completely (more than 95%) is excreted by the kidneys unchanged. Within 24 hours after a single oral intake, 50-70% is output. Hydrochlorothiazide is determined in the urine after 60 minutes after ingestion. T1 / 2 hydrochlorothiazide is in the range of 5 to 15 hours.

    If the renal function is impaired, the excretion decreases and T1 / 2 increases. Renal clearance of hydrochlorothiazide reveals a high correlation with QC. In patients with a glomerular filtration rate of less than 10 ml / min. only 10% of the dose is determined in urine. According to the latest research, hydrochlorothiazide partially injected with bile. Significant changes in pharmacokinetics in liver cirrhosis are not observed. Patients with heart failure did not undergo pharmacokinetics.

    Ramipril and hydrochlorothiazide

    The simultaneous administration of ramipril and hydrochlorothiazide does not affect the bioavailability of each of the components. We can assume that a fixed combination of 5 mg of ramipril and 25 mg of hydrochlorothiazide inthe form of Hartil-D tablets is biologically equivalent to the combination of 5 mg of ramipril and 25 mg of hydrochlorothiazide.

    Indications:

    Arterial hypertension (for patients who are shown combination therapy).

    Contraindications:

    Hypersensitivity to ramipril and other ACE inhibitors, thiazides or sulfonamide derivatives as well as any of the excipients of the drug. Angioedema in history, including those associated with previous therapy with ACE inhibitors.

    Hereditary / idiopathic angioedema.

    Severe renal dysfunction (CK less than 30 mL / 1.73 m2), anuria.

    Pronounced violations of the liver and / or cholestasis.

    Primary aldosteronism.

    Arterial hypotension (see section "Special instructions").

    Hemodialysis.

    Condition after kidney transplantation (no experience of application).

    Galactose intolerance, hereditary deficiency of lactose malabsorption syndrome or glucose-galactose (because of the content of lactose in the formulation).

    Pregnancy and lactation (see "Pregnancy and lactation period")

    Age to 18 years (efficiency and safety not established)

    Carefully:

    severe damage to the coronary and cerebral arteries (risk of blood flow reduction with excessive blood pressure lowering), unstable angina, severe ventricular arrhythmias, chronic heart failure of stage IV, decompensated pulmonary heart disease, conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting), systemic connective tissue diseases, diabetes mellitus, oppression of bone marrow hematopoiesis, elderly age, aortic and mitral stenosis, hypertrophic obstruction cardiomyopathy, bilateral stenosis of the renal arteries or stenosis of the single kidney artery, gout, hyperkalemia, hyponatremia (including diuretics and diet with reduced salt intake), hypokalemia, hypercalcemia, ischemic heart disease, renal and / or liver failure, cirrhosis liver.

    Pregnancy and lactation:

    Pregnancy

    It is not recommended to take Hartil-D during the first trimester of pregnancy. In the case of a planned or confirmed pregnancy, it is necessary to switch to another therapy as soon as possible.Controlled studies of the administration of ACE inhibitors during pregnancy have not been conducted.

    Hartil-D is contraindicated during the second and third trimesters of pregnancy. Long-term admission during the second and third trimesters can cause the appearance of signs of intoxication in the fetus (oppression of kidney function, oligohydramnion, delayed ossification of the skull) and newborn (renal failure of newborns, arterial hypotension, hyperkalemia).

    Long-term intake of hydrochlorothiazide during the third trimester of pregnancy can cause fetal and placental ischemia, the risk of growth retardation. Moreover, in some cases, taking shortly before delivery can cause hypoglycemia and thrombocytopenia in newborns. Hydrochlorothiazide can reduce the volume of blood plasma and reduce uteroplacental blood flow.

    Women who took Hartil-D during pregnancy (beginning in the second trimester) should undergo an ultrasound examination to check the condition of the kidneys and the skull of the fetus.

    Pelactation

    Hartil-D is contraindicated during breastfeeding. AND ramipril and hydrochlorothiazide are excreted in breast milk.Reduction and termination of milk allocation is associated with the use of thiazides during breastfeeding. There may be reactions of hypersensitivity to drugs of the group of sulfonamides, hyperkalemia and nuclear jaundice. Because of the potential for serious side effects in infants, consideration should be given to stopping breastfeeding.

    Dosing and Administration:

    Hartil-D should be taken once daily in the morning, with plenty of fluids; The drug can be taken regardless of reception Pandsoup Tablets are not intended to be divided into parts.

    Adults:

    It is recommended to prescribe the combined drug Hartil-D only after individual selection of the doses of each of the components. The dose can be increased with an interval of at least 3 weeks. The usual initial dose is 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide. The usual maintenance dose is 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide or 5 mg of ramipril and 25 mg of hydrochlorothiazide. The recommended maximum daily dose is 5 mg ramipril and 25 mg hydrochlorothiazide.

    Elderly patients and patients with impaired Functions kidneys

    For elderly patients and patients with QC from 30 to 60 ml / min. Individual doses of each component (ramipril and hydrochlorothiazide) should be carefully selected before switching to the combined Hartil-D preparation.

    The dose of Hartil-D should be as low as possible. The recommended maximum daily dose is 5 mg ramipril and 25 mg hydrochlorothiazide.

    Hartil-D is contraindicated in patients with severe renal dysfunction, ie, when the QC is less than 30 ml / min / 1.73 m2.

    Impaired liver function

    Before switching to Hartil-D, patients with mild or moderate impairment of liver function should choose a dose of ramipril.

    Do not take the drug Hartil-D patients with severe impairment of liver function and / or cholestasis (see Contraindications section).

    Children and teenagers (under the age of 18)

    Hartil-D is not recommended for children and adolescents (under the age of 18) due to the lack of safety and efficacy data for this age group.

    Side effects:

    During the administration of ACE inhibitors, ramipril or hydrochlorothiazide, a number of adverse reactions were noted.

    At the beginning of the course of treatment and after increasing the dose, pronounced arterial hypotension was observed. This effect is especially characteristic for some groups of risk. Symptoms such as dizziness, general weakness, blurred vision, sometimes combined with loss of consciousness (fainting) can be observed. Individual cases of tachycardia, palpitations, arrhythmias, angina, myocardial infarction, severe hypertension and shock, dynamic cerebral blood flow, cerebral hemorrhage and ischemic stroke were observed while receiving ACE inhibitors on arterial hypotension.

    The frequency is defined as follows: often (> 1/100 <1/10) infrequently (> 1/1000 <1/100), rare (> 1/10000, <1/1000), very rare (<1 / 10000), including in single cases.

    Violations of the blood and lymph system: rarely: a decrease in the concentration of hemoglobin and hematocrit, leukopenia, thrombocytopenia, very rarely: agranulocytosis, pancytopenia, eosinophilia, hemolytic anemia in patients with deficiency of glucose-6-phosphate dehydrogenase

    Metabolic and nutritional disorders: often: hypokalemia, increased levels of uric acid, urea and creatinine in blood, hyperglycemia, gout, infrequently: hyperkalemia, hyponatremia, hypomagnesemia, hyperchloremia, hypercalcemia,rarely: disturbances of water electrolyte balance (especially in patients with kidney disease), hypochloraemia, metabolic alkalosis, very rarely: increased serum triglyceride levels, hypercholesterolemia, increased serum amylase, decompensation of diabetes mellitus.

    Disorders of the psyche: infrequently: apathy, nervousness, rarely: a sense of fear, confusion, sleep disturbances.

    Impaired nervous system: often: dizziness, fatigue, headache, weakness, infrequent: drowsiness, rarely: anxiety, impaired sense of smell, imbalance, paresthesia.

    Disorders from the side of the organ of vision: infrequently: conjunctivitis, blepharitis, rarely: transient myopia, blurred vision.

    Hearing impairment: rarely: ringing in the ears.

    Violations of the cardiovascular system: pronounced BP reduction, infrequently: swelling of the ankles, rarely: fainting, thromboembolic complications, very rarely: angina, myocardial infarction, arrhythmias, palpitations, tachycardia, cerebral circulatory dysfunction, cerebral hemorrhage, exacerbation of Raynaud's disease, vasculitis, venous disease, thrombosis , embolism.

    Disturbances from the respiratory system: dry cough, bronchitis, rarely: dyspnea, sinusitis, rhinitis, pharyngitis, glossitis, bronchospasm, allergic interstitial pneumonia, very rarely: angioedema with lethal airway obstruction pathways lungs due to hypersensitivity to hydrochlorothiazide

    Disturbances On the part of the digestive system: nausea, abdominal pain, vomiting, dyspepsia, infrequent: epigastric spasms, thirst, constipation, diarrhea, loss of appetite, rarely: dry mouth, vomiting, taste disorders, inflammation of the mucous membranes of the mouth and tongue, sialadenitis, glossitis, very rarely : intestinal obstruction, (hemorrhagic) pancreatitis

    Disorders from the liver: rarely: increased activity of "hepatic" enzymes and / or bilirubin 2) , very rarely: cholestatic jaundice 2), hepatitis, cholecystitis (against cholelithiasis), liver necrosis

    Disturbances from the skin and subcutaneous fat 3): infrequently: photosensitization, skin itching, urticaria, rarely: "hot flushes" of blood to the skin of the face, increased sweating, peripheral edema, very rarely: erythema multiforme, Stevens-Johnson syndrome,toxic epidermal necrolysis, skin reactions such as psoriatic or pemphigoid, systemic lupus erythematosus, alopecia, exacerbation of psoriasis, onycholus. Disturbances from the musculoskeletal system and connective tissue: rarely: muscle spasm, myalgia, arthralgia, muscle weakness, arthritis, very rarely: paralysis. Disorders from the urinary system: infrequently: proteinuria, rarely: impaired renal function, increased residual nitrogen and serum creatinine, dehydration, very rare: (acute) renal failure, nephrotic syndrome, interstitial nephritis, oliguria

    Violations of the reproductive organs and mammary glands: infrequently: decreased libido, rarely: impotence

    Common violations: very rarely: anaphylactic reactions, angioedema. Angioedema often develops in people with dark skin. In a small group of patients, the onset of angioedema and the oropharyngeal area is associated with the administration of ACE inhibitors.

    1. In the case of jaundice or increased activity of "hepatic" enzymes, the patient must be taken under medical supervision.

    2. If skin reactions are pronounced, urgent medical consultation is needed.

    It has been reported that the intake of the drug may cause symptom represented by at least one of the following components: fever, vasculitis, myalgia, arthralgia / arthritis, a positive reaction for antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis, rash, photosensitivity (other skin manifestations are also possible).

    Overdose:

    Symptoms

    Depending on the extent of the following symptoms may occur overdose: urinary retention, electrolytes disorders, marked reduction in blood pressure, impaired consciousness (including coma), convulsions, paresis, arrhythmia, bradikardyya, shock, kidney failure and bowel obstruction (paralysis).

    Treatment

    Treatment for overdose or poisoning depends on the method and duration of the drug, as well as the type and severity of the symptoms. In addition to common measures (prevention of gastric lavage and suction intake of activated carbon, the acceleration passage through the intestines with sodium sulphate) are required surveillance and maintenance (sometimes intense) therapy. Ramipril can be completely removed from the body by dialysis (note Anaphylactoid reactions in patients on hemodialysis).

    The first measure with a pronounced decrease in blood pressure is the restoration of the volume of fluid with saline. In the absence of an adequate reaction, catecholamines can be administered intravenously. You can consider the possibility of angiotensin II.

    With severe bradycardia, an artificial pacemaker must be installed. It is necessary to monitor the volume of circulating blood, the level of electrolytes, the acid-alkaline state, the level of glucose in the blood and diuresis. When hypokalemia is necessary to restore the level of potassium.

    If angioedema is life-threatening and covers the tongue, vocal chord, and / or throat, the following urgent measures are recommended:

    • Immediate subcutaneous injection of 0.3-0.5 mg epinephrine (adrenaline) or slow intravenous injection of adrenaline, in combination with ECG and blood pressure monitoring.

    • Intravenous or intramuscular administration of glucocorticoids.

    • It is also recommended to introduce antihistamines.

    • In addition to adrenaline, you can enter C i-inactivator, if it is known that the patient has a deficit Ci-inactivator (a protein that suppresses binding of the C1 component of the complement with an immune complex, its insufficiency leads to uncontrolled activation of the early complement components and the formation of a kinin-like factor that causes an increase in vascular permeability and leads to angioedema edema).

    Interaction:

    The interactions of the components of Hartil-D with other ACE inhibitors and preparations containing hydrochlorothiazide.

    Ramipril
    diuretics

    The appointment of a diuretic to a patient receiving ramipril, usually leads to a summation of the antihypertensive effect.

    In patients who are already taking diuretics, especially those diuretics who have recently been prescribed, the addition of ramipril can sometimes cause an excessive decrease in blood pressure. The likelihood of symptoms of arterial hypotension under the influence of ramipril decreases if you stop taking a diuretic before starting treatment with ramipril (see section Special instructions). Tricyclic antidepressants / antipsychotics (antipsychotics) / anesthetics The intake of certain anesthetics, tricyclic antidepressants and antipsychotics against the background of ACE inhibitors can enhance arterial hypotension (see section Special instructions).

    Sympathomimetics

    Sympathomimetics can weaken the hypotensive effect of ACE inhibitors, so patients need careful monitoring.

    Hypoglycemic agents

    Epidemiological studies have shown that simultaneous administration of ACE inhibitors and hypoglycemic agents (insulin and hypoglycemic agents for oral administration) can enhance the effect of the latter, up to the development of hypoglycemia. The likelihood of such events is especially high during the first weeks of combined treatment of patients, as well as in violation of kidney function.

    Thrombolytics and / or beta-blockers

    Ramipril can be used against thrombotic beta-blockers.

    Other antihypertensive drugs

    Simultaneous intake of nitroglycerin and other organic nitrates or vasodilators can enhance the hypotensive effect of ramipril.

    Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (3 g / day)

    Ramipril can be used against the background of taking acetylsalicylic acid (in small doses under the supervision of a doctor). Long-term use of NSAIDs may weaken the hypotensive effect of ACE inhibitors. The effects of NSAIDs and ACE inhibitors on increasing serum potassium levels are summarized, which can lead to impaired renal function. These effects are usually reversible. In rare cases, acute renal failure may occur, especially if renal function is impaired, for example in elderly or dehydrated patients. Allopurinol

    Simultaneous treatment with an ACE inhibitor and allopurinol increases the risk of kidney failure and may lead to an increased risk of leukopenia.

    Cyclosporin

    Simultaneous administration of ACE inhibitors and cyclosporine increases the risk of renal failure and hyperkalemia.

    Lovastatin

    Simultaneous administration of ACE inhibitors and lovastatin increases the risk of hyperkalemia. Procainamide, cytostatics and immunosuppressants

    Taking these drugs simultaneously with ACE inhibitors may increase the risk of leukopenia. Hemodialysis

    Hartil-D is not indicated for patients whose condition requires dialysis,since the use of ACE inhibitors against the background of dialysis using membranes that provide a high current intensity is often accompanied by anaphylactoid reactions. This combination is unacceptable.

    Hydrochlorothiazide

    Amphotericin B (parenterally), carbenoxolone, corticosteroids, corticotropin (ACTH), or laxative stimulant action

    Hydrochlorothiazide can cause electrolyte imbalance, especially hypokalemia.

    Salts of calcium

    With the simultaneous administration of these drugs with thiazide diuretics, a decrease in the excretion of calcium ions can increase the level of calcium in the blood serum.

    Cardiac glycosides

    The risk of poisoning with digitalis preparations and thiazide hypokalemia increases. Cholestyramine resins and colestipol

    These drugs can reduce or slow the absorption of hydrochlorothiazide. Therefore, sulfonamide diuretics should be taken at least one hour before or 4-6 hours after taking the resin.

    Non-depolarizing muscle relaxants (i.e. tubocurarachloride)

    Hydrochlorothiazide can enhance the effect of these drugs.

    Medicines that cause tachycardia such as "pirouette"

    The risk of hypokalemia causes caution in the simultaneous administration of hydrochlorothiazide and drugs that cause tachycardia such as pirouettes, for example, some antipsychotic and other agents.

    Sotalol

    On the background of thiazide hypokalemia, the risk of arrhythmia increases due to the intake of cotalol.

    Ramipril / 'hydrochlorothiazide

    Potassium-containing food additives, potassium-sparing diuretics or potassium-containing substitutes

    Although serum potassium levels in clinical trials of ACE inhibitors have usually remained within normal limits, in some patients, hyperkalemia has developed.

    The risk of hyperkalemia is associated with a number of factors, including renal insufficiency, diabetes mellitus and simultaneous intake of potassium-sparing diuretics (for example, spironolactone, triamterene or amiloride), as well as potassium-containing food additives or salt substitutes. The use of potassium-containing food additives, potassium-sparing diuretics or potassium-containing substitutes can lead to a significant increase in potassium levels in the blood serum, especially in patients with impaired renal function.

    During the reception of ramipril on the background of potassium-releasing diuretics, hypokalemia caused by their intake may be weakened.

    Lithium


    With the simultaneous administration of lithium and ACE inhibitors, the level of lithium in the serum is reversibly increased and toxic effects develop. The use of thiazide diuretics can increase the risk of lithium intoxication and increase lithium intoxication if it is already caused by the simultaneous administration of ACE inhibitors. Use ramipril concomitant with lithium is not recommended, but in cases where this combination is necessary, careful monitoring of serum lithium levels should be carried out (see Special instructions).

    . Trimethoprim

    Admission of ACE inhibitors and thiazides simultaneously with trimethoprim increases the risk of hyperkalemia.

    Oral hypoglycemic agents (eg, sulfo-urea derivatives and biguanides, such as metformin) and insulin

    Maybe, hydrochlorothiazide weakens the hypoglycemic effect of these drugs, while ramipril potentiates it.

    Sodium chloride

    Weakening of the antihypertensive effect of a fixed combination of ramipril and hydrochlorothiazide.

    Treatment with high doses of salicylates (> 3 g / day)

    Hydrochlorothiazide can increase the toxic effects of salicylates on the central nervous system.

    Special instructions:

    Ramipril

    Symptoms of arterial hypotension

    In patients with uncomplicated arterial hypertension, symptoms of arterial hypotension are rare. In patients with hypertension taking ramipril, the likelihood of developing arterial hypotension increases with a decrease in the volume of circulating blood (for example, as a result of diuretic treatment, restriction of salt intake, dialysis, diarrhea, or vomiting), and severe forms of renin-dependent hypertension. Symptoms of arterial hypotension were observed in patients with heart failure, regardless of whether it is combined with renal insufficiency. This is most often observed in patients with more severe heart failure who are forced to take high doses of "loop" diuretics who have hyponatremia or functional renal failure.

    Patients with an increased risk of hypotension need close monitoring in the initial period of treatment and in the selection of a dose.This also applies to patients with coronary artery disease or cerebrovascular disease, in whom a significant fall in blood pressure can lead to myocardial infarction or cerebral circulation impairment.

    In the case of arterial hypotension, the patient should be placed on his back, legs raised and, if necessary, an intravenous infusion of sodium chloride solution. Transient hypotensive reaction is not a contraindication for the subsequent administration of the drug.

    In some patients with heart failure who have normal or low blood pressure, ramipril may cause an additional decrease in systolic blood pressure. This effect can be foreseen, therefore it is usually not a basis for discontinuing treatment. If hypotension is symptomatic, it may be necessary to reduce the dose or stop treatment.

    Aortic and mitral stenosis / hypertrophic cardiomyopathy Like other ACE inhibitors, ramipril requires caution for patients with aortic stenosis or difficulty in ejection from the left ventricle (eg, in aortic stenosis or hypertrophic cardiomyopathy).In some cases, the hemodynamic picture may make it unacceptable to take a fixed combination of ramipril and gydrochlorothiazide.

    Primary aldosteronism (Conn's disease)

    The use of fixed combinations of ramipril and hydrochlorothiazide is contraindicated, since patients with primary aldosteronism are not sensitive to antihypertensive agents, the action of which is based on the suppression of the renin-angiotensin system. Impaired renal function

    In patients with heart failure at the beginning of treatment with ACE inhibitors, impaired renal function may be observed. In such situations, cases of acute renal failure, usually transient, are described.

    In some patients with narrowing of both renal arteries or with stenosis of the artery of a single kidney, ACE inhibitors increase the level of urea in the blood and creatinine in the serum; usually these changes occur after discontinuation of medication. The likelihood of this is especially high in renal failure. In the presence of renovascular hypertension, the risk of severe arterial hypotension and renal failure is high.In such patients, treatment should be started under close medical supervision with small doses, which must be accurately matched. Because diuretics can contribute to the clinical dynamics described above, during the first weeks of treatment with ramipril, their intake should be discontinued and the kidney function needs careful monitoring.

    In some patients with arterial hypertension without an obvious renal vessel disease, taking ramipril, especially against diuretics, causes an increase in the level of urea in the blood and creatinine in the serum; these changes tend to be minor and transient. The probability of their occurrence is higher in patients already suffering from impaired renal function. In such cases, it may be necessary to reduce the dose and / or stop taking the diuretic and / or ramipril.

    Condition after kidney transplantation

    In connection with the lack of experience with the use of ramipril in patients who have recently undergone kidney transplantation, ramipril it is not recommended to take such patients.

    Increased Sensitivity / angioedema

    Angioedema of the face, extremities, lips, tongue, vocal cords and / or larynx rarely develops in patients receiving ACE inhibitors, including ramipril. During treatment, angioedema may develop at any time. In this case, the taking of ramipril should be stopped immediately, the appropriate treatment should be carried out and the patient should be monitored; Before releasing the patient, you should make sure that all the symptoms of the edema are eliminated. Even in cases where edema is limited to the tongue and signs of breathing are not present, patients may need long-term follow-up, since treatment with angstamines and corticosteroids may not be sufficient. In rare cases death of patients due to angioedema of the larynx or tongue is documented.

    If swelling spreads to the tongue, vocal cords, or larynx, it is very likely that the airway is blocked, especially in patients who have previously undergone surgery on the respiratory system. In such cases it is necessary to take emergency therapy (see Overdose section). It can include the administration of epinephrine (adrenaline) and / or maintenance of airway patency. The patient should be under careful medical supervision until the symptoms disappear completely and persistently.

    Patients who have a history of angioedema, not associated with an inhibitor of ACE, may be at increased risk of angioedema in Response to an ACE inhibitor.

    Anaphylactoid reactions in patients receiving hemodialysis treatment

    There are reports of anaphylactoid reactions in patients on hemodialysis using membranes with high hydraulic permeability (for example, AN 69) with simultaneous use of ACE inhibitors. In such cases, another type of membrane or other antihypertensive medication should be considered. Anaphylactoid reactions in the apheresis of low density lipoproteins (LDL)

    In rare cases, life-threatening anaphylactoid reactions develop in patients taking an ACE inhibitor against a background of low-density lipoprotein (LDL) apheresis with dextrin sulfate. Such reactions can be avoided if temporarily refraining from taking an ACE inhibitor before each apheresis procedure.

    Desensitization

    In patients taking ACE inhibitors against the background of desensitizing therapy (for example, the venom of Hymenoptera), long anaphylactoid reactions develop.If such patients refrained from taking ACE inhibitors for the time of desensitization, no reactions were observed, but a random injection of ACE provoked an anaphylactoid reaction.

    Liver failure

    FROM the use of ACE inhibitors is associated with the development of a rare syndrome that begins with cholestatic jaundice or hepatitis and passes into transient liver necrosis, sometimes with a fatal outcome. The mechanism of development of this syndrome is not clear. If patients taking ramipril, jaundice develops or the activity of "liver" enzymes increases significantly, the drug must be canceled, leaving the patient under the supervision of a doctor until the symptoms disappear.

    Neutropenia / agranulocytosis

    It has been reported that patients taking ACE inhibitors may develop neutropenia / agranulocytosis, thrombocytopenia and anemia. With normal kidney function and in the absence of complications, neutropenia develops rarely. Neutropenia and agranulocytosis are reversible and pass after discontinuation of the ACE inhibitor. Caution should be exercised when appointing ramipril to patients suffering from connective tissue diseases with vascular manifestations undergoing treatment with antidepressants taking allopurinol or procainamide, as well as a combination of these factors, especially against a background of impaired renal function. Some of these patients develop severe infections, which are not always accompanied by intensive antibiotic therapy. If the treatment of such patients is used ramipril, it is recommended to periodically check the number of white blood cells, and patients should be warned about the need to report any signs of infection.

    Race

    ACE inhibitors often cause the development of angioedema in patients of the Negroid race as compared to patients of other race.

    Like other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black patients than in other races, possibly due to a higher incidence of low renin in a population of black patients suffering from hypertension.

    Cough

    It was reported that the administration of ACE inhibitors may be accompanied by a cough. It is characteristic that the cough is dry and persistent; it passes after the drug is discontinued. The fact that the cough is caused by the intake of an ACE inhibitor should be considered as a differential diagnostic feature.

    Surgery / general anesthesia

    In patients undergoing surgery or general anesthesia with drugs that reduce blood pressure, ramipril can block the increase in the formation of angiotensin II under the influence of compensatory release of renin. If it is assumed that arterial hypotension develops by this mechanism, it can be corrected by increasing the volume of circulating blood. _

    Hyperkalemia

    In some patients taking ACE inhibitors, including ramipril, there is an increase in potassium in the serum. The risk group for hyperkalemia includes patients suffering from renal insufficiency or diabetes mellitus, taking potassium-sparing diuretics, or potassium-containing salt substitutes, as well as those who take other medicines that increase potassium levels in the serum (eg, heparin). If the reception of the above drugs against the background of treatment with an ACE inhibitor is considered necessary, regular monitoring of serum potassium levels is recommended (see Interaction).

    Patients with diabetes mellitus

    In patients with diabetes mellitus, who take hypoglycemic drugs for ingestion or insulin, you must carefully monitor blood sugar levels during the first month of treatment with an ACE inhibitor (see Interactions).

    Lithium

    It is usually not recommended to combine lithium and ramipril (see Interaction). Potassium-containing food additives, potassium-sparing diuretics or potassium-containing substitutes

    Although serum potassium levels in clinical studies of ACE inhibitors usually remained within normal limits, some patients still developed hyperkalemia. The risk of hyperkalemia is associated with a number of factors, including renal insufficiency, diabetes mellitus, and simultaneous use of potassium-sparing diuretics (for example, spironolactone, triamterene or amiloride), as well as potassium-containing food additives or salt substitutes. The use of potassium-containing food additives, potassium-sparing diuretics or potassium-containing substitutes can lead to a significant increase in potassium levels in the serum, especially in patients with impaired renal function.

    During the reception of ramipril on the background of potassium-releasing diuretics, hypokalemia caused by their intake may be weakened.

    Guiduochlorooctiazide Impaired renal function

    In patients with kidney disease, thiazides can cause azotemia. Taking medicines against a background of impaired renal function can lead to cumulative effects. If kidney failure improves, characterized by an increase in non-protein nitrogen, the need for therapy should be carefully assessed and the possibility of stopping diuretics should be considered.

    Impaired liver function

    Patients with a violation or progressive impairment of liver function, thiazides should be administered with caution, since even minor fluctuations in the water-electrolyte balance can cause hepatic coma.

    Metabolic and endocrine effects

    Thiazide therapy can reduce glucose tolerance. With diabetes, it may be necessary to choose a dose of insulin or oral hypoglycemic agents. Thiazide therapy can cause a manifestation of latent diabetes mellitus.

    With therapy, thiazide diuretics are associated with an increase in cholesterol and triglyceride levels.In some patients receiving thiazide diuretics, there may be an increase in the level of uric acid or the manifestation of gout.

    Gout

    In some patients, thiazide therapy may increase the level of uric acid and / or cause gout. but ramipril can increase the excretion of uric acid, thereby weakening the degree of increase in the level of uric acid under the influence of hydrochlorothiazide. Violations of the water-electrolyte balance

    Any patient receiving treatment with diuretics should periodically determine the content of electrolytes in the blood serum.

    ThiazidY, including hydrochlorothiazide, can cause a violation of the water-electrolyte balance (gipokaliemiyu, hyponatremia and hypochloremic alkalosis). Harbinger violations of water or electrolyte balance are dry mouth, thirst, weakness, lethargy, drowsiness, anxiety, myalgia or muscle spasms, muscle fatigue, arterial hypotension, oliguria, tachycardia and gastrointestinal disorders such as nausea and vomiting.

    Although the use of thiazide diuretics and may lead to the development of hypokalemia, with the simultaneous administration of ramipre can reduce the severity of hypokalemia caused by diuretics.The likelihood of hypokalemia is highest in cirrhosis, in patients with elevated diuresis, in inadequate oral administration of electrolytes, as well as in the treatment of corticosteroids and ACTH (see Interaction). In hot weather, it is possible to develop hyponatremia in patients with peripheral edema. The lack of chlorides is usually minor and does not need treatment.

    Thiazides can reduce the excretion of calcium ions in the urine, resulting in a slight periodic increase in the level of calcium in the blood, even in the absence of obvious violations of calcium metabolism. Explicit hypercalcemia may indicate latent hyperparathyroidism. The administration of thiazides should be discontinued until the results of the parathyroid gland function are obtained. It has been shown that thiazides increase the renal excretion of magnesium, which can lead to a decrease in the level of magnesium in the blood.

    Neutropenia / agranulocytosis

    It is necessary to stop taking a combination of fixed doses of ramipril and hydrochlorothiazide in case of occurrence or suspicion of neutropenia (the number of neutrophils is less than 1000 / mm3).

    Anti-doping tests

    Hydrochlorothiazide, which is part of this drug, can give a positive reaction in the anti-doping control.

    Other

    Regardless of the history of allergy or bronchial asthma, patients may develop hypersensitivity reactions. The possibility of exacerbation of systemic lupus erythematosus was reported.

    Lactose intolerance

    This medication contains lactose monohydrate.

    It should not be prescribed to patients with a rare hereditary impairment of tolerance to galactose, hereditary lactose deficiency or a syndrome of glucose-galactose absorption impairment.

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

    Hartil-D has a weak or moderate influence on the ability to drive and work with machinery. Due to differences in individual reactions, some patients may be impaired ability to drive, work with mechanisms, and perform other types of work that require increased attention. This is especially pronounced at the start of treatment and / or after an increase in dosage.

    Form release / dosage:

    Tablets 2.5 mg + 12.5 mg, 5 mg + 25 mg.

    For 14 tablets in a blister of PVC / PCTFE / al.folga.2 blisters together with instructions for medical use in a cardboard box.

    Packaging:For 14 tablets in a blister of PVC / PCTFE / al.folga. 2 blisters together with instructions for medical use in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after expiration date

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005317/08
    Date of registration:07.07.2008
    The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp16/10/2014
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