Hopten - instructions for use, dose, side effects, contraindications

Active substanceTrandolaprilTrandolapril

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Hopten®

capsules inwards

Abbott Airland Pharmaceutical Operations Ireland

Hopten®

capsules inwards

Abbott Airland Pharmaceutical Operations Ireland

Dosage form: & nbspcapsules

Composition:

Each capsule contains:

Active substance: Trandolapril 2.00 mg.

Excipients: corn starch - 37.15 mg, lactose monohydrate - 54.50 mg, povidone (K25) - 5.35 mg, sodium stearyl fumarate - 1.00 mg.

Capsule shell: hard gelatin capsule (size 4),

capsule cap: gelatin - 15.7904 mg, titanium dioxide E 171 - 0.0640 mg, iron oxides and hydroxides E 172 (yellow iron oxide) - 0.1136 mg, sodium lauryl sulfate - 0.0320 mg;

Capsule body: gelatin 23.6856 mg, titanium dioxide E 171-0.0960 mg, iron oxides and hydroxides E 172 (yellow iron oxide) 0.1704 mg, sodium lauryl sulfate 0.0480 mg.

Description:Hard gelatin capsule, size 4, the lid is red, opaque, the case is red, opaque. The contents of the capsule are white granules.

Pharmacotherapeutic group:Angiotensin-converting enzyme inhibitor

ATX: & nbsp

C.09.A.A.10 Trandolapril

Pharmacodynamics:Trandolapril is an ethyl ester (prodrug) of a non-sulfhydryl angiotensin converting enzyme (ACE) inhibitor. Trandolapril quickly absorbed and nonspecifically hydrolyzed to tradolaprilat (pharmacologically active metabolite).

Pharmacodynamics

Trandolaprilat strongly binds to the ACE.Inhibition of ACE leads to a decrease in the concentration of angiotensin II, aldosterone, atrial natriuretic factor and an increase in plasma renin activity and angiotensin I concentration. Thus, trandolapril modulates the renin-angiotensin-aldosterone system (RAAS), which plays a major role in regulating circulating blood volume (BCC), blood pressure (BP), and consistently exerts an antihypertensive effect. In patients with hypertension, the use of trandolapril in therapeutic doses leads to a comparable decrease in blood pressure in the "lying" and "standing" positions. The antihypertensive effect of trandolapril is manifested 1 hour after ingestion and persists for at least 24 hours. The maximum effect is achieved after 8-12 hours.

Data were obtained showing a decrease in myocardial hypertrophy along with an improvement in diastolic function and an increase in the elasticity of the arteries in patients under the action of trandolapril.

It has been shown that the Hopten® drug improves survival after a myocardial infarction in patients with left ventricular dysfunction (left ventricular ejection fraction ≤35%) regardless of the presence of symptoms of heart failure and / or ischemia. With prolonged treatment with Hopten®, there is a decrease in the rate of cardiovascular mortality, the risk of sudden death and the incidence of severe or treatment-resistant heart failure.

Pharmacokinetics:

Suction

Trandolapril is rapidly absorbed after oral administration. The absolute bioavailability of trandolapril is about 10%. Time to reach the maximum concentration (C_m_Oh) Trandolapril in blood plasma - about 1 h.

Distribution and Metabolism

Trandolapril is hydrolyzed to the active diacid metabolite of trandolaprilate. Absolute bioavailability of trandolapril with trandolapril is about 13 %. Time to reach C_m_Oh Trandolaprilata in blood plasma is 3-8 hours. C_m_Oh and AUC (area under the "concentration-time" curve) do not depend on the time of food intake. The association of trandolapril with plasma proteins is about 80% and does not depend on concentration. Volume of distribution (V_d) trandolapril - about 18 liters. In healthy volunteers trandolapril is rapidly excreted from the blood plasma with an average half-life (T_1/2) less than 1 hour.The association of trandolaprilat with blood proteins depends on the concentration and varies from 65% at a concentration of 1000 ng / ml to 94% at a concentration of 0.1 ng / ml.

With repeated application, the equilibrium state of the concentration is reached approximately after 4 days both in healthy volunteers, and in patients of young and elderly ages with arterial hypertension. When the equilibrium state of the concentration effective T_1/2 Trandolaprilat together with a small part of the drug taken varies between 15 hours and 23 hours, which probably reflects a binding to plasma and tissue ACE.

Excretion

About 9-14% of the dose of trandolapril is excreted as trandolaprilate by the kidneys. After receiving labeled trandolapril, 33% were excreted through the kidneys and 66% through the intestine. In an insignificant amount trandolapril is excreted unchanged through the kidneys (less than 0.5%). The renal clearance of trandolaprilate varies from 0.15 l / h to 4 l / h, depending on the dose.

Special patient groups

Children

The pharmacokinetics of trandolapril in children under 18 years of age have not been studied.

Patients of advanced age and gender differences

The pharmacokinetic properties of trandolapril have been studied in elderly patients (over 65 years) and in both sexes.The concentration of trandolapril in the blood plasma increases in elderly patients. However, the plasma concentration of trandolaprilate and its ACE inhibitory activity in patients with hypertension of the elderly and younger age is comparable. The pharmacokinetics of trandolapril and trandolaprilate, as well as ACE inhibitory activity in elderly patients of both sexes are comparable.

Race

Pharmacokinetics in representatives of various races has not been studied.

Renal insufficiency

Compared with healthy volunteers, the plasma concentrations of trandolapril and trandolaprilate are approximately 2-fold higher in patients on hemodialysis and with creatinine clearance (CK) <30 ml / min, and the renal clearance is reduced by approximately 85%. Patients with renal failure are recommended to correct the dose of the drug.

Liver failure

In comparison with healthy volunteers, in patients with alcoholic cirrhosis of the liver in the initial or expanded stage after taking trandolapril, the plasma concentrations of trandolapril and trandolaprilat were increased by 9 and 2 times, respectively,but the ACE inhibitory activity did not change. Patients with hepatic impairment may require the administration of smaller doses of the drug.

Indications:

Hypertension of mild to moderate severity.
Left ventricular dysfunction after myocardial infarction.

Contraindications:

- Hypersensitivity to the active substance or any of the excipients;

- increased sensitivity to other ACE inhibitors;

- angioedema, including those associated with previous treatment with ACE inhibitors;

- hereditary / idiopathic angioedema;

- aortic stenosis or obstruction of the outflow tract of the left ventricle;

- pregnancy;

- the period of breastfeeding;

- age under 18 years (effectiveness and safety not established);

- lactase deficiency in lobes (Saami), intolerance to galactose, glucose-galactose malabsorption syndrome (the preparation contains lactose);

- simultaneous use with aliskiren and aliskirenoderzhaschimi drugs in patients with diabetes mellitus and / or renal dysfunction (GFR less than 60 ml / min / 1.73 m²).

Carefully:Violation of the function of the liver and / or kidneys (with creatinine clearance less than 30 ml / min); Systemic diseases of connective tissue (including systemic lupus erythematosus, scleroderma), especially in cases of impaired renal function and concomitant therapy with corticosteroids and antimetabolites; Hyperkalemia, especially in cases of impaired renal function; oppression of bone marrow hematopoiesis; symptomatic arterial hypotension; conditions, accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting, diet with restriction of table salt and liquid, hemodialysis); one or bilateral stenosis of the renal arteries; stenosis of the artery of a single kidney; condition after kidney transplantation; surgical interventions or general anesthesia with the use of drugs that cause arterial hypotension (long-term treatment with diuretics); use of Negroid race in patients (see section "Special instructions"); simultaneous use with beta-blockers (see section "Interaction with other drugs"); dry, unproductive cough; simultaneous desensitization of the organism to the poisons of the Hymenoptera; simultaneousLDL-apheresis (see section "Special instructions"); elderly age.

Pregnancy and lactation:

Pregnancy

The drug Gopten® contraindicated in pregnancy.

Data on the teratogenic effects of ACE inhibitors in the first trimester of pregnancy are not available, but this possibility can not be completely ruled out. Patients planning a pregnancy should be prescribed antihypertensives, for which safety of use during pregnancy has been proven, unless continuation of therapy with ACE inhibitors is necessary. If pregnancy occurs during the administration of an ACE inhibitor, it must be immediately discontinued and, if necessary, an alternative therapy should be prescribed.

It is known that with the use of ACE inhibitors in the II and III trimester of pregnancy, fetotoxic effects (renal dysfunction, hypochondria, slowing ossification of the skull bones) and toxic effects (kidney failure, arterial hypotension, hyperkalemia) on a newborn baby are possible. In the case of the use of the drug Hopten® since the second trimester of pregnancy, an ultrasound evaluation of the function of the kidneys of the fetus and the state of the bones of the skull is recommended.Newborns whose mothers took ACE inhibitors during pregnancy should be under the supervision of a physician to exclude arterial hypotension.

Breastfeeding period

There are no data on the penetration of trandolapril into breast milk. The drug Gopten® contraindicated during breastfeeding. It is more preferable for this group of patients to prescribe drugs with a proven safety profile, especially when feeding newborns and premature babies.

Dosing and Administration:

Inside. Capsule swallowed whole and washed down with water. The drug Hopten® is taken regardless of the time of ingestion, at the same time, once a day. Selection of an individual dose of the drug should be performed by a doctor.

To ensure the following dosage regimen, you can use the drug Hopten® in another dosage form: 0.5 mg capsules.

Arterial hypertension

In patients with hypertension without signs of heart failure, without signs of renal or hepatic insufficiency, not taking diuretic drugs, the recommended initial dose is from 0.5 to 1 mg to 2 mg once a day.For patients of the Negroid race, the usual initial dose is 2 mg. Depending on the clinical efficacy, an increase in the dose is possible after 1 to 4 weeks of administration of the drug Hopten® to a maximum dose of 4-8 mg / day.

The maintenance dose is 1 to 4 mg once a day. If there is no therapeutic effect with the use of the drug Hopten in doses 4-8 mg / day, combined therapy with diuretics and / or "slow" calcium channel blockers (BCCs) should be considered.

Left ventricular dysfunction after myocardial infarction

Treatment with the drug Hopten® can be started from the third day after a previous myocardial infarction. The initial dose is 0.5-1 mg per day, then a single daily dose is gradually increased to 4 mg. Depending on the tolerability of therapy (the limiting moment - the development of symptomatic arterial hypotension), the increase in the dose can be temporarily stopped. When arterial hypotension occurs, concomitant therapy with vasodilators, including nitrates and diuretics, should be reviewed and, if possible, reduced in dose. Dosage of the drug Hopten ® should be reduced only if the previous measures were ineffective or impossible.

Special patient groups

Elderly patients

In elderly patients, the same dosages of Hopten® are used as in young patients. In elderly patients with normal renal and hepatic function, dose adjustment is not required. With caution and under the control of blood pressure, the dose of Hopten® should be increased in elderly patients with chronic heart failure, impaired liver and / or kidney function, or in patients taking diuretics.

Previous use of diuretics

In patients at risk of activation of the renin-angiotensin-aldosterone system (ie in patients with a disturbance of the water-electrolyte balance) two or three days before the appointment of the drug Hopten® at a dose of 0.5 mg, it is necessary to cancel the intake of diuretics in order to reduce the possibility development of symptomatic arterial hypotension. Later, if necessary, you can resume therapy with diuretics.

Heart failure

In patients with arterial hypertension and chronic heart failure, without or with renal insufficiency, after the initiation of treatment with ACE inhibitors symptomatic arterial hypotension was noted.In this group of patients, therapy with Hopten® should be started at a dose of 0.5 mg-1 mg / day, under close medical supervision.

Renal insufficiency

In patients with moderate renal function impairment (creatinine clearance from 30 to 70 ml / min), administration of the drug in a usual dose is recommended. When creatinine clearance is less than 30 ml / min, the initial dose should not exceed 0.5 mg once a day. In the future, if necessary, the dose may be increased. Therapy with Hopten® in these patients should be performed under close medical supervision.

Dialysis

The possibility of excretion of trandolapril or trandolaprilate in patients with dialysis is not accurately established. However, one can expect that the concentration of the active metabolite - trandolaprilate - decreases during dialysis, which can lead to an increase in blood pressure. Therefore, in patients during dialysis, careful monitoring of blood pressure with a possible correction, if necessary, a dose of the drug is recommended.

Lack of liver function

In patients with severe liver function deficiency, due to a decrease in hepatic clearance of trandolapril and its active metabolite trandolaprilat, a significant increase in plasma concentrations of both trandolapril and trandolapril (to a lesser extent) can be observed.Treatment begins with a dose of 0.5 mg per day under close supervision of a doctor.

Children

The effectiveness and safety of the use of the drug Hopten ® in children are not established.

Side effects:

The side effects that were observed during clinical trials and post-marketing use of trandolapril are presented below. According to the WHO classification, all reactions are distributed according to organ systems and the frequency of development: very often (≥1/10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000); frequency is unknown (can not be determined from available data).

Infectious and parasitic diseases:

infrequently: upper respiratory tract infection; rarely: bronchitis, urinary tract infection, pharyngitis; frequency is unknown: sinusitis *, rhinitis *, glossitis *.

Violations from the blood and lymphatic system:

rarely: anemia, leukopenia, thrombocyte disorders, leukocyte disorders;

frequency is unknown: pancytopenia, agranulocytosis, a decrease in the number of thrombocytes, hemolytic anemia.

Immune system disorders:

rarely: hypersensitivity reactions.

Disorders from the metabolism and nutrition:

rarely: anorexia, increased appetite, hyperlipidemia, hypercholesterolemia, hyperglycemia, hyponatremia, hyperuricemia, gout, enzymatic dysfunction;

frequency is unknown: hyperkalemia.

Disorders of the psyche:

infrequently: insomnia, decreased libido;

rarely: depression, hallucinations, anxiety, agitation, apathy, sleep disorders;

frequency is unknown: confusion of consciousness.

Impaired nervous system:

often: headache, dizziness;

infrequently: drowsiness;

rarely: violation of cerebral circulation, fainting, migraine (with aura and without), paresthesia, taste disorder, muscle cramps;

frequency is unknown: transient ischemic attack, cerebral hemorrhage, imbalance.

Disorders from the side of the organ of vision:

rarely: blurred vision, blepharitis, edema of the eye, eye diseases;

frequency is unknown: blurred vision *.

Hearing impairment and labyrinthine disturbances:

infrequently: vertigo;

rarely: noise in ears.

Heart Disease:

infrequently: a feeling of palpitations;

rarely: myocardial infarction, myocardial ischemia, tachycardia, ventricular tachycardia, bradycardia, heart failure, angina pectoris;

frequency is unknown: atrioventricular blockade, arrhythmia, cardiac arrest.

Vascular disorders:

often: marked decrease in blood pressure;

infrequently: "tides" of blood to the skin of the face;

rarely: Orthostatic hypotension, arterial hypertension, angiopathy, peripheral vascular disorders, varicose veins;

Disturbances from the respiratory system, chest and mediastinal organs:

often: cough;

infrequently: inflammation of the upper respiratory tract, obstruction of the upper respiratory tract;

rarely: dyspnea, wet cough, pharyngitis, pain in the oropharynx, epistaxis, breathing disorders;

frequency is unknown: bronchospasm.

Disorders from the digestive system:

infrequently: nausea, diarrhea, constipation, gastrointestinal pain, gastrointestinal violations;

rarely: vomiting (including blood), dyspepsia, gastritis, abdominal pain, dryness of the oral mucosa, flatulence;

frequency is unknown: intestinal obstruction, pancreatitis, angioedema, intestinal edema *.

Disorders from the liver and bile ducts:

rarely: hepatitis; rarely: cholestasis;

frequency is unknown: jaundice, deviations from the norm of functional liver tests.

Disturbances from the skin and subcutaneous tissues:

infrequently: skin rash, itchy skin;

rarely: angioedema, hyperhidrosis, psoriasis, eczema, acne, dry skin, skin diseases;

rarely: dermatitis;

frequency is unknown: Stevens-Johnson syndrome, erythema multiforme *, toxic epidermal necrolysis, urticaria, alopecia, psoriasis-like dermatitis *.

Disturbances from the musculoskeletal and connective tissue:

infrequently: muscle spasms, back pain, pain in the limbs;

rarely: arthralgia, osteoarthritis, bone pain;

frequency is unknown: myalgia.

Disorders from the kidneys and urinary tract:

rarely: pollakiuria, polyuria, renal insufficiency, azotemia.

Violations of the genitals and breast:

infrequently: erectile disfunction.

Congenital, hereditary and genetic disorders:

rarely: congenital malformation of arteries, ichthyosis.

General disorders:

often: asthenia;

infrequently: pain in the chest, peripheral edema, weakness, impaired well-being;

rarely: edema, increased fatigue;

frequency is unknown: fever.

Laboratory and instrumental data:

rarely: hyperbilirubinemia;

rarely: an increase in potassium in the blood, an increase in the activity of gamma-glutamyltransferase, an increase in lipase activity, an increase in the level of immunoglobulin;

frequency is unknown: a decrease in the number of platelets; increasing the concentration of creatinine in the blood, increasing the concentration of urea nitrogen in the blood; increased activity of lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (ACT), alanine aminotransferase (ALT), liver enzymes; decreased hemoglobin; reduction of hematocrit; deviations from the norm of ECG parameters.

Trauma, intoxication and complications of manipulation:

rarely: injury.

* - side effects related to the whole class of ACE inhibitors.

Overdose:

Symptoms of overdose: marked decrease in blood pressure, shock, stupor, bradycardia, water-electrolyte disorders and renal failure.

Treatment: symptomatic and supportive therapy. In the case of an overdose of trandolapril, when taken orally, a gastric and intestinal flushing is indicated. Careful monitoring of blood pressure is necessary.In the case of a pronounced decrease in blood pressure, it is recommended that BCC be supplemented. There is no specific antidote for trandolapril. Data on the possibility of excretion of trandolapril or trandolaprilate by hemodialysis are unknown.

Interaction:

Diuretics and other antihypertensives

Diuretics and other antihypertensives can enhance the antihypertensive effect of trandolapril. Beta-blockers should be used in combination with trandolapril only under the close supervision of a physician. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, eplerenone) or potassium preparations increase the risk of hyperkalemia, especially in patients with renal insufficiency. Trandolapril can reduce potassium loss with the use of thiazide diuretics.

Hypoglycemic agents

The simultaneous use of trandolapril, as well as any ACE inhibitors, with hypoglycemic agents (insulin or hypoglycemic agents for oral administration) can increase hypoglycemic effect and lead to an increased risk of hypoglycemia.

Lithium

Trandolapril may worsen the excretion of lithium.It is necessary to monitor the concentration of lithium in the blood serum.

Angiotensin II receptor blockers, aliskiren

Clinical studies have shown that the double blockade of the renin-angiotensin-aldosterone system (RAAS) by the combined use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren is associated with a higher incidence of side effects such as hypotension, hyperkalemia and decreased renal function acute renal failure) compared with the use of a single drug that acts on RAAS (see "Contraindications", "Special instructions").

Other

When using high-flux polyacrylonitrile membranes during hemodialysis in patients receiving ACE inhibitors, anaphylactoid reactions were described. The use of such membranes should be avoided in the appointment of ACE inhibitors to patients on dialysis.

Non-steroidal anti-inflammatory drugs (NSAIDs) (including acetylsalicylic acid, used in high doses as an anti-inflammatory drug, for example, to relieve pain) can reduce the antihypertensive effect of trandolapril, however, like the rest of the antihypertensive drugs.Therefore, in the appointment or withdrawal of NSAIDs, patients receiving trandolapril, careful monitoring of blood pressure is necessary.

Patients with heart failure should not simultaneously be prescribed ACE inhibitors and NSAIDs (including acetylsalicylic acid), except when acetylsalicylic acid is used in lower doses as an antiplatelet agent.

ACE inhibitors can enhance the antihypertensive effect of some agents for inhalation anesthesia.

Allopurinol, cytostatics, immunosuppressive agents and systemic glucocorticosteroids or procainamide may increase the risk of developing leukopenia in the treatment of ACE inhibitors.

Antacids can reduce the bioavailability of ACE inhibitors. Ethanol increases the risk of developing arterial hypotension.

The antihypertensive effect of ACE inhibitors can be reduced by joint admission with sympathomimetics. Careful observation of patients is necessary. Joint use of trandolapril, as well as any other antihypertensive drugs, with neuroleptics and tricyclic antidepressants increases the risk of orthostatic hypotension.

In a joint administration of ACE inhibitors and gold injections (sodium aurotomyalate), nitrate-like reactions ("hot flushes" of the face, nausea, vomiting, and a marked decrease in blood pressure) were observed in rare cases.

Clinically significant signs of the interaction of trandolapril with thrombolytic, acetylsalicylic acid (as an antiplatelet agent), beta-blockers, blockers of "slow" calcium channels, nitrates, anticoagulants or digoxin in patients with left ventricular dysfunction after a previous myocardial infarction was not noted. Clinically significant signs of interaction between trandolapril and cimetidine were not detected.

Special instructions:General Precautions

In some patients receiving diuretics, after prescribing the drug Hopten®, there may be an excessive decrease in blood pressure.

Impaired liver function

Trandolapril is a prodrug that turns into an active form in the liver, so special care must be taken in patients with impaired liver function. Such patients should be carefully monitored.

Symptomatic arterial hypotension

In patients with uncomplicated arterial hypertension after the first dose of the drug Hopten ®, as well as after its increase, the development of symptomatic arterial hypotension was noted. The risk of developing arterial hypotension is higher in patients with hypovolemia and hyponatremia, developed as a result of prolonged diuretic therapy, restriction of consumption of table salt, dialysis, diarrhea or vomiting. In such patients, before therapy with Hopten® begins, diuretic therapy should be discontinued and the BCC and / or sodium content should be replenished.

Agranulocytosis / suppression of bone marrow function

In the treatment of ACE inhibitors, cases of agranulocytosis and suppression of bone marrow function have been described. The risk of developing neutropenia is dose-dependent, determined by the type of drug and depends on the clinical condition of the patient. These adverse events are more common in patients with impaired renal function, especially with diffuse connective tissue diseases. In such patients (for example, with systemic lupus erythematosus or systemic scleroderma), it is advisable to regularly monitor the number of leukocytes in the blood and the concentration of protein in the urine, especially if the kidney function is impaired and treated with glucocorticosteroids and antimetabolites.The listed phenomena are reversible and return to normal after the cessation of therapy with an ACE inhibitor.

Angioedema

The drug Hopten® can cause angioedema, swelling of the face, limbs, tongue, vocal cords and / or larynx. Angioedema in patients with ACE inhibitors is more common in patients of the Negroid race. Against the background of treatment with ACE inhibitors, cases of angioedema of the intestine were also noted. This possibility should be considered when developing abdominal pain (both with nausea and vomiting, and without) against the background of taking the drug Hopten®.

Patients with angioneurotic edema should immediately stop treatment with ACE inhibitors and monitor before the edema is eliminated. Angioedema in the face is usually resolved spontaneously. Edema that spreads not only the facial area, but also the vocal folds, can be life-threatening because of the risk of airway obstruction. With angioneurotic edema of the tongue, vocal cords or larynx, immediate subcutaneous injection of 0.3-0.5 ml of epinephrine (adrenaline) solution (1: 1000) is required, as well as other therapeutic measures if necessary.

Patients with vasorenal arterial hypertension

ACE inhibitors can be used prior to the initiation of therapy for vasorenal hypertension or in cases where such therapy is not available. In patients with unilateral or bilateral stenosis of the renal arteries, the risk of development of severe arterial hypotension and renal failure in the treatment of ACE inhibitors is increased. Taking diuretics can increase the risk. Impaired renal function may result in minor changes in serum creatinine concentration even in patients with unilateral renal artery stenosis. In such patients, treatment should be initiated in a hospital with small doses of the drug Hopten ® followed by careful selection of the dose under close medical supervision. Diuretics should be discontinued; kidney function and potassium content in serum should be monitored in the first weeks of treatment.

Impaired renal function

Patients with a creatinine clearance of less than 30 mL / min may need to reduce the dose of Hopten®, the kidney function should be carefully monitored.In patients with impaired renal function, chronic heart failure, bilateral or unilateral stenosis of the renal arteries, in patients with one functioning kidney or after its transplantation, the risk of impaired renal function is increased. In some patients with hypertension who do not have kidney disease, the administration of Hopten® in combination with a diuretic may result in an increase in urea nitrogen in the blood and serum creatinine concentration. In addition, proteinuria may develop, especially in patients with impaired renal function or when taking relatively high doses of ACE inhibitors.

Double blockade of the renin-angiotensin-aldosterone system (RAAS)

There is evidence that concomitant use of ACE inhibitors and angiotensin II or aliskiren receptor blockers increases the risk of hypotension, hyperkalemia and decreased renal function (including acute renal failure). For this reason, the double blockade of RAAS by the combined use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren is not recommended.sections "Contraindications", "Interaction with other medicinal products").

If double blockade therapy is considered absolutely necessary, it should be performed only under the supervision of a specialist and with careful monitoring of kidney function, blood pressure and electrolyte concentration.

ACE inhibitors and angiotensin II receptor blockers should not be used simultaneously in patients with diabetic nephropathy.

Hyperkalemia

In patients with hypertension, especially with impaired renal function, the drug Hopten® can cause hyperkalemia. The risk factors for hyperkalemia include renal failure, the intake of potassium-sparing diuretics, the simultaneous use of drugs for the treatment of hypokalemia, diabetes mellitus and / or left ventricular dysfunction after a previous myocardial infarction.

Cough

With the use of ACE inhibitors, dry non-productive cough may occur, disappearing after the withdrawal of therapy.

Surgical interventions / general anesthesia

In surgical interventions or general anesthesia with the use of drugs that cause arterial hypotension,the Hopten® preparation can block the secondary formation of angiotensin II, which is associated with compensatory release of renin.

Desensitization

When carrying out desensitization of the organism to poisons of Hymenoptera in patients receiving ACE inhibitors, it is possible to develop anaphylactic reactions (in some cases - life-threatening).

LDL-apheresis

When LDL-apheresis was performed in patients receiving ACE inhibitors, life-threatening anaphylactic reactions were observed.

Effect on the ability to drive transp. cf. and fur:Based on the pharmacological properties of trandolapril, the Hopten® preparation should not affect the ability to drive vehicles and work with mechanisms. However, in some patients, especially at the initial stages of treatment with ACE inhibitors or when replacing one drug with another, or in patients who consume alcohol, it is possible to influence the ability to drive and work with mechanisms. Therefore, after taking the first dose of the drug Hopten ® or after increasing its dose, it is not recommended for several hours to drive vehicles or work with mechanisms.

Form release / dosage:Capsules 2 mg.

Packaging:By 5, 7, 10 or 14 capsules in a blister of PVC / PVDC / A1. 1, 2, 3 or 4 blisters with instructions for 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:4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015212 / 01-2003

Date of registration:17.07.2008

Expiration Date:Unlimited

The owner of the registration certificate:Abbott Airland Pharmaceutical Operations Abbott Airland Pharmaceutical Operations Ireland

Manufacturer: & nbsp

ABBOTT LABORATORIES, LTD. Russia

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp06.05.2017

Illustrated instructions

Instructions

Hopten® (Gopten®)