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Coronim 10 mg No. 20 tablet.

Instructions for medical use of the drug CORONIM® 5 CORONIM® 10 Trade name CORONIM® 5 CORONIM® 10 International nonproprietary name Amlodipine Dosage form Tablets 5 mg, 10 mg Composition One tablet contains the active substance - amlodipine besilate 6.935 mg (equivalent to 5 mg amlodipine) or amlodipine besylate 13.87 mg (equivalent to 10 mg amlodipine), excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose RN 102, explotab (sodium starch glycolate), aerosil 200, magnesium stearate. Description White round tablets with a score on one side. Pharmacotherapeutic group: Blockers of “slow” calcium channels. Blockers of “slow” calcium channels are selective. Dihydropyridine derivatives. Amlodipine. ATC code C08CA01 Pharmacological properties Pharmacokinetics The absolute bioavailability of the drug CORONIM® is 64-80%. The maximum concentration in blood plasma is observed after 6-12 hours. Amlodipine is 97.5% bound to plasma proteins. Food intake does not affect the bioavailability of amlodipine and penetrates the blood-brain barrier. Elimination from the systemic circulation occurs in two stages, the half-life is about 35-50 hours. This time does not increase in case of renal failure. A stable equilibrium concentration in the blood plasma is achieved after 7-8 days of continuous use. Amlodipine is metabolized in the liver to form inactive metabolites, of which 60% are excreted in the urine, and 10% are excreted unchanged. Pharmacodynamics Amlodipine, the active substance of the drug Coronim®, is a dihydropyridine derivative. By binding to dihydropyridine receptors, it blocks “slow” calcium channels, inhibits the transmembrane transition of calcium into the smooth muscle cells of the heart and blood vessels (to a greater extent into vascular smooth muscle cells than into cardiomyocytes). It has a hypotensive and antianginal effect. The mechanism of the hypotensive effect of the drug Coronim® is due to a direct relaxing effect on vascular smooth muscles. The antianginal effect is due to the expansion of coronary and peripheral arteries and arterioles. In case of angina pectoris, it reduces the severity of myocardial ischemia. By expanding peripheral arterioles, it reduces the total peripheral vascular resistance and reduces the myocardium's need for oxygen. By expanding the main coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, it increases the supply of oxygen to the myocardium (especially with vasospastic angina). Prevents the development of constriction of the coronary arteries (including those caused by smoking). In patients with arterial hypertension, a single daily dose of Coronim provides a decrease in blood pressure over 24 hours both in the “lying” and “standing” positions. Due to its slow onset of action, amlodipine does not cause a sharp decrease in blood pressure. In patients with angina pectoris, a single daily dose of the drug increases exercise tolerance, delays the development of angina attacks and ST segment depression (by 1 mm) during physical activity, reduces the frequency of angina attacks and nitroglycerin consumption. In patients with cardiovascular diseases (including coronary atherosclerosis with damage to one vessel and up to stenosis of 3 or more arteries and atherosclerosis of the carotid arteries), who have had myocardial infarction, percutaneous transluminal angioplasty of the coronary arteries (TLP) or suffering from angina, the use of Coronim prevents the development of thickening of the intima-media of the carotid arteries. Also, the use of Coronim significantly reduces mortality from cardiovascular causes, myocardial infarction, stroke, TLP, coronary artery bypass grafting, leads to a decrease in the number of hospitalizations for unstable angina and progression of chronic heart failure (CHF), reduces the frequency of interventions aimed at restoring coronary artery disease blood flow Indications for use - arterial hypertension (both in monotherapy and in combination with other antihypertensive drugs) - stable angina and vasospastic angina (Prinzmetal's angina) (both in monotherapy and in combination with other antihypertensive drugs) Method of administration and dosage The drug is prescribed orally with a sufficient amount of water (100 ml). Eating does not affect the absorption of the drug from the gastrointestinal tract. The recommended starting dose is 2.5 - 5 mg once daily. For arterial hypertension and angina pectoris - 5 mg per day. Depending on the individual response of the patient, the dose can be increased to a maximum daily dose of 10 mg per day. The duration of treatment is determined by the attending physician. Use in the elderly. It is recommended to use it in normal doses; no change in the dose of the drug is required. Use for renal failure. It is recommended to use it in normal doses, however, it is necessary to take into account a possible slight increase in T1/2. A change in the dosage regimen of Coronim is not required during concomitant use of thiazide diuretics, beta-blockers or angiotensin-converting enzyme (ACE) inhibitors. Side effects - headache, dizziness, drowsiness, fatigue - tachycardia - facial flushing - nausea, abdominal pain - edema, including peripheral edema Rarely - heart rhythm disturbances (ventricular tachycardia, atrial flutter), bradycardia, chest pain - allergic reactions , including itching, rash, angioedema, exudative erythema multiforme - arterial hypotension - leukopenia, thrombocytopenia - hyperglycemia - mood changes - peripheral neuropathy, tremor, hypesthesia, paresthesia - fainting - perversion of taste - visual disturbances - tinnitus - vasculitis - shortness of breath , cough, rhinitis - dyspeptic disorders, dry mouth, stool changes, gum hyperplasia, weight gain/loss - pancreatitis - hyperhidrosis - alopecia, skin discoloration - arthralgia, myalgia, muscle cramps, back pain - pollakiuria, dysuria, nocturia - decreased potency, gynecomastia - increased fatigue, asthenia Very rare - gastritis, hepatitis, jaundice, increased levels of liver transaminases (mainly with cholestasis) - urticaria Contraindications - hypersensitivity to amlodipine, other derivatives of the dihydropyridine group or to the excipients included in the composition drug. - arterial hypotension (systolic blood pressure less than 90 ml Hg) - collapse - pregnancy and lactation - vascular and cardiogenic shock - children and adolescents under 18 years of age (efficacy and safety have not been established) With caution in: - impaired liver function - syndrome weakness of the sinus node (severe bradycardia, tachycardia) - chronic heart failure in the stage of decompensation - mitral and aortic stenosis - acute myocardial infarction (and within 1 month after) Drug interactions Amlodipine is safe to prescribe with thiazide diuretics, alpha-blockers, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, non-steroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs. Data from in vitro studies indicate that amlodipine does not affect the protein binding of drugs such as digoxin, phenytoin, warfarin or indomethacin. Simvastatin: Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin increased the effect of simvastatin by 77% compared with simvastatin monotherapy. Therefore, the maximum dose of simvastatin in patients receiving amlodipine should be up to 20 mg per day. Grapefruit juice: Concomitant use of 240 ml of grapefruit juice with a single oral dose of 10 mg of amlodipine in volunteers did not have a significant effect on the pharmacokinetics of amlodipine. The study did not allow us to study the influence of genetic polymorphism of CYP3A4, the main enzyme responsible for the metabolism of amlodipine, therefore the use of amlodipine with grapefruit or grapefruit juice is not recommended, since it may increase bioavailability, which can cause a sharp hypotensive effect in some patients with high blood pressure. CYP3A4 inhibitors: Concomitant use of a daily dose of 180 mg of diltiazem with 5 mg of amlodipine in elderly patients with arterial hypertension (69 - 87 years) resulted in a 57% increase in systemic exposure to amlodipine. When administered concomitantly with erythromycin in healthy volunteers (18 to 43 years), the systemic exposure of amlodipine did not change significantly (22% increase in AUC). Although the clinical significance of these data is unclear, pharmacokinetic changes may be more pronounced in older adults. Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) may increase plasma concentrations of amlodipine to a greater extent than diltiazem. Therefore, caution should be exercised when using amlodipine with CYP3A4 inhibitors. CYP3A4 inducers: There is no data on the effect of CYP3A4 inducers on amlodipine. Concomitant use of CYP3A4 inducers (for example, rifampicin, St. John's wort) can significantly reduce the plasma concentration of amlodipine. Therefore, caution should be exercised when using amlodipine with CYP3A4 inducers. In the following studies listed below, there were no significant changes in the pharmacokinetics of either amlodipine or the other study drug during concomitant use. Special studies of the effect of other drugs on amlodipine Cimetidine: Co-administration of amlodipine with cimetidine does not change the pharmacokinetics of amlodipine. Aluminum/Magnesium (antacid): Concomitant use of aluminum/magnesium antacids with a single dose of amlodipine did not have a significant effect on the pharmacokinetics of amlodipine. Sildenafil (Viagra): A single dose of 100 mg of sildenafil in patients with hypertension had no effect on the pharmacokinetic parameters of amlodipine. When a combination of amlodipine and sildenafil was used, each drug independently had a blood pressure-lowering effect. Special studies of the effect of amlodipine on other drugs Atorvastatin: Concomitant use of multiple doses of 10 mg amlodipine and 80 mg atorvastatin did not lead to significant changes in the pharmacokinetic parameters of atorvastatin at steady state. Digoxin: Concomitant use of amlodipine with digoxin did not alter serum digoxin concentrations or renal clearance of digoxin. Ethanol (alcohol): Single and multiple doses of 10 mg amlodipine did not have a significant effect on the pharmacokinetics of ethanol. Warfarin: Concomitant use of amlodipine with warfarin did not change the response changes in prothrombin time under the influence of warfarin. Cyclosporine: Pharmacokinetic studies with cyclosporine have shown that amlodipine does not significantly alter the pharmacokinetics of cyclosporine. Special instructions In rare cases, at the initial stage of treatment with calcium channel inhibitors or when the dose is increased in patients with obstruction of the coronary arteries, severe angina pectoris worsens. In cases of acute hypotension, caution must be exercised when using other vasodilators in patients with severe aortic stenosis. When using the drug Coronim® in patients with chronic heart failure of functional class III and IV according to the NUHA classification, pulmonary edema may develop. Minimum initial doses are recommended for elderly patients. Use with caution in patients with severe hepatic impairment, as amlodipine is metabolized in the liver and the half-life increases. Pregnancy and lactation The safety of Coronim® during pregnancy and lactation has not been established, therefore use during pregnancy is possible only if the benefit to the mother outweighs the risk to the fetus and newborn. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Use with caution during work by vehicle drivers and people whose profession is associated with increased concentration (dizziness and drowsiness are possible at the beginning of treatment) Overdose Symptoms: excessive peripheral vasodilation with a significant decrease blood pressure, reflex tachycardia is possible. Treatment: gastric lavage, administration of activated charcoal, maintaining the function of the cardiovascular system, monitoring indicators of heart and lung function, giving the patient a horizontal position with raised legs, monitoring the volume of circulating blood and diuresis. To restore vascular tone and blood pressure, if there are no contraindications, it is possible to use vasoconstrictor drugs (dopamine, norepinephrine). Intravenous calcium gluconate is used, which may help counteract calcium channel blockade. Hemodialysis is ineffective. Release form and packaging 10 or 14 tablets in a blister pack made of polyvinyl chloride film and printed aluminum foil. 2 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard pack with a hologram of the manufacturer. Storage conditions At a temperature not exceeding 25 ºС, in a dry place, protected from light. Keep out of the reach of children! Shelf life 2 years Do not use after the expiration of the shelf life Conditions for dispensing from pharmacies By prescription Republic of Kazakhstan, Almaty, st. Shevchenko 162 E. Owner of the registration certificate of Nobel Almaty Pharmaceutical Factory JSC, Republic of Kazakhstan Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan: Nobel Almaty Pharmaceutical Factory JSC, Republic of Kazakhstan, Almaty, st. Shevchenko 162 E. Phone number: (+7 Fax number: (+7 Email address

Types and forms of release

The drug is produced in tablet form. 10 mg of Coronim contains 13.87 mg of the active substance, and 5 mg of Coronim contains 6.935 mg of amlodipine.

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Auxiliary components are represented by the following substances:

dicalcium phosphate;
MCC;
magnesium stearate;
Primogel;
silica.

Tablets of 5 mg or 10 mg are in blister packs of 10 or 14 tablets, packed in a cardboard pack.

Indications for use

The medicine is indicated for the following diseases:

angina pectoris;
unstable angina (in monotherapy, as well as in combination with other antihypertensive medications);
hypertension.