Enanorm - instructions for use, analogs, reviews and release forms (tablets 10 mg + 20 mg) drugs for the treatment of hypertension and high blood pressure in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drugEnanorm. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Enanorm in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Enanorm with available structural analogues. Use to treat hypertension and reduce high blood pressure in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Enanorm - a combined antihypertensive drug consisting of two antihypertensive drugs with a complementary mechanism for reducing blood pressure: Enalapril (one of the active substances of the drug Enanorm) - an ACE inhibitor and nitrendipine (one of the active substances of the drug Enanorm) - a blocker of slow calcium channels. Enalapril is a prodrug. As a result of its hydrolysis, an active metabolite enalaprilat is formed, which also inhibits ACE. The mechanism of action is associated with a decrease in the formation of angiotensin 1 angiotensin 2, a decrease in the content of which leads to a direct decrease in the release of aldosterone. At the same time, the overall peripheral vascular resistance (OPSS), systolic and diastolic blood pressure (AD), postload and preload on the myocardium decrease. Nitrendipine - a blocker of slow calcium channels from the group of dihydropyridine derivatives, has an antihypertensive effect. Reduces the current of calcium ions in the smooth muscle cells of the coronary and peripheral arteries. Causes some increase in the excretion of sodium and water. Reduces afterload and myocardial oxygen demand, does not inhibit the conduction of the heart muscle.

Composition

Enalapril maleate + Nitrendipine + excipients.

Pharmacokinetics

Enalapril after oral absorption is absorbed from the digestive tract by 60%. Bioavailability of enalapril - 40%. The maximum concentration of enalapril in the blood plasma is reached after 1 hour, enalaprilata - after 3-4 hours. Eating does not affect the absorption of enalapril. The binding of enalapril to plasma proteins is 50-60%. Enalaprilat easily passes through the histohematological barriers, with the exception of the blood-brain barrier (BBB). A small amount penetrates the placental barrier and into breast milk. Enalapril is rapidly metabolized in the liver to form an active metabolite, enalaprilate. The half-life of enalaprilata is about 11 hours. Enalapril is excreted mainly with kidneys - 60% (20% in the form of enalapril and 40% in the form of enalaprilate), 33% through the intestine (6% in the form of enalapril and 27% in the form of enalaprilate).

Nitrendipine is rapidly absorbed from the digestive tract by 88%. Bioavailability is 20-30% because of the pronounced effect of "first passage" through the liver. Relationship with plasma proteins (albumin) - 96-98%. The maximum concentration in the blood plasma is observed after 1-3 hours after application. Metabolised in the liver, mainly by oxidation.Metabolites are pharmacologically inactive. Nitrendipine is excreted mainly through the kidneys: in the form of metabolites, approximately 77% of the dose taken is excreted, less than 0.1% of the dose taken is unchanged. The rest of nitrendipine is excreted through the intestine.

Indications

Essential hypertension (patients who are shown combined therapy).

Forms of release

Tablets 10 mg + 20 mg.

Instructions for use and dosing regimen

The drug is taken no more than 1 tablet per day. Tablets should be swallowed whole, do not break and do not chew, squeezed with enough water.

Side effect

• flushes of blood to the skin of the face;
• peripheral edema;
• tachycardia;
• dizziness;
• marked decrease in blood pressure;
• violation of peripheral circulation;
• dyspnea;
• headache;
• asthenia (general weakness);
• hypothermia (low body temperature);
• drowsiness;
• paresthesia (burning tingling, crawling crawling);
• tremor;
• convulsions;
• cough;
• pharyngitis (inflammation of the pharyngeal mucosa);
• tracheitis (inflammation of the mucosa of the trachea);
• dyspnea (violation of frequency and depth of breathing, accompanied by a feeling of lack of air);
• nausea;
• dyspepsia (indigestion);
• flatulence (swelling);
• erythematous rash;
• hematuria (blood in the urine);
• muscular spasm;
• hypokalemia (low potassium concentration).

Contraindications

• a history of angioedema, associated with treatment with ACE inhibitors;
• hereditary or idiopathic angioedema;
• shock, collapse;
• acute heart failure;
• various pathological syndromes (chronic heart failure in the stage of decompensation, requiring inotropic therapy) and conditions if unstable hemodynamics are present during their course (eg, cardiovascular shock, acute heart failure, acute coronary syndrome, acute stroke period);
• severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
• under conditions of unstable hemodynamics: acute myocardial infarction (in the first 4 weeks after myocardial infarction), chronic cardiac insufficiency 3-4 of the functional class (according to the NYHA classification);
• hemodynamically significant stenosis of the aortic or mitral valve and hypertrophic obstructive cardiomyopathy;
• bilateral stenosis of the renal artery or stenosis of the artery of a single kidney;
• severe renal dysfunction (KK less than 10 ml per minute) and hemodialysis;
• severe violations of liver function;
• intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption (the preparation contains lactose);
• pregnancy;
• lactation period (breastfeeding);
• age under 18 years (effectiveness and safety not established);
• hypersensitivity to the components of the drug;
• hypersensitivity to other dihydropyridine derivatives.

With caution when:

• aortic stenosis;
• cerebrovascular diseases (including cerebral circulatory insufficiency);
• ischemic heart disease (CHD);
• coronary insufficiency;
• severe autoimmune systemic diseases of connective tissue (including systemic lupus erythematosus, scleroderma);
• oppression of bone marrow hematopoiesis;
• diabetes mellitus;
• hyperkalemia;
• condition after kidney transplantation;
• renal failure;
• slight or moderate violations of liver function;
• Conditions accompanied by a decrease in the volume of circulating blood (BCC) (including diarrhea, vomiting);
• Compliance with diet with restriction of table salt;
• in elderly patients.

Application in pregnancy and lactation

Contraindicated use of the drug Enanorm during pregnancy. Epidemiological data on the risk of teratogenic effects of ACE inhibitors in the first trimester of pregnancy are not convincing, but this risk can not be ruled out. If continued use of ACE inhibitors in pregnancy is not absolutely necessary, then when planning pregnancy, patients should be transferred to alternative therapy, whose safety during pregnancy is established. It is known that the use of ACE inhibitors in the second and third trimester of pregnancy has a toxic effect on the fetus (renal dysfunction, low blood pressure, ossification of the skull) and newborns (renal dysfunction, arterial hypotension, hyperkalemia). If ACE inhibitors have been used in the second or third trimesters of pregnancy, ultrasound is recommended to evaluate the function of the kidneys and the condition of the bones of the skull. It should also be carefully monitored for newborns to detect arterial hypotension, if the mother took ACE inhibitors.

A few pharmacokinetic data indicate a very low concentration of enalapril in breast milk. Although these concentrations appear to be clinically insignificant, the drug should not be used during the breastfeeding of premature infants, and also in the first few weeks after birth because of the theoretically possible risk of action on the cardiovascular system and neonatal kidneys and due to the lack of sufficient clinical data. In older infants, the possibility of taking the drug by nursing women should be considered, if such treatment is necessary for the mother, and if the child is monitored to detect any adverse events.

Use in children

Contraindicated in childhood and adolescence under 18 years (efficacy and safety not established).

Application in elderly patients

Caution should be given to elderly patients.

special instructions

With the use of ACE inhibitors, especially in the first weeks, and also in rare cases after prolonged use, it is possible to develop an angioedema of the extremities, face, lips, mucous membranes, tongue, larynx or pharynx. In such cases, treatment should be immediately canceled.With angioneurotic edema of the tongue, larynx or throat, a fatal outcome is possible - in these cases, emergency therapy with hospitalization of the patient should be carried out, the patient should be monitored for at least 12-24 hours, and it can be discharged from the hospital only after the symptoms have completely disappeared.

Enalapril should be used with extreme caution in patients with systemic connective tissue diseases, in patients receiving immunosuppressants, Allopurinol or procainamide, or a combination thereof, especially if there is a kidney function disorder. When using the drug Enanorm in these patients it is recommended to control the leukocyte formula. During the treatment period, patients should be instructed to tell the doctor about any signs of infection. Enanorm should be discarded when neutropenia is detected or suspected.

In patients with impaired renal function with the use of ACE inhibitors, monitoring of kidney function is necessary, especially in the first weeks of treatment. Care should be exercised in patients with the activated renin-angiotensin system. In some patients, a marked decrease in blood pressure at the start of treatment with ACE inhibitors may lead to a slight further deterioration in kidney function.In such circumstances, there were cases of acute renal failure, which was usually reversible.

The experience of using Enanorm in patients with mild or moderate liver dysfunction is not present, so this drug should be used in such patients with caution if there is evidence for this. Since individual cases of the syndrome starting with cholestatic jaundice and progressing to fatal liver necrosis are described, then if there is jaundice or a marked increase in the activity of hepatic transaminases, it is necessary to stop treatment and monitor patients.

In some cases, the Enanorm product may cause orthostatic hypotension, the risk of which is increased in patients with activated RAAS. For example, with reduced bcc or violation of water-electrolyte balance of blood, or deficiency of salts due to the use of diuretics, compliance with low-salt diet, hemodialysis, the presence of diarrhea or vomiting, as well as weakening left ventricular function and with renovascular hypertension. In such patients, the BCC or the concentration of salts must first be adjusted.Patients with heart failure (with or without concomitant renal dysfunction) may develop symptomatic arterial hypotension. The risk of developing arterial hypotension in these patients is increased with severe heart failure, with the use of "loop" diuretics in high doses and in the presence of hyponatremia or impaired renal function. The transient hypotensive reaction is not a contraindication for the continuation of the Enanorm drug, and usually does not present difficulties after the recovery of bcc and blood pressure.

In large surgical operations or anesthesia with drugs that cause orthostatic hypotension, enalapril blocks the synthesis of angiotensin 2, due to compensatory release of renin. In such cases, if orthostatic hypotension develops (and it is assumed that the development of orthostatic hypotension occurs according to this mechanism), then it should be corrected by an increase in the volume of blood plasma.

In some cases, in vitro fertilization, slow calcium channel blockers, similar to nitrendipine, caused reversible biochemical changes in the sperm heads, which could lead to a disruption of sperm function.With repeated unsuccessful attempts at artificial insemination, one should take into account, among other factors, the use of slow blocking calcium channels such as nitrendipine by a male blocker.

Impact on the ability to drive vehicles and manage mechanisms

When using Enanorm, care must be taken when driving vehicles and complex mechanisms.

Drug Interactions

Antihypertensive effect of the drug Enanorm can be strengthened with simultaneous use with other antihypertensive drugs, for example, diuretics, beta-adrenoblockers or alpha-adrenoblockers.

Enalapril

ACE inhibitors reduce the loss of potassium caused by diuretics. Potassium-sparing diuretics, potassium preparations, and other drugs that can increase serum potassium levels (eg, heparin) can have an additive effect on serum potassium, especially in patients with impaired renal function. If the joint use of such drugs is necessary, for example, to eliminate hypokalemia, then caution should be exercised and the potassium content in the blood serum should be monitored frequently.

The use of enalapril in combination with lithium is not recommended because of the risk of a significant increase in serum lithium concentration followed by the development of severe neurotoxicity. If the joint use of these drugs is necessary, then the concentration of lithium in the serum should be carefully monitored.

Non-steroidal anti-inflammatory drugs (NSAIDs) and ACE inhibitors additively increase the serum potassium content, which can lead to impaired renal function. In elderly patients and patients with reduced BCC, this combination can cause acute renal failure due to a direct effect on the rate of glomerular filtration. Moreover, NSAIDs can reduce the antihypertensive effect of ACE inhibitors.

Enalapril may increase the hypoglycemic effect of hypoglycemic agents for oral administration, so you should carefully monitor the concentration of glucose in the blood.

Baclofen can enhance the antihypertensive effect. If necessary, combined use should monitor blood pressure and adjust the dose.

The use of Enanorm together with neuroleptics and tricyclic antidepressants can cause orthostatic hypotension.

Nitrendipine

Cimetidine and, to a lesser extent, ranitidine, can increase the concentration of nitrendipine in blood plasma, but the clinical significance of these data is unknown.

The simultaneous use of nitrendipine and Digoxin can lead to an increase in the concentration of digoxin in the blood plasma. Therefore, the appearance of symptoms of an overdose of digoxin or, if necessary, monitor the concentration of digoxin in the blood plasma.

The use of nitrendipine may increase the duration and severity of the effects of muscle relaxants, for example, pancuronium bromide.

Grapefruit juice suppresses the oxidative metabolism of nitrendipine. Admission of the latter with grapefruit juice increases the concentration of nitrendipine in the blood plasma, which can enhance its antihypertensive effect.

CYP3A4 isoenzyme inductors, for example, anticonvulsants (phenytoin, phenobarbital, carbamazepine) and rifampicin, can significantly reduce the bioavailability of nitrendipine. Inhibitors of the isoenzyme CYP3A4, for example, antifungal imidazoles (including itraconazole) can increase the concentration of nitrendipine in the blood plasma.

Nitrendipine and beta-blockers act synergistically.This may be of particular importance for patients in whom an additional blockade of beta-adrenoceptors does not compensate for sympathetic vascular reactions and caution is recommended for such patients.

Analogues of the drug Enanorm

The medicine has no structural analogues in composition of active substances.

Analogues on the pharmacological group (ACE inhibitors, including in combinations):

• Accoustic massage;
• Amprilan;
• Berlipril;
• Vazolong;
• Dalnev;
• De Cris;
• Dilaprel;
• Diroton;
• The Zocardis;
• Isuzid;
• Caphid;
• Coripren;
• Lercamen;
• Lysinopril;
• Lysinoton;
• The Lizorethic;
• Listril;
• Liten;
• Noliprel;
• Parnavell;
• Perindapam;
• Perindid;
• Prestan;
• Prestylol;
• Prilar;
• Prilenap;
• Ramazid;
• Renipril;
• Roxer;
• Skopril;
• Tark;
• Tenliza;
• Triapin;
• Triplicksam;
• Tritace;
• Fozid;
• Fosicard;
• Hartil;
• Egipres;
• Ecquard;
• The Ecuador;
• Eclamiz;
• Enalapril;
• Enam;
• Enap;
• Enafarm;
• Enziks.

Response of a therapist

Enanorm - a combined antihypertensive drug. Its high efficiency is explained by the fact that the main active substances by the mechanism of action successfully complement each other.I appoint Enanorm to patients with primary hypertension, when the causes of high blood pressure are still unknown. The tablets work quickly, the pressure drops just an hour after ingestion. The antihypertensive effect persists throughout the day, so the dose is one tablet per day. When using the drug should be remembered that he has many serious contraindications and side effects - taking medicine without a doctor's appointment is not recommended.

Similar medicines:

Other medicines: