Lercamen Duo, 10 mg+10 mg 28 pcs

The drug is a combination of an ACE inhibitor and a slow calcium channel blocker.

Indications

Essential hypertension (if monotherapy with lercanidipine 10 mg is ineffective) – dose 10 mg+10 mg;
essential hypertension (if monotherapy with enalapril 20 mg is ineffective) – dose 10 mg + 20 mg.

Pharmacological effect

The drug is a combination of an ACE inhibitor and a slow calcium channel blocker.

Special instructions

Particular attention in the treatment of arterial hypertension requires patients with severe arterial hypotension with systolic blood pressure less than 90 mm Hg, as well as patients with decompensated heart failure.

Transient arterial hypotension is not a contraindication to continued treatment, because after replenishment of the blood volume, an adequate response to the drug can be expected.

Particular care must be taken during the initial stages of treatment in patients with mild to moderate renal impairment.
Patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney are particularly at risk of developing hypotension or renal failure from taking ACE inhibitors. For this group of patients, treatment should be carried out under the strict supervision of a physician, with careful dose selection and low doses of the drug. Before starting and during treatment, it is necessary to monitor kidney function.

Particular caution should be observed in the initial stages of treatment in patients with mild to moderate liver failure. If jaundice occurs and a significant increase in the activity of liver enzymes, you must immediately stop taking ACE inhibitors and consult a doctor.

Due to the increased risk of anaphylactic reactions, the drug should not be prescribed to patients undergoing hemodialysis using high-strength polyacrylonitrile membranes (AN69), undergoing low-density lipoprotein apheresis with dextran sulfate and immediately before undergoing desensitization to wasp or bee venom.

Like other ACE inhibitors, it has a less pronounced antihypertensive effect in patients of the Negroid race compared to representatives of other races.

Due to the use of enalapril, angioedema of the face, extremities, tongue, pharynx or larynx may develop. In this case, you should immediately stop taking the drug. Angioedema of the larynx can be fatal. Angioedema of the tongue, pharynx or larynx can lead to airway obstruction; it is necessary to immediately administer 0.3-0.5 ml of epinephrine (adrenaline) solution subcutaneously in a ratio of 1:1000 and maintain airway patency (intubation or tracheostomy).

Among black patients receiving ACE inhibitor therapy, the incidence of angioedema is higher than among patients of other races.

Patients with a history of angioedema not associated with the use of ACE inhibitors are at increased risk of developing angioedema when using any ACE inhibitor.

Before surgery (including dentistry), the surgeon/anesthesiologist must be warned about the use of ACE inhibitors. During surgery and/or during general anesthesia with the use of drugs that cause arterial hypotension, ACE inhibitors may block the formation of angiotensin II in response to compensatory release of renin. If a pronounced decrease in blood pressure develops, explained by a similar mechanism, it can be corrected by increasing the blood volume.

Hyperkalemia can develop during therapy with ACE inhibitors, incl. and enalapril. Risk factors for hyperkalemia are renal failure, old age, diabetes mellitus, some concomitant conditions (decrease in blood volume, acute heart failure in the stage of decompensation, metabolic acidosis), simultaneous use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as potassium preparations or potassium-containing substitutes table salt and the use of other drugs that increase the potassium content in the blood plasma (for example, heparin). Hyperkalemia can cause serious heart rhythm disturbances, sometimes fatal. The combined use of the drugs listed above must be carried out with caution.
It is not recommended to drink alcohol during drug therapy.

There is information about reversible biochemical changes in the heads of spermatozoa when using calcium channel blockers, which can impair their ability to fertilize.

Impact on the ability to drive vehicles and operate machinery

The possibility of weakness and drowsiness should be borne in mind, so care must be taken when performing work that requires increased attention, especially at the beginning of treatment, when increasing the dose of the drug and when driving.

Active ingredient

Lercanidipine, Enalapril

Composition

1 tab. contains:

Contraindications

Impaired left ventricular outflow, including aortic valve stenosis;
chronic heart failure in the stage of decompensation;
hereditary and/or idiopathic angioedema (including a history);
angioedema when using ACE inhibitors (history);
unstable angina;
the first month after myocardial infarction (within 28 days);
severe renal failure (creatinine clearance <30 ml/min), including patients on hemodialysis; severe liver failure; simultaneous use with powerful inhibitors of the CYP3A4 isoenzyme (ketoconazole, itraconazole, erythromycin, ritonavir, troleandomycin), cyclosporine, grapefruit juice; lactase deficiency, lactose intolerance, glucose/galactose malabsorption syndrome; children and adolescents up to 18 years of age; hypersensitivity to lercanidipine, enalapril or any other ACE inhibitor and other BMCCs, dihydropyridine derivatives, as well as to any other component of the drug. With caution
sick sinus syndrome (without simultaneous use of an artificial heart pacemaker);
dysfunction of the left ventricle and coronary artery disease;
renal failure (creatinine clearance more than 30 ml/min);
renovascular hypertension;
condition after kidney transplantation (experience is limited);
liver failure;
inhibition of bone marrow hematopoiesis;
severe autoimmune connective tissue diseases (including scleroderma, systemic lupus erythematosus);
simultaneous use with immunosuppressants, allopurinol, procainamide;
diabetes mellitus;
surgical interventions and general anesthesia;
patients on a diet with limited salt intake;
hyperkalemia;
conditions accompanied by a decrease in blood volume, incl. diarrhea, vomiting, primary aldosteronism.

Side Effects

The incidence of adverse events was classified as follows: very common (1/10), common (1/100), uncommon (1/1000), rare (1/10,000), very rare (<1/10,000).Lercanidipine + enalapril

Interaction

The antihypertensive effect of Koripren can be potentiated by other drugs that lower blood pressure, such as diuretics, beta-blockers, alpha-blockers and others.

In addition, when used simultaneously with other drugs, the following interaction effects may occur:
Lercanidipine

The drug should not be taken in combination with CYP3A4 inhibitors, such as ketoconazole, itraconazole, erythromycin and others, with cyclosporine and grapefruit juice (increase blood concentrations and lead to potentiation of the antihypertensive effect).
Caution should be exercised when coadministered with drugs such as terfenadine, astemizole, class III antiarrhythmic drugs (eg, amiodarone) and quinidine.

Concomitant use with anticonvulsants (eg, phenytoin, carbamazepine) and rifamycin may reduce the antihypertensive effect of lercanidipine.

Digoxin use should be closely monitored for clinical signs of digoxin toxicity.
Taking the drug with midazolam leads to an increase in the absorption of lercanidipine in the gastrointestinal tract and a decrease in the rate of absorption.
Metaprolol reduces the bioavailability of lercanidipine by 50%.

Cimetidine at a dose of 800 mg/day does not lead to significant changes in the content and concentration of lercanidipine in the blood serum, however, with such a combination, special caution is required, because at higher doses of cimetidine, the bioavailability of lercanidipine, and, consequently, its antihypertensive effect, may increase.

Fluoxetine has no effect on the pharmacokinetics of lercanidipine.
When taking the drug with simvastatin, the drug should be taken in the morning, and simvastatin in the evening.
Taking lercanidipine simultaneously with warfarin does not affect the pharmacokinetics of the latter.

Enalapril
Concomitant use of the drug with potassium salts, potassium-sparing diuretics (spironolactone, triamterene, eplerenone, amiloride), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim increases the risk of developing hyperkalemia.

It is also not recommended to use it together with lithium salts (if taking such a combination is necessary, then carefully monitor the concentration of lithium in the blood plasma).

Concomitant use with antidiabetic drugs (both oral and insulin) may cause the development of hypoglycemia in the first week of treatment.

Diuretics (loop and thiazide) can cause a decrease in blood volume and thus increase the risk of a pronounced decrease in blood pressure during treatment with the drug.

Long-term use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors.
Both NSAIDs and ACE inhibitors (enalapril) increase potassium levels in the blood, which can lead to impaired kidney function.
Baclofen enhances the antihypertensive effect.
Cyclosporine increases the risk of hyperkalemia.

Ethanol enhances the antihypertensive effect of ACE inhibitors.
Tricyclic antidepressants, antipsychotics, drugs for general anesthesia, opioid analgesics can lead to a further decrease in blood pressure.

Corticosteroids (except hydrocortisone as replacement therapy for Addison’s disease) reduce the antihypertensive effect (fluid retention with a subsequent increase in blood volume).

Concomitant use with other antihypertensive drugs may enhance the antihypertensive effect of enalapril.
Combined use with nitroglycerin and other nitrates and vasodilators leads to an even more pronounced decrease in blood pressure.
Allopurinol, cytostatics, immunosuppressants, systemic corticosteroids and procainamide may lead to an increased risk of leukopenia.

Antacids help reduce the bioavailability of ACE inhibitors.

Sympathomimetics may reduce the antihypertensive effect.

Enalapril can be used simultaneously with acetylsalicylic acid (as an antiplatelet agent).
When used simultaneously with the drug gold (sodium aurothiomalate) intravenously, side effects may develop.

Overdose

There is no information about drug overdose. Presumably, in case of overdose, it can cause conditions caused by an overdose of any of the active substances.

Lercanidipine
Symptoms: peripheral vasodilation with a pronounced decrease in blood pressure and reflex tachycardia, vomiting.
Treatment: treatment is symptomatic, the choice of treatment depends on the degree of overdose and the observed symptoms. The following methods of medical care are used: gastric lavage, taking high doses of catecholamines, furosemide, cardiac glycosides and plasma expanders, activated charcoal, laxatives and intravenous administration of dopamine. Also, to prevent the development of bradycardia, intravenous administration of atropine is possible.

Enalapril
Symptoms: the main sign of overdose is a pronounced decrease in blood pressure, which is accompanied by blockade of the renin-angiotensin-aldosterone system. Collapse, electrolyte imbalance, renal failure, hyperventilation, tachycardia, rapid heart rate, bradycardia, dizziness, anxiety and cough may also occur.

Treatment: treatment is symptomatic. In severe cases, intravenous administration of 0.9% sodium chloride solution and, if possible, infusion of angiotensin II and/or catecholamines are recommended. If symptoms of overdose develop immediately after taking the drug, then it is necessary to induce vomiting, perform gastric lavage and take drugs from the group of adsorbents or sodium sulfate.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life

2 years.

Manufacturer

Recordati chemical and pharmaceutical industry, Italy