active substance:flecainide acetate;
1 tablet contains flecainide acetate 50 mg or 100 mg
other ingredients:corn starch maize, cellulose microcrystalline, starch maize, sodium croscarmellose, magnesium stearate.The
50 mg tabletswhite, round, biconvex, without sheath, embossed "C" on one side and identifying letters" FI " ON the other side;
100 mg tabletswhite, round, biconvex, without sheath, with split line and embossed identifying letters "C" above line and "FJ" below line, on the other side - split line.The
antiarrhythmic agents of IP class. Flecainide. Code ATH S01V S04.The
Flecainide acetate is an antiarrhythmic agent of class IP is intended for treatment of life-threatening symptomatic ventricular arrhythmias and supraventricular arrhythmias high severity.
electrophysiological properties flecainide is a local anesthetic (class IC) Antiarrhythmic action. It is a local anesthetic of amide type, structurally close to procainamide and encainide, since these substances are also derivatives of benzamide.
Flecainide, as a compound of class is, has three main properties: pronounced inhibition of rapid sodium channels of the heart; slow onset of action and shifted kinetic characteristics of inhibition of sodium channels (which is a consequence of slow binding and separation from sodium channels) differentiated effect of the means on the duration of the change of the bioelectric potential of the muscles of the ventricles and Purkinje fiber, namely: no effect on the first and a significant reduction in the duration of the change for the latter. This combination of properties provides a significant reduction in the conductivity of fibers, depolarization of which depends on rapid sodium channels, with moderate growth of the effective refractory period, as evidenced by the results of studies using isolated cardiac tissues. The specified electrophysiological properties flecainide acetate due to the possibility of lengthening of the PR interval, and QRS complex on ECG. In a very high concentration flecainide causes mild suppression of the slow channels of the myocardium. This effect is associated with a negative inotropic effect.
SandozFlecainide at oral administration is absorbed almost completely and does not experience active metabolic transformation of the first pass. According to the available information, the bioavailability of the acetate-shaped flecainide is approximately 90%. The range of therapeutic concentrations in blood plasma is considered to be from 200 to 1000 ng/ml. With intravenous administration, the average duration of the period before reaching the maximum concentration in serum is 0.67 hours, and the average bioavailability - 98%, compared with 1:00 and 78%, respectively, when receiving funds in the form of a solution for oral administration and 4:00 and 81%, respectively - in the form of tablets. Approximately 40% of flecainide binds to plasma proteins.
flecainide Sandozpenetrates the placenta and is excreted into breast milk.
flecainide Sandozis experiencing active metabolic transformation (dependent on genetic polymorphism), the two main target metabolites are o-dealkylation flecainide and meta-o-dealkylation lactam flekainide, both metabolites are relatively active. Metabolic transformation occurs with the participation of the enzyme cytochrome P450, namely the enzyme CYP2D6, and associated with genetic polymorphism.
flecainide Sandozis excreted primarily in the urine, about 30% of the resulting dose is excreted in the form of unchanged substance, the rest - in the form of metabolites. Approximately 5% is excreted with feces. The output level flecainide is reduced in renal failure, liver disease, heart failure, and in alkaline urine. Hemodialysis produces only 1% of the flecainide in the form of unchanged substance. Half-life of flecainide is approximately 20 hours.
ENU AV-nodular persistent tachycardia; arrhythmias associated with wolf - Parkinson - white syndrome and similar disorders due to the presence of additional pathways - in case of inefficiency of other treatments.
EN symptomatic paroxysmal ventricular arrhythmia of high severity, life-threatening patient, in the absence of an answer to other types of therapy. Also used in case of intolerance or failure to carry out other forms of therapy.
Enya Paroxysmal atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) in patients with adverse symptoms after conversion, provided that there is an undeniable need for therapy is confirmed by the severity of clinical symptoms, if other treatments are ineffective.
before use, the presence of heart disease of organic Genesis and/or left ventricular ejection fraction disorders should be excluded, since in this case the risk of unwanted arrhythmia enhancement.
Anti-arrhythmic class I. Flekainid Sandozmust not be used simultaneously with Antiarrhythmic means class I.
Anti-arrhythmic class II B. you Should consider increasing unwanted inotropic effect of antiarrhythmic drugs of class AI, such as beta-blockers, while the use of flecainide.
Antiarrhythmic agents of class III. With the simultaneous use of flecainide withamiodarone, the usual dose of flecainide should be halved and a thorough monitoring of the patient's condition for the timely detection of adverse events should be ensured. Also, it is recommended to monitor the concentration of substances in the blood plasma.
Antiarrhythmic agents of class IV. Simultaneous use of flecainide with calcium channel blockers, e.g.verapamil, should be carried out with caution.
possible side effects that threaten the life of the patient, associated with drug interactions, causing an increase in the concentration of the substance in the blood plasma. Metabolic transformation of flekainida is provided mainly by CYP2D6 isoenzymes, and at the same time the use of drugs, inhibiting (eg., Antidepressants, neuroleptics, propranolol, ritonavir, some antihistamines) or increase activity (eg., Phenytoin, phenobarbital, carbamazepine) of this enzyme there is a corresponding increase or decrease in the concentration of flecainide in blood plasma.
an Increase in the concentration of flecainide in blood plasma may also be due to impaired renal function, due to a decrease in clearance of flecainide.
Hypokalemia, as well as hyperkalemia, or other electrolyte imbalance disorders should be corrected before starting the use of flecainide. Hypokalemia can be a consequence of the simultaneous use of diuretics, corticosteroids or laxatives.
Antihistamines. The risk of ventricular arrhythmia increases with the appointment ofmizolastinandterfenadine.simultaneous use should be avoided.
Antiviral agents. The concentration of the substance in the blood plasma increases while the use ofritonavir, lopinavirandindinavir(increased risk of ventricular arrhythmia) (should be avoided simultaneously).
The Antidepressants. TheFluoxetine paroxetineand other antidepressants promote the growth of flecainide concentration in plasma when administered simultaneously withtricyclic antidepressantsincreases the risk of ventricular arrhythmias.
Anti-epileptic means. Limited data obtained in patients taking the drug with enzyme activators (phenytoin, phenobarbital, carbamazepine), indicate a 30% increase in the rate of withdrawal of flecainide.
Neuroleptics. TheClozapine- increase risk of arrhythmia.
anti-Malaria treatment. TheQuininecontributes to the growth of flecainide concentration in blood plasma.
Antifungal agents. TheTerbinafinecan to promote the increase of concentration of flecainide in blood plasma due to inhibition of CYP2D6 enzyme activity.
Diuretics: the class effect of drugs, hypokalemia, which results in an increase in cardiotoxic effect.
H2antihistamines (for the treatment of gastric ulcers). Antagonist of the N2receptor,cimetidinethat inhibits the metabolic conversion of flecainide. In healthy volunteers who receivedcimetidine(1 g per day) within 1 week, the value of the fluoride AUC increased by about 30%, and the half-life period increased by about 10%.
tools to help quit Smoking: concomitant use ofbupropion(metabolic transformation of which is carried out with the participation of the enzyme CYP2D6) and flecainide should be carried out with caution and begin treatment with a minimum dose of the recommended range. If bupropion is prescribed when the patient receives flecainide, it is necessary to consider the feasibility of reducing the dose of the latter.
Cardioglycosides. When using flecainide may increase the content of digoxin in blood plasma by 15%, which is unlikely to have clinical significance in plasma concentrations of patients in the therapeutic range. It is recommended to determine the level of digoxin in the blood plasma of patients receiving digitalis preparations at least 6:00 after receiving digoxin, regardless of the dose, before or after taking flecainide.
Anticoagulants. Flecainide can be used simultaneously with anticoagulants for oral administration.
flecainide Sandozfor oral administration should be prescribed only in hospital or under the direct supervision of a specialist for the treatment of patients with:The
use of the preparation for other indications should be started in a hospital.
flecainide has been Shown to increase the risk of mortality in patients after myocardial infarction with asymptomatic ventricular arrhythmia.
Flekainid Sandoz, as well as other Antiarrhythmic action might contribute to arrhythmias, that is, can cause arrhythmia is more severe, the increase in frequency of episodes of arrhythmia or an increase in the intensity of unwanted symptoms.
the use of flecainide in the treatment of patients with heart disease of organic Genesis or left ventricular ejection fraction disorders should be avoided.
Flecainide should be used with caution in the treatment of patients with acute development of atrial fibrillation after cardiac surgery.
Flecainide causing lengthening of the QT interval and the width of the QRS complex by 12-20%. The effect on the QT interval slightly.
there may be a symptom of Brugada when a patient receives flecainide. In the case of detection of changes in the results of ECG-examination, which may indicate the presence of Brugada syndrome, against the background of therapy with flecainide, the feasibility of canceling further therapy should be considered.
since the removal of flecainide from blood plasma in patients with severe hepatic impairment may be significantly slower, flecainide should not be used in the treatment of such patients, unless the potential benefits exceed the potential risks. Recommended monitoring of substance concentration in blood plasma.
SandozFlecainide should be used with caution in the treatment of patients with renal impairment (creatinine clearance 35 ml/min/1.73 m2or below) recommended therapeutic monitoring.
the rate of withdrawal of flecainide from blood plasma in elderly patients may be reduced. This should be remembered when adjusting the dosing regimen.
electrolyte imbalance (e.g. hypokalemia and hyperkalemia) should be corrected prior to therapy with flecainide.
severe Bradycardia or significant hypotension should be addressed before starting therapy with the use flecainide.
it is Known that Sandoz Flecainideincreases the threshold of sensitivity of the endocardium to pacemaker signals, that is, the sensitivity of the endocardium to pacemaker decreases. This effect is reversible and more of an impact on the threshold of acute, not chronic sensitivity. Thus, flecainide should be used with caution in the treatment of patients with established permanent or temporary pacemakers and should not be used in the treatment of patients with high sensitivity to pacemaking and in the case of use of non-programmable pacemaker in the absence of proper resuscitation equipment.
as a rule, doubling the frequency or amplitude of the stimulating pulse (voltage) is sufficient for the normalization of the heart, but in the initial stages after implantation, when the patient receives a flecainide, it is very difficult to provide a ventricular sensitivity below 1 volt.
difficulties with defibrillation were Observed. In most of these cases, patients with a history of heart disease with increasing heart size, myocardial infarction, arteriosclerotic heart disease and heart failure.
there are reports of an increase in ventricular contraction rate in atrial fibrillation in the absence of a therapeutic effect. Sandozflecainide has a selective effect, promotes the refractory period of anterograde and, especially, retrograde conduct from the sinus node to the ventricles of the heart. This effect is manifested on the ECG of most patients as an elongation of THE corrected Qt interval, so the effect on THE Qt interval is negligible. However, there are reports of cases of lengthening THE Qt interval by 4%. However, this effect is less expressive than when using antiarrhythmic agents class 1A.
application in pediatric practice.
flecainide Sandozis not recommended for use in therapy in children under the age of 12 years due to lack of adequate data on safety and efficacy.
Dairy products (milk, baby food and possibly yoghurts) may reduce the absorption of flecainide in children and in newborns. It was reported on the toxicity of flecainide, which was used to children with the reduced consumption of milk, and a newborn, which infant formula was replaced with a food containing glucose.
use during pregnancy or lactation.
flecainide Sandozpenetrates the placenta and fetus when taking the drug during pregnancy. Therefore, it should not be used during pregnancy, if the expected benefit does not exceed the potential risk.
application during lactation
Flekainid Sandozpasses into breast milk. Concentration in blood plasma of the child who is on breastfeeding in 5-10 times less therapeutic. If necessary, the treatment should stop breast-feeding.
Ability to influence the reaction rate when driving motor transport or operating other mechanisms.
it is Recommended to refrain from driving vehicles or working with other mechanisms, taking into account the possibility of dizziness, visual impairment.
the Drug is administered orally. To eliminate the influence of food on the absorption of the drug flekainid Sandozshould be taken on an empty stomach or an hour before meals. Pill Flekainid Sandozis 100 mg can be divided into two equal parts.
initiation of therapy with the use of flecainide acetate and modify the dosage regimen should be under the supervision with ECG monitoring and controlling the concentration of the substance in the blood plasma. Some patients currently require hospitalization, in particular in patients with ventricular arrhythmia, life-threatening. The decision on the need for hospitalization is made by a specialist. In patients with cardiac diseases of organic origin, especially when there is a history of myocardial infarction, therapy with the use of flecainide should be started only in cases where other drugs have Antiarrhythmic action, with the exception of drugs class of IP (especially amiodarone), are ineffective or intolerable, and on the condition that drug-free treatment (surgery, amputation, implantation of a defibrillator) is not shown. During the therapy requires constant ECG monitoring and control of the concentration of matter in the blood plasma.
Adults and children aged 13
Supraventricular arrhythmia:the recommended starting dose is 50 mg twice daily. For most patients, taking this dose provides control of unwanted symptoms. If necessary, the dose can be increased to a maximum of 300 mg per day.
Ventricular fibrillation:the recommended dose is 100 mg twice a day. The maximum daily dose is 400 mg, but this dose is used only in the treatment of patients with a larger build or when it is necessary to control the arrhythmia. After 3 to 5 days, it is recommended to gradually adjust the dose to a minimum sufficient level, which provides monitoring of arrhythmia. Long-term use of the drug may reduce the dose of the drug.
application in therapy of elderly patients
in the treatment of elderly patients, the drug is used at an initial daily dose not exceeding 100 mg (1 tablet 50 mg twice a day), since the rate of excretion of flecainide from plasma blood of the elderly can be reduced. This should also be taken into account when adjusting the dose. The maximum dose for elderly patients should not exceed 300 mg (150 mg twice a day).
Level in the blood plasma
In terms of eliminating ventricular extrasystoles, to maximize the therapeutic effect of a substance in the blood plasma needs to be 200 - 1000 ng/ml. Concentration in blood plasma more than 700 - 1000 ng/ml is associated with increased likelihood of adverse events.
in the treatment of patients with severe renal impairment (creatinine clearance 35 ml/min/1.73 m2or below), the initial dose should not exceed 100 mg/day (or 50 mg twice a day). When using the drug in the treatment of such patients, it is strongly recommended to monitor the concentration of the substance in the blood plasma. Depending on effect and tolerability, the dose can be gradually and carefully increased. After 6 to 7 days dosing regimen is subject to adjustment, taking into account the effectiveness and endurance therapy. Some patients with impaired renal function, severe clearance flecainide very slow, resulting in a longer half-life (60 - 70 hours).
violation of the liver functions
When using the drug in therapy of patients with impaired liver function careful monitoring is required, the initial dose should not exceed 100 mg/day (50 mg twice a day).
in the treatment of patients with implanted pacemaker drug should be used with caution, the daily dose should not exceed 100 mg, divided into 2 admission.
when used in conjunction with cimetidine or amiodarone, careful monitoring is required. In the treatment of some patients, the dose should be reduced, the daily dose should not exceed 100 mg, divided into 2 admission. It is necessary to monitor the status of patients during both initial and maintenance therapy.
Recommended monitoring the concentration of the substance in the blood plasma and ECG monitoring (monitoring and EKG once a month). At the stage of initial therapy and increasing the dose of ECG - examination should be carried out every 2 to 4 days.
when using Sandozflecainide in the treatment of patients requiring dose limitation, ECG monitoring should often be done (in addition to monitoring the concentration of flecainide in blood plasma). Dose adjustment is made at intervals of 6 to 8 days. To control the individual dosing regimen of ECG-examination of such patients should be carried out 2 and 3 weeks after the start of therapy.
Flekainid Sandozis not recommended for use in the treatment of children under 13 years of westnet adequate data on safety and efficacy.
Overdose flecainide Sandozis a life threatening and requires immediate medical intervention. Hypersensitivity to the drug and an increase in blood plasma concentration to a level higher than therapeutic may also be due to interaction with other drugs. The specific antidote is unknown. There is no known method to quickly remove Flekainid Sandozfrom the body. Dialysis or hemoperfusion is ineffective.
maintenance therapy Is needed, it is possible to eliminate the substance not yet absorbed from the gastrointestinal tract. Further application of preparations of inotropic action or stimulants of cardiac activity, such as dopamine, dobutamine or isoproterenol, and also mechanical ventilation of lungs and measures for maintenance of blood circulation (for example the pump for auxiliary blood circulation) is possible. Consideration should be given to the feasibility of using a temporary transvenous pacemaker in the case of a conduction blockade. Since the half-life of plasma is about 20 hours, these maintenance therapy measures should be carried out for a long time.
Forced diuresis with acidification of urine, in theory, promotes the excretion of the substance.
As with other antiarrhythmic agents, flecainide can aggravate arrhythmias. It is possible to increase the intensity of the symptoms of an existing arrhythmia or development of a new episode. The risk of Proarrhythmic exposure is the highest for patients with heart disease of organic Genesis and/or with significant left ventricular dysfunction.
the Most common side effects are AV blockade II-III degree, bradycardia, cardiac failure, chest pain, myocardial infarction, hypotension, cessation of activity of the sinus node tachycardia (atrial and ventricular tachycardia) and palpitations.
frequent side effects such as dizziness and visual impairment are observed in approximately 15% of patients receiving therapy. These adverse events are usually temporary, and disappear with further therapy or dose reduction. The above list of side effects is based on the experience gained during clinical trials, and information obtained in the framework of pharmacological supervision after registration of the drug.
Side effects are classified by organ systems and classes as well as by frequency. Frequency is defined as follows: very common (3 1/10), often (3 1/100,<1/10), uncommon (3 1/1000,<1/100), rare (? 1/10000,
the hematopoietic system and lymphatic system
Uncommon: reduction in the number of red blood cells, reducing the number of leukocytes and the decrease in the number of platelets.
by the immune system
Rare: an increase in the number of antinuclear antibodies associated or not associated with systemic inflammation.
Rare: hallucinations, depression, confused state of consciousness, anxiety, amnesia, insomnia.
from nervous system
Very common: dizziness, which generally passes quickly.
Rare: paresthesia, ataxia, hyposthesia, hyperhidrosis, fainting, tremor, tides, drowsiness, headache, peripheral neuropathy, convulsions, dyskinesia.
on the part of the visual organs
Very common: visual disturbances such as diplopia and blurred vision.
Rare: precipitate on the cornea.
on the part of the hearing and equilibrium organs
Rare: ringing in the ears, vertigo type of vertigo.
on the cardiovascular side
Frequently: proarrhythmic effect (most likely for patients with heart disease of organic Genesis).
Uncommon: patients with atrial flutter may develop 1: 1 AV conduction with increased heart rate.
the Frequency is unknown: possible dose-dependent increase in PR and QRS intervals.
Change the threshold of sensitivity to the pacemaker signal.
AV(BP) blockade II-III degree, heart failure, bradycardia, cardiac failure/congestive heart failure, chest pain, hypotension, myocardial infarction, palpitations, cessation of activity of the sinus node tachycardia (atrial and ventricular), or atrial fibrillation . The manifestation of the symptoms of Brugada syndrome.
from the respiratory system
Frequent: shortness of breath.
frequency unknown: pulmonary fibrosis, interstitial lung disease.
from the digestive system
Infrequently: nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhea, dyspepsia, flatulence.
from the digestive system
Rare: increased liver enzyme activity, with or without jaundice.
Frequency unknown: violation of liver function.
on the part of the skin and subcutaneous tissue
Infrequently: allergic dermatitis, including rash, alopecia.
Rare: urticaria severe.
Rare: photosensitivity reaction.
Systemic and site-related violations
Frequent: asthenia, fatigue, fever, swelling.The
2 years old.
Store at a temperature not exceeding 25 ° C in its original packaging.
keep out of reach of children.The
Blister contains 10 tablets, 3 or 6, or 12 blisters in a cardboard box.The
According to the recipe.The
Salutas Pharma GmbH
Otto-on-Gurik-alle 1, 39179, Barleben, Germany
Trecartin – heart drops 25 ml, used oral route. The main active components of the drug are tinctures Valerian, hawthorn and motherwort. The drug has a yellow-brown or red-brown color. With prolonged storage, the formation of the precipitate. Among the contraindications note:
Ulcer in any region of the gastrointestinal tract. The
the Tool can be used if:
the Drug is administered for oral use for twenty or thirty drops 3 times a day before meals. Children over the age of twelve need to take a solution in the amount of 1 drop per year of life three times a day before meals. The duration of therapy is determined for each patient individually. Before starting treatment, consult a doctor.