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

Mild to moderate essential hypertension.

Active ingredient

Composition

One film-coated tablet contains:

the 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.

coating composition:

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

How to take, the dosage

Orally.

The drug Zanidip®-Recordati is prescribed 10 mg once daily in the morning, at least 15 minutes before meals, without chewing, with plenty of water.

The dose may be increased to 20 mg (if the expected effect is not achieved with 10 mg). The therapeutic dose is adjusted gradually, increasing the dose to 20 mg in 2 weeks after the start of the drug.

Use in elderly patients

There is no need to adjust the dose; however, continuous monitoring of patients is necessary while taking the drug.

Patients with renal or hepatic impairment

In the presence of mild to moderate renal or hepatic impairment, usually no dose adjustment is required; the initial dose is 10 mg; increase in dose to 20 mg per day should be given with caution. If the antihypertensive effect is too pronounced, the dose should be reduced.

Interaction

The drug should not be taken concomitantly with CYP3A4 inhibitors (hepatic cytochrome P450 isoenzyme) such as ketoconazole, intraconazole, erythromycin (they increase the blood concentration of lercanidipine and lead to potentiation of the antihypertensive effect). Concomitant administration of lercanidipine with cyclosporine is contraindicated because it leads to increased plasma levels of both substances. Lercanidipine should not be taken together with grapefruit juice, because this leads to inhibition of lercanidipine metabolism and potentiation of the antihypertensive effect.

Cautious concomitant administration with drugs such as terfenadine, astemizole, quinidine and a third class of antiarrhythmic drugs (e.g., amiodarone) is necessary.Concomitant use with anticonvulsants (e.g., phenytoin, carbamazepine) and rifamycin may lead to decreased plasma levels of lercanidipine and, in connection with this, to a decrease in the antihypertensive effect of lercanidipine.

In concomitant administration of digoxin, regular monitoring for signs of digoxin intoxication should be performed.

The administration of the drug with midazolam in the elderly leads to increased absorption of lercanidipine and decreased absorption rate.

Metoprolol decreases the bioavailability of lercanidipine by 50%; the bioavailability of metoprolol remains unchanged. This effect may occur due to decreased hepatic blood flow caused by beta-adrenoblockers; therefore, it may also occur when used with other drugs of this group.

Cimetidine at a dose of 800 mg daily does not cause significant changes in plasma concentrations of lercanidipine, however, special caution is required because the bioavailability of lercanidipine, and therefore its antihypertensive effect, may increase at higher doses of cimetidine. When concomitant use 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 concomitantly with warfarin has no effect on the pharmacokinetics of the latter. Lercanidipine may be used concomitantly with beta-adrenoblockers, diuretics, angiotensin-converting enzyme inhibitors (ACE). Ethanol may increase the antihypertensive effect of drugnidipine.

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), for chronic heart failure: must be compensated, before starting the drug. Particular caution should be observed during the initial stages of treatment in patients with mild to moderate hepatic function insufficiency.

Influence on ability to operate machinery and drive

At the beginning of treatment, caution should be exercised when performing tasks requiring increased attention, driving vehicles, especially at the beginning of treatment and when increasing the dose of the drug (risk of drowsiness, headache and dizziness).

Contraindications

Side effects

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

Nervous system disorders: rare – somnolence; infrequent – headache, dizziness;

Immune system disorders: very rare – hypersensitivity;

Cardiovascular system disorders: not frequent – tachycardia, palpitations; “rushes” of blood to the skin of the face; rare – angina pectoris; very rare – fainting, marked decrease in blood pressure, chest pain, myocardial infarction;

Digestive system disorders: rare – nausea, vomiting, diarrhea, abdominal pain, dyspepsia, very rare – increased activity of “liver” enzymes (reversible);

Skin: rare – skin rash;

Musculoskeletal disorders: rarely – myalgia;

Urinary system: rarely – polyuria;

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

Overdose

Symptoms: peripheral vasodilation with marked reduction of blood pressure (BP) and reflex tachycardia, increased frequency and duration of angina attacks, myocardial infarction.

Treatment: symptomatic therapy.

Similarities