Kordaflex is a selective calcium channel blocker with antihypertensive and antianginal effects.
Release form and composition
Cordaflex dosage form - tablets:
- Coated (n / a) - round, biconvex, dull or slightly shiny, yellow in color, with a faint characteristic odor (100 pieces each in dark glass bottles, 1 bottle in carton packs);
- Prolonged action (p / d), coated - round, biconvex, brownish-purple color, with a matte or slightly shiny surface, with a faint characteristic odor or odorless (30 or 60 pcs. In dark glass jars, 1 can in cardboard boxes).
The composition of the tablets coated:
- Active ingredient: nifedipine - 10 mg;
- Auxiliary components: polyvinyl butyral, hydroxypropyl cellulose, talc, croscarmellose sodium, hypromellose, titanium dioxide, microcrystalline cellulose, lactose monohydrate, magnesium stearate, ferric oxide yellow.
The composition of the tablets prolonged action:
- Active ingredient: nifedipine - 20 mg;
- Auxiliary components: copolymer of methyl methacrylate and ethyl acrylate [1: 2], lactose monohydrate, microcrystalline cellulose, hyprolose, magnesium stearate, talc and croscarmellose sodium;
- Shell composition: magnesium stearate, titanium dioxide, iron dye red oxide (E172).
Indications for use
- Arterial hypertension of any nature of origin, including hypertensive crises (for tablets 10 mg);
- Coronary heart disease: prevention of attacks in various forms of angina, including with Prinzmetal angina (angiospastic);
- Raynaud's syndrome (for tablets 20 mg).
- Severe heart failure;
- Cardiogenic shock;
- Severe mitral or aortic stenosis, idiopathic hypertrophic subaortic stenosis;
- Severe arterial hypotension (systolic blood pressure below 90 mm Hg);
- Acute stage of myocardial infarction;
- I trimester of pregnancy;
- Lactation period;
- Age up to 18 years;
- Hypersensitivity to the drug.
Relative (special caution required):
- Chronic heart failure;
- Severe disorders of cerebral circulation;
- Hypertrophic obstructive cardiomyopathy;
- Sick sinus syndrome;
- Severe tachycardia;
- Malignant arterial hypertension;
- Severe renal / hepatic function;
- Period of hemodialysis;
- Lactose intolerance;
- Elderly age.
In the II and III trimesters of pregnancy, the use of the drug is possible only if other antihypertensive drugs to normalize blood pressure fails.
Dosing and Administration
Kordafleks accept inside, washing down with a small amount of water. Coated tablets (10 mg) should be taken before meals, tablets of prolonged action (20 mg) - regardless of the meal.
The doctor sets the dose in each case individually, taking into account the severity of the disease and the tolerability of the drug.
In the form of tablets p / o the drug is prescribed in 1 pc. 3 times a day, if necessary, increase the dose to 2 tablets 1-2 times a day. The maximum allowable daily dose - 4 tablets. The minimum interval between doses is 2 hours.
In order to accelerate the effect of Cordaflex at the beginning of a hypertensive crisis or an attack of angina pectoris, it is recommended to chew the tablet, hold it for a while in the mouth and then swallow it with a small amount of water.
If it becomes necessary to increase the dose to 80-120 mg of nifedipine per day in the treatment of angina pectoris and arterial hypertension, the patient is transferred to p / d tablets.
When conducting a course of therapy, the drug is recommended to be used in p / d tablets. At the beginning of treatment, 1 tablet is prescribed 2 times a day at 12-hour intervals. If necessary, gradually increase the dose to achieve the optimal effect. The maximum daily dose is 6 tablets (120 mg). With prolonged maintenance therapy, as a rule, it is enough to take 1-2 tablets 2 times a day.
Elderly patients reduce the therapeutic dose by 2 times. Lower doses may also be required to maintain a therapeutic effect.
The maximum daily dose for patients with severe liver dysfunction is 40 mg of nifedipine.
- Cardiovascular system: peripheral edema, facial skin flushing, tachycardia, severe hypotension; rarely, fainting, increased heart failure or angina attacks;
- The endocrine system: in isolated cases - galactorrhea, change in body weight, hyperglycemia and gynecomastia (these symptoms completely disappear after the cancellation of Cordaflex);
- Digestive system: nausea, diarrhea / constipation, heartburn; rarely (with long-term use of the drug) - flatulence, dry mouth, increased activity of hepatic transaminases, intrahepatic cholestasis; in some cases - gingivitis, gingival hyperplasia, anorexia;
- Central and peripheral nervous system: sleep disturbances (drowsiness or insomnia), dizziness, headache, fatigue; in isolated cases - visual impairment, lability of mood; with prolonged use in high doses - tremor, paresthesias in the limbs;
- Musculoskeletal system: myalgia; in some cases, arthritis;
- Blood system: rarely - leukopenia, thrombocytopenic purpura, thrombocytopenia; in some cases - anemia;
- Urinary system: an increase in daily diuresis; rarely in patients with chronic renal insufficiency - impaired renal function;
- Others: feeling hot; in rare cases - fever, sweating, chills, weakness, photodermatitis;
- Allergic reactions: rarely - rash, pruritus, urticaria; in some cases, autoimmune hepatitis.
In isolated cases, chest pain (angina due to paradoxical ischemia) is possible at the beginning of the application of Cordaflex or with an increase in its dose soon after administration. If it is proved that this symptom is associated with angina and taking the drug, treatment should be discontinued.
The antihypertensive effect of Cordaflex increases with hypovolemia (including after dialysis) and a decrease in pressure in the pulmonary artery. In these cases, it is recommended to reduce the dose of nifedipine.
Abrupt withdrawal of the drug in diseases of the coronary vessels and arterial hypertension can lead to the development of hypertensive crisis and myocardial ischemia (rebound phenomenon).
During the entire period of treatment is prohibited to consume alcoholic beverages.
At the initial stage of therapy, you should refrain from engaging in any potentially hazardous activities, including driving vehicles. The degree of further restriction is determined individually depending on the patient's response to Kordaflex.
It should be borne in mind that nifedipine:
- It inhibits the excretion of vincristine, which may cause an increase in its side effects. If necessary, the use of such a combination is required to reduce the dose of vincristine;
- Increases the concentration of theophylline and digoxin in the blood plasma. The clinical effect and / or content of these substances in the blood plasma should be monitored;
- It may displace drugs with a high degree of binding (for example, nonsteroidal anti-inflammatory drugs, indirect anticoagulants), due to which it is possible to increase their concentration in blood plasma.
Nifedipine is metabolized by a CYP3A4 isoenzyme, therefore any inhibitor or inducer of this enzyme can affect the metabolism of the active substance Cordaflex. Cyclosporine is also a substrate of the CYP3A4 isoenzyme, therefore, with simultaneous use, it is possible to increase the duration of the effect of each of them.
Diltiazem, erythromycin and antifungals of the azole group (ketoconazole, intraconazole, fluconazole) can inhibit nifedipine metabolism, thereby enhancing its effects. If necessary, the appointment of such combinations should reduce the dose of Cordaflex. Grapefruit juice has a similar effect.
Tricyclic antidepressants, ranitidine and cimetidine increase the hypotensive effect of nifedipine; rifampicin, phenytoin and calcium supplements - weaken.
Particular caution should be exercised with the simultaneous use of methyldopa, clonidine, prazosin or octadine, since may develop severe orthostatic hypotension.
Quinidine, procaine, and other drugs that prolong the QT interval increase the negative inotropic effect of Cordaflex and increase the risk of prolongation of the QT interval. When using such combinations, it is necessary to carefully monitor the condition of patients, especially with impaired left ventricular function.
Terms and conditions of storage
Store at a temperature of 15-25 ºС in a place protected from light and inaccessible to children.
Shelf life - 4 years.