Corinfar uno - official instructions for use. Interaction with other drugs. Legal entity in whose name the RC is issued

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.

Description of the drug

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 the 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.

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Official instructions for use

Corinfar® UNO

Pharmacological properties

Indications for use

Corinfar UNO Corinfar UNO

Active substance

›› Nifedipine* (Nifedipine*)

Latin name

Pharmacological group: Calcium channel blockers

Nosological classification (ICD-10)

Composition and form of release

in a blister 10 pcs.; in a pack of cardboard 2, 5 or 10 blisters.

Description of the dosage form

Round, biconvex film-coated tablets, red-brown, odorless.

Characteristic

Selective calcium channel blocker, a derivative of 1,4-dihydropyridine.

pharmachologic effect

pharmachologic effect- antianginal, hypotensive.

Pharmacokinetics

Absorption is high (more than 90%). Bioavailability - 40-60%. Eating increases bioavailability. It has the effect of "first pass" through the liver. The dosage form - tablets with a modified release - provides a gradual release of the active substance into the systemic circulation. C max in blood plasma is reached after 2.3-7.7 hours and its value is 17-41.4 ng / ml.
Penetrates through the BBB and the placental barrier, excreted in breast milk. Plasma protein binding - 90%. Completely metabolized in the liver.
Excreted by the kidneys in the form of inactive metabolites (70-80% of the dose), 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.

Pharmacodynamics

Reduces the flow of extracellular calcium into cardiomyocytes and peripheral smooth muscle cells, incl. coronary 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 OPSS, myocardial tone, afterload. Almost no effect on the sinoatrial and AV 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.

Indications

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 (within 4 weeks);
unstable angina;
severe aortic stenosis;
severe arterial hypotension (SBP below 90 mm Hg);
concomitant use of rifampicin;
pregnancy;
lactation period;
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 disorders of cerebral circulation;
obstruction of the gastrointestinal tract;
renal and hepatic insufficiency (high risk of excessive and unpredictable decrease in blood pressure, especially for patients on hemodialysis);
elderly age.

Use during pregnancy and lactation

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects

From the side of the cardiovascular system: flushes of blood to the face; flushing of the skin of the face; 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 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 - possible violations of the liver (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 (for example, swelling of the mucous membranes, larynx, spasm of the bronchial muscles up 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 (including transient blindness - at the maximum concentration of nifedipine in plasma), gynecomastia (in elderly patients, completely disappearing after discontinuation of the drug), galactorrhea, hyperglycemia, pulmonary edema, weight gain.

Interaction

The hypotensive effect of nifedipine is enhanced with the simultaneous use of other antihypertensive drugs, nitrates, cimetidine (to a lesser extent - ranitidine), inhalation anesthetics, diuretics.
Certain drugs from the CCB group can further enhance the negative inotropic effect (lowering the force of heart contractions) of antiarrhythmic drugs such as amiodarone and quinidine.
Nifedipine causes a decrease in the concentration of quinidine in the blood plasma, after the abolition of nifedipine, the concentration of quinidine may sharply increase.
It increases the concentration of digoxin and theophylline in blood plasma, and therefore the clinical effect and the content of digoxin and theophylline in blood plasma should be monitored.
Inducers of microsomal liver enzymes (rifampicin, etc.) reduce the concentration of nifedipine.
In combination with nitrates, tachycardia increases.
The hypotensive effect is reduced by 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, quinine, NSAIDs, including salicylates, sulfinpyrazone), as a result of which their concentration may increase in blood plasma.
Suppresses 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).
Lithium preparations can enhance toxic effects (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
With the simultaneous appointment of cephalosporins (for example, cefixime) and nifedipine in probands, the bioavailability of cephalosporin increased 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 (when used together, careful monitoring is necessary), if necessary, reduce the dose of nifedipine.
Grapefruit juice inhibits the metabolism of nifedipine in the body, and therefore its use with nifedipine is contraindicated.

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, the introduction of a 10% solution of calcium chloride or calcium gluconate (antidote), followed by switching to 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, the appointment of atropine, isoprenaline, or the use of 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 ineffective.

Dosage and administration

inside, after eating, without chewing and drinking plenty of fluids. The dosage is selected individually, usually for adults - 1 table. (40 mg) 1 time per day.

Precautionary measures

Caution should be exercised when using the drug in patients on hemodialysis with high blood pressure and irreversible renal failure with reduced BCC, because. a sharp drop in blood pressure is possible.
Patients with impaired liver function should be closely monitored and, if necessary, reduce the dose of the drug or use other dosage forms of nifedipine.
With severe heart failure, the drug should be 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.
When prescribing simultaneously with disopyramide and flecainamide, care should be taken (possibly increased negative inotropic effect).
Caution should be exercised in elderly patients due to the greatest likelihood of age-related renal dysfunction.

special instructions

The regularity of treatment is important, regardless of how you feel, because. the patient may not feel the symptoms of arterial hypertension.
During treatment, positive results are possible when performing a direct Coombs test and laboratory tests for antinuclear bodies.
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 for vasospastic angina 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).
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.

- 10 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 increases. 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.

Catad_pgroup Calcium channel blockers

Corinfar Uno - official instructions for use

Currently, the drug is not listed in the State Register of Medicines or the specified registration number has been excluded from the register.

Registration number:

LS-001381-190911

Tradename:

Corinfar ® UNO

International non-proprietary name:

nifedipine

Dosage form:

Compound

1 tablet contains: active substance nifedipine 40.00 mg; Excipients: microcrystalline cellulose 48.50 mg, cellulose 10.00 mg, lactose monohydrate 30.00 mg, hypromellose-4000cP 20.00 mg, magnesium stearate 1.50 mg, colloidal silicon dioxide 0.75 mg; shell: hypromellose-15cP 2.00 mg, macrogol-6000 0.07 mg, macrogol-400 1.10 mg, iron dye red oxide (E 172) 0.90 mg, titanium dioxide (E 171) 2.00 mg, talc 1 .00 mg.

Description: round, biconvex, red-brown film-coated tablets.

Pharmacotherapeutic group:

ATX code: C08CA05

Pharmacological properties

Indications for use

Contraindications

Use during pregnancy and lactation

Dosage and administration

Inside, 30 minutes before a meal, without breaking or chewing, drinking plenty of water at the same time of day (i.e. with a 24-hour interval), preferably in the morning (morning).
1 tablet (40 mg) 1 time per day.

Side effect

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%; often - at least 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including individual messages.
From the blood and lymphatic system: rarely - anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura; very rarely - agranulocytosis.
From the side of the cardiovascular system: often - peripheral edema (feet, ankles, legs), symptoms of vasodilation (reddening of the skin of the face, a feeling of heat); infrequently - tachycardia, palpitations, fainting, marked decrease in blood pressure; in some cases - pain behind the sternum (stenocardia) up to the development of myocardial infarction, the development or aggravation of the course of chronic heart failure, arrhythmias.
From the nervous system: very often - headache, especially at the beginning of treatment; often - dizziness, general weakness, drowsiness, insomnia; infrequently - paresthesia, tremor, hypesthesia, dysesthesia, irritability, migraine, vertigo; rarely - anorexia, emotional lability, depression.
From the side of the organ of vision: infrequently - blurred vision, pain in the eyes.
From the digestive system: often - nausea; infrequently - dyspepsia, diarrhea, abdominal pain, constipation, flatulence, vomiting, dryness of the oral mucosa, cholestasis; rarely - jaundice, flatulence, belching, gingival hyperplasia, disappearing after discontinuation of the drug; very rarely - the formation of bezoars, dysphagia, intestinal ulcers, insufficiency of the gastroesophageal sphincter; in some cases - intestinal obstruction.
From the organs of the respiratory system, organs of the chest and mediastinum: infrequently - shortness of breath, nosebleeds; rarely - swelling of the larynx, bronchospasm, nasal congestion.
From the musculoskeletal system and connective tissue: infrequently - arthralgia, myalgia, muscle spasm, muscle cramps.
From the skin and subcutaneous tissues: often - erythema, especially at the beginning of treatment; infrequently - itching, rash, exanthema, angioedema, increased sweating; rarely - urticaria, photosensitivity, purpura; very rarely - exfoliative dermatitis, toxic epidermal necrolysis.
From the side of the kidneys and urinary tract: infrequently - transient renal failure in patients with initially reduced kidney function, sudden urge to urinate, nocturia, polyuria.
From the genital organs and mammary glands: rarely - gynecomastia, disappearing after discontinuation of the drug, impotence.
Laboratory data: infrequently - an increase in the activity of "liver" transaminases in the blood serum; rarely - hyperglycemia
Other: infrequently - nonspecific pain; rarely - fever, chills.

Overdose

Interaction with other drugs

Drugs affecting the metabolism of nifedipine. Nifedipine is metabolized by the CYP3A4 isoenzyme of the cytochrome P450 system, localized in the liver and intestinal mucosa. Therefore, drugs that inhibit or induce this enzyme system may affect the first pass effect through the liver of nifedipine (when taken orally) and clearance. Nifedipine is a high clearance drug. Since hepatic clearance is determined mainly by the volume of hepatic blood flow, the following possible interactions, which may affect the pharmacokinetic parameters of nifedipine when used simultaneously, cannot be compared with interactions when using nifedipine in the form of a solution for infusion.
Rifampicin- a powerful inducer of the CYP3A4 isoenzyme. With simultaneous use with rifampicin, the bioavailability of nifedipine is significantly reduced and, accordingly, its effectiveness is reduced. The use of nifedipine concomitantly with rifampicin is contraindicated (see section "Contraindications").
Simultaneous administration of nifedipine with weak and moderate inhibitors of the CYP3A4 isoenzyme requires regular monitoring of blood pressure and, if necessary, a dose reduction of nifedipine.
macrolide antibiotics (eg, erythromycin) were not carried out. It is known that some macrolides are inhibitors of the CYP3A4 isoenzyme. As a result, it is impossible to exclude the possibility of an increase in the concentration of nifedipine in the blood plasma when these drugs are used together.
Azithromycin, belonging to the macrolide group, is not an inhibitor of the CYP3A4 isoenzyme.
Clinical interaction studies of nifedipine with HIV protease inhibitors (eg, ritonavir) were not carried out. It is known that drugs of this group are inhibitors of the CYP3A4 isoenzyme. These drugs inhibit the CYP3A4-mediated metabolism of nifedipine. in vitro. In the case of joint use with nifedipine, a significant increase in the concentration of nifedipine in the blood plasma is possible due to slow metabolism during the "primary passage" through the liver and delayed excretion.
Clinical studies of the interaction of nifedipine with azole antifungals (eg ketoconazole) were not carried out. It is known that drugs of this group are inhibitors of the CYP3A4 isoenzyme. In the case of simultaneous use with nifedipine, a noticeable increase in the concentration of nifedipine in the blood plasma due to slow metabolism during the "primary passage" through the liver cannot be ruled out.
Clinical studies of the interaction of nifedipine with fluoxetine were not carried out. Fluoxetine is known to be an inhibitor of CYP3A4 isoenzyme Fluoxetine inhibits nifedipine metabolism due to CYP3A4 in vitro. In the case of simultaneous use with nifedipine, a significant increase in the concentration of nifedipine in the blood plasma is possible.
Clinical studies of the interaction of nifedipine with nephazodon were not carried out. It is known that nefazodone is an inhibitor of the CYP3A4 isoenzyme. In the case of simultaneous use with nifedipine, a significant increase in the concentration of nifedipine in the blood plasma is possible.
quinupristin or dalfopristin their simultaneous use with nifedipine can lead to an increase in the concentration of nifedipine in the blood plasma.
Clinical studies of the interaction of nifedipine with valproic acid were not carried out. Since it has been shown that valproic acid increases the plasma concentration of nimodipine, a blocker of "slow" calcium channels structurally similar to nifedipine, by inhibiting microsomal liver enzymes, the possibility of an increase in the concentration of nifedipine in blood plasma cannot be ruled out.
Due to inhibition of the CYP3A4 isoenzyme cimetidine simultaneous use with nifedipine can lead to an increase in the concentration of nifedipine in the blood plasma.
Grapefruit juice inhibits the CYP3A4 isoenzyme and increases the concentration of nifedipine in plasma.
Other research. The simultaneous use of cisapride and nifedipine can lead to an increased concentration of nifedipine in the blood plasma, which requires regular monitoring of blood pressure and, if necessary, reducing the dose of nifedipine.
Antiepileptic drugs - inducers of the CYP3A4 isoenzyme (phenytoin, carbamazepine, phenobarbital)
Phenytoin induces the CYP3A4 isoenzyme and reduces the bioavailability of nifedipine and, as a result, reduces its effectiveness, which requires clinical observation and, if necessary, an increase in its dose. If the dose of nifedipine was increased during co-administration, after discontinuation of phenytoin, the dose of nifedipine should be reduced to the initial dose.
Clinical studies of the interaction of nifedipine with carbamazepime and phenobarbital were not carried out. Since both drugs have been shown to reduce the plasma concentration of nimodipine, a blocker of “slow” calcium channels structurally similar to nifedipine, due to the induction of microsomal liver enzymes, it is impossible to exclude the possibility of a decrease in the concentration of nifedipine in blood plasma and, consequently, a decrease in its effectiveness.
Effect of nifedipine on other medicinal products. Nifedipine may enhance the antihypertensive effect when used concomitantly with other antihypertensive drugs, such as: diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, other slow calcium channel blockers, alpha-blockers, phosphodiesterase 5 (PDE5) inhibitors, methyldopa.
magnesium sulfate (intravenous administration) may develop neuromuscular blockade (impulsive movements, difficulty swallowing, paradoxical breathing and muscle weakness) and a pronounced decrease in blood pressure.
With the simultaneous use of nifedipine with beta-blockers monitoring of patients is necessary, since in some cases it is possible to aggravate the course of chronic heart failure.
Nifedipine reduces clearance digoxin, which leads to an increase in the concentration of digoxin in the blood plasma. Therefore, patients should be closely monitored clinically and ECG for early detection of digoxin overdose; if necessary, the dose of digoxin should be reduced taking into account its concentration in blood plasma.
In some cases, the simultaneous use of nifedipine and quinidine there was a decrease in the concentration of quinidine in the blood plasma, as well as a marked increase in the concentration of quinidine in the blood plasma after the abolition of quinidine. Therefore, in the case of the joint use of nifedipine as an additional agent, or the refusal of nifedipine, the concentration of quinidine in the blood plasma should be monitored and, if necessary, dose adjustment of quinidine is required. In some cases, the combined use of nifedipine and quinidine may increase the concentration of nifedipine in plasma. Therefore, it is necessary to control blood pressure and, if necessary, reduce the dose of nifedipine.
Tacrolimus metabolized by the CYP3A4 isoenzyme. In some cases, it is possible to increase the concentration of tacrolimus in the blood plasma with simultaneous use with nifedipine. Therefore, in the case of simultaneous use, it is necessary to control the concentration of tacrolimus in the blood plasma and, if necessary, reduce the dose of tacrolimus.
Drugs that do not affect the pharmacokinetics of nifedipine: aimaline, benazepril, debrisoquine, doxazosin, irbesartan, omeprazole, orlistat, pantoprazole, ranitidine, rosiglitazone, talinolol, triamterene/hydrochlorothiazide, acetylsalicylic acid, and candesartan.
acetylsalicylic acid at a dose of 100 mg does not affect the pharmacokinetics of nifedipine; nifedipine, in turn, does not change the antiplatelet properties of acetylsalicylic acid at a dose of 100 mg (platelet aggregation and bleeding time).
Concomitant use of nifedipine and candesartan does not affect the pharmacokinetics of both drugs.

special instructions

Influence on the ability to drive vehicles and control mechanisms

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

Release form

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

2 years. Do not use after the expiry date stated on the packaging.

Terms of dispensing from pharmacies

On prescription.

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