Zanidip-Recordati, 10 mg 28 pcs

Zanidip-Recordati is a “slow” calcium channel blocker. Lercanidipine is a racemic mixture of right- (R) and left- (S) stereoisomers, a derivative of 1,4-dihydropyridine, is able to selectively block the flow of calcium ions inside the cells of the vascular wall, cardiac cells and smooth muscle cells.

The mechanism of hypotensive action is due to direct relaxant action on the vascular smooth muscle cells. It has a prolonged antihypertensive effect. Therapeutic effect is reached 5-7 hours after oral administration and its duration lasts for 24 hours.

Owing 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.

Active ingredient

Composition

1 tablet contains:

Active ingredients:

Lercanidipine 10 mg.

Associates:

Lactose monohydrate – 30 mg,

MCC – 39 mg;

Sodium carboxymethyl starch 15.5 mg;

Povidone K30 – 4.5 mg;

Magnesium stearate – 1 mg.

Shell (10 mg dosage):

Opadry yellow (OY-SR-6497) – 3 mg (hypromellose, talc, titanium dioxide (E171), macrogol-6000, iron oxide yellow dye (E172).

How to take, the dosage

Zanidip-Recordati is taken orally, in the morning, at least 15 minutes before a meal, without chewing, with plenty of water, 10 mg once a day.

The dose may be increased to 20 mg (depending on individual effect). Increase the dose to 20 mg 2 weeks after starting the drug.

In mild to moderate renal or hepatic impairment, increasing the dose to 20 mg daily should be done with caution.

Interaction

Compatible with beta-adrenoblockers, diuretics, ACE inhibitors.

In concomitant use with cardiac glycosides, symptoms and signs of intoxication with digoxin should be controlled.

Concomitant use with cimetidine does not cause significant changes in plasma concentrations of lercanidipine; the bioavailability and corresponding hypotensive effect of lercanidipine are increased at high doses of cimetidine.

With caution, use with CYP3A4 inhibitors (including ketoconazole, itraconazole, erythromycin).

The inducers of CYP3A4 isoenzyme (antidepressants, rifampicin) may decrease the hypotensive effect of the drug.

Grapefruit juice, ethanol may increase the hypotensive effect of drugnidipine.

Special Instructions

During treatment, caution should be exercised when driving vehicles and engaging in potentially hazardous activities that require increased concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity,
decompensated CHF, unstable angina, aortic stenosis, recent myocardial infarction (within 1 month),
Significant liver function abnormalities, renal function abnormalities (CK less than 12 ml/min),
women of childbearing age who do not use reliable contraception, pregnancy, lactation,
childhood and adolescence (under 18 years).

For LF containing lactose (additionally): lactose intolerance, galactosemia, glucose/galactose malabsorption syndrome.
With caution. Renal and/or hepatic failure, CCSU (without pacemaker), CHD, LV dysfunction, advanced age.

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 BP reduction and reflex tachycardia, increased frequency and duration of angina attacks, myocardial infarction.

Treatment: symptomatic therapy.

Similarities