Berlipril 5 - Instructions For Use, Price, Reviews, Tablet Analogs

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Berlipril 5

Latin name: Berlipril 5

ATX code: C09AA02

Active ingredient: enalapril (Enalapril)

Manufacturer: Menarini-Von Heyden, GmbH (Germany); Berlin-Chemie (Germany)

Description and photo update: 2020-11-06

Prices in pharmacies: from 66 rubles.

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Berlipril 5 is an antihypertensive drug, an angiotensin-converting enzyme (ACE) inhibitor.

Release form and composition

The drug is produced in the form of tablets: slightly biconvex, round, with beveled edges, almost white, on one side there is a dividing line [10 pcs. in blisters, in a cardboard box 2, 3, 5 or 10 packs and instructions for the use of Berlipril 5].

1 tablet contains:

• active substance: enalapril maleate - 5 mg;
• auxiliary components: lactose monohydrate, magnesium hydroxycarbonate, gelatin, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Berlipril 5 is an antihypertensive drug. Its active substance, enalapril, is a prodrug and belongs to the group of ACE inhibitors. As a result of hydrolysis, enalapril is biotransformed into enalaprilat, which has an inhibitory effect on ACE. The mechanism of action of the drug is due to a decrease in the formation of angiotensin II from angiotensin I, which contributes to a direct reduction in the release of aldosterone. In this case, there is a decrease in the total peripheral vascular resistance, systolic and diastolic blood pressure (BP), post- and preload on the myocardium.

The vasodilating effect is more pronounced in relation to arteries than veins; a reflex increase in the heart rate (HR) is not observed.

With a high activity of blood plasma renin, a more pronounced antihypertensive effect is observed than with a normal or reduced level. Lowering blood pressure within the therapeutic range has no effect on cerebral circulation; blood flow in the cerebral vessels is maintained at a sufficient level. Enalapril helps to increase coronary and renal blood flow.

Long-term use of Berlipril 5 helps to reduce left ventricular myocardial hypertrophy and myocytes of the walls of resistive arteries, prevents the progression of heart failure, slows down the development of left ventricular dilatation. There is an improvement in the blood supply to the ischemic myocardium.

Berlipril 5 has a slight diuretic effect.

After taking the pill inside, the hypotensive effect occurs after 1 hour, after 4-6 hours it reaches its maximum and lasts 24 hours. In some cases, the optimal blood pressure level is achieved after taking the drug regularly for several weeks. In heart failure, a significant clinical effect can be observed only after 6 months of therapy or more.

Pharmacokinetics

After oral administration, 60% of the active substance is absorbed. Simultaneous food intake does not affect its absorption. The maximum concentration in blood plasma (C _max) of enalapril is achieved after 1 hour.

Plasma protein binding - no more than 60%.

It is metabolized rapidly in the liver with the formation of an active metabolite - enalaprilat, its C _{max is} reached within 3-4 hours. Enalaprilat easily overcomes histohematogenous barriers, excluding the blood-brain barrier. A small amount of it crosses the placenta and into breast milk.

The half-life of the active metabolite is about 11 hours.

It is excreted mainly by the kidneys: 20% of the dose taken - unchanged, 40% - in the form of enalaprilat. Through the intestines, 33% of the dose taken is excreted, of which 27% is in the form of enalaprilat.

It is removed during hemodialysis (elimination rate - 62 ml / min) and peritoneal dialysis.

In elderly patients, the rate of elimination of enalapril is reduced.

Indications for use

• arterial hypertension (including renovascular hypertension);
• combination therapy of asymptomatic left ventricular dysfunction - in order to prevent the development of clinically severe heart failure;
• chronic heart failure - as part of combination therapy.

Contraindications

Absolute:

• a history of angioedema caused by the use of ACE inhibitors;
• hereditary or idiopathic angioedema;
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
• period of pregnancy and lactation;
• age up to 18 years;
• established hypersensitivity to other ACE inhibitors;
• individual intolerance to the components of the drug.

Berlipril should be taken with caution in 5 patients on hemodialysis with renal failure (proteinuria more than 1 g / day), bilateral renal artery stenosis, stenosis of the artery of a single kidney, hyperkalemia, primary hyperaldosteronism, hepatic failure, ischemic heart disease, aortic stenosis stenosis (with impaired hemodynamic parameters), systemic connective tissue diseases, idiopathic hypertrophic subaortic stenosis, cerebrovascular diseases, diabetes mellitus, inhibition of bone marrow hematopoiesis; in conditions that are accompanied by a decrease in circulating blood volume (BCC) (including diarrhea and vomiting); if you follow a diet with limited sodium chloride, the simultaneous use of immunosuppressants or saluretics,condition after kidney transplantation; patients over the age of 65.

Berlipril 5, instructions for use: method and dosage

Berlipril 5 tablets are taken orally, regardless of food intake.

The use of the drug is indicated both as a means of monotherapy and in combination with other antihypertensive drugs.

The duration of therapy depends on its effectiveness.

Recommended dosage:

• arterial hypertension: the initial dose is from 5 to 20 mg once a day. The dose of Berlipril 5 is selected individually for each patient and depends on the severity of arterial hypertension, with a mild severity it should be 5-10 mg, in other cases - 20 mg once a day. The maintenance dose is 20 mg once a day. The maximum daily dose is 40 mg, it can be taken by dividing it into two doses, or once;
• renovascular hypertension: the initial dose is 5 mg (or less) once a day. It should be borne in mind that in this category of patients, blood pressure and renal function may be more sensitive to ACE inhibition, therefore, therapy should be started with the lowest dose. Further, it can be increased, taking into account the response to the therapy, to a clinically effective daily dose, which is usually 20 mg. If the patient is on diuretic treatment, then when Berlipril 5 is prescribed, the diuretic should be discontinued 2-3 days before starting the drug. In cases where this is not possible, the initial daily dose of an ACE inhibitor should not exceed 2.5 mg (1/2 tablet). With hyponatremia (the amount of sodium ions in the blood serum is less than 130 mmol / l) or the concentration of creatinine in the blood serum is more than 0.14 mmol / l, the initial dose of the drug is 2,5 mg once a day. The maximum daily dose is 20 mg;
• chronic heart failure, asymptomatic left ventricular dysfunction: initial dose - 2.5 mg once a day. The use of Berlipril 5 should be started under close medical supervision to establish its primary effect on blood pressure. For the treatment of severe clinical manifestations of heart failure, the use of the drug in combination with diuretics and cardiac glycosides is indicated. If Berlipril 5 is well tolerated, its dose should be gradually increased to a maintenance daily dose of 20 mg, which is taken once or in the morning and evening in equal shares. If symptomatic arterial hypotension occurs while taking the drug, it is necessary to adjust the dose of the ACE inhibitor accordingly. Individual dose selection usually lasts from 14 to 28 days,but if there are residual signs and symptoms of heart failure, it is carried out in a shorter time.

If taking Berlipril 5 causes a pronounced decrease in blood pressure, its dose is gradually reduced.

The initial dose in elderly patients should be 1.25 mg, this will reduce the risk of developing a pronounced hypotensive effect.

The recommended daily dosage of Berlipril 5 for patients with chronic renal failure, taking into account the following creatinine clearance (CC) indicators:

• CC 30–80 ml / min: 5–10 mg;
• CC 10-30 ml / min: 2.5-5 mg;
• CC less than 10 ml / min: 1.25–2.5 mg only on the days of hemodialysis. If hemodialysis is not performed, then the dose is adjusted depending on blood pressure. Cumulation of enalapril occurs when CC is less than 10 ml / min.

Side effects

The incidence of adverse reactions when using Berlipril 5 is classified as follows: very often (more than 1/10); often (less than 1/10, but more than 1/100); infrequently (less than 1/100, but more than 1/1000); rarely (less than 1/1000, but more than 1/10000); very rare (less than 1/10 000); the frequency has not been established (it is impossible to establish the frequency of occurrence of adverse reactions based on the available data).

• on the part of the blood and lymphatic system: infrequently - aplastic, hemolytic and other types of anemia; rarely - a decrease in the level of hemoglobin and hematocrit, thrombocytopenia, neutropenia, agranulocytosis, pancytopenia, enlarged lymph nodes, inhibition of bone marrow function, autoimmune diseases;
• on the part of metabolism and nutrition: infrequently - hypoglycemia;
• from the central nervous system: often - headache, depression; infrequently - drowsiness, irritability, insomnia, dizziness, confusion, paresthesia; rarely - sleep disturbances, changes in the nature of dreams;
• on the part of the cardiovascular system: very often - dizziness; often - a marked decrease in blood pressure, chest pain, syncope, heart rhythm disturbances, tachycardia, angina pectoris, myocardial infarction, cerebral stroke; infrequently - palpitations, orthostatic hypotension; rarely - Raynaud's syndrome;
• from the respiratory system: very often - cough; often - dyspnea; infrequently - sore throat, hoarseness, rhinorrhea, bronchospasm, bronchial asthma; rarely - rhinitis, pulmonary infiltrates, eosinophilic pneumonia, allergic alveolitis;
• from the liver and biliary system: rarely - cholestasis, liver failure, hepatocellular or cholestatic hepatitis (including hepatic necrosis), jaundice;
• from the digestive system: very often - nausea; often - a change in taste, abdominal pain, diarrhea; infrequently - dryness of the oral mucosa, lack of appetite, vomiting, dyspepsia, constipation, pancreatitis, symptoms of stomach irritation, peptic ulcer, intestinal obstruction; rarely - stomatitis, glossitis, aphthous ulcers; very rarely - intestinal angioedema;
• from the urinary system: infrequently - functional disorders of the kidneys, proteinuria, renal failure; rarely - oliguria;
• on the part of the organ of vision: very often - violation of accommodation;
• on the part of the skin and subcutaneous fat: often - skin rash, hypersensitivity reactions, angioedema (including the face, lips, tongue, vocal folds and / or larynx, limbs); infrequently - itchy skin, increased sweating, urticaria, alopecia; rarely - pemphigus, erythroderma, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; the frequency is not established - the development of a symptom complex, accompanied by the following side effects (all or some of them): fever, serositis, vasculitis, arthralgia or arthritis, myalgia or myositis, eosinophilia, leukocytosis, increased titer of anti-nuclear antibodies (ANA) and erythrocyte sedimentation rate, rash, photosensitivity;
• from the reproductive system and mammary glands: infrequently - impotence; rarely - gynecomastia;
• laboratory parameters: often - hyperkalemia, increased serum creatinine levels; infrequently - hyponatremia, increased serum urea concentration; rarely - hyperbilirubinemia, increased activity of liver transaminases;
• others: very often - asthenia; often - fatigue; infrequently - facial skin redness, discomfort, muscle cramps, tinnitus, fever.

Overdose

Symptoms: a pronounced decrease in blood pressure, including the possible development of myocardial infarction, collapse, acute cerebrovascular accident and thromboembolic complications, convulsions, stupor.

Treatment: in case of mild overdose, immediate gastric lavage and ingestion of saline are indicated. The patient should take a horizontal position with a low headboard. To stabilize blood pressure in a serious condition of the patient, intravenous administration of saline, plasma substitutes, the use of angiotensin II, and hemodialysis are prescribed.

special instructions

Before starting treatment with Berlipril 5, the patient should undergo an examination to determine blood parameters (hemoglobin, potassium, urea, creatinine, hepatic transaminase activity) and protein in the urine. During the period of taking the drug, these indicators should be periodically monitored and regularly - blood pressure.

It should be borne in mind that with a reduced BCC, the risk of a sudden and pronounced decrease in blood pressure increases significantly even after taking the initial dose of an ACE inhibitor. A decrease in the BCC occurs as a result of diuretic therapy, restriction of salt intake, diarrhea and vomiting, and hemodialysis.

In the case of transient arterial hypotension, the abolition of Berlipril 5 is not required, after stabilization of blood pressure, treatment can be continued. With a repeated pronounced decrease in blood pressure, you should reduce the dose or stop taking enalapril.

The use of high-flow membranes during dialysis increases the risk of anaphylactic reaction.

The use of Berlipril 5 in patients with ischemic heart disease, severe chronic heart failure or cerebrovascular disease requires careful monitoring due to the fact that a sharp decrease in blood pressure can cause myocardial infarction, stroke or renal dysfunction in this category of patients.

During the period of treatment, the use of alcoholic beverages is contraindicated.

For any surgical intervention (including dentistry), the patient should warn the surgeon or anesthesiologist about taking an ACE inhibitor.

Sudden cessation of treatment with enalapril does not cause a sharp rise in blood pressure.

Influence on the ability to drive vehicles and complex mechanisms

During the period of application of Berlipril 5, care must be taken when driving vehicles or engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Application during pregnancy and lactation

The use of Berlipril 5 during gestation and breastfeeding is contraindicated.

Patients of childbearing age should be informed about the potential risk to the fetus and that if conception is confirmed, taking the pills should be stopped immediately.

The use of ACE inhibitors in the II and III trimesters of pregnancy has a negative effect on the fetus, including the development of renal failure, arterial hypotension, hyperkalemia and / or hypoplasia of the skull bones in a newborn, and can cause death of the fetus or newborn. In addition, a complication such as oligohydramnios is possible, which leads to deformation of the bones of the skull, including its facial part, contracture of the extremities, and hypoplasia of the lungs.

In cases where Berlipril 5 cannot be canceled during pregnancy, careful monitoring of the newborn is required for oliguria, lowering blood pressure and hyperkalemia. Peritoneal dialysis or exchange transfusion can be used to remove enalapril from the newborn's circulation.

If during lactation it is necessary to use Berlipril 5, then breastfeeding should be discontinued.

Pediatric use

Berlipril 5 tablets are not used for the treatment of patients under 18 years of age due to the unknown efficacy and safety of such therapy in this age group.

With impaired renal function

It is recommended to take Berlipril 5 with caution in case of renal failure (proteinuria more than 1 g / day), bilateral renal artery stenosis, stenosis of an artery of a single kidney, hyperkalemia, patients in a state after kidney transplantation or undergoing hemodialysis.

For patients with chronic renal failure, the daily dose should be prescribed taking into account the individual CC indicator.

For violations of liver function

Berlipril should be taken with caution in 5 patients with hepatic impairment.

Use in the elderly

Berlipril should be prescribed with caution to 5 patients over the age of 65 years.

The initial dose in elderly patients should not exceed 1.25 mg.

Drug interactions

• selective inhibitors of cyclooxygenase-2 (COX-2 inhibitors) and other non-steroidal anti-inflammatory drugs (NSAIDs): with concomitant therapy with each of these drugs, a decrease in the antihypertensive effect is possible. Patients with impaired renal function are at increased risk of impaired renal function;
• spironolactone, amiloride, triamterene: combination with potassium-sparing diuretics may cause hyperkalemia;
• lithium preparations: a transient increase in the concentration of lithium in the blood serum is possible, leading to the development of its toxic effects. In this regard, it is recommended to avoid the combined use of Berlipril 5 and lithium preparations or to ensure careful monitoring of the lithium content in the blood serum;
• antipyretic and pain relievers: help to reduce the hypotensive effect of the drug;
• theophylline: preparations containing theophylline weaken their effect;
• diuretics, beta-blockers, nitrates, methyldopa, blockers of slow calcium channels of the dihydropyridine series, prazosin, hydralazine: enhance the antihypertensive effect of Berlipril 5;
• immunosuppressants, cytostatics, allopurinol: a combination with each of these agents increases hematotoxicity;
• drugs that cause bone marrow suppression: these drugs should be taken with caution due to the fact that they can cause the development of neutropenia and / or agranulocytosis;
• insulin, hypoglycemic agents for oral administration: each of these drugs can enhance its hypoglycemic effect, increasing the likelihood of hypoglycemia. In this regard, patients with diabetes mellitus taking hypoglycemic agents must carefully monitor the level of glucose in the blood;
• sodium aurothiomalate: parenteral administration of gold preparations can cause the appearance of a symptom complex, including nausea, vomiting, redness of the facial skin and arterial hypotension;
• ethanol: alcohol and ethanol-containing drugs for oral administration enhance the hypotensive effect of the drug.

Analogs

Berlipril 5 analogs are Berlipril 10, Berlipril 20, Renipril, Renitek, Ednit, Enalapril, Enalapril HEXAL, Enalapril Forte, Enalapril-Ajio, Enalapril-Teva, Enam, Enap, Enapharm, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Berlipril 5

Reviews of Berlipril 5 are mostly positive. Patients report that taking the drug effectively lowers blood pressure.

In some cases, patients have to abandon its use due to the appearance of serious side effects.

Price for Berlipril 5 in pharmacies

The price of Berlipril 5 for a pack containing 30 tablets can range from 60 rubles.

Berlipril 5: prices in online pharmacies

Drug name Price Pharmacy

Berlipril 5 5 mg tablets 30 pcs. RUB 66 Buy

Berlipril 5 tablets 5mg 30 pcs. RUB 70 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!