Corinfar retard, 20 mg, extended-release film-coated tablets, 50 pcs.

Corinfar retard, 20 mg, extended-release film-coated tablets, 50 pcs.

During the treatment period it is necessary to refrain from taking ethanol.

It is recommended to stop treatment with the drug gradually.

It should be borne in mind that angina pectoris may occur at the beginning of treatment, especially after recent abrupt withdrawal of beta-blockers (the latter should be withdrawn gradually).

The simultaneous administration of beta-blockers must be carried out under conditions of careful medical supervision, as this may cause an excessive decrease in blood pressure, and in some cases, aggravation of symptoms of heart failure.

In case of severe heart failure, the drug is dosed with great caution.

Diagnostic criteria for prescribing the drug for vasospastic angina are: a classic clinical picture, accompanied by an increase in the ST segment, the occurrence of ergonovine-induced angina or coronary artery spasm, detection of coronary spasm during angiography or identification of an angiospastic component without confirmation (for example, with a different voltage threshold or with unstable angina, when ECG data indicate transient vasospasm).

For patients with severe obstructive cardiomyopathy, there is a risk of increased frequency, severity and duration of angina attacks after taking nifedipine; in this case, discontinuation of the drug is necessary.

In patients with irreversible renal failure who are on hemodialysis, have high blood pressure and a reduced total blood volume, the drug should be used with caution, because a sharp drop in blood pressure is possible.

Patients with impaired liver function are closely monitored; if necessary, reduce the dose of the drug and/or use other dosage forms of nifedipine.

If surgical intervention under general anesthesia is necessary, it is necessary to inform the anesthesiologist about the patient's treatment with nifedipine.

During in vitro fertilization, in some cases, BCC caused changes in the head of the sperm, which can lead to dysfunction of the sperm. In cases in which repeat in vitro fertilization has failed for an unclear reason, the use of CCBs, including nifedipine, can be considered a possible reason for failure.

During treatment, it is possible to obtain a false positive result from the direct Coombs test and laboratory tests for antinuclear antibodies.

In the spectophotometric determination of vanillylmandelic acid in urine, nifedipine may cause a falsely elevated result, however, nifedipine does not affect the results of tests performed using HPLC.

Caution should be exercised during simultaneous treatment with nifedipine, disopyramide and flecainamide due to a possible increase in inotropic effect.

Influence on the ability to drive a car and other mechanisms.

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

Corinfar Retard

Release form, composition and packaging

Extended-release film-coated tablets 1 tablet. nifedipine 20 mg. Excipients: lactose monohydrate, magnesium stearate, macrogol 6000, macrogol 35,000, talc, potato starch, methylhydroxypropylcellulose, polyvidone K25, microcrystalline cellulose, dyes (E104, E171).

Clinical and pharmacological group: Calcium channel blocker.

pharmachologic effect

Selective class II calcium channel blocker, dihydropyridine derivative. Causes antianginal and hypotensive effects. Relaxes the smooth muscles of blood vessels. Relieves spasm and dilates coronary and peripheral arteries. Reduces peripheral resistance and slightly reduces myocardial contractility, reduces afterload on the heart and myocardial oxygen demand. Improves coronary blood flow, poststenotic circulation in atherosclerotic obstructions. Does not inhibit the automatism and conductivity of the myocardium, can cause reflex tachycardia.

Pharmacokinetics

Suction

Quickly and almost completely (90-100%) absorbed from the gastrointestinal tract. Systemic bioavailability is 50-70%.

Distribution

Binds to plasma proteins (albumin) by 95%. No cumulation is observed.

Metabolism

Almost completely metabolized in the liver with the formation of inactive metabolites.

Removal

T1/2 is 2-5 hours. 60-80% of nifedipine in the form of metabolites is excreted in the urine, the rest in feces. Less than 0.1% of the active substance is found unchanged in urine.

Pharmacokinetics in special clinical situations

If liver function is impaired, T1/2 increases and total plasma clearance decreases.

Indications

• stable angina (angina pectoris);
• angiospastic angina (Prinzmetal's angina, variant angina);
• essential arterial hypertension.

Dosage regimen

Installed individually. The average dose is 20 mg 2 times/day.

If the clinical effect is insufficient, it is possible to gradually increase the dose of Corinfar retard to 40 mg 2 times a day. The maximum daily dose is 80 mg. The interval between doses should not be less than 4 hours.

When prescribing the drug 2 times a day, the recommended dosage interval is approximately 12 hours (morning and evening). The tablets are taken after meals, without chewing and with a sufficient amount of liquid.

Side effect

• From the cardiovascular system: at the beginning of treatment - flushing of the face and skin of the upper body with a feeling of heat, an increase in the frequency, duration and severity of angina pectoris; a state of stupor, tachycardia, decreased blood pressure, and swelling of the legs may occur; in isolated cases - the development of myocardial infarction.
• From the digestive system: rarely - nausea, feeling of fullness in the epigastrium, diarrhea; in isolated cases - increased levels of liver transaminases, allergic hepatitis, gum hyperplasia.
• From the urinary system: rarely (soon after taking the drug at the beginning of treatment) - increased urine output is possible; in patients with impaired renal function, a temporary deterioration in renal function may occur. Allergic reactions: skin itching, urticaria, exanthema; in isolated cases - the occurrence of exfoliative dermatitis.
• From the central nervous system and peripheral nervous system: at the beginning of treatment, often - transient headaches; sometimes - a state of numbness, dizziness, feeling of fatigue, paresthesia; in isolated cases - the occurrence of tremor, mild visual disturbances (especially when using the drug in high doses).
• From the hematopoietic system: anemia, leukopenia, thrombocytopenia (sometimes with manifestations of purpura). Other: transient increase in plasma glucose levels; in some cases - myalgia (especially when using the drug in high doses).

Isolated cases of gynecomastia have been described (in elderly patients, especially with long-term use of the drug).

Contraindications

• cardiogenic shock;
• severe stenosis of the aortic mouth;
• unstable angina;
• acute period of myocardial infarction (during the first 4 weeks);
• pregnancy;
• lactation period (breastfeeding);
• hypersensitivity to nifedipine.

Pregnancy and lactation

Corinfar retard is contraindicated for use during pregnancy. Nifedipine is excreted in breast milk. There is insufficient data on the effect of nifedipine on infants. Therefore, if it is necessary to use Corinfar retard during lactation, breastfeeding should be stopped.

Use for liver dysfunction

For patients with impaired liver function, Corinfar retard is prescribed only with careful medical supervision; if necessary, dose adjustment should be made.

Use for renal impairment

Caution should be exercised when prescribing Corinfar retard to patients with severe arterial hypertension and irreversible renal failure and hypovolemia who are on hemodialysis (due to the high risk of a sharp drop in blood pressure).

special instructions

Caution should be exercised when prescribing Corinfar retard to patients with severe arterial hypotension (systolic blood pressure less than 90 mm Hg), chronic heart failure in the decompensation phase, as well as elderly patients over the age of 60 years and patients with severe arterial hypertension and irreversible renal failure and hypovolemia, those on hemodialysis (due to the high risk of a sharp drop in blood pressure).

For patients with impaired liver function, Corinfar retard is prescribed only with careful medical supervision; if necessary, dose adjustment should be made. Corinfar retard should be discontinued gradually, since if the drug is suddenly stopped (especially after long-term treatment), withdrawal syndrome may develop, expressed in a sharp increase in blood pressure or the development of myocardial ischemia.

When drinking alcohol during therapy with Corinfar retard, the speed of psychomotor reactions may slow down, associated with a decrease in blood pressure. Use in pediatrics Clinical experience with the drug in children is insufficient.

Impact on the ability to drive vehicles and operate machinery

When taking Corinfar retard, especially at the beginning of treatment and when changing the drug, a slowdown in the speed of psychomotor reactions associated with a decrease in blood pressure is possible. This must be taken into account by persons engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: loss of consciousness up to the development of coma, drop in blood pressure, tachycardia or bradycardia, hyperglycemia, metabolic acidosis, hypoxia. Treatment: artificial vomiting, gastric lavage, symptomatic therapy aimed at maintaining the activity of the cardiovascular system.

Drug interactions

• With the simultaneous use of Corinfar retard with other antihypertensive drugs, as well as with tricyclic antidepressants, an increase in the hypotensive effect of Corinfar retard is observed.
• With the simultaneous use of Corinfar retard with nitrates, an increase in the effect of Corinfar retard on blood pressure and heart rate is observed.
• With the simultaneous use of Corinfar retard with beta-blockers, a sharper drop in blood pressure may occur, and cases of weakening of cardiac activity have also been observed.
• With the simultaneous use of Corinfar retard and cimetidine (to a lesser extent ranitidine), the effects of Corinfar retard may be enhanced.
• With the simultaneous use of Corinfar retard with quinidine, in some cases there was a decrease in the concentration of quinidine in the blood plasma, and after the withdrawal of Corinfar retard - a sharp increase in the concentration of quinidine in the plasma.
• With the simultaneous use of Corinfar retard with digoxin and theophylline, in some cases changes in the concentration of the latter in the blood plasma were observed.

Storage conditions and periods

The drug should be stored in a place protected from light. Shelf life: 3 years.

Corinfar 20 mg No. 30 tablet p.o.retard

Instructions for medical use of the drug Corinfar retard Trade name of the drug Corinfar retard International nonproprietary name Nifedipine Dosage form Film-coated tablets, 20 mg Composition One tablet contains the active substance - nifedipine 20 mg, excipients: lactose monohydrate, potato starch, microcrystalline cellulose, polyvidone K 25, magnesium stearate, methylhydroxypropylcellulose, macrogol 6000, macrogol 35000, quinoline yellow dye (E 104), titanium dioxide (E 171), talc Description Yellow, biconvex, round, film-coated tablets Pharmacotherapeutic group Blockers of “slow” calcium channels. Blockers of “slow” calcium channels are selective. Dihydropyridine derivatives. Nifedipine. ATC code C08CA05 Pharmacological properties Framacokinetics After oral administration on an empty stomach, the active substance nifedipine is quickly and almost completely absorbed from the gastrointestinal tract. Nifedipine undergoes active metabolism during the first passage through the liver, so that systemic bioavailability is 50 - 70%. Maximum concentrations in plasma or serum are reached after approximately 0.9 -3.7 hours and their value averages 28.3 ng/ml. Penetrates through the blood-brain and placental barriers and is excreted in breast milk. Approximately 95% of nifedipine administered into the body binds to blood plasma proteins (albumin). In the form of metabolites, nifedipine is excreted from the body primarily through the kidneys. In this case, the main metabolite is M-1, accounting for 60-80% of the nifedipine dose taken. The remaining amount of the drug is excreted in the form of metabolites along with feces. Only traces of the active substance in unchanged form are found in urine (less than 0.1%). The half-life is 2-5 hours. Accumulation of the drug in the body during long-term treatment with therapeutic doses has not been described. With reduced liver function, there is a clear prolongation of the half-life of the active substance and a decrease in total plasma clearance. Chronic renal failure, hemodialysis and peritoneal dialysis do not affect the pharmacokinetics. Pharmacodynamics Corinfar retard is a representative of the calcium antagonists of the group of 1,4-dihydropyridine derivatives. Calcium antagonists in a highly specific form react with voltage-gated calcium channels and block the entry of calcium ions through type L calcium channels into the cell. There is a decrease in calcium concentration inside cells and thereby inhibition of intracellular impulse transmission. Corinfar retard primarily affects the smooth muscle cells of the coronary arteries and peripheral vessels. The consequence of this is the expansion of coronary and peripheral arterial vessels. When used in therapeutic doses, Corinfar retard has virtually no direct effect on the myocardium. In the heart, Corinfar retard reduces the muscle tone of the coronary vessels, resulting in their dilation and increased coronary blood flow. Due to the expansion of arterial vessels, Corinfar retard simultaneously reduces peripheral vascular resistance. At the beginning of treatment, the heart rate and cardiac output may reflexively increase. This increase is not strong enough to compensate for the vasodilation. As a result, blood pressure decreases. With long-term treatment with Corinfar retard, the increased cardiac output returns to its original level. A particularly clear decrease in blood pressure during treatment with Corinfar retard is observed in patients with hypertension. Indications for use - stable angina (angina pectoris) - vasospastic angina (Prinzmetal's angina, variant angina) - essential arterial hypertension Method of administration and dosage Doses of the drug are selected by the doctor individually in accordance with the severity of the disease and the patient's sensitivity to the medication. 1. Stable and vasospastic angina The average daily dose is 40 mg, the frequency of administration is 1 tablet (20 mg) 2 times a day. If the clinical effect is insufficient, it is possible to gradually increase the daily dose of the drug to 80 mg, the frequency of administration is 2 tablets (20 mg) 2 times a day. The maximum daily dose should not exceed 80 mg. 2. Essential hypertension The average daily dose is 40 mg, the frequency of administration is 1 tablet (20 mg) 2 times a day. If the clinical effect is insufficient, it is possible to gradually increase the daily dose of the drug to 80 mg, the frequency of administration is 2 tablets 2 times a day. The maximum daily dose should not exceed 80 mg. Corinfar retard tablets are taken orally after meals, without chewing and with a sufficient amount of liquid. The interval between taking two single doses of Corinfar retard should not be less than 4 hours. The recommended interval for taking retard tablets is approximately 12 hours (morning and evening). Sudden interruption of treatment can lead to a sharp deterioration of the disease, therefore therapy, especially if carried out in high doses and/or over a long period, is stopped by gradually reducing the dose, after prior consultation with a doctor. For people over 60 years of age, the drug is prescribed with great caution. Side effects - headache, dizziness and fatigue - flushing of the face and skin hyperemia (erythema, erythromelalgia) - paresthesia is possible with long-term use of high doses - decrease in blood pressure below normal - temporary deterioration in renal function. In the first weeks of treatment, the daily amount of urine excreted may increase. Rarely - tachycardia, palpitations and due to vasodilation, ankle swelling - restlessness, sleep disturbances - erectile dysfunction - nausea, bloating and diarrhea, constipation, dry mouth, abdominal pain - itching, urticaria and rash, erythema - pathological hypersexuality, especially in elderly patients with long-term treatment - at the beginning of treatment, attacks of angina are possible or the frequency, duration and severity of attacks may increase in patients with existing angina Very rarely - changes in the gums (hypertrophic gingivitis) - myalgia, tremor, muscle cramps, swelling of the joints - minor temporary changes in visual perception (with a large dosage) - anemia, leukopenia, thrombocytopenia and thrombocytopenic purpura, agranulocytosis, hyperglycemia In isolated cases - intrahepatic stagnation of bile, increased transaminase activity, jaundice - esfoliative dermatitis, photodermatitis, toxic epidermal necrolysis - fainting - reversible anaphylactic reactions, angioedema (including laryngeal edema with a possible life-threatening outcome) - myocardial infarction - shortness of breath - vomiting Contraindications - cardiogenic shock - severe stenosis of the aorta - unstable angina - acute period of myocardial infarction (within the first 4 weeks) - during treatment rifampicin - hypersensitivity to nifedipine - pregnancy and lactation - liver cirrhosis - decompensated hepatic, renal and heart failure - arterial hypotension (systolic blood pressure below 90 mm Hg) - children and adolescents under 18 years of age - hereditary fructose intolerance, Lapp enzyme deficiency -lactase, glucose-galactose malabsorption Drug interactions The hypotensive effect of Corinfar may be enhanced by the simultaneous use of other antihypertensive drugs, as well as tricyclic antidepressants. With the simultaneous use of Corinfar and beta blockers, patients should be carefully monitored, because in this case, a sharp drop in blood pressure can occur, in addition, cases of weakening of cardiac activity have been observed. Certain calcium channel blocker drugs may further enhance the negative inotropic effects (lowering the force of heart contraction) of antiarrhythmics (drugs used to treat abnormal heart rhythms) such as amiodarone and quinidine. During combination therapy with quinidine, it is recommended to monitor the level of quinidine concentration in the blood, because in some cases, Corinfar retard causes a decrease in it, or after the abolition of Corinfar retard, its sharp increase occurs. Corinfar retard can cause an increase in the levels of digoxin (cardiac glycoside) and theophylline (an anti-asthma drug), so their levels in the blood plasma should be monitored. Cimetidine, and to a lesser extent, ranitidine, may enhance the effect of Corinfar retard. Special instructions Under close supervision, Corinfar should be prescribed to patients with impaired liver function. Use with caution in patients with hypertrophic obstructive cardiomyopathy, severe bradycardia or tachycardia, sick sinus syndrome, heart failure, mild or moderate arterial hypertension, severe cerebrovascular accidents, and gastrointestinal obstruction. In patients with high blood pressure or coronary heart disease, after suddenly stopping the drug, a “withdrawal phenomenon” may develop, manifested by a sharp increase in blood pressure (hypertensive crisis) or a decrease in blood supply to the heart muscle (myocardial ischemia), so the drug should be discontinued gradually. Features of the effect of the drug on the ability to drive vehicles and perform work requiring precise movements. The possibility of slowing psychomotor reactions associated with a decrease in blood pressure should be taken into account. Overdose Symptoms: loss of consciousness up to the development of coma, drop in blood pressure, tachycardia or bradycardia, hyperglycemia, metabolic acidosis, hypoxia. Treatment: drug removal, restoration of a stable state of the cardiovascular system. First of all, induce vomiting, rinse the stomach abundantly, if necessary, in combination with lavage of the small intestine. If necessary, plasmapheresis is recommended. If bradycardia develops, atropine and/or beta-sympathomimetics should be prescribed; if bradycardia threatens the patient's life, a pacemaker should be temporarily implanted. For arterial hypotension, 1-2 g of calcium gluconate is administered intravenously, dopamine is administered intravenously (up to 25 mcg/kg body weight/min.), dobutamine is administered up to 15 mcg/kg body weight/min., adrenaline or norepinephrine is administered. up to 2 ml. Release form and packaging 10 tablets are placed in a blister pack made of polyvinyl chloride and aluminum foil. 3 cell packs together with instructions for use in the state and Russian languages ​​are placed in a cardboard box. Storage conditions Store in a place protected from light, at a temperature not exceeding 30 °C. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer PLIVA Hrvatska d.o.o. Prilaz Baruna Filipovic, 25 10 000 Zagreb, Croatia Registration certificate holder Teva Pharmaceutical Industries Ltd, Israel Address of the organization that accepts claims from consumers regarding the quality of products (products) in the Republic of Kazakhstan Representative office in the Republic of Kazakhstan 050040 Republic of Kazakhstan Almaty, Al-Ave. Farabi 19, Nurly Tau Business Center 1B of. 603 Telephone, fax; 311-07-34 [email protected]