Zanidip-Recordati tablets coated. 10 mg film 56 pcs. (Lerkanydypyn)

Release form

Tablets, film-coated, light yellow, round, biconvex, with a risk on one side on the fracture - light yellow.

Packing

56 pcs.

Pharmacological action of

Slow calcium channel blocker. Lercanidipine is a racemic mixture of right- (R) and left-handed (S) stereoisomers, a derivative of 1,4-dihydropyridine, which is capable of selectively blocking the flow of calcium ions into the cells of the vascular wall, heart cells, and smooth muscle cells.

The mechanism of antihypertensive action is due to the direct relaxing effect on vascular smooth muscle cells. It has a prolonged antihypertensive effect. The therapeutic effect is achieved 5-7 hours after ingestion and its duration persists for a day (24 hours). Due to its high selectivity to vascular smooth muscle cells, there is no negative inotropic effect.

Zanidip®-Recordati is a metabolically neutral drug and does not significantly affect the serum lipoproteins and apolipoproteins, and also does not change the lipid profile in patients with arterial hypertension.

Indications

Zanidip-Recordati is prescribed for the treatment of essential hypertension occurring in mild to moderate severity.

Contraindications

- chronic heart failure at the stage of decompensation

- unstable angina pectoris

- obstruction of blood vessels originating from the left ventricle of the heart

- recent myocardial infarction (within 1 month)

- severe liver function (dysfunction - liver function glomerular filtration less than 39 ml / min)

- simultaneous use with powerful inhibitors of the CYP3A4 isoenzyme (ketoconazole, itraconazole, erythromycin), as well as with grapefruit juice, cyclosporine

- de itsit lactase, lactose intolerance, malabsorption of glucose / galactose

syndrome - Children and teens under 18 years of age (efficacy and safety have not been established)

-

pregnancy - lactation

- women of childbearing age,

not using reliable contraceptives - hypersensitivity to lercanidipine, other derivatives of the dihydropyridine series or any component of the drug.

Caution: impaired liver function of mild to moderate severity of the sinus node weakness syndrome (without pacemaker) left ventricular failure and coronary heart disease chronic heart failure concomitant use of beta-blockers, digoxin.

Special instructions

Caution should be exercised when prescribing to patients with impaired renal function, ischemic heart disease (there is a risk of increased frequency of angina attacks).

Before starting the use of the drug, it is necessary to compensate for chronic heart failure.

Special care should be taken in the initial stages of treatment of patients with mild to moderate severity of liver failure.

Influence on the ability to drive vehicles and control mechanisms

During treatment, care must be taken when performing work requiring 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).

Composition

1 tablet:

active substance: lercanidipine hydrochloride - 10 mg

ol 30 mg mg carboxymel mg sodium 15.5 mg povidone K30 - 4.5 mg magnesium stearate - 1 mg.

shell (dosage of 10 mg): Opadry yellow (OY-SR-6497) - 3 mg (hypromellose, talc, titanium dioxide (E171), macrogol-6000, dye iron oxide yellow (E172.

Dosage and administration

The drug is prescribed 10 mg 1 time / day (in the morning) at least 15 minutes before meals. Depending on the individual effect, the dose of the drug can be increased to 20 mg. The therapeutic dose is selected gradually, if necessary, the dose is increased 2 weeks after the start of the drug.

Tablets are taken orally without chewing with a sufficient amount of water.

In elderly patients, dose adjustment is not required, however, when taking the drug, constant monitoring of the patient's condition is necessary.

In the presence of mild or moderate renal or hepatic insufficiency, as a rule, a dose adjustment does not require an initial dose of 10 mg, then the dose should be carefully increased to 20 mg / day. If the antihypertensive effect is too pronounced, the dose should be reduced.

Drug interaction

The drug cannot be taken simultaneously with CYP3A4 inhibitors (isoenzyme of the cytochrome P450 of the liver), such as ketoconazole, itraconazole, erythromycin (increase the concentration of lercanidipine in the blood and lead to a potentiation of the antihypertensive effect).

Concurrent use of lercanidipine with cyclosporine is contraindicated, because this leads to an increase in the content of both substances in blood plasma.

Lercanidipine should not be taken with grapefruit juice, as this leads to inhibition of the metabolism of lercanidipine and potentiation of the antihypertensive effect.

Caution should be exercised while taking with drugs such as terfenadine, astemizole, quinidine, and class III antiarrhythmic drugs (eg, amiodarone).

Concomitant use with anticonvulsants (e.g. phenytoin, carbamazepine) and rifamycin can lead to a decrease in plasma lercanidipine levels and, therefore, to reduce the antihypertensive effect of lercanidipine.

With the simultaneous administration of digoxin, regular monitoring for signs of digoxin intoxication is necessary.

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 can occur due to a decrease in hepatic blood flow, which is caused by beta-blockers, therefore, it can also occur when used with other drugs in this group.

Cimetidine at a dose of 800 mg / day does not lead to significant changes in the concentration of lercanidipine in blood plasma, however, special care is required, because at higher doses of cimetidine, bioavailability of lercanidipine, a, therefore, its antihypertensive effect may increase.

With simultaneous 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 does not affect the pharmacokinetics of the latter.

Lercanidipine can be used simultaneously with beta-blockers, diuretics, ACE inhibitors.

Ethanol may enhance the antihypertensive effect of drug medication.

overdose

Symptoms: peripheral vasodilation with marked decrease in blood pressure and reflex tachycardia, increase in frequency and duration of angina attacks, myocardial infarction.

Treatment: carry out symptomatic therapy.

Storage Conditions

The product should be stored out of the reach of children at a temperature not exceeding 30 ° C.

Shelf life

3 years.

Active ingredient nature of

lercanidipine

Terms of sale from drugstores

Prescription

dosage form

tablets

Possible product names

Zanidip-Recordati tablets coated. 10 mg 56 pcs.



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