Koronim

General characteristics. Structure:

Active ingredient: 6,935 mg or 13,87 mg of an amlodipin of a besilat (equivalent 5 mg or 10 mg of an amlodipin).

Excipients: calcium hydrophosphate dihydrate, cellulose microcrystallic PH 102, эксплотаб, aerosil 200, magnesium stearate.

Anti-hypertensive drug.

Pharmacological properties:

Pharmacodynamics. Koronim – is a blocker of a calcium channel of long action which inhibits transmembrane transfer of calcium ions in smooth muscles of vessels and cardiomyocytes. Amlodipin selectively blocks transfer of calcium ions in cells.

Influences unstriated muscles of vessels more, than cardiomyocytes owing to what, does not exert significant impact on cordial emission and on a stroke output. Amlodipin does not exert impact on calcium level in a blood plasma. As the peripheral vazodilatator, амлодипин influences directly unstriated muscles of vessels owing to what resistance of peripheral vessels decreases and arterial pressure decreases owing to what the need of cardiomyocytes for oxygen decreases.

The anti-hypertensive effect remains about 24 hours. Amlodipin does not change function of a sinuatrial node or atrioventricular conductivity. Despite approximately identical changes of diastolic pressure at young and elderly patients, systolic pressure decreased at elderly more considerably.

Pharmacokinetics. Absolute bioavailability of drug KORONIM makes 64-80%. The maximum concentration in a blood plasma is observed in 6-12 hours. Meal does not influence bioavailability of an amlodipin. Amlodipin for 97,5% contacts proteins of plasma.

Elimination from a system blood-groove is carried out in two stages, half-life about 30-50 hours. This time does not increase at a renal failure. Css in plasma is reached in 7-8 days of constant reception. Amlodipin is metabolized in a liver, 60% of metabolites are removed with urine, 10% in not changed look.

Indications to use:

- essential arterial hypertension;

- symptomatic arterial hypertension;

- stable stenocardia;

- unstable stenocardia (Printsmetala).

Route of administration and doses:

Drug is appointed orally. Meal has no effect on absorption of drug from digestive tract.

The recommended initial dose makes 2,5 - 5 mg once a day. At arterial hypertension and stenocardia - 5 mg a day. If necessary the daily dose can be increased to 10 mg a day. The maximum daily dose makes 10 mg.

Duration of treatment is determined by the attending physician.

Features of use:

In rare instances at the initial stage of treatment inhibitors of calcium channels or at increase in a dose at patients with obturation of coronary arteries aggravate stenocardia of heavy degree.

At sharply developed hypotension, patients need to be careful at use of other vasodilators with the expressed aorta stenosis.

At patients with congestive heart failure the elimination half-life of an amlodipin therefore it is necessary to appoint with care increases.

To patients with heavy degree of a liver failure to appoint with care as амлодипин it is metabolized in a liver and the elimination half-life increases.

The minimum initial doses are recommended to elderly patients.

Features of influence of medicine on ability to manage the vehicle or potentially dangerous mechanisms. With care to apply in operating time to drivers of vehicles and people whose profession is connected with the increased concentration of attention (in an initiation of treatment dizziness and drowsiness are possible).

Side effects:

- headache, dizziness, drowsiness, fatigue;

- tachycardia;

- hyperemia of the person;

- nausea, abdominal pains;

- hypostases, including peripheral hypostases.

Seldom:

- disturbances of a heart rhythm (ventricular tachycardia,  atrial flutter), thorax pain;

- itch, rash, Quincke's disease, exudative multiformny  erythema;

- arterial hypotension;

- leukopenia, thrombocytopenia, purpura;

- hyperglycemia;

- changes of mood;

- peripheral neuropathy, tremor, hypesthesia, paresthesias;

- syncope;

- perversion of flavoring feelings;

- vision disorders

- sonitus;

- vasculitis;

- short wind, cough, rhinitis;

- dispeptic frustration, dryness in a mouth, disturbances  of gastrointestinal motility, a hyperplasia of gums, increase / decrease in body weight;

- pancreatitis;

- the increased perspiration;

- alopecia, disturbances of coloring of skin;

- arthralgias, mialgiya, muscular spasms, dorsodynias;

- pollakiuria, dysuria, nocturia;

- decrease in a potentiality, gynecomastia;

- the increased fatigue, an adynamy.

Very seldom:

 - gastritis, hepatitis, the jaundice (caused by a cholestasia);

 - small tortoiseshell;

 - increase in level of hepatic transaminases.

Interaction with other medicines:

At a concomitant use of a koronim with drugs of lithium strengthening is possible
manifestations of neurotoxic effects of lithium (nausea, vomiting,
diarrhea, ataxy, sonitus).

Does not exert impact on pharmacokinetic parameters of digoxin and warfarin.

Cimetidinum does not influence pharmacokinetics of a koronim.

Drugs of calcium can reduce effect of blockers of "slow" calcium channels.

The procaineamide, quinidine and other medicines causing lengthening of an interval of QT strengthen a negative inotropic effect and can increase risk of considerable lengthening of an interval of QT.

Sildenafil. Reception of one dose of a sildenafil of 100 mg does not exert impact on pharmacokinetic parameters of an amlodipin. Koronim also sildenafit are applied in a combination, each drug independently from each other renders hypotensive effect.

Inhibitors of a microsomal oxidation increase concentration of a koronim in a blood plasma, increasing risk of development of side effects, inductors of microsomal enzymes of a liver reduce concentration of an amlodipin.

Indometacin and other non-steroidal anti-inflammatory drugs (a delay of sodium and blockade of synthesis of prostaglandin kidneys), alpha адреностимуляторы, reduce sympathomimetics and estrogen (a sodium delay)
hypotensive action of a koronim.

Thiazide and "loopback" diuretics, beta adrenoblockers, verapamil, APF inhibitors and nitrates strengthen anti-anginal and hypotensive effects.

Amiodaronum, quinidine, alfa1-adrenoblockers, antipsychotic medicines (neuroleptics) can strengthen hypotensive action.

Joint Koronima 10 and an atorvastatina of 80 mg does not exert impact on pharmacokinetic parameters of an atorvastatin.

Proved pharmacokinetic researches with cyclosporines that korony does not change significantly pharmacokinetics of immunodepressive drugs.

Contraindications:

- hypersensitivity to an amlodipin, other derivatives of dihydropyridinic group or to excipients.

- arterial hypotension (systolic arterial pressure is less than 90 mm hg)

- acute myocardial infarction;

- tachycardia;

- collapse;

- pregnancy and period of a lactation;

- vascular and cardiogenic shock;

- the expressed heart failure;

- children's and teenage age up to 18 years (efficiency and safety are not established).

Overdose:

Symptoms: the excessive peripheral vazodilatation with considerable pressure decrease, is possible reflex tachycardia

Treatment: a gastric lavage, purpose of absorbent carbon, giving to the patient of horizontal position with the raised legs, monitoring of indicators of cardiac performance and lungs, control by the volume of the circulating blood and a diuresis, a symptomatic and maintenance therapy, in/in administration of liquids, a gluconate of calcium, a dopamine, phenylephine hydrochloride. The hemodialysis is not effective.

Storage conditions:

To store at a temperature of 15 °C - 30 °C, in the dry, protected from light place. To store in the place, unavailable to children! Period of storage 2 years. Not to apply after a period of storage.

Issue conditions:

According to the recipe

Packaging:

Tablets of 5 mg, 10 mg, in a blister strip packaging on 10 or 14 tablets, 1 or 2 packagings in a cardboard pack together with the instruction on a medical use.