Zanidip-Recordati, 20 mg 56 pcs

Slow calcium channel blocker.

It has prolonged antihypertensive effect.

Therapeutic effect is achieved 5-7 hours after oral administration and lasts for 24 hours.

Due to high selectivity to vascular smooth muscle cells there is no negative inotropic effect.

Lercanidipine is metabolically neutral and has no significant effect on serum lipoprotein and apolipoprotein content and does not change lipid profile in patients with arterial hypertension.

Indications

Essential hypertension of mild to moderate severity.

Pharmacological effect

Blocker of “slow” calcium channels.

Has a prolonged antihypertensive effect.

The therapeutic effect is achieved 5-7 hours after oral administration and its duration persists throughout the day (24 hours).

Due to its high selectivity for vascular smooth muscle cells, there is no negative inotropic effect.

Lercanidipine is a metabolically neutral drug and does not have a significant effect on the content of lipoproteins and apolipoproteins in the blood serum, and does not change the lipid profile in patients with arterial hypertension.

Special instructions

Caution should be exercised when prescribing to patients with impaired renal function, coronary heart disease (there is a risk of increased angina attacks), and chronic heart failure: it is necessary to compensate before starting to use the drug. Particular caution should be observed in the initial stages of treatment in patients with mild to moderate liver failure.

Effect on the ability to drive machinery and a car

During the treatment period, care must be taken when performing work that requires increased attention, when driving, especially at the beginning of treatment and when increasing the dose of the drug (risk of drowsiness, headache and dizziness).

Active ingredient

Lercanidipine

Composition

One film-coated tablet contains:

active ingredient:

lercanidipine hydrochloride 20 mg;

excipients:

lactose monohydrate – 60 mg,

microcrystalline cellulose – 78 mg,

sodium carboxymethyl starch – 31 mg,

povidone K30 – 9 mg,

magnesium stearate – 2 mg.

shell composition:

opadry pink (02F25077) – 6 mg (hypromellose, talc, titanium dioxide (E171), macrogol 6000, red iron oxide dye (E172)).

Contraindications

Hypersensitivity to lercanidipine, other dihydropyridine derivatives or any component of the drug;
Chronic heart failure in the stage of decompensation;
Unstable angina, obstruction of blood vessels originating from the left ventricle of the heart, recent myocardial infarction (within 1 month);
Severe liver dysfunction, renal dysfunction (glomerular filtration rate less than 39 ml/min);
Simultaneous use with powerful inhibitors of the CYP3A4 isoenzyme (ketoconazole, itraconazole, erythromycin), as well as with grapefruit juice, cyclosporine;
Pregnancy and breastfeeding; use in women of childbearing age who do not use reliable contraception;
Children under 18 years of age (efficacy and safety have not been established);
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Side Effects

WHO statistics: very often – 1/10 prescriptions, often – 1/100 prescriptions, not often – 1/1000 prescriptions, rarely – 1/10000 prescriptions, very rarely – less than 1/10000 prescriptions.

From the nervous system: rarely – drowsiness; infrequently – headache, dizziness;

From the immune system: very rarely – hypersensitivity;

From the cardiovascular system: not often – tachycardia, palpitations; “flushes” of blood to the skin of the face; rarely – angina pectoris; very rarely – fainting, marked decrease in blood pressure, chest pain, myocardial infarction;

From the digestive system: rarely – nausea, vomiting, diarrhea, abdominal pain, dyspepsia, very rarely – increased activity of liver enzymes (reversible);

From the skin: rarely – skin rash;

From the musculoskeletal system: rarely – myalgia;

From the urinary system: rarely – polyuria;

General disorders and local reactions: not often – peripheral edema, rarely – asthenia, increased fatigue; very rarely – gum hyperplasia.

Interaction

The drug should not be taken simultaneously with inhibitors of CYP3A4 (liver cytochrome P450 isoenzyme), such as ketoconazole, intraconazole, erythromycin (increase the concentration of lercanidipine in the blood and lead to potentiation of the antihypertensive effect). The simultaneous use of lercanidipine with cyclosporine is contraindicated, as this leads to an increase in the content of both substances in the blood plasma. Lercanidipine should not be taken together with grapefruit juice, as this leads to inhibition of lercanidipine metabolism and potentiation of the antihypertensive effect.

Caution must be exercised when taken concomitantly with drugs such as terfenadine, astemizole, quinidine and third class antiarrhythmic drugs (for example, amiodarone). Concomitant use with anticonvulsants (for example, phenytoin, carbamazepine) and rifamycin may lead to a decrease in the level of lercanidipine in the blood plasma and, therefore, a decrease in the antihypertensive effect lercanidipine.

When taking digoxin concomitantly, it is necessary to regularly monitor for signs of digoxin intoxication.

Taking the drug with midazolam in old age leads to an increase in the absorption of lercanidipine and a decrease in the rate of absorption.

Metoprolol reduces the bioavailability of lercanidipine by 50%, while the bioavailability of metoprolol remains unchanged. This effect may occur due to a decrease in hepatic blood flow, which is caused by beta-blockers, and may therefore also occur when used with other drugs in this group.

Cimetidine at a dose of 800 mg per day does not lead to significant changes in the concentration of lercanidipine in the blood plasma, however, special caution is required, since at higher doses of cimetidine the bioavailability of lercanidipine, and therefore its antihypertensive effect, may increase. When used simultaneously with simvastatin, the drug should be taken in the morning, and simvastatin in the evening. Fluoxetine has no effect on the pharmacokinetics of lercanidipine.

Taking lercanidipine simultaneously with warfarin does not affect the pharmacokinetics of the latter. Lercanidipine can be used simultaneously with beta-blockers, diuretics, and angiotensin-converting enzyme (ACE) inhibitors. Ethanol may enhance the antihypertensive effect of lecarnidipine.

Overdose

Symptoms: peripheral vasodilation with a pronounced decrease in blood pressure (BP) and reflex tachycardia, increased frequency and duration of angina attacks, myocardial infarction.

Treatment: symptomatic therapy.

Manufacturer

Recordati chemical and pharmaceutical industry, Italy