Zanidip-Recordati, pills 20mg 56pcs

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 K 30-9 mg,

magnesium stearate-2 mg

. shell composition:

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

Pharmacological action

Slow calcium channel blocker.

It has a prolonged antihypertensive effect.

The therapeutic effect is achieved 5-7 hours after ingestion and its duration is maintained for a day (24 hours).

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

Lercanidipine is a metabolically neutral drug and does not significantly affect the content of lipoproteins and apolipoproteins in the blood serum, and also does not change the lipid profile in patients with arterial hypertension.

Indications

Essential hypertension of mild to moderate severity.

Contraindications

• Hypersensitivity to lercanidipine, other dihydropyridine derivatives or any component of the drug;
• Chronic heart failure in the decompensation stage;
• Unstable angina, obstruction of vessels originating from the left ventricle of the heart, a recent myocardial infarction (within 1 month);
• Severe hepatic impairment, renal impairment (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 lactation; 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 appointments, often-1/100 appointments, not often-1/1000 appointments, rarely-1/10000 appointments, very rarely-less than 1/10000 appointments.

Nervous system disorders:  rarely-drowsiness; infrequently-headache, dizziness;

From the immune system:  very rarely-hypersensitivity.

From the cardiovascular system:  not often-tachycardia, palpitation sensation; “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 side of 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). Concomitant 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 should be exercised when taking concomitant medications such as terfenadine, astemizole, quinidine, and a third class of antiarrhythmic drugs (for example, amiodarone). Concomitant use with anticonvulsants (e. g. phenytoin, carbamazepine) antihypertensive effect of lercanidipine and rifamycin can lead to a decrease in the level of lercanidipine in blood plasma and, therefore, to a decrease in the antihypertensive effect of lercanidipine.

When taking digoxin at the same time, it is necessary to regularly monitor for signs of digoxin intoxication.

Taking the drug with midazolam in the elderly 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 can occur due to a decrease in hepatic blood flow, which is caused by beta-blockers, so it can also occur when used with other drugs of this group.

Cimetidine at a dose of 800 mg per day does not cause significant changes in the concentration of lercanidipine in blood plasma, however, special caution is required, since with higher doses of cimetidine, the bioavailability of lercanidipine, and therefore its antihypertensive effect, may increase. When used concomitantly 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 does not affect the pharmacokinetics of the latter. Lercanidipine can be used simultaneously with beta-blockers, diuretics, angiotensin converting enzyme (ACE) inhibitors. Ethanol may enhance the antihypertensive effect of lignidipine.

How to take, course of use and dosage

Inside.

The drug Zanidip® – Recordati is prescribed 10 mg 1 time a day in the morning, at least 15 minutes before meals, without chewing, with a sufficient amount of water.

The dose can be increased to 20 mg (if taking 10 mg does not achieve the expected effect). The therapeutic dose is selected gradually, increasing the dose to 20 mg is carried out 2 weeks after the start of taking the drug.

Use in elderly patients

No dose adjustment is required, however, when taking the drug, constant monitoring of the patient’s condition is necessary.

Use in patients with impaired renal or hepatic function

In the presence of mild or moderate renal or hepatic insufficiency, as a rule, no dose adjustment is required, the initial dose is 10 mg, and an increase in the dose to 20 mg per day should be carried out with caution. If the antihypertensive effect is too pronounced, the dose should be reduced.

Overdose

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

Treatment:  symptomatic therapy.

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), in relation to chronic heart failure: it is necessary to compensate before starting the drug. Special care should be taken in the initial stages of treatment of patients with mild to moderate hepatic insufficiency.

Influence on the ability to drive mechanisms and a car

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

Form of production

Film-coated tablets

Active ingredient

Lercanidipine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Hypertension