Corinfar uno - official instructions for use. Visitor survey results. Application restrictions

- 10 mg;

  • excipients: lactose monohydrate - 15.8 mg, potato starch - 15.7 mg, - 15.5 mg, Povidone K25 - 2.7 mg, magnesium stearate- 0.3 mg.
  • Shell composition: titanium dioxide - 0.77 mg, macrogol 6000 - 0.48 mg, quinoline yellow dye - 0.27 mg, talc- 0.38 mg, hypromellose - 2.88 mg, macrogol 35000- 0.22 mg.

    One tablet Corinfara Retard includes:

    • nifedipine - 20 mg;
    • excipients: lactose monohydrate - 31.6 mg, potato starch - 31.4 mg, microcrystalline cellulose - 31 mg, K25 povidone - 5.4 mg, magnesium stearate - 0.6 mg.

    Shell composition: titanium dioxide - 1.377 mg, hypromellose - 5.188 mg, quinoline yellow dye - 0.143 mg, talc - 1.038 mg, macrogol 6000 - 0.861 mg, macrogol 35000 - 0.393 mg.

    One tablet Corinfara UNO includes:

    • nifedipine - 40 mg;
    • excipients - lactose monohydrate - 30 mg, microcrystalline cellulose - 48.5 mg, cellulose - 10 mg, hypromellose 4000 cp - 20 mg, magnesium stearate - 1.5 mg, colloidal silicon dioxide - 0.75 mg.

    Shell composition: titanium dioxide - 2 mg, macrogol 6000 - 0.07 mg, hypromellose - 2 mg, iron oxide red - 0.9 mg, macrogol 400 - 1.1 mg, talc - 1 mg.

    Release form

    corinfar and Corinfar Retard are tablets of prolonged action, which are coated with a straw-colored shell, biconvex, round, with a beveled edge; on the cut - a homogeneous substance of yellow color.

    10 such tablets corinfara or Corinfara Retard in blisters, three blisters in a cardboard box. Or 50 of these tablets corinfara or Corinfara Retard in a dark glass bottle, one such bottle in a cardboard box. Corinfar is also available separately in the amount of 100 tablets in a dark glass bottle and a cardboard box.

    Corinfar UNO- prolonged-release tablets, coated dark red, biconvex, round. 10 such tablets in a blister; 5, 2 or 10 such blisters in a paper pack.

    pharmachologic effect

    The drug has hypotensive and antianginal .

    Pharmacodynamics and pharmacokinetics

    Pharmacodynamics

    This medicine is a selective blocker (inhibitor) slow» calcium channels, chemically related to derivatives dihydropyridine . It inhibits the movement of Ca2 + from the intercellular space to cardiomyocytes and cells of smooth muscles, peripheral and cardiac arteries; in high doses, it inhibits the release of Ca2+ from intracellular depots.

    In therapeutic doses, it normalizes the intercellular exchange of Ca2 +, which can be disturbed in a number of pathological conditions (and others). Does not affect the tone of the veins. Increases coronary blood flow, enhances blood supply to ischemic areas myocardium without the development of the “steal” syndrome, stimulates the work of collaterals. Expands the peripheral arteries, reduces the total peripheral vascular resistance, myocardial tone, the heart's need for oxygen. Does not affect atrioventricular and sinoatrial nodes , has a small antiarrhythmic action. Also, the drug activates the renal blood flow.

    The time for the appearance of the clinical effect is close to 20 minutes, the duration of the effect is 5-6 hours.

    Pharmacokinetics

    Up to 90% of the drug is absorbed in the intestine. Bioavailability is about 60%. Food intake increases bioavailability. 95% of the drug binds to plasma proteins. Maximum concentration nifedipine in the blood of ingestion of two tablets (20 mg of nifedipine) occurs after 2-3 hours. Completely converted in the liver.

    Excreted by the kidneys as an inert metabolite (70%), with bile (30%). The half-life is about 3-5 hours.

    Renal failure, conduction do not change the pharmacokinetics of Corinfar. In persons with liver disease, clearance decreases and the half-life is prolonged. With long-term use (more than two months), tolerance to the drug may develop.

    Indications for Corinfar's use

    Indications for use Corinfara Retard (corinfara) and indications for use Corinfara UNO are the same - the choice of the drug is carried out by the attending physician, depending on the severity of the disease and individual sensitivity.

    • Vasospastic angina (Prinzmetal's angina ).
    • Chronic tension.

    Contraindications

    • Allergy to nifedipine and any other derivative dihydropyridine or drug components.
    • Low pressure (systolic pressure less than 90 mm Hg).
    • Unstable.
    • Cardiogenic shock .
    • Chronic decompensated cardiac insufficiency , heavy aortic stenosis .
    • First four weeks.
    • First 13 weeks of pregnancy.
    • Period.
    • Reception.

    It is necessary to use the drug with caution when mitral valve stenosis , heavy tachycardia or bradycardia , malignant , syndrome sinus node weakness , hypovolemia , expressed violations cerebral circulation , with insufficiency of left ventricular function, intestinal obstruction , liver and kidney failure, (possible development of arterial hypotension), 14-40 weeks of pregnancy, age less than 18 years, joint intake, beta blockers .

    Side effects

    • From the circulatory system: tachycardia , peripheral edema, excessive vasodilation (decrease in blood pressure, aggravation of heart failure, flushing of the face, a feeling of heat), a strong decrease in pressure, fainting. In a small number of patients, seizures may occur at the beginning of therapy or after increasing the dose, and in very rare cases -.
    • From the nervous system: dizziness, headache, weakness, fatigue, drowsiness. With long-term treatment with the drug in high doses - trembling, extrapyramidal disorders (mask-like face, ataxia, change in gait), .
    • From the digestive system: dry mouth, flatulence , increased appetite. Less commonly, gingival hyperplasia disappears after treatment is stopped. With prolonged use - liver damage ( cholestasis, increased activity of liver enzymes).
    • From the musculoskeletal system: myalgia , swelling of the joints, cramps of the limbs.
    • Hypersensitivity reactions: rarely - autoimmune hepatitis , .
    • From the hematopoietic system: leukopenia , anemia , thrombocytopenia , agranulocytosis .
    • From the excretory system: increase diuresis , impaired renal function (in persons with kidney failure).
    • Other: rarely - visual impairment, temporary gynecomastia , hyperglycemia, galactorrhea, bronchospasm, increase in body weight.

    Instructions for use Corinfar

    Instructions for use Corinfara Retard and corinfara explains how to take this medicine. Tablets are used after meals orally, without chewing and drinking plenty of water. Simultaneous intake with food inhibits adsorption active substance from the intestine. Usually the drugs are taken in the morning and in the evening, but it is worth remembering that Corinfar UNO 40 mg can only be used once a day.

    The dose and frequency of taking the drug is selected by the attending physician individually, taking into account the severity of the disease and other clinical aspects.

    At vasospastic angina and voltage : 1 tablet Corinfara Retard or corinfara

    Essential hypertension : 1 tab. Corinfara Retard or corinfara(depending on severity and individual sensitivity) 2 times a day. With a mild effect, the dose of the drug is slowly increased to two tablets 2 times a day.

    With a double prescription of the drug per day, the interval between doses should be an average of 12 hours. Corinfar UNO the same time of day is taken with an interval of 24 hours, preferably before lunch, 1 tablet (40 mg) once a day.

    Overdose

    Symptoms: flushing of the face, headache, bradycardia/ , a strong long-term decrease in blood pressure, suppression sinus node . In severe cases - fainting,.

    Therapy: symptomatic. As a rule, gastric lavage is carried out, they are used. The antidote will be calcium preparations - intravenously 10% solution calcium chloride or . With a strong decrease in blood pressure, slow intravenous administration is recommended. , norepinephrine or . In the event of heart failure - administered intravenously. With development - isoprenaline , .

    Hemodialysis in case of overdose is ineffective, it is recommended plasmapheresis .

    Interaction

    The following effects from interactions with the following medicinal products should be taken into account:

    • With tricyclic antidepressants, antihypertensives, vasodilators - increased hypotensive effect;
    • With beta-blockers - pronounced decrease in blood pressure;
    • c - suppression of metabolism;
    • With quinidine - a sharp decrease in concentration quinidine in the blood, after withdrawal nifedipine - sharp rise in content quinidine in blood;
    • With carbamazepine , phenobarbital – content reduction nifedipine in blood.

    Terms of sale

    In Ukraine, the drug can only be bought with a prescription; in Russia, the drug is on the OTC list.

    Storage conditions

    Store at temperatures up to 30 degrees in the original packaging. Keep away from children.

    Best before date

    special instructions

    • It is necessary to stop therapy with the drug gradually.
    • At the beginning of treatment, it may occur, especially if there has been a sharp cancellation recently. beta blockers (they also need to be phased out).
    • With severe heart failure Corinfar should be dosed with caution.
    • In persons with severe obstructive cardiomyopathy there is a risk of increased frequency, severity and duration of seizures angina pectoris after use nifedipine ; in this case, the drug is canceled.
    • In persons with severe kidney failure , which are on hemodialysis , have high blood pressure and reduced blood volume, the drug is recommended to be used with caution, as there is a risk of a sharp drop in blood pressure.
    • If surgery is planned using general anesthesia, it is necessary to inform the anesthetist about the appointment. nifedipine .
    • The drug affects the ability to drive vehicles. You need to be careful when driving.


    Corinfar uno analogs are presented, in accordance with medical terminology, called "synonyms" - drugs that are interchangeable in terms of effects on the body, containing one or more identical active substances. When choosing synonyms, consider not only their cost, but also the country of origin and the reputation of the manufacturer.

    Description of the drug

    Corinfar UNO- Selective calcium channel blocker, a derivative of 1,4-dihydropyridine. It has antianginal and hypotensive effect. Reduces the flow of extracellular calcium into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries, in high doses inhibits the release of calcium from intracellular depots. Reduces the number of functioning calcium channels without affecting the time of their activation, inactivation and recovery. Uncouples the processes of excitation and contraction in the myocardium (mediated by tropomyosin and troponin) and in vascular smooth muscle (mediated by calmodulin). In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Does not affect the tone of the veins. Enhances coronary blood flow, improves blood supply to ischemic areas of the myocardium without the development of the "steal" phenomenon, activates the functioning of collaterals. Expanding the peripheral arteries, reduces OPSS, myocardial tone, afterload. Almost no effect on the sinoatrial and AV node, has a weak antiarrhythmic activity. Enhances renal blood flow, causes moderate natriuresis. Negative chrono-, dromo- and inotropic effects are overridden by reflex activation of the sympathoadrenal system in response to peripheral vasodilation.

    The onset of the clinical effect is 30 minutes, its duration is 12-24 hours. With prolonged use (2-3 months), tolerance to the drug's action develops.

    List of analogues

    Note! The list contains synonyms Corinfar UNO, which have a similar composition, so you can choose a replacement yourself, taking into account the form and dose of the medicine prescribed by your doctor. Give preference to manufacturers from the USA, Japan, Western Europe, as well as well-known companies from Eastern Europe: Krka, Gedeon Richter, Actavis, Egis, Lek, Geksal, Teva, Zentiva.


    Release form(by popularity)price, rub.
    40mg tab po N20 (AVD.pharma GmbH and Co.KG (Germany)94.60
    40mg tab N50 (AVD.pharma GmbH and Co.KG (Germany)327
    Vials 0.01% , 50 ml679
    20mg No. 30 tab prolong.p / pl.o (Torrent Pharmaceuticals Ltd (India)64.90
    20mg tab N100 (TORRENT (India)158.40
    Tab 10mg N50 (Polpharma Pharmaceutical plant (Poland)12
    20mg tab N30 (Egis Pharmaceutical plant JSC (Hungary)94.80
    10mg tab N100 (Egis Pharmaceutical plant JSC (Hungary)94
    20mg No. 30 tab (Egis Pharmaceutical plant JSC (Hungary)100
    20mg No. 60 tab (Egis Pharmaceutical plant JSC (Hungary)128.50
    40mg tab N30 (Egis Pharmaceutical plant JSC (Hungary)252.60
    CL 40mg tab N20 (KRKA, d.d. Novo mesto (Slovenia)171.10
    20mg tab N30 (KRKA,d.d. Novo mesto (Slovenia)86.60
    10mg №50 tab (AVD.pharma GmbH / Pliva Hrvatska (Croatia)72.70
    20mg №30 tab prolong. p / pl.o (AVD.pharma GmbH / Pliva Hrvatska (Croatia)112.80
    20mg №50 tab (AVD.pharma GmbH / Pliva Hrvatska (Croatia)157.30
    Tab p / o 10mg N50 Ozone (Ozon LLC (Russia)29.50
    10mg No. 50 tab Obolenskoe...4478 (Obolenskoe FP CJSC (Russia)38.70
    Tab 60mg N30 (Lek d.d. (Slovenia)335.90
    30mg №28 tab (Bayer Pharma AG (Germany)183.50
    Tablet with control. 30mg N28 (Bayer Healthcare AG (Germany)196.70
    60mg №28 tab (Bayer Pharma AG (Germany)311
    60mg №28 tab (Bayer Healthcare AG (Germany)325.20
    10mg No. 50 tab Health Bank (Health FK LLC (Ukraine)24.40

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    Official instructions for use

    There are contraindications! Before use, read the instructions

    Corinfar® UNO

    Corinfar UNO - Drug dossier
    Features and Benefits

    Registration certificate No. LS-001381 dated 03/10/2006
    Tradename: Corinfar® UNO
    International non-proprietary name: Corinfar UNO
    Dosage form: coated tablets, modified release, 40 mg
    Compound: one tablet contains the active substance nifedipine 40 mg and auxiliary components (core); microcrystalline cellulose, cellulose, lactose, hypromellose 4000 mPa.s, magnesium stearate, colloidal anhydride silicon oxide,
    Shell: hypromellose 15 mPa.s, macrogol 6000, macrogol 400, iron oxide red E 172, titanium dioxide E 171, talc
    Description: Round, biconvex film-coated tablets, red-brown, odorless.
    Pharmacotherapeutic group: blocker of "slow" calcium channels
    ATX code: C08CA05

    Pharmacological properties

    Pharmacodynamics
    Selective blocker of "slow" calcium channels (BCCC), a derivative of 1,4-dihydropyridine. It has antianginal and hypotensive effects. Reduces the flow of extracellular calcium into cardiomyocytes and smooth muscle cells of the coronary peripheral arteries, in high doses inhibits the release of calcium from intracellular depots. Reduces the number of functioning channels without affecting the time of their activation, inactivation and recovery.
    Dissociates the processes of excitation and contraction in the myocardium, mediated by tropomyosin and troponin, and in vascular smooth muscle, mediated by calmodulin. In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Does not affect the tone of the veins. It enhances coronary blood flow, improves blood supply to ischemic areas of the myocardium without the development of the "steal" phenomenon, activates the functioning of collaterals. Expanding the peripheral arteries, reduces the total peripheral vascular resistance, myocardial tone, afterload. Almost no effect on the sinoatrial and atrioventricular nodes, has a weak antiarrhythmic activity. Enhances renal blood flow, causes moderate natriuresis. Negative chrono-, dromo- and inotropic effects are overridden by reflex activation of the sympathoadrenal system in response to peripheral vasodilation.
    The time of onset of the clinical effect is 30 minutes, the duration of the clinical effect is 12-24 hours.
    Pharmacokinetics
    Absorption - high (more than 90%). Bioavailability - 40-60%. Eating increases bioavailability. It has the effect of "first pass" through the liver. The dosage form of the modified release tablet provides a gradual release of the active substance into the systemic circulation. The maximum concentration in blood plasma is reached after 2.3-7.7 hours and its value is 17-41.4 ng / ml.
    Penetrates through the blood-brain and placental barrier, excreted in breast milk. Communication with blood plasma proteins - 90%. Completely metabolized in the liver.
    It is excreted by the kidneys in the form of inactive metabolites (70-80% of the dose taken). 20% - with bile.
    In patients with hepatic insufficiency, the total clearance decreases and the half-life increases.
    There is no cumulative effect. With prolonged use (2-3 months), tolerance to the action of the drug develops.

    Indications for use

  • stable angina (angina pectoris),
  • vasospastic angina (Prinzmetal's angina),
  • arterial hypertension.

    Contraindications

  • hypersensitivity to nifedipine and other derivatives of 1,4-dihydropyridine;
  • cardiogenic shock;
  • acute period of myocardial infarction (during the first 4 weeks);
  • unstable angina; severe aortic stenosis;
  • severe arterial hypotension (systolic blood pressure below 90 mm Hg);
  • concomitant use of rifampicin;
  • pregnancy and lactation;
  • age up to 18 years (efficacy and safety have not been established).
    Carefully: severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, severe bradycardia or tachycardia, sick sinus syndrome, chronic heart failure, mild or moderate arterial hypotension, severe cerebrovascular accident, obstruction of the gastrointestinal tract, renal and hepatic insufficiency (especially patients on hemodialysis - high risk of excessive and unpredictable lowering of blood pressure), advanced age.

    Dosage and administration

    Inside, in the morning during meals, without chewing and drinking plenty of fluids.
    1 tablet (40 mg nifedipine) 1 time per day.

    Side effects

    From the side of the cardiovascular system:“flushing” of blood to the skin of the face, flushing of the skin of the face, a feeling of heat, tachycardia, arrhythmia, peripheral edema (ankles, feet, legs), excessive lowering of blood pressure (BP), syncope, heart failure, in some patients, especially at the beginning of treatment , the occurrence of angina attacks is possible, which requires discontinuation of the drug. Isolated cases of myocardial infarction have been described.
    From the nervous system: headache, dizziness, general weakness, fatigue, drowsiness, paresthesia. With prolonged use of the drug in high doses - extrapyramidal (parkinsonian) disorders (ataxia, "mask-like" face, shuffling gait, stiffness of the movements of the arms and legs, tremor of the hands and fingers, difficulty swallowing), depression.
    From the digestive system: dry mouth, increased appetite, dyspepsia (nausea, diarrhea or constipation), gingival hyperplasia, completely disappearing after discontinuation of the drug. With prolonged use, liver dysfunction is possible (intrahepatic cholestasis, increased activity of "liver" enzymes).
    From the musculoskeletal system: arthritis, myalgia, rarely - arthralgia, swelling of the joints.
    Allergic reactions: itching, urticaria, exanthema, exfoliative dermatitis, photodermatitis, autoimmune hepatitis, acute allergic generalized reactions, such as swelling of the mucous membranes, swelling of the larynx, spasm of the bronchial muscles of the flesh to the development of shortness of breath, threatening the life of the patient.
    From the side of the hematopoietic organs: anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
    From the urinary system: increase in daily diuresis, deterioration of kidney function (in patients with renal insufficiency).
    Others: visual impairment (i.e. transient blindness at the maximum concentration of nifedipine in plasma), gynecomastia (in elderly patients, completely disappearing after withdrawal), galactorrhea, hyperglycemia, pulmonary edema, weight gain.

    Overdose

    Symptoms: headache, flushing of the skin of the face, prolonged pronounced decrease in blood pressure, inhibition of the activity of the sinus node, bradycardia and / or tachycardia, bradyarrhythmia.
    In severe poisoning, loss of consciousness, coma.
    Treatment: lavage of the stomach and small intestine.
    Calcium preparations are an antidote, it is shown in / in the introduction of a 10% solution of calcium chloride or calcium gluconate, followed by switching to a long-term infusion.
    With a pronounced decrease in blood pressure, a slow intravenous administration of dopamine, dobutamine, epinephrine (adrenaline) or norepinephrine (norepinephrine) is indicated.
    For conduction disorders - atropine, isoprenaline or an artificial pacemaker. It is recommended to monitor the content of glucose in the blood (the release of insulin may decrease) and electrolytes (potassium, calcium).
    Hemodialysis is not effective.

    Interaction with other drugs

    The hypotensive effect of nifedipine is enhanced with simultaneous use other antihypertensives, nitrates, cimetidine (ranitidine to a lesser extent), inhalation anesthetics, diuretics.
    Certain drugs from the CBCC group can further enhance the negative inotropic effect (reducing the force of cardiac contraction) of antiarrhythmic drugs such as amiodarone and quinidine.
    Corinfar UNO causes a decrease in the concentration of quinidine in the blood plasma, after the abolition of nifedipine, a sharp increase in the concentration of quinidine may occur.
    Increases concentration digoxin and theophylline in blood plasma, in connection with which the clinical effect and the content of digoxin and theophylline in blood plasma should be monitored.
    Microsomal liver enzyme inducers(rifampicin, etc.) reduce the concentration of nifedipine.
    In conjunction with nitrates increased tachycardia.
    The hypotensive effect is reduced sympathomimetics, non-steroidal anti-inflammatory drugs, estrogens, calcium preparations.
    Corinfar UNO can displace from protein binding drugs with a high degree of binding(including indirect anticoagulants - coumarin and indandione derivatives, anticonvulsants, non-steroidal anti-inflammatory drugs, quinine, salicylates, sulfinpyrazone), as a result of which their concentration in blood plasma may increase.
    Suppresses metabolism prazosin and other alpha-blockers, resulting in an increase in the hypotensive effect.
    Corinfar UNO inhibits excretion vincristina from the body and may increase the side effects of vincristine, if necessary, reduce the dose of vincristine.
    Preparations lithium may increase toxic effects (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
    When administered concurrently cephalosporins(for example, cefixime) and nifedipine in probands increased the bioavailability of cephalosporin by 70%.
    Procaine, quinidine, and other drugs that prolong the QT interval, enhance the negative inotropic effect and increase the risk of a significant prolongation of the QT interval.
    Diltiazem inhibits the metabolism of nifedipine in the body, careful monitoring is necessary, if necessary, reduce the dose of nifedipine.
    Grapefruit juice inhibits the metabolism of nifedipine in the body, and therefore it is contraindicated to use it with nifedipine.

    special instructions

    During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, as well as from the use of ethanol.
    The regularity of treatment is important, regardless of how you feel, since the patient may not feel the symptoms of arterial hypertension.
    In patients on hemodialysis with high blood pressure and irreversible kidney failure with a reduced total amount of blood, the drug should be used carefully, a sharp drop in blood pressure may occur.
    Patients with impaired liver function are carefully monitored and, if necessary, reduce the dose of the drug or use other dosage forms of nifedipine,
    With severe heart failure, the drug is dosed with great care.
    The simultaneous appointment of beta-blockers should be carried out under conditions of careful medical supervision, since this may cause an excessive decrease in blood pressure, and in some cases, aggravation of the phenomena of heart failure.
    During treatment, positive results are possible when performing a direct Coombs test and laboratory tests for antinuclear antibodies.
    It should be borne in mind that angina pectoris may occur at the beginning of treatment, especially after the recent abrupt withdrawal of beta-blockers (the latter should be canceled gradually).
    Diagnostic criteria for prescribing the drug in vasospastic angina pectoris are: the classic clinical picture, accompanied by an increase in the ST segment, the occurrence of ergonovine-induced angina or spasm of the coronary arteries, the detection of coronary spasm during angiography or the detection of an angiospastic component without confirmation (for example, with a different threshold of tension or with unstable angina, when electrocardiogram data indicate transient angiospasm).
    It is recommended to stop treatment gradually.
    Caution should be given simultaneously with disopyramide and flecainamide due to a possible increase in the inotropic effect.
    If during therapy the patient requires surgery under general anesthesia, it is necessary to inform the anesthesiologist about the nature of the therapy being carried out.
    Caution should be exercised in elderly patients due to the greatest likelihood of age-related renal dysfunction.

    Release form

    40 mg film-coated tablets, modified release.
    10 tablets are placed in a PVC / PVDC / aluminum foil blister.
    2, 5 or 10 blisters with instructions for use in a cardboard box.

    Storage conditions

    In a place protected from light at a temperature not exceeding 30 ° C.
    Keep out of the reach of children.

    Best before date

    3 years.
    Do not use after the date indicated on the package.

    Holiday conditions

    On prescription.

    Manufacturer

    AVD.pharmaGmbH and Co. KG",
    Leipziger Strasse 7-13 Dresden, Germany
    produced by Siegfried CMS Ltd.
    Unters Brühlstraße 4, CH-4800 Zofingen, Switzerland

    The information on the page was verified by the therapist Vasilyeva E.I.


  • A drug Corinfar Uno - selective calcium antagonist with a predominant effect on the vessels.
    Nifedipine is a calcium antagonist of the 1,4-dihydropyridine type. Calcium antagonists reduce the flow of calcium ions through the "slow" channels of calcium into the cells. Nifedipine acts mainly on the smooth muscles of the coronary arteries and peripheral vessels, with virtually no effect on the myocardium when used in therapeutic doses.
    At the beginning of therapy with the use of calcium antagonists, a reflex increase in heart rate and an increase in cardiac output may be observed. However, this is not enough to compensate for vasodilation.
    In cases of long-term therapy with nifedipine, the primary increase in cardiac output returns to the previous values. A significant decrease in blood pressure during the use of nifedipine can be observed in patients with arterial hypertension.

    Pharmacokinetics

    .
    After oral administration on an empty stomach, nifedipine is rapidly and almost completely absorbed. Nifedipine has the effect of "first pass" through the liver, the systemic bioavailability of the drug when taken orally is 50-70%. The maximum concentration of nifedipine in plasma and blood serum is reached after 30-85 minutes - in the case of taking the drug in the form of prolonged-release tablets. 95-98% of nifedipine binds to plasma proteins (albumin). The mean volume of distribution of nifedipine (Vss) is 0.77-1.12 L/kg. After oral administration, nifedipine is almost completely metabolized in the liver, mainly due to oxidative processes, the metabolites are inactive.
    Nifedipine is excreted from the body mainly by the kidneys in the form of metabolites and only 5-15% - bile in the feces. Only trace amounts of unchanged substance (less than 0.1%) were detected in the urine.
    The duration of the half-life is from 1.7 to 3.4 hours.
    The accumulation of the drug in the body during long-term treatment at 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. If necessary, in such cases, the dose of the drug should be reduced.

    Indications for use

    A drug Corinfar Uno used to treat essential hypertension.

    Mode of application

    Doses of the drug Corinfar Uno and the duration of treatment is determined by the doctor individually in accordance with the severity of the disease and the patient's response to treatment.
    Depending on the patient's condition, in each individual case, the dose should be increased gradually until the optimal therapeutic effect is achieved.
    Patients with impaired liver function may require close supervision and, in severe cases, dose reduction.
    Patients who have severe disorders of cerebral circulation (severe cerebrovascular disease), the drug should be prescribed in reduced doses.
    Essential hypertension.
    The average daily dose is 1 tablet 1 time per day (40 mg 1 time per day).
    The drug is taken orally in the morning 30 minutes before breakfast, without chewing, with a sufficient amount of liquid (for example, 1 glass of water). Tablets are recommended to be taken at the same time, avoid drinking grapefruit juice with the drug.
    Simultaneous ingestion of food increases the bioavailability and maximum concentrations of the active substance in the blood plasma.
    Corinfar Uno 40 tablets must not be separated because after that the protection from light that provides the coating of the tablet will not be guaranteed.
    Children. The drug should not be used in children.

    Side effects

    From the hematopoietic and lymphatic system: changes in blood counts, anemia, leukopenia, thrombocytopenia and thrombotic microangiopathy, agranulocytosis.
    From the immune system: allergic reactions, allergic edema / angioedema (including laryngeal edema), itching, urticaria, rash, anaphylactic / anaphylactoid reactions, swelling of the face.
    On the part of the psyche: anxiety, sleep disorders, mood changes, nervousness.
    On the part of metabolism: hyperglycemia.
    From the nervous system: headache, especially at the beginning of treatment; dizziness, migraine, tremor, paresthesia, dysesthesia, hypoesthesia, drowsiness, weakness, vertigo.
    On the part of the organ of vision: a slight temporary change in visual perception, blurred vision, pain in the eyes.
    From the side of the cardiovascular system: hot flashes, palpitations, tachycardia, edema, vasodilation, loss of consciousness, hypotension, myocardial infarction, chest pain, erythromegaly, especially at the beginning of treatment; thrombocytopenic purpura. At the beginning of therapy in patients with angina pectoris, there may be an increase in the frequency, duration of attacks or an increase in the severity of symptoms.
    From the respiratory system: epistaxis; nasal congestion, pulmonary edema (in case of use in pregnant women as a tocolytic agent); convulsions of the bronchial muscles, including shortness of breath, life-threatening, which disappears after discontinuation of treatment.
    From the digestive tract: constipation, disorders of the digestive tract, such as dyspepsia, diarrhea, abdominal pain, flatulence, nausea, vomiting, dry mouth, gingival hyperplasia, gastroesophageal sphincter insufficiency, feeling of fullness in the stomach, belching, lack of appetite, pain in gastrointestinal tract, bezoar, dysphagia, intestinal ulcer, intestinal obstruction.
    From the digestive system: transient increase in transaminase activity, jaundice, intrahepatic cholestasis.
    From the skin and subcutaneous tissue: erythema, hot flashes, Mitchell's disease, especially at the beginning of treatment; hypersensitivity reactions of the skin, such as itching, rash, swelling of the skin and mucous membranes, sweating, urticaria, photodermatitis, purpura, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity reaction.

    In cases of long-term use of nifedipine, gingival hyperplasia is possible, which completely disappears after discontinuation of the drug.
    From the musculoskeletal system: myalgia, arthralgia, muscle cramps, swelling of the joints.
    From the side of the kidneys and urinary tract: a temporary decrease in kidney function in patients with renal insufficiency, polakiuria, dysuria, nocturia, increased frequency of urination, an increase in the amount of daily urine output.
    From the reproductive system and mammary glands: gynecomastia, the process is reversible, the symptoms disappear after stopping nifedipine, erectile dysfunction.
    General disorders: fatigue, malaise, fever, non-specific pain, chills.

    Contraindications

    Contraindications to the use of the drug Corinfar Uno are: hypersensitivity to the active substance or to any component of the drug; cardiogenic shock; aortic stenosis of a high degree; unstable angina; acute myocardial infarction (during the first 4 weeks); simultaneous administration of rifampicin (due to the inability to achieve effective plasma levels of nifedipine due to enzyme induction); ileostomy or colostomy.

    Pregnancy

    Application Corinfar Uno contraindicated during pregnancy up to the 20th week.
    The use of nifedipine during pregnancy after the 20th week requires a careful assessment of the risk / benefit ratio, the question of drug therapy should be considered only in the case when alternative treatment is not indicated or has proven to be ineffective. There are no data from studies on the use of the drug in pregnant women.
    With the intravenous use of calcium channel blockers, including nifedipine, to reduce labor activity and / or the simultaneous use of beta-2 agonists, acute pulmonary edema has been reported (especially in the case of multiple pregnancies).
    When using the drug simultaneously with the introduction of magnesium sulfate, careful monitoring of blood pressure is necessary due to the possibility of a significant decrease in it, which can harm the mother and fetus.
    Nifedipine passes into breast milk, therefore, if necessary, the use of nifedipine should be discontinued.

    Interaction with other drugs

    Drugs affecting the effectiveness of nifedipine.
    Corinfar Uno It is metabolized via the cytochrome P450 ZA4 system, so drugs that inhibit or induce this enzyme system may alter the first pass (after oral administration) or clearance of nifedipine.
    When using nifedipine together with the following drugs, the degree and duration of interaction should be taken into account.
    Rifampicin significantly induces the cytochrome P450 ZA4 system. With simultaneous use with rifampicin, the bioavailability of nifedipine is significantly reduced, and thus its effectiveness is weakened. Despite this, the combination of nifedipine with rifampicin is contraindicated.
    With the simultaneous use of the following weak or moderate inhibitors of the cytochrome P450 ZA4 system, it is necessary to control blood pressure and, if necessary, consider reducing the dose of nifedipine.
    Macrolide antibiotics (eg, erythromycin)
    No interaction studies have been conducted with nifedipine and macrolide antibiotics. Some macrolide antibiotics inhibit cytochrome P450 3A4-mediated metabolism of other drugs. Despite this, it is impossible to exclude the possibility of an increase in the concentration of nifedipine in the blood plasma with the simultaneous use of both drugs.
    Azithromycin, which is structurally similar to members of the macrolide antibiotic class, is not inhibited by CYP3A4.
    Anti-HIV protease inhibitors (eg, ritonavir)
    An interaction study of nifedipine and certain anti-HIV protease inhibitors has not been conducted. It is known that drugs of this class inhibit the cytochrome P450 3A4 system. In addition, drugs of this class inhibit in vitro cytochrome P450 ZA4-mediated metabolism of nifedipine. With simultaneous use with nifedipine, a significant increase in the concentration of nifedipine in the blood plasma due to a decrease in first-pass metabolism and a decrease in the rate of excretion from the body cannot be ruled out.
    Azole antifungals (ketoconazole)
    A formal clinical study investigating the potential for an interaction between nifedipine and certain azole antifungals has not yet been conducted. It is known that drugs of this class inhibit the cytochrome P450 3A4 system. When administered orally simultaneously with nifedipine, a significant increase in the systemic bioavailability of nifedipine due to a decrease in first-pass metabolism cannot be ruled out.
    An interaction study between nifedipine and fluoxetine has not been conducted. Fluoxetine is known to inhibit in vitro cytochrome P450 3A4-mediated metabolism of nifedipine. With the simultaneous use of these drugs, an increase in the concentration of nifedipine in the blood plasma cannot be excluded.
    An interaction study between nifedipine and nefazodone has not been conducted. Nefazodone is known to inhibit in vitro cytochrome P450 3A4-mediated metabolism of other drugs. With the simultaneous use of these drugs, an increase in the concentration of nifedipine in the blood plasma cannot be excluded.
    Quinupristin / dalfopristin
    The simultaneous use of quinupristin / dalfopristin and nifedipine can lead to an increase in the concentration of nifedipine in the blood plasma.
    A study of the interaction of nifedipine and valproic acid has not been conducted. Valproic acid is known to increase plasma concentrations of the structurally similar calcium channel blocker nimodipine due to enzyme inhibition, although an increase in plasma concentrations of nifedipine and an increase in efficacy cannot be ruled out.
    Due to the inhibition of cytochrome P450 ZA4, it increases the concentration of nifedipine in the blood plasma and may enhance the antihypertensive effect.
    Tricyclic antidepressants, vasodilators
    In the case of a combination of nifedipine with tricyclic antidepressants, vasodilators, it is possible to increase the hypotensive effect.
    The simultaneous use of cisapride and nifedipine can lead to an increase in the concentration of nifedipine in the blood plasma.
    Antiepileptic drugs that induce the cytochrome P450 3A4 system, such as phenytoin, carbamazepine, and phenobarbital
    Phenytoin induces the cytochrome P450 ZA4 system. With simultaneous use with phenytoin, the bioavailability of nifedipine decreases, and the effectiveness is weakened. With the simultaneous use of these drugs, it is necessary to monitor the clinical response to nifedipine therapy and, if necessary, consider increasing the dose of nifedipine. In the event of an increase in the dose of nifedipine while the use of both drugs, with the abolition of phenytoin, consideration should be given to reducing the dose of nifedipine.
    No formal clinical studies have been conducted to investigate the likelihood of a potential interaction between nifedipine and carbamazepine or phenobarbital. Both drugs are known to reduce plasma concentrations of the structurally similar calcium channel blocker nimodipine due to enzyme induction. Despite this, a decrease in the concentration of nifedipine in the blood plasma and a decrease in efficacy cannot be ruled out.
    thiazem reduces the degradation of nifedipine, which may cause a dose reduction.
    Effect of nifedipine on other drugs
    Nifedipine may increase the antihypertensive effect of antihypertensive drugs used simultaneously, such as: diuretics, β-blockers; ACE inhibitors, AT-1 receptor antagonists, other calcium antagonists; α-adrenergic receptors; PDE-5 inhibitors; α-methyldopa; magnesium sulfate.
    With the simultaneous use of nifedipine with β-blockers, careful monitoring of the patient is necessary, since isolated cases of exacerbation of heart failure are known.
    Digoxin, theophylline lead to an increase in plasma levels of digoxin and theophylline (consider symptoms of digoxin overdose, after determining the level of digoxin, a reduction in the dose of glycoside may be required).
    With the simultaneous use of nifedipine and quinidine, in some cases, a decrease in the level of quinidine was observed, and when nifedipine was canceled, a sharp increase in the concentration of quinidine in the blood plasma was observed. Despite this, with the simultaneous use or cancellation of nifedipine, it is recommended to monitor the concentration of quinidine in the blood plasma, and, if necessary, adjust the dose of quinidine. Some authors reported an increase in the concentration of nifedipine in the blood plasma with the simultaneous use of these drugs, but other authors did not note a change in the pharmacokinetics of nifedipine.
    Despite this, blood pressure should be carefully monitored when quinidine is included in the nifedipine therapy regimen. If necessary, reduce the dose of nifedipine.
    It is known that tacrolimus is metabolized through the cytochrome P450 ZA4 system. Published data indicate that in some cases the dose of tacrolimus can be reduced when co-administered with nifedipine. With simultaneous use of both drugs, plasma concentrations of tacrolimus should be monitored, and, if necessary, a reduction in the dose of tacrolimus should be considered.
    With the simultaneous administration of vincristine, there is a weakening of the output of vincristine, a decrease in the dose of cephalosporins - an increase in the level of cephalosporin in the blood plasma.

    Overdose

    Symptoms of acute drug intoxication Corinfar Uno: impaired consciousness, coma, arterial hypotension, tachycardia / bradycardia, hyperglycemia, metabolic acidosis, hypoxia, cardiogenic shock, accompanied by pulmonary edema.
    Treatment. The most important therapeutic measures are the removal of the drug from the body and the restoration of the stability of the functioning of the cardiovascular system.
    After oral administration, it is recommended to completely empty the stomach, if necessary in combination with small bowel lavage to prevent absorption of the active substance.
    When using laxatives, it should be borne in mind that calcium antagonists lead to a decrease in the tone of the intestinal muscles to intestinal atony. Since nifedipine is characterized by a high degree of binding to plasma proteins and a relatively small volume of distribution, hemodialysis is ineffective, but plasmapheresis is recommended.
    Bradycardia can be eliminated with ß-sympathomimetics. When the heart rate slows down, life threatening, the use of an artificial pacemaker is recommended.
    Arterial hypotension resulting from cardiogenic shock and vasodilation can be eliminated with calcium preparations (10-20 ml of a 10% solution of calcium chloride or gluconate is administered slowly, then repeated as often as necessary). As a result, serum calcium levels may reach the upper limit of normal or be slightly elevated. If calcium administration is not effective enough, the use of dopamine, dobutamine, epinephrine or norepinephrine is advisable. Doses of these drugs should be determined taking into account the achieved therapeutic effect. The additional introduction of fluid should be approached very carefully, since this increases the risk of overloading the heart.

    Storage conditions

    A drug Corinfar Uno does not require special storage conditions. Keep out of the reach of children.

    Release form

    Corinfar Uno - prolonged action tablets.
    Packing: 10 tablets in a blister, 2 or 5, or 10 blisters in a box.

    Compound

    1 tablet Corinfar Uno contains 40 mg of nifedipine.
    Excipients: microcrystalline cellulose, cellulose, lactose, magnesium stearate, hypromellose, colloidal silicon dioxide, macrogol, talc, red iron oxide (E172), titanium dioxide (E 171).

    Additionally

    With severe arterial hypotension (systolic pressure below 90 mm Hg. Art.), Severe heart failure, the drug should be used with caution.
    Data on the safety and efficacy of the drug based on well-controlled studies involving pregnant women are not available.
    Animal studies have shown a range of embryotoxic, placentotoxic and fetotoxic effects when administered during and after the organogenesis period.
    Based on the available clinical evidence, a specific prenatal risk has been established. Although an increase in the incidence of perinatal asphyxia, delivery by caesarean section, as well as preterm birth and intrauterine growth retardation has been reported. It is not completely clear whether these reports are due to the presence of hypertension, its therapy, or a specific effect of the drug.
    The available information is insufficient to rule out serious side effects on the fetus or newborns. Despite this, any use of the drug during pregnancy after the 20th week requires a very careful assessment of the risk-benefit ratio of treatment, and the question of drug therapy should only be considered when alternative treatment is not indicated or has proven ineffective.
    When using nifedipine concomitantly with the introduction of magnesium sulfate, careful monitoring of blood pressure is necessary due to the possibility of a significant decrease in blood pressure, which can harm the mother and fetus.
    As with other materials that do not deform, care must be taken when using the drug in patients with existing severe narrowing of the gastrointestinal tract due to the possibility of obstructive symptoms. Very rarely, bezoars may occur, which may require surgery.
    In isolated cases, obstructive symptoms are described in the absence of a history of disorders of the gastrointestinal tract.
    The drug should not be used in patients with ileostomy (after proctocolectomy).
    The use of the drug can lead to false-positive results in an x-ray examination using a barium contrast agent (for example, filling defects are interpreted as a polyp).
    Patients with impaired liver function need careful monitoring and, in severe cases, dose reduction.
    Nifedipine is metabolized via the cytochrome P450 3A4 system, so drugs that inhibit or induce this enzyme system may alter the first pass or clearance of nifedipine.
    Drugs that are mild or moderate inhibitors of the cytochrome P450 3A4 system and can lead to an increase in plasma concentrations of nifedipine include, for example: macrolide antibiotics (eg, erythromycin), anti-HIV protease inhibitors (eg, ritonavir), azole antimycotics ( e.g. ketoconazole), antidepressants nefazodone and fluoxetine, quinupristin/dalfopristin, valproic acid, cimetidine.
    With simultaneous use with these drugs, it is necessary to control blood pressure and, if necessary, consider reducing the dose of nifedipine.
    Separate in vitro experiments have revealed a relationship between the use of calcium antagonists, in particular nifedipine, and reversible biochemical changes in spermatozoa that impair the ability of the latter to fertilize. If in vitro fertilization attempts are unsuccessful, in the absence of other explanations, calcium antagonists, such as nifedipine, may be considered as a possible cause of this phenomenon.
    The drug should not be used if there is an association between previous use of nifedipine and ischemic pain. In patients with angina pectoris, attacks may occur more frequently, and their duration and intensity may increase, especially at the beginning of treatment.
    Medicines with the active substance nifedipine should not be used in patients with an acute attack of stable angina pectoris.
    It should be used with caution in patients on hemodialysis with malignant arterial hypertension or hypovolemia, since dilation of blood vessels can cause a significant decrease in blood pressure.
    The use of nifedipine in diabetic patients may require treatment adjustments.
    Patients suffering from rare hereditary diseases such as galactose intolerance, the Lapp lactase deficiency or malabsorption of glucose-galactose should not be prescribed Corinfar ® Uno 40.

    main parameters

    Name: CORINTHAR UNO
    ATX code: C08CA05 -

    Corinfar is a calcium channel blocker drug that has a pronounced antianginal and hypotensive effect. The composition of the drug Corinfar includes the active substance nifedipine, a synthetic derivative of dihydropyridine. Nifedipine is a representative of the first generation of selective calcium channel blockers, derivatives of dihydropyridine. The mechanism of action of the drug is associated with its ability to slow down the penetration of calcium ions into the cells of the smooth muscle layer of blood vessels and the heart through slow L-type calcium channels. Due to a decrease in the concentration of calcium ions in the cells of the myocardium and the smooth muscle layer of the vessels, there is a decrease in the contractile activity of the cells of the vascular wall, the expansion of peripheral and coronary vessels. The drug does not affect the walls of the vessels of the venous bed, does not change the preload, does not cause the development of orthostatic hypotension. In various diseases that are accompanied by a violation of the transmembrane current of calcium ions, including arterial hypertension, Corinfar helps to normalize the passage of calcium ions through slow calcium channels.

    Indications and dosage:

      Essential hypertension

      IHD (stable exertional angina, vasospastic angina)

    Doses of the drug are selected by the doctor individually, taking into account the severity of the disease and the patient's sensitivity to the drug. Depending on the clinical picture, the dose is gradually increased. The condition of patients with impaired liver function is carefully monitored, if necessary, the dose of the drug is reduced. With concomitant severe violation of cerebral circulation (severe cerebrovascular disease), the drug is prescribed in reduced doses. Essential hypertension The drug is prescribed in an average daily dose of 1 tablet 1 time per day (40 mg 1 time per day). Stable exertional angina and vasospastic angina. The drug is prescribed in an average daily dose of 1 tablet per day (40 mg 1 time per day). The drug is taken orally in the morning during meals, without chewing and drinking a sufficient amount of liquid (a glass of water). Simultaneous ingestion of food increases the bioavailability and maximum concentrations of the active substance in the blood plasma. The duration of treatment is determined by the doctor.

    Overdose:

    Symptoms of acute intoxication with nifedipine:

      Impairment of consciousness, up to the development of coma

      Arterial hypotension

      Tachycardia/bradycardia

      hyperglycemia

      metabolic acidosis

      hypoxia

      Cardiogenic shock with pulmonary edema.

    Treatment. The most important therapeutic measures are the removal of the drug from the body and the restoration of the stability of the functioning of the cardiovascular system. After oral administration, it is recommended to completely empty the stomach, if necessary, in combination with small bowel lavage. In case of intoxication caused by drugs with a prolonged release of the active substance, it is necessary to remove the drug from the body as completely as possible, including from the small intestine, to prevent absorption of the active substance. When using laxatives, it should be borne in mind that calcium antagonists lead to a decrease in the tone of the intestinal muscles up to intestinal atony. Since nifedipine is characterized by a high degree of binding to blood plasma proteins and a relatively small volume of distribution, hemodialysis is ineffective, but plasmapheresis is recommended. Bradycardia can be treated with β-adrenergic blockers. With life-threatening bradycardia, the use of an artificial pacemaker is recommended. Arterial hypotension resulting from cardiogenic shock and vasodilation can be stopped with calcium preparations (10-20 ml of 10% calcium chloride or calcium gluconate solution is injected slowly in / in, then repeated if necessary). As a result, serum calcium levels may reach the upper limit of normal or be elevated. If calcium administration is not effective enough, the use of dopamine, dobutamine, epinephrine or norepinephrine is advisable. The doses of these drugs are determined taking into account the achieved therapeutic effect. The additional administration of fluid should be approached very carefully, since this increases the risk of overloading the heart.

    Side effects:

    The drug is usually well tolerated by patients, however, in some patients, especially at the beginning of therapy with Corinfar, the following side effects may develop:

      From the gastrointestinal tract and liver: nausea, vomiting, discomfort in the stomach, impaired stool, reversible gingival hyperplasia. With prolonged use of the drug in isolated cases, the development of undesirable effects on the part of the liver was noted, including a violation of the outflow of bile, hepatitis, an increase in the activity of liver enzymes, a transient increase in the level of serum transaminases.

      From the side of the cardiovascular system: blood flow to the head and upper body, which is accompanied by hyperemia of these areas and a feeling of heat, reflex tachycardia, a sharp decrease in blood pressure, increased angina attacks, swelling of the extremities. In isolated cases, patients developed myocardial infarction.

      On the part of the hematopoietic system: anemia, thrombocytopenic purpura, thrombocytopenia, leukopenia.

      From the side of the central and peripheral nervous system: headache, dizziness, paresthesia, irritability, drowsiness, disturbed sleep and wakefulness, fatigue, tremor.

      Allergic reactions: skin rash, itching, urticaria, exfoliative dermatitis.

      Others: there have been isolated cases of hyperglycemia in patients with diabetes mellitus. In elderly men who took the drug Corinfar, in isolated cases, the development of gynecomastia was noted, which disappeared after discontinuation of the drug. In addition, the use of the drug may develop visual impairment and myalgia.

    With a sharp withdrawal of the drug, the development of arterial hypertension and myocardial ischemia is possible, therefore it is recommended to stop taking the drug by gradually reducing the dose.

    Contraindications:

      Hypersensitivity to nifedipine or other components of the drug,

      Acute period of myocardial infarction (in the first 4 weeks)

      Unstable angina

      Severe aortic stenosis

      Concomitant use of rifampicin

      During pregnancy and breastfeeding

    Interaction with other drugs and alcohol:

    Antihypertensive drugs, as well as tricyclic antidepressants, nitrates, ranitidine and cimetidine, when used simultaneously, enhance the effects of Corinfar.

    With the simultaneous use of nifedipine and beta-blockers, the risk of arterial hypotension and the development of symptoms of circulatory failure increases.

    With simultaneous use, the drug reduces the concentration of quinidine in the blood.

    With the simultaneous use of nifedipine increases the plasma concentrations of theophylline and digoxin.

    Composition and properties:

    1 film-coated tablet Corinfar contains: Nifedipine - 10 mg; Excipients.

    1 film-coated tablet Corinfar Retard contains: Nifedipine - 20 mg; Excipients.

    1 film-coated tablet Corinfar UNO with modified release contains: Nifedipine - 40 mg; Excipients.

    Release form:

      Corinfar tablets, film-coated, 10 pieces in a blister, 3 blisters in a carton.

      Corinfar tablets, film-coated, 50 or 100 pieces in a dark glass bottle, 1 bottle in a carton.

    Selective calcium channel blocker, a derivative of 1,4-dihydropyridine. It has antianginal and hypotensive effect. Reduces the flow of extracellular calcium into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries, in high doses inhibits the release of calcium from intracellular depots. Reduces the number of functioning calcium channels without affecting the time of their activation, inactivation and recovery. Uncouples the processes of excitation and contraction in the myocardium (mediated by tropomyosin and troponin) and in vascular smooth muscle (mediated by calmodulin). In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Does not affect the tone of the veins. Enhances coronary blood flow, improves blood supply to ischemic areas of the myocardium without the development of the "steal" phenomenon, activates the functioning of collaterals. Expanding the peripheral arteries, reduces OPSS, myocardial tone, afterload. Almost no effect on the sinoatrial and AV node, has a weak antiarrhythmic activity. Enhances renal blood flow, causes moderate natriuresis. Negative chrono-, dromo- and inotropic effects are overridden by reflex activation of the sympathoadrenal system in response to peripheral vasodilation.

    The onset of the clinical effect is 30 minutes, its duration is 12-24 hours. With prolonged use (2-3 months), tolerance to the drug's action develops.

    Pharmacokinetics

    Suction

    After taking the drug inside, nifedipine is highly absorbed from the gastrointestinal tract (more than 90%). Bioavailability is 40-60% and increases when taken simultaneously with meals. The dosage form of the modified release tablet provides a gradual release of the active substance into the systemic circulation. Cmax in blood plasma is reached after 2.3-7.7 hours and is 17-41.4 ng / ml.

    Distribution

    Penetrates through the BBB and the placental barrier, excreted in breast milk. Binding to plasma proteins - 90%. There is no cumulative effect.

    Metabolism and excretion

    Subject to the effect of "first pass" through the liver. Completely metabolized in the liver. It is excreted by the kidneys in the form of inactive metabolites (70-80% of the dose taken). 20% - with bile.

    Pharmacokinetics in special clinical situations

    In patients with hepatic insufficiency, the total clearance decreases and the half-life increases.

    Indications

    - stable angina pectoris (angina pectoris);

    - variant angina (Prinzmetal's angina);

    - arterial hypertension.

    Instructions for use / dosage

    Tablets are taken in the morning with meals as a whole, without chewing and drinking plenty of liquid.

    Cancellation of the drug should be carried out gradually.

    Side effect

    From the side of the cardiovascular system: hot flashes, flushing of the skin of the face, a feeling of heat, tachycardia, arrhythmia, peripheral edema (ankles, feet, legs), excessive decrease in blood pressure, syncope, heart failure; in some patients, especially at the beginning of treatment, angina attacks may occur, which requires discontinuation of the drug. Isolated cases of myocardial infarction have been described.

    From the side of the central nervous system and peripheral nervous system: headache, dizziness, general weakness, fatigue, drowsiness, paresthesia. With prolonged use in high doses - extrapyramidal (parkinsonian) disorders (ataxia, mask-like face, shuffling gait, stiffness of the movements of the arms and legs, tremor of the hands and fingers, difficulty swallowing), depression.

    From the digestive system: dry mouth, increased appetite, dyspepsia (nausea, diarrhea or constipation), gingival hyperplasia (completely disappearing after discontinuation of the drug). With prolonged use, liver dysfunction is possible (intrahepatic cholestasis, increased activity of liver enzymes).

    From the musculoskeletal system: arthritis, myalgia; rarely - arthralgia, swelling of the joints.

    From the hematopoietic system: anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

    From the urinary system: increase in daily diuresis, deterioration of kidney function (in patients with renal insufficiency).

    Allergic reactions: itching, urticaria, exanthema, exfoliative dermatitis, photodermatitis, autoimmune hepatitis, acute allergic generalized reactions - swelling of the mucous membranes, swelling of the larynx, bronchospasm (up to the development of shortness of breath, threatening the life of the patient).

    Others: visual impairment (including transient blindness when the maximum concentration of nifedipine in plasma is reached), gynecomastia (in elderly patients, completely disappearing after discontinuation of the drug), galactorrhea, hyperglycemia, pulmonary edema, weight gain.

    Contraindications

    - cardiogenic shock;

    - acute period of myocardial infarction (during the first 4 weeks);

    - unstable angina;

    - severe aortic stenosis;

    - severe arterial hypotension (systolic blood pressure below 90 mm Hg);

    - concomitant use of rifampicin;

    - pregnancy;

    - lactation (breastfeeding);

    - age up to 18 years (efficacy and safety have not been established);

    - hypersensitivity to nifedipine and other derivatives of 1,4-dihydropyridine.

    FROM caution use the drug for severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, severe bradycardia or tachycardia, SSSU, chronic heart failure, mild or moderate arterial hypotension, severe cerebrovascular accident, gastrointestinal obstruction, renal and hepatic insufficiency (especially in patients who are on hemodialysis, due to the high risk of excessive and unpredictable reduction in blood pressure), in the elderly.

    Use during pregnancy and lactation

    The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

    Application for violations of liver function

    FROM caution use the drug for liver failure.

    Application for violations of kidney function

    FROM caution use the drug for renal failure (especially in patients on hemodialysis, due to the high risk of excessive and unpredictable decrease in blood pressure).

    special instructions

    The patient should be warned about the need to take the drug regularly, regardless of well-being.

    In patients on hemodialysis, with high blood pressure and irreversible renal dysfunction and with a reduced total amount of blood, the drug should be used with caution, because. a sharp drop in blood pressure is possible.

    In case of impaired liver function, patients require careful monitoring and, if necessary, a reduction in the dose of the drug or the use of other dosage forms of nifedipine.

    With severe heart failure, dose selection of nifedipine should be carried out carefully.

    The simultaneous appointment of beta-blockers should be carried out under conditions of careful medical supervision, since this may cause an excessive decrease in blood pressure, and in some cases, aggravation of the phenomena of heart failure.

    During treatment, positive results are possible when performing a direct Coombs test and laboratory tests for antinuclear antibodies.

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

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

    Caution should be given simultaneously with disopyramide and flecainamide due to a possible increase in the inotropic effect.

    If the patient requires surgery under general anesthesia, it is necessary to inform the anesthesiologist about the nature of the therapy being carried out.

    Caution should be exercised in elderly patients due to the high likelihood of age-related renal dysfunction.

    Against the background of ongoing therapy, you should not drink alcohol.

    Influence on the ability to drive vehicles and control mechanisms

    During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

    Overdose

    Symptoms: headache, flushing of the skin of the face, prolonged pronounced decrease in blood pressure, inhibition of the activity of the sinus node, bradycardia and / or tachycardia, bradyarrhythmia; in severe overdose - loss of consciousness, coma.

    Treatment: washing the stomach and small intestine. Calcium preparations are an antidote, it is shown in / in the introduction of a 10% solution of calcium chloride or calcium gluconate, followed by a long-term infusion. With a pronounced decrease in blood pressure - slow intravenous administration of dopamine, dobutamine, epinephrine (adrenaline) or norepinephrine (norepinephrine). For conduction disorders - atropine, isoprenaline or an artificial pacemaker. It is recommended to control the content of glucose in the blood (the release of insulin may decrease) and electrolytes (potassium, calcium). Hemodialysis is not effective.

    drug interaction

    The hypotensive effect of nifedipine is enhanced by simultaneous use with other antihypertensive drugs, nitrates, cimetidine (to a lesser extent - with ranitidine), inhalation anesthesia, diuretics.

    It should be borne in mind that calcium channel blockers can enhance the negative inotropic effect of amiodarone and quinidine.

    When used together, nifedipine causes a decrease in the concentration of quinidine in the blood plasma, after the abolition of nifedipine, a sharp increase in the concentration of quinidine may occur.

    With simultaneous use, nifedipine increases the concentration of digoxin and theophylline in blood plasma (the use of this combination requires monitoring of clinical efficacy and the content of digoxin and theophylline in blood plasma).

    Inducers of microsomal liver enzymes (including rifampicin) reduce the concentration of nifedipine.

    With the combined use of nifedipine with nitrates, tachycardia increases.

    The hypotensive effect of nifedipine is reduced when used simultaneously with sympathomimetics, NSAIDs, estrogens, calcium preparations.

    Nifedipine can displace drugs with a high degree of binding from protein binding (including indirect anticoagulants - coumarin and indandione derivatives, anticonvulsants, NSAIDs, quinine, salicylates, sulfinpyrazone), as a result of which their concentration in blood plasma may increase.

    When used together, nifedipine inhibits the metabolism of prazosin and other alpha-blockers, as a result of which an increase in the hypotensive effect is possible.

    Nifedipine inhibits the excretion of vincristine from the body and may increase the side effects of vincristine (if necessary, reduce the dose of vincristine).

    When used together, lithium preparations can increase toxic effects (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

    With the simultaneous appointment of cephalosporins (for example, cefixime) and nifedipine, the bioavailability of cephalosporin increases by 70%.

    Procaine, quinidine and other drugs that cause QT prolongation increase the negative inotropic effect and increase the risk of significant prolongation of the QT interval.

    Diltiazem inhibits the metabolism of nifedipine in the body (the use of this combination requires careful monitoring and, if necessary, a dose reduction of nifedipine).

    Grapefruit juice inhibits the metabolism of nifedipine in the body, and therefore it is contraindicated to use it with nifedipine.

    Terms of dispensing from pharmacies

    The drug is dispensed by prescription.

    Terms and conditions of storage

    The drug should be stored in a place protected from light, out of the reach of children, at a temperature not exceeding 30°C. Shelf life - 3 years.

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