Кордафлекс

Кордафлекс – derivative 1,4 dihydropyridines, the selection blocker of slow calcium channels, drug with anti-hypertensive and anti-anginal action.

Form of release and structure

• Tablets, coated: round, convex from two parties, yellow color, with opaque or slightly brilliant surface, with a slight characteristic smell (on 100 pieces in dark glass bottles, in a cardboard pack 1 bottle);
• Tablets of the prolonged action, film coated: round, convex from two parties, brownish-violet color, opaque or slightly brilliant, with a slight characteristic smell or in general inodorous; on a break – yellow color with a narrow strip of brownish-violet color at the edges (on 30 or 60 pieces in dark glass jars, in a box of cardboard 1 bank).

Active ingredient – nifedipine:

• 1 tablet, coated – 10 mg;
• 1 tablet of the prolonged action – 20 mg.

Excipients of tablets of 10 mg: lactoses monohydrate, titanium dioxide, hydroxypropyl cellulose, talc, sodium of a kroskarmelloz, magnesium stearate, cellulose microcrystallic, polyvinylbutyral, gipromelloz, ferrous oxide yellow.

Additional components of tablets of 20 mg:

• Excipients: lactoses monohydrate, copolymer of methylmethacrylate and ethyl acrylate [1:2], cellulose microcrystallic, talc, croscarmellose sodium, hypro rod, magnesium stearate;
• Structure of a cover: titanium dioxide, gipromelloz, magnesium stearate, dye ferrous oxide red (E172).

Indications to use

• Arterial hypertension of various genesis, including hypertensive crises (tablet of 10 mg);
• Reynaud's syndrome (for tablets of 20 mg);
• Coronary heart disease: prevention of attacks at various forms of stenocardia, including angiospastic (Printsmetal's stenocardia).

Contraindications

Absolute:

• The expressed arterial hypotension (indicators of systolic arterial pressure are lower than 90 mm hg);
• Acute stage of a myocardial infarction;
• Idiopathic hypertrophic subaortal stenosis, the expressed mitral or aortal stenosis;
• Cardiogenic shock;
• Heavy heart failure;
• Age up to 18 years;
• I trimester of pregnancy;
• Lactation;
• Hypersensitivity to drug components.

Relative:

• Chronic heart failure;
• Sick sinus syndrome;
• Hypertrophic subaortic stenosis;
• Heavy disturbances of cerebral circulation;
• The expressed tachycardia;
• The expressed dysfunctions of kidneys/liver;
• Malignant arterial hypertension;
• Lactose intolerance;
• Advanced age.

The patients who are on a hemodialysis should apply Kordafleks with care.

In II and III trimesters of pregnancy of Kordafleks it can be appointed only if other hypotensive drugs did not possible to normalize arterial pressure.

Route of administration and dosage

Кордафлекс it is necessary to accept inside, without chewing and washing down with enough water: tablets of 10 mg – before food, tablets of 20 mg – regardless of meals.

Doses are defined individually depending on weight of a course of a disease and reaction of the patient to drug.

The adult appoint 10 mg 3 times a day, if necessary the dose is increased to 20 mg (2 tablets on 10 mg) by 1-2 times a day. The most admissible daily dose – 40 mg (4 tablets on 10 mg). The interval between receptions should not be less than 2 hours.

For acceleration of action of Kordafleks at development of hypertensive crisis or an attack of stenocardia the tablet is recommended to be chewed, to take some time in a mouth and only then to swallow with a small amount of water.

If at arterial hypertension or stenocardia there is a need of increase in a daily dose up to 80-120 mg, the patient is transferred to tablets of the prolonged action in a dose of 20 mg.

When performing course therapy of Kordafleks it is recommended to apply 20 mg in tablets. In an initiation of treatment appoint on 1 tablet 2 times a day with 12-hour intervals. If the effect is not enough, the dose is gradually raised. The most admissible daily dose – 120 mg (6 tablets). For a long maintenance therapy it is usually enough to accept 1-2 tablets (20-40 mg) 2 times a day.

To patients of advanced age the initial dose is reduced twice. For maintenance of therapeutic effect use of lower doses can be also required.

At patients with the expressed abnormal liver functions the daily dose should not exceed 40 mg.

Side effects

• Allergic reactions: seldom – a dieback, a skin itch, a small tortoiseshell; in some cases – autoimmune hepatitis;
• Cardiovascular system: peripheral hypostases, the expressed arterial hypotension, tachycardia, a dermahemia of the person; seldom – faints, strengthening of heart failure, strengthening of attacks of stenocardia;
• Central and peripheral nervous system: вертиго, headache, sleep disorders (sleeplessness or drowsiness), increased fatigue; in isolated cases – vision disorders, lability of mood; at prolonged use in high doses – a tremor, paresthesias in extremities;
• Alimentary system: heartburn, nausea, diarrheas/locks; seldom (at long administration of drug) – a meteorism, dryness in a mouth, increase in activity of hepatic transaminases, an intra hepatic cholestasia; in some cases – an ulitis, a hyperplasia of gums, anorexia;
• Urinary system: increase in a daily urine; seldom – deterioration in function of kidneys at patients with a chronic renal failure;
• Endocrine system: in isolated cases – a galactorrhoea, a gynecomastia, change of body weight, a hyperglycemia;
• System of a hemopoiesis: seldom – a leukopenia, a Werlhof's disease, thrombocytopenia; in some cases – anemia;
• Musculoskeletal system: mialgiya; in isolated cases – arthritis;
• Others: feeling of heat; in isolated cases – fever, perspiration, a fever, a photodermatitis, weakness.

Special instructions

At a hypovolemia hypotensive action of Kordafleks amplifies. Pressure decrease in a pulmonary artery and a hypovolemia after dialysis can also promote strengthening of effect of drug therefore reduction of its dose is recommended.

In rare instances at the beginning of therapy or at increase in a dose of drug soon after its reception emergence of a stethalgia testimonial of stenocardia owing to paradoxical ischemia is possible. If development of stenocardia is connected with Kordafleks's reception, treatment should be stopped.

At patients with arterial hypertension and diseases of coronary vessels sharp drug withdrawal can lead to ischemia of a myocardium or hypertensive crisis (a phenomenon of "ricochet").

In need of carrying out planned surgical intervention using the general anesthesia it is necessary to warn the anesthesiologist about Kordafleks's reception.

During performing course therapy it is not recommended to take alcoholic beverages since perhaps excessive lowering of arterial pressure.

At the initial stage of treatment it is necessary to refrain from driving of vehicles and performance of potentially dangerous types of activity demanding the speed of mental and physical reactions. Further extent of restrictions is defined individually.

Medicinal interaction

• Tricyclic antidepressants, ranitidine, Cimetidinum: strengthening of hypotensive effect is noted;
• Digoxin, theophylline: their concentration in a blood plasma increases;
• Rifampicin, Phenytoinum, calcium drugs: effect of nifedipine is weakened;
• Vincristinum: its removal is slowed down that can lead to strengthening of side effects;
• Grapefruit juice, diltiazem, erythromycin and antifungal means of group of azoles (кетоконазол, итраконазол, флуконазол): metabolism of nifedipine in an organism is suppressed owing to what strengthening of its side effects is possible;
• The quinidine, Procainum, other drugs causing lengthening of an interval of QT: the negative inotropic effect amplifies, the risk of lengthening of a QT interval increases. Nifedipine promotes decrease in concentration of quinidine, and after its cancellation the tranzitorny increase in concentration of quinidine (approximately twice) reaching the maximum level for 3-4 day is observed. At use of such combinations it is necessary to observe extra care, especially at patients with dysfunction of a left ventricle;
• Inhibitors and inductors of an isoenzyme CYP3A4: nifedipine metabolism changes. At simultaneous use of the cyclosporine which is CYP3A4 isoenzyme substrate, each of drugs can increase duration of effect of other means.

Also nifedipine can force out from communication with proteins the drugs which are characterized by high extent of binding (including non-steroidal anti-inflammatory drugs, indirect anticoagulants – derivatives of an indandion and coumarin) because of what their concentration in a blood plasma can increase.

In need of strengthening of anti-anginal and hypotensive action of Kordafleks it is possible to combine with nitrates, diuretics, beta adrenoblockers, inhibitors of an angiotensin-converting enzyme. These combinations lead to summation or potentiation of effects. In most cases they are effective and safe, however in certain cases can lead to the expressed lowering of arterial pressure and strengthening of symptoms of heart failure.

In the presence of indications of Kordafleks it is possible to combine with metildopy, Prazozinum, a clonidine, Octadinum, however it is necessary to consider probability of development of severe orthostatic hypotension.

Terms and storage conditions

To store in the place unavailable to children and protected from light. To observe temperature condition 15-25 ºС.

Period of validity – 4 years.