Lercanidipine-SZ, 10 mg 30 pcs

Slow calcium channel blocker.

Pharmacodynamics:

.

Indications

Active ingredient

Composition

1 film-coated tablet contains:

dose 10 mg

the active ingredient:

lercanidipine hydrochloride, 10 mg;

auxiliary substances (core):

Lactose monohydrate (milk sugar) – 31.5 mg;

Microcrystalline cellulose – 38.5 mg;

Starch sodium glycolate – 15.5 mg;

Hypromellose (hydroxypropyl methylcellulose) – 3.5 mg;

Magnesium stearate – 1.0 mg;

Auxiliary substances (coating):

Opadray II (polyvinyl alcohol, partially hydrolyzed, 1.2 mg; E 171 titanium dioxide, 0.67998 mg; talc, 0.444 mg; macrogol (polyethylene glycol) 3350, 0.606 mg; Iron oxide yellow dye E 172 – 0.06825 mg; iron oxide red dye E 172 – 0.00096 mg; iron oxide black dye E 172 – 0.00081 mg).

How to take, the dosage

Ingestion. Lercanidipine-SZ 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.

The effectiveness of the drug is unlikely to increase with doses greater than 20 mg daily, while at the same time the risk of side effects increases.

Periodic use in older patients

There is no need for dose adjustment, but constant monitoring of patients is necessary when 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 undertaken with caution. If the antihypertensive effect is too pronounced, the dose should be reduced.

Interaction

Lercanidipine should not be taken together with grapefruit juice because this inhibits the metabolism of lercanidipine and potentiates the antihypertensive effect.

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), with regard to chronic heart failure: it should be compensated before starting the drug.

Particular caution should be used in patients with sinus node weakness syndrome (without a pacemaker).

While controlled studies of hemodynamics have shown no abnormalities in left ventricular function, calcium channel blockers should be used with extreme caution in patients with signs of left ventricular dysfunction. There is also a view that patients with coronary heart disease receiving short-acting dihydropyridines are a high-risk group for cardiovascular disease.

Particular caution should be exercised during the initial stages of treatment in patients with mild to moderate hepatic function impairment.

Attention should be exercised during treatment for work 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

– Hypersensitivity to lercanidipine, other dihydropyridine-type derivatives or any component of the drug;

– Untreated heart failure;

– Unstable angina pectoris;

– left ventricular outflow tract obstruction;

– within 1 month after myocardial infarction;

– severe hepatic insufficiency;

– severe renal impairment (CKG less than 30 ml/min);

– pregnancy and breastfeeding;

– use in women of childbearing age who are not using reliable contraception;

– age less than 18 years (efficacy and safety not established);

– lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;

– simultaneous use with cyclosporine;

– simultaneous use with grapefruit juice.

– Renal insufficiency (creatinine clearance more than 30 ml/min);

– liver function disorders of mild to moderate severity;

– elderly age;

– sinus node weakness syndrome (without a pacemaker);

– left ventricular dysfunction and coronary heart disease;

– chronic heart failure;

– simultaneous use with beta-adrenoblockers, digoxin.

Side effects

The following is a list of adverse reactions by organ system and frequency of occurrence (World Health Organization classification):

often more than 1/100 to less than 1/10,

infrequently more than 1/1000 to less than 1/100,

rarely more than 1/10000 to less than 1/1000,

very rarely less than 1/10000, including individual reports.

Nervous system disorders

Infrequent: headache, dizziness;

Rare: drowsiness.

Cardiovascular system disorders

Infrequent: palpitations, tachycardia, “rushes” of blood to the face;

Rare: angina pectoris;

Very rare: fainting, marked decrease in blood pressure, chest pain, myocardial infarction, in patients with angina pectoris, an increase in the frequency, duration and severity of attacks is possible.

Gastrointestinal disorders

Rare: nausea, vomiting, diarrhea, abdominal pain, dyspepsia;

Very rare: increased activity of “liver” enzymes (reversible).

Skin and subcutaneous tissue disorders

Rarely: skin rash.

Muscular and connective tissue disorders

Rarely: myalgia.

Rarely: pollakiuria (increased frequency of urination).

General disorders

Infrequent: peripheral edema;

Rarely: asthenia, increased fatigue;

Very rare: gum hyperplasia.

Immune system disorders:

Very rare: hypersensitivity reactions.

Overdose

Symptoms

Presumably, in case of overdose of lercanidipine, symptoms similar to those of overdose of other dihydropyridine derivatives (peripheral vasodilation with marked BP decrease and reflex tachycardia), nausea will be observed.

Treatment

Symptomatic. Cardiovascular therapy is indicated in case of marked BP decrease, loss of consciousness; intravenous injection of atropine is indicated in bradycardia. There is no information about the effectiveness of hemodialysis. Given the high degree of binding to plasma proteins, dialysis may not be effective.

There are data on three cases of overdose when taking lercanidipine in doses of 150 mg, 280 mg and 800 mg. In all overdose cases, patients survived.

In case of concomitant administration of 150 mg of lercanidipine with ethanol (unspecified amount) drowsiness was observed. Treatment: gastric lavage, oral administration of activated charcoal.

Pregnancy use

Similarities