Zanidip-Recordati, pills 20mg, 28pcs

Composition

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of 1 tab. contains:

Active ingredients:

lercanidipine hydrochloride 20 mg.

Auxiliary substances:

lactose monohydrate-60 mg,

MCC-78 mg;

sodium carboxymethyl starch-31 mg;

povidone K 30-9 mg;

magnesium stearate-2 mg.

Shell (dosage 20 mg):

Opadry pink (02F25077) — 6 mg (hypromellose, talc, titanium dioxide (E 171), macrogol 6000, iron oxide dye red (E 172).

Pharmacological action

of Zanidip-Recordati-a blocker of “slow” calcium channels. Lercanidipine is a racemic mixture of right-(R) and left-rotating (S) stereoisomers, a 1,4-dihydropyridine derivative, and is capable of selectively blocking the flow of calcium ions into vascular wall cells, 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 is maintained 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 content of lipoproteins and apolipoproteins in the blood serum, and also does not change the lipid profile in patients with arterial hypertension.

Pharmacokinetics:

 Absorption After oral use, lercanidipine is absorbed almost completely from the gastrointestinal tract. Cmax in blood plasma is reached in 1.5-3 hours and is 3.3 ng / ml and 7.66 ng/ml after taking 10 mg and 20 mg, respectively.

Distributiondistribution from blood plasma to tissues and organs is rapid. Binding to plasma proteins exceeds 98%. When repeated use, it does not accumulate.

Metabolismmetabolized during the” primary passage ” through the liver by biotransformation of CYP3A4 with the formation of a number of metabolites that do not have pharmacological activity.

Excretion is eliminated by the kidneys and intestines after biotransformation. There are 2 phases of lercanidipine elimination: early (T1/2 – 2-5 hours) and final (T1/2 – 8-10 hours). The drug in unchanged form is practically not detected in the urine and feces.

Pharmacokinetics in special clinical cases

In patients with renal and hepatic insufficiency, the plasma protein content is reduced, so the free fraction of lercanidipine can be increased.

Indications

Mild to moderate essential hypertension.

Contraindications

Hypersensitivity, decompensated CHF, unstable angina, aortic stenosis, recent myocardial infarction (within 1 month), severe liver function disorders, renal function disorders (creatinine clearance less than 12 ml / min), women of childbearing age who do not use reliable contraception, pregnancy, lactation, children and adolescents (up to 18 years).

For LF containing lactose (optional): lactose intolerance, galactosemia, glucose/galactose malabsorption syndrome.

With caution. Renal and / or hepatic insufficiency, SSR (without pacemaker), IHD, LV dysfunction, elderly age.

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

Compatible with beta-blockers, diuretics, and ACE inhibitors.

When used concomitantly with cardiac glycosides, it is necessary to monitor the symptoms and signs of digoxin intoxication. Concomitant use with cimetidine does not cause significant changes in the concentration of lercanidipine in plasma, with high doses of cimetidine, the bioavailability increases and, accordingly, the hypotensive effect of lercanidipine increases.

Use with caution with CYP3A4 inhibitors (including ketoconazole, itraconazole, and erythromycin).

Inducers of the CYP3A4 isoenzyme (antidepressants, rifampicin) may reduce the hypotensive effect of the drug.

Grapefruit juice and ethanol may enhance the antihypertensive effect of lignidipine.

How to take, course of use and dosage

of Zanidip-Recordati is taken orally, in the morning, at least 15 minutes before meals, without chewing, with a sufficient amount of water,10 mg 1 time a day.

The dose can be increased to 20 mg (depending on the individual effect). An increase in the dose to 20 mg is carried out 2 weeks after the start of taking the drug.

In patients with mild or moderate renal or hepatic insufficiency, increasing the dose to 20 mg per day should be carried out with caution.

Overdose

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

Treatment: symptomatic therapy.

Special instructions

During the treatment period, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Film-coated tablets.

Storage conditions

At a temperature not exceeding 30 °C. Keep out of reach of children.

Active ingredient

Lercanidipine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Hypertension