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 fails) – 10 mg+10 mg dose;
• Essential hypertension (if monotherapy with enalapril 20 mg fails) – 10 mg+20 mg dose.

Active ingredient

Lercanidipine, Enalapril

How to take, the dosage

Tablets are taken orally, preferably in the morning, at least 15 minutes before a meal, without chewing, with plenty of water. Do not drink grapefruit juice.

Coripren® is not intended for initial treatment of hypertension.

If monotherapy with lercanidipine 10 mg is ineffective, the drug Coripren® 10 mg lercanidipine + 10 mg enalapril should be started.

If monotherapy with enalapril 20 mg is ineffective, Coripren® 10 mg lercanidipine + 20 mg enalapril should be started. The dose of the drug shall be determined by the physician.

Interaction

The antihypertensive effect of Coripren may be potentiated by other drugs that reduce BP, such as diuretics, beta-adrenoblockers, alpha-adrenoblockers and others.

In addition, when used simultaneously with other drugs the following interaction effects may be observed.
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 concentration and lead to potentiation of antihypertensive effect).
Caution should be exercised when concomitant use with such drugs as terfenadine, astemizole, antiarrhythmic drugs of class III (e.g., amiodarone) and quinidine.

Concurrent administration with anticonvulsants (e.g., phenytoin, carbamazepine) and rifamycin may decrease the antihypertensive effect of lercanidipine.

Administration of digoxin should be closely monitored for clinical symptoms of digoxin toxicity.
Administration with midazolam results in increased GI absorption of lercanidipine and decreased absorption rate.
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 serum concentrations of lercanidipine, however, special caution is required in this combination, because.

Fluoxetine has no effect on the pharmacokinetics of lercanidipine.
If the drug is taken with simvastatin, the drug should be taken in the morning and simvastatin in the evening.
Taking lercanidipine simultaneously with warfarin has no effect on the pharmacokinetics of the latter.

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

It is also recommended to use together with lithium salts (if the use of such a combination is necessary, the concentration of lithium in the blood plasma is carefully monitored).

Simultaneous use with antidiabetic drugs (both oral and insulin) may cause hypoglycemia during the first week of treatment.

Diuretics (“loop” and thiazide) may cause decreased blood pressure and thus increase the risk of marked BP reduction during drug treatment.

Prolonged use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors.
Both NSAIDs and ACE inhibitors (enalapril) contribute to an increase in blood potassium, which may lead to impaired renal function.
Baclofen enhances the antihypertensive effect.
Cyclosporine increases the risk of hyperkalemia.

Ethanol increases the antihypertensive effect of ACE inhibitors.
Tricyclic antidepressants, neuroleptics, drugs for general anesthesia, opioid analgesics may lead to a further decrease in BP.

Corticosteroids (except hydrocortisone as substitution therapy in Addison’s disease) reduce the antihypertensive effect (fluid retention with subsequent increase in the BOD).

Co-administration with other hypotensive agents may increase the antihypertensive effect of enalapril.
Co-administration with nitroglycerin and other nitrates and vasodilators leads to an even more pronounced BP reduction.
Allopurinol, cytostatics, immunosuppressors, systemic corticosteroids and procainamide may lead to an increased risk of leukopenia.

Antacids contribute to reduced bioavailability of ACE inhibitors.

Sympathomimetics may reduce the antihypertensive effect.

Enalapril may be used simultaneously with acetylsalicylic acid (as an antiplatelet agent).
Simultaneous use with the gold drug (sodium aurothiomalate) by IV may lead to side effects.

Special Instructions

Patients with severe arterial hypotension with systolic BP less than 90 mm Hg require special attention during treatment of arterial hypertension,

Transient arterial hypotension is not a contraindication to the continuation of therapy since after the BOD replenishment an adequate response to the drug administration can be expected.

Particular caution should be exercised in the initial stages of treatment in patients with mild to moderate renal insufficiency.
Patients with bilateral renal artery stenosis or artery stenosis of the only functioning kidney are particularly at risk of hypotension or renal failure due to ACE inhibitors. For this group of patients, treatment should be performed under close supervision of a physician, with careful dosage selection and prescription of low doses of the drug. Renal function should be monitored before and during treatment.

Particular caution should be exercised during the initial stages of treatment in patients with mild to moderate degree of hepatic function insufficiency. In case of jaundice and significant increase in liver enzymes activity, the ACE inhibitors should be stopped immediately and a physician should be consulted.

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

Like other ACE inhibitors, it has less pronounced antihypertensive effect in patients of Negro race compared to other races.

Enalapril administration may result in angioedema of the face, extremities, tongue, pharynx or larynx. If this occurs, the drug should be stopped immediately. Angioedema of the larynx may be fatal. Angioedema of the tongue, pharynx or larynx may cause airway obstruction, 0.3-0.5 ml of epinephrine (adrenaline) solution 1:1000 by injection and airway patency should be maintained (intubation or tracheostomy).

The incidence of angioedema is higher among patients of the Negro race receiving ACE inhibitor therapy than among patients of other races.

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

Before surgical procedures (including dentistry) the surgeon/anesthesiologist should be warned about the use of ACE inhibitors. During surgical interventions and/or during general anesthesia with the use of agents causing arterial hypotension, ACE inhibitors may block angiotensin II formation in response to compensatory renin release. If in this case a marked BP decrease develops due to such a mechanism, it can be corrected by the increase of the circulatory volume.

Hyperkalemia may develop against the background of therapy with ACE inhibitors, including enalapril. Risk factors of hyperkalemia are renal insufficiency, elderly age, diabetes mellitus, some concomitant conditions (decreased BCC, acute decompensated heart failure, metabolic acidosis), concomitant use of potassium-saving diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as potassium preparations or potassium-containing table salt substitutes and other drugs that increase plasma potassium content (eg, heparin). Hyperkalemia can lead to serious cardiac arrhythmias, sometimes fatal. The combined use of the above drugs should be conducted with caution.
It is not recommended to drink alcohol during therapy with the drug.

There is information about reversible biochemical changes in sperm heads when using calcium channel blockers, which may impair their ability to fertilize.

Effect on driving and operating machinery

It is necessary to be aware of the possibility of weakness and drowsiness, so caution should be exercised when performing work requiring increased attention, especially at the beginning of treatment, when increasing the dose of the drug and when driving vehicles.

Contraindications

• Left ventricular outflow tract abnormalities, including aortic valve stenosis;
• chronic heart failure in decompensation;
• hereditary and/or idiopathic angioedema (including history.
• angioedema when using ACE inhibitors (in anamnesis);
• unstable angina pectoris;
• the first month after myocardial infarction (within 28 days);
• severe renal insufficiency (CK < 30 ml/min), including patients on hemodialysis;
• severe hepatic insufficiency;
• lactase deficiency, lactose intolerance, glucose/galactose malabsorption syndrome;
• children and adolescents under 18 years of age;
• hypersensitivity to lercanidipine, enalapril or any other ACE inhibitor and other PBMCs, dihydropyridine derivatives, or any other component of the drug.

With caution

• Sinus node weakness syndrome (without concomitant use of an artificial pacemaker);
• left ventricular dysfunction and CHD;
• renal insufficiency (CK more than 30 ml/min);
• Renovascular hypertension;
• post kidney transplantation status (experience with limited use);
• hepatic insufficiency;
• inhibition of medullary hematopoiesis;
• severe autoimmune diseases of connective tissue (including.ч. scleroderma, systemic lupus erythematosus);
• simultaneous use with immunosuppressants, allopurinol, procainamide;
• diabetes;
• Patients on a salt restricted diet;
• Hyperkalemia
• CRC-associated conditions includingdiarrhea, vomiting, primary aldosteronism.

Side effects

The frequency of adverse events was classified as follows: very frequently (1/10), frequently (1/100), infrequently (1/1000), rarely (1/10,000), very rarely (<1/10,000).