What is the difference between Finlepsin and Finlepsin Retard? ATX and registration number.

– 200 mg.

Additional components: MCC, gelatin, croscarmellose sodium, magnesium stearate.

Release form

Finlepsin is produced in the form of tablets, packaged in blisters of 10 pieces, 3, 4 or 5 blisters per pack.

pharmachologic effect

Finlepsin tablets have antiepileptic, antipsychotic And analgesic action.

Pharmacodynamics and pharmacokinetics

For this antiepileptic a product that is a derivative dibenzazepine , also typical antidepressant, antipsychotic, antidiuretic And analgesic Effect. The effect of the drug is related to the blockade voltage-gated sodium channels , which helps stabilize the membranes of overexcited neurons, reduce synaptic conduction of impulses and inhibit serial discharges of neurons. The release of neurotransmitter amino acids is reduced - glutamate , which has a stimulating effect, which helps reduce the convulsive threshold of the nervous system, and, consequently, the likelihood of an epileptic attack.

The effectiveness of the drug is manifested in simple or complex epileptic seizures, which may be accompanied by secondary generalization and so on. There was a decrease in symptoms anxiety, irritability And aggressiveness.

This drug is characterized by a slow but complete absorption , independent of food consumption. The concentration of the substance in the body is achieved within 12 hours with a single use Finlepsin retard 400 mg, maintaining therapeutic effectiveness for 4–5 hours. In this case, equilibrium concentrations of the active substance in the plasma are achieved after a therapeutic course of 1–2 weeks. However, this may depend on the characteristics of the patient: autoinduction of enzyme systems in the liver, heteroinduction by other drugs taken simultaneously, the patient's condition, dosage and duration of treatment. It has been established that carbamazepine passes into breast milk and through the placental barrier.

Metabolism of the drug occurs in the liver with the formation of the main: carbamazepine-10,11-epoxide - active action and inactive conjugate with glucuronic acid . As a result of the metabolic process, a less active metabolite, 9-hydroxy-methyl-10-carbamoylacridan, is formed, which is capable of inducing its own metabolism. The drug is excreted primarily in urine, some in feces.

Indications for use of Finlepsin

Main indications for use of Finlepsin:

  • various shapes ;
  • pain due to nervous disorders in patients with ;
  • different types of convulsive conditions - spasms, seizures, and so on;
  • alcohol withdrawal syndrome;
  • psychotic disorders.

Contraindications for use

Finlepsin is not prescribed for:

  • hypersensitivity to its components or tricyclic antidepressants;
  • disorders of bone marrow hematopoiesis;
  • acute intermittent porphyria ;
  • AV block;
  • while taking lithium drugs or MAO inhibitors.

It is recommended to be careful when treating patients with decompensated chronic heart failure, dilution hyponatremia, liver and kidney disorders, elderly age, active alcoholism, suppression of bone marrow hematopoiesis, while taking certain medications, prostatic hyperplasia, increased intraocular pressure, and so on.

Side effects of Finlepsin

As a rule, side effects during treatment with this drug can develop due to excess dosage or significant fluctuations in the concentration of the active substance in the body. In most cases, abnormalities in the functioning of the nervous system occur: ataxia, general weakness, and so on. It is also possible to manifest, for example, , erythroderma , skin rashes and other symptoms.

The hematopoietic and blood system may respond by causing: leukopenia, thrombocytopenia, eosinophilia, leukocytosis, lymphadenopathy . There remains a possibility of developing abnormalities in the gastrointestinal tract: nausea, vomiting, dry mouth, increased gamma-glutamyltransferase activity, liver transaminase activity, or.

In addition, disturbances associated with the functioning of the endocrine system and metabolism may occur: swelling, fluid retention, weight gain, vomiting, hyponatremia And so on. The development of abnormalities in the functions of the cardiovascular and genitourinary systems, musculoskeletal system and sensory organs should not be excluded.

Finlepsin tablets, instructions for use (Method and dosage)

This medicine is intended to be taken orally, regardless of food intake.

During treatment, tablets are prescribed as monotherapy. If Finlepsin is added to antiepileptic therapy, then this is done gradually, strictly controlling the dosage. In cases where a pill is missed, it should be taken as soon as the omission occurs, but the missed dose should not be made up for with a double dose.

According to the instructions for use Finlepsin retard , adult patients are prescribed a daily dose of 200–400 mg at the beginning of treatment. Then a gradual increase in dosage is possible to achieve optimal effectiveness. The maintenance daily dose is 800-1200 mg, with this amount divided into 1-3 doses. The maximum permissible daily dose should not exceed 1.6–2 g.

For children, the dose of the drug depends on age. In addition, when it is difficult for a child to take a whole tablet, it can be chewed, crushed and dissolved in a small volume of liquid.

Children 1-5 years old are prescribed 100–200 mg, gradually increasing the daily dosage to achieve optimal effect.

The initial daily dosage for children 11-15 years old is 100-300 mg. After which it is gradually increased by 100 mg until the optimal effect appears.

Average maintenance daily doses: for young patients 1–5 years old – 200–400 mg, 6–10 years old within 400–600 mg, 11–15 years old – 600–1000 mg, divided into several doses.

The duration of treatment is directly dependent on the indication and individual characteristics of the patient. In any case, all decisions related to therapy remain within the competence of the doctor. Typically, the issue of reducing the dose or discontinuing the drug is discussed when the patient has been seizure-free for 2-3 years.

Discontinuation of treatment involves a gradual reduction in dose, lasting 1-2 years, under regular EEG monitoring. In children, increasing weight and age must be taken into account.

During the treatment of other disorders according to indications, the dosage and duration of administration are determined by the doctor, taking into account the complexity of the disease and the characteristics of the individual patient.

Overdose

With an overdose of Finlepsin, various symptoms may develop, indicating disruption of the nervous, cardiovascular and respiratory systems, sensory organs and general abnormalities.

This is manifested by: depression of central nervous system functions, disorientation, drowsiness, agitation, coma, blurred vision, low blood pressure, fainting, breathing problems, lung problems, nausea, vomiting, urinary retention, and so on.

It has been established that there is no antidote to treat an overdose, so supportive treatment is carried out depending on the symptoms that appear, in difficult cases - in a hospital setting.

Interaction

The combination of this drug with CYP3A4 inhibitors causes an increase in concentration in the composition and the development of undesirable reactions. Combination with inducers of CYP3A4 often speeds up metabolism carbamazepine , reducing its concentration and therapeutic effect.

Simultaneous use , dextropropoxyphene, viloxazine, fluoxetine, cimetidine, , desipramine, and macrolides - troleandomycin, some azoles - , and can significantly increase concentration. The same action is typical for , propoxyphene , grapefruit juice, viral protease inhibitors. In this case, it is necessary to adjust the dosage and control the concentration of the substance in the plasma.

A combination can lead to a mutual decrease or increase in concentration felbamate And .

INN: Carbamazepine

Manufacturer: Teva Operations Poland Sр.z.о.о.

Anatomical-therapeutic-chemical classification: Carbamazepine

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 015893

Registration period: 14.10.2015 - 14.10.2020

ALO (Included in the List of free outpatient drug provision)

Instructions

Tradename

Finlepsin 200 retard

Finlepsin 400 retard

International nonproprietary name

Carbamazepine

Dosage form

Extended-release tablets, 200 mg or 400 mg

Compound

active substance- carbamazepine 200 mg or 400 mg,

Excipients: Eudragit RS 30D-ammonium methacrylate copolymer (type B) dispersive, triacetin (glycerol triacetate), talc, Eudragit L 30D-55-methacrylic acid-ethyl acrylate copolymer (1:1) dispersive 30%, crospovidone, colloidal anhydrous silicon, magnesium stearate , microcrystalline cellulose.

Description

Tablets are white or yellowish in color, round, cloverleaf-shaped with beveled edges, with a flat surface, with cross-shaped break lines on both sides and 4 notches on the side surface.

Pharmacotherapeutic group

Antiepileptic drugs. Carboxamide derivatives.

Carbamazepine.

ATX code N03AF01

Pharmacological properties

Pharmacokinetics

Absorption is slow but complete (food intake does not significantly affect the speed and extent of absorption). After a single dose of the tablet, Cmax is reached after 32 hours. The average Cmax value of the unchanged active substance after a single dose of 400 mg of carbamazepine is about 2.5 μg/ml. Css of the drug in plasma are achieved in 1-2 weeks (the speed of achievement depends on the individual characteristics of metabolism: autoinduction of liver enzyme systems, heteroinduction by other simultaneously used drugs), as well as on the patient’s condition, the dose of the drug and the duration of treatment. There are significant individual differences in Css values ​​in the therapeutic range: in most patients these values ​​range from 4 to 12 μg/ml (17-50 μmol/l). Concentrations of carbamazepine-10,11-epoxide (a pharmacologically active metabolite) are approximately 30% of those of carbamazepine. Communication with plasma proteins in children is 55-59%, in adults - 70-80%. Apparent Vd - 0.8-1.9 l/kg. In the cerebrospinal fluid and saliva, concentrations are created that are proportional to the amount of active substance not bound to proteins (20-30%). Penetrates through the placental barrier. The concentration in breast milk is 25-60% of that in plasma. Metabolized in the liver, mainly along the epoxide pathway with the formation of the main metabolites - active carbamazepine-10,11-epoxide and an inactive conjugate with glucuronic acid. The main isoenzyme that ensures the biotransformation of carbamazepine into carbamazepine-10,11-epoxide is cytochrome P450 (CYPZA4). As a result of these metabolic reactions, the metabolite 9-hydroxymethyl-10 - carbamoylacridan, which has weak pharmacological activity, is also formed. Carbamazepine can induce its own metabolism. T1/2 after oral administration of a single dose is 60-100 hours (on average about 70 hours); with prolonged use, T1/2 decreases due to autoinduction of liver enzyme systems. After a single oral dose of carbamazepine, 72% of the dose taken is excreted in the urine and 28% in the feces; in this case, about 2% of the dose taken is excreted in the urine in the form of unchanged carbamazepine, about 1% in the form of a 10,11-epoxide metabolite.

There is no data indicating that the pharmacokinetics of carbamazepine changes in elderly patients.

Pharmacodynamics

An antiepileptic drug (dibenzazepine derivative), which also has antidepressant, antipsychotic and antidiuretic effects, has an analgesic effect in patients with neuralgia. The mechanism of action is associated with the blockade of voltage-gated sodium channels, which leads to stabilization of the membrane of overexcited neurons, inhibition of the occurrence of serial neuronal discharges and a decrease in synaptic conduction of impulses. Prevents the repeated formation of Na+-dependent action potentials in depolarized neurons. Reduces the release of the excitatory neurotransmitter amino acid glutamate, increases the reduced convulsive threshold of the central nervous system and, thus, reduces the risk of developing an epileptic attack. Increases K+ conductivity, modulates voltage-gated Ca+ channels, which may contribute to the anticonvulsant effect of the drug. Effective for focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, for generalized tonic-clonic epileptic seizures, as well as for a combination of these types of seizures (usually ineffective for minor seizures - petit mal, absence seizures and myoclonic seizures). In patients with epilepsy (especially children and adolescents), a positive effect on symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness, was noted. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).

In case of essential and secondary trigeminal neuralgia, carbamazepine in most cases prevents the occurrence of painful attacks. Pain relief from trigeminal neuralgia is observed after 8-72 hours. In alcohol withdrawal syndrome, it increases the threshold of convulsive readiness, which in this condition is usually reduced, and reduces the severity of the clinical manifestations of the syndrome (increased excitability, tremor, gait disturbance). The antipsychotic (antimanic) effect develops after 7-10 days and may be due to inhibition of the metabolism of dopamine and norepinephrine. The prolonged dosage form ensures the maintenance of a more stable concentration of carbamazepine in the blood when taken 1-2 times a day.

Indications for use

    epilepsy: partial seizures, both simple and complex

symptoms; grand mal seizures, mainly of focal origin (grand mal seizures during sleep, diffuse grand mal seizures); mixed forms of epilepsy

    trigeminal neuralgia

    glossopharyngeal neuralgia

    pain due to diabetic neuropathy

    epileptiform seizures in multiple sclerosis, such as neuralgia

trigeminal nerve; tonic convulsions; paroxysmal dysarthria and

ataxia; paroxysmal paresthesia and attacks of pain - prevention of seizures during alcohol withdrawal

syndrome

Prevention of psychosis in manic-depressive states, hypochondriacal depression

Directions for use and doses

Finlepsin retard is prescribed orally, individually, taking into account the indications and condition of the patient, during or after meals, with a sufficient amount of water. Extended-release tablets can be taken after first dissolving them in water, since the property of prolonged release of the active substance is preserved after dissolving the tablet in liquid.

In each individual case, treatment with Finlepsin retard should begin individually, depending on the type and severity of the clinical picture, and in the future, the dose should be gradually increased to achieve the most effective maintenance dose.

The daily dose usually ranges from 400 to 1200 mg, divided into 1-2 doses per day. As a rule, the total daily dose should not exceed 1600 mg of carbamazepine.

The optimal dose of the drug for the patient, especially in combination treatment, is determined based on the level of carbamazepine in the blood plasma.

Experience shows that the therapeutic level of carbamazepine is 4-12 µg/ml.

In some cases, the required dose may differ significantly from the recommended initial and maintenance dose (possibly due to increased metabolism caused by enzymatic induction or interaction with other drugs in combination treatment).

Epilepsy

In the treatment of epilepsy, Finlepsin retard should preferably be used as monotherapy. Treatment should be supervised by an experienced specialist. When switching to Finlepsin retard, the dose of the previously used antiepileptic drug should be reduced gradually. If the patient forgot to take the next dose of the drug in a timely manner, the missed dose should be taken as soon as this omission became noticed, and a double dose of the drug should not be taken.

Adults: the dosage should be individually selected for each patient. Monitoring plasma concentrations of carbamazepine may be helpful to determine the optimal dose.

Children

The initial dose for children from 6 to 15 years is 200 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved. For children, the average maintenance dose is 10-20 mg/kg body weight/day. Maintenance dose for children 6-10 years old - 400-600 mg per day (in 2 doses); for children 11-15 years old - 600-1000 mg per day (in 2 doses). The following dosage regimen is recommended:

For trigeminal neuralgia and glossopharyngeal neuralgia the drug is prescribed at an initial dose of 200-400 mg/day, which is divided into 2 doses. The initial dose is increased until pain disappears completely to 400-800 mg/day, which is taken 1-2 times a day. After this, treatment can be continued using a lower maintenance dose of 400 mg/day, divided into 2 doses. For elderly patients and patients sensitive to carbamazepine, Finlepsin retard is prescribed at an initial dose of 200 mg 1 time per day.

P for pain syndrome in diabetic neuropathy the average daily dose is 200 mg in the morning and 400 mg in the evening. In exceptional cases, up to 1.2 g/day (600 mg 2 times a day) can be prescribed.

For epileptiform seizures in multiple sclerosis the average daily dose is 400-800 mg, divided into 2 doses.

Prevention of the development of convulsive seizures during alcohol withdrawal syndrome (in a hospital setting)

The average daily dose is 600 mg (200 mg in the morning, 400 mg in the evening).

In severe cases, in the first days the dose can be increased to 600 mg 2 times a day. Finlepsin retard should not be combined with sedative-hypnotics. If necessary, Finlepsin retard can be combined with other substances used to treat alcohol withdrawal. During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma. Due to the development of side effects from the central and autonomic nervous system, the patient is closely monitored in a hospital setting.

For the prevention of psychosis the drug is prescribed at a dose of 200-400 mg/day. If necessary, this dose can be increased to 800 mg/day, which is divided into 2 doses. The duration of treatment varies depending on the case and is determined by the attending physician.

Antiepileptic treatment is always long-term. When treating epilepsy, issues such as stabilization and duration of treatment with Finlepsin retard should be resolved individually by an experienced specialist. The decision to reduce the dose and stop taking the drug should not be made before the patient has been seizure-free for two or three years.

To stop treatment, it is necessary to gradually reduce the dose over a year or two years under EEG monitoring. In children, when reducing the daily dose of the drug, the increase in body weight with age should be taken into account.

When treating neuralgia, it is sufficient to continue treatment for several weeks with a maintenance dose to ensure there is no pain. By carefully reducing the dose, it is necessary to determine whether spontaneous regression of the symptoms of the disease has occurred. If pain attacks recur, treatment is continued using the previous maintenance dose.

The duration of treatment for pain in diabetic neuropathy and epileptiform seizures in multiple sclerosis is the same as for neuralgia.

Treatment of patients with alcohol withdrawal syndrome with Finlepsin retard is stopped, gradually reducing the dose over 7-10 days.

Prevention of manic-depressive phases is long-term.

The duration of therapy depends on the case and is determined by the attending physician.

Side effects

From the central nervous system:

Often - dizziness, ataxia, drowsiness, general weakness, headache, paresis, accommodation;

Sometimes - abnormal involuntary movements (eg, tremor, fluttering tremor - asterixis, dystonia, tics); nystagmus;

Rarely - hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, psychomotor agitation, disorientation, activation of psychosis, orofacial dyskinesia, oculomotor disorders, speech disorders (for example, dysarthria or slurred speech), choreathetoid disorders, peripheral neuritis, paresthesias, muscle weakness and symptoms of paresis. The role of carbamazepine as a drug that causes or contributes to the development of neuroleptic malignant syndrome, especially when it is prescribed together with antipsychotics, remains unclear.

Allergic reactions:

Often - hives;

Sometimes - erythroderma, multiorgan delayed-type hypersensitivity reactions with fever, skin rash, vasculitis (including erythema nodosum as a manifestation of cutaneous vasculitis), lymphadenopathy, signs resembling lymphoma, arthralgias, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function tests (specified manifestations occur in various combinations). Other organs may also be involved (eg, lungs, kidneys, pancreas, myocardium, colon), and aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, hypersensitivity pneumonitis, or eosinophilic pneumonia are possible. If the above allergic reactions occur, use of the drug should be discontinued.

Rarely - lupus-like syndrome, itching, skin, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.

From the hematopoietic organs:

Often - leukopenia, thrombocytopenia, eosinophilia;

Rarely - leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocyte aplasia, megaloblastic anemia, acute “intermittent” porphyria, reticulocytosis, hemolytic anemia, splenomegaly.

From the digestive system:

Often - nausea, vomiting, dry mouth, increased activity of gammaglutamyltransferase (due to the induction of this enzyme in the liver), increased activity of alkaline phosphatase.

Sometimes - increased activity of “liver” transminases, diarrhea or constipation, abdominal pain.

Rarely- glossitis, gingivitis, stomatitis, pancreatitis, cholestatic, parenchymal (hepatocellular) type hepatitis, jaundice, granulomatous hepatitis, liver failure.

From the cardiovascular system:

Rarely - intracardiac conduction disturbances, decrease or increase in blood pressure, bradycardia, arrhythmias, atrioventricular block with fainting, collapse, worsening or development of chronic heart failure, exacerbation of coronary heart disease (including the appearance or increase in angina attacks), thrombophlebitis, thromboembolic syndrome.

From the endocrine system and metabolism:

Often - edema, fluid retention, weight gain, hyponatremia (a decrease in plasma osmolarity due to an effect similar to the action of antidiuretic hormone, which in rare cases leads to dilution hyponatremia, accompanied by lethargy, vomiting, headache, disorientation and neurological disorders);

Rarely- increased concentration of prolactin (may be accompanied by galactorrhea and gynecomastia); a decrease in the concentration of L-thyroxine and an increase in the concentration of thyroid-stimulating hormone (usually not accompanied by clinical manifestations); disturbances of potassium-phosphorus metabolism in bone tissue (decrease in the concentration of Ca2+ and 25-OH-cholecalciferol in the blood plasma); osteomalacia, hypercholesterolemia (including high-density lipoprotein cholesterol), hypertriglyceridemia and lymph node enlargement, hirsutism.

From the genitourinary system: Rarely - interstitial nephritis, renal failure, renal dysfunction (eg, albuminuria, hematuria, oliguria, increased urea/azotemia), frequent urination, urinary retention, decreased potency.

From the musculoskeletal system:

Rarely - arthralgia, myalgia or seizures

From the senses: Rarely - disturbance of taste, increased intraocular pressure, clouding of the lens, conjunctivitis, hearing impairment, incl. tinnitus, hyperacusis, hypoacusia, changes in the perception of pitch.

Others: skin pigmentation disorders, purpura, acne, sweating, alopecia.

Contraindications

Combination with monoamine oxidase inhibitors (MAOIs), administration

MAO inhibitors should be discontinued at least 2 weeks before administration

carbamazepine

Concomitant use of lithium drugs

Concomitant use of voriconazole

Bone marrow hematopoiesis disorders (anemia, leukopenia)

Conduction disturbances (atrioventricular block)

Hypersensitivity to active and auxiliary

substances, tricyclic antidepressants

Acute intermittent porphyria (including history)

Absence seizures

Severe dysfunction of the heart, liver and kidneys

Sodium metabolism disorder

Children under 6 years old

Carefully:

Decompensated chronic heart failure; dilution hyponatremia (ADH hypersecretion syndrome, hypopituitarism, hypothyroidism, adrenal insufficiency); insufficiency of liver and kidney function; elderly patients; active alcoholism (increased depression of the central nervous system, increased metabolism of carbamazepine); suppression of bone marrow hematopoiesis due to medication (history); prostatic hyperplasia; increased intraocular pressure; combination with sedative-hypnotics.

Drug interactions

Co-administration of carbamazepine with CYP3A4 inhibitors may lead to an increase in its concentration in the blood plasma and the development of adverse reactions. The combined use of CYP3A4 inducers can lead to an acceleration of the metabolism of carbamazepine, a decrease in its concentration in the blood plasma and a decrease in the therapeutic effect; on the contrary, their cancellation may reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration.

Increase the concentration of carbamazepine in plasma verapamil, diltiazem, felodipine, dextropropoxyphene, viloxazine, fluoxetine, fluvoxamine, cimetidine, acetazolamide, danazol, desipramine, nicotinamide (in adults, only in high doses); macrolides (erythromycin, josamycin, clarithromycin, troleandomycin); azoles (itraconazole, ketoconazole, fluconazole), terfenadine, loratadine, isoniazid, propoxyphene, grapefruit juice, viral protease inhibitors used in the treatment of HIV infection (for example, ritonavir) - dosage adjustment or monitoring of carbamazepine plasma concentrations is required.

Felmabate reduces the plasma concentration of carbamazepine and increases the concentration of carbamazepine-10,11-epoxide, and a simultaneous decrease in the serum concentration of felbamate is possible.

The concentration of carbamazepine is reduced by phenobarbital, phenytoin, primidone, methsuximide, fensuximide, theophylline, rifampicin, cisplatin, doxorubicin, possibly clonazepam, valpromide, valproic acid, oxcarbazepine and herbal preparations containing St. John's wort (Hypericum perforatum). There is a possibility of valproic acid and primidone displacing carbamazepine from binding to plasma proteins and increasing the concentration of the pharmacologically active metabolite (carbamazepine-10,11-epoxide). When finlepsin is used in combination with valproic acid, in exceptional cases, coma and confusion may occur.

Isotretinoin alters the bioavailability and/or clearance of carbamazepine and carbamazepine-10,11-epoxide (monitoring of carbamazepine plasma concentrations is necessary). Carbamazepine may reduce plasma concentrations (reduce or even completely eliminate the effects) and may require dose adjustment of the following drugs: clobazam, clonazepam, digoxin, ethosuximide, primidone, valproic acid, alprazolam, glucocorticosteroids (prednisolone, dexamethasone), cyclosporine, tetracyclines (doxycycline) , haloperidol, methadone, oral medications containing estrogens and/or progesterone (selection of alternative methods of contraception is necessary), theophylline, oral anticoagulants (warfarin, phenprocoumon, dicumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriptyline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors used in the treatment of HIV infection (indinavir, ritonavir, saquinovir), calcium channel blockers (dihydropyridone group, for example felodipine), itraconazole, levothyroxine, midazolam, olanzapine, praziquantel, risperidone, tr madola, ciprasidone. There is a possibility of an increase or decrease in the level of phenytoin in the blood plasma against the background of carbamazepine and an increase in the level of mephenytoin. With the simultaneous use of carbamazepine and lithium preparations, the neurotoxic effects of both active substances may be enhanced.

Tetracyclines may weaken the therapeutic effect of carbamazepine. When used together with paracetamol, the risk of its toxic effect on the liver increases and therapeutic effectiveness decreases (acceleration of paracetamol metabolism).

The simultaneous administration of carbamazepine with phenothiazine, pimozide, thioxanthenes, molindone, haloperidol, maprotiline, clozapine and tricyclic antidepressants leads to an increased inhibitory effect on the central nervous system and a weakening of the anticonvulsant effect of carbamazepine. Monoamine oxidase inhibitors increase the risk of hyperpyretic crises, hypertensive crises, convulsions, and death (before prescribing carbamazepine, monoamine oxidase inhibitors should be discontinued at least 2 weeks in advance or, if the clinical situation allows, even longer).

Concomitant administration with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia, accompanied by clinical manifestations. Weakens the effects of non-depolarizing muscle relaxants (pancuronium). If this combination is used, it may be necessary to increase the dose of muscle relaxants, and careful monitoring of the patient's condition is necessary due to the possibility of faster cessation of the effect of muscle relaxants. Carbamazepine reduces ethanol tolerance. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Accelerates the metabolism of indirect anticoagulants, hormonal contraceptives, folic acid; praziquantel may enhance the elimination of thyroid hormones.

Accelerates the metabolism of anesthetics (enflurane, halothane, fluorothane) and increases the risk of developing hepatotoxic effects; enhances the formation of nephrotoxic metabolites of methoxyflurane. Strengthens the hepatotoxic effect of isoniazid.

special instructions

Monotherapy for epilepsy begins with a low initial dose, gradually increasing it until the desired therapeutic effect is achieved.

When selecting the optimal dose, it is advisable to determine the concentration of carbamazepine in the blood plasma, especially during combination therapy.

In some cases, the optimal dose may deviate significantly from the recommended initial and maintenance dose, for example, due to the induction of microsomal liver enzymes or due to interactions during combination therapy.

Finlepsin retard should not be combined with sedative-hypnotics. If necessary, it can be combined with other substances used to treat alcohol withdrawal. During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma. Due to the development of side effects from the central and autonomic nervous system, patients are closely monitored in a hospital setting. When transferring a patient to carbamazepine, the dose of the previously prescribed antiepileptic drug should be gradually reduced until it is completely discontinued. Sudden cessation of carbamazepine may trigger epileptic seizures. If it is necessary to abruptly interrupt treatment, the patient should be transferred to another antiepileptic drug under the cover of the drug indicated in such cases (for example, diazepam administered intravenously or rectally, or phenytoin administered intravenously).

Several cases of vomiting, diarrhea and/or decreased nutrition, convulsions and/or respiratory depression have been described in newborns whose mothers took carbamazepine concomitantly with other anticonvulsants (these reactions may represent neonatal withdrawal syndrome). Before prescribing carbamazepine and during treatment, liver function testing is necessary, especially in patients with a history of liver disease, as well as in elderly patients. If existing liver dysfunction worsens or active liver disease develops, the drug should be discontinued immediately. Before starting treatment, it is necessary to conduct studies of the blood picture (including counting platelets, reticulocytes), iron level in the blood serum, general urine analysis, urea level in the blood, electroencephalogram, determination of the concentration of electrolytes in the blood serum (and periodically during treatment, because hyponatremia may develop). Subsequently, these indicators should be monitored weekly during the first month of treatment and then monthly.

In most cases, a transient or persistent decrease in the number of platelets and/or leukocytes is not a precursor to the onset of aplastic anemia or agranulocytosis. However, before starting treatment, and periodically during treatment, clinical blood tests should be performed, including platelet counts and possibly reticulocyte counts, and serum iron levels should be determined. Non-progressive asymptomatic leukopenia does not require discontinuation, however, treatment should be discontinued if progressive leukopenia or leukopenia accompanied by clinical symptoms of an infectious disease occurs. Carbamazepine should be discontinued immediately if hypersensitivity reactions or symptoms indicating the development of Stevens-Johnson syndrome or Lyell's syndrome occur. Mild skin reactions (isolated macular or maculopapular exanthema) usually disappear within a few days or weeks, even with continued treatment or after a reduction in the dose of the drug (the patient should be under close medical supervision at this time).

The possibility of activation of latent psychoses should be taken into account, and in the elderly, the possibility of developing disorientation or psychomotor agitation. Male fertility and/or spermatogenesis disorders are possible, but the relationship between these disorders and carbamazepine has not yet been established. Intermenstrual bleeding may occur with simultaneous use of oral contraceptives. Carbamazepine may adversely affect the reliability of oral contraceptives, so women of reproductive age should use alternative methods of birth control during treatment. Carbamazepine should only be used under medical supervision.

Patients should be informed of early signs of toxicity, as well as skin and liver symptoms. The patient is informed of the need to immediately consult a doctor in case of adverse reactions such as fever, sore throat, rash, ulceration of the oral mucosa, causeless bruising, hemorrhages in the form of petechiae or purpura.

Before starting treatment, it is recommended to conduct an ophthalmological examination, including fundus examination and measurement of intraocular pressure. If the drug is prescribed to patients with increased intraocular pressure, constant monitoring of this indicator is required.

Patients with severe cardiovascular diseases, liver and kidney damage, as well as elderly people are prescribed lower doses of the drug. Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very small, regular determination of carbamazepine levels may be useful in the following situations: with a sharp increase in the frequency of attacks; to check whether the patient is taking the drug properly; during pregnancy; when treating children or adolescents; if there is a suspicion of impaired absorption of the drug; if toxic reactions are suspected if the patient is taking several medications.

Pregnancy and lactation

During pregnancy, carbamazepine should be prescribed only after carefully weighing the benefits and risks. Women of childbearing age need to be explained about the need to plan and control pregnancy. Whenever possible, carbamazepine should be prescribed to women of childbearing potential as monotherapy, as the risk of birth defects increases when combined with other antiepileptic drugs.

If pregnancy occurs during treatment with carbamazepine or there is a need for treatment with carbamazepine during pregnancy, the attending physician should carefully weigh the potential benefits of using the drug against the possible risks to the fetus, especially in the first trimester of pregnancy. It is necessary to prescribe the minimum effective dose and monitor the concentration of the drug in the blood plasma. In no case should you stop treatment without consulting a doctor, since epileptic seizures can threaten the health of both mother and child.

As with other anticonvulsants, a variety of congenital defects have been reported following fetal exposure to carbamazepine, including spina bifida, maxillofacial dysarthrosis, nail hypoplasia, and developmental delay.

Epidemiological studies have shown that the risk of developing spina bifida is 1%, which is approximately ten times the normal rate. It is still unclear whether birth defects are caused by carbamazepine treatment, since there may also be an association with the underlying disease and genetic factors also cannot be excluded. Patients should be informed of the increased risk of developing birth defects and should be given the option of prenatal screening.

Folic acid deficiency, caused by the enzyme-inducing effect of carbamazepine, may be an additional factor contributing to the development of birth defects. Therefore, it may make sense to administer folic acid before and during pregnancy. To prevent bleeding disorders, vitamin K1 can be given to mothers in the last few weeks of pregnancy and to the newborn as a preventative measure.

Convulsions and/or respiratory depression, as well as several cases of vomiting, diarrhea and/or decreased appetite, have been reported in neonates while taking Finlepsin retard and other antiepileptic drugs. These reactions may be attributed to neonatal withdrawal syndrome. Carbamazepine passes into breast milk (25-60% of plasma concentrations), so the benefits and possible undesirable consequences of breastfeeding should be weighed against ongoing treatment. If breastfeeding continues while taking the drug, the child should be monitored due to the possibility of adverse reactions.

(for example, severe drowsiness, decreased rate of weight gain, allergic skin reactions). If these and other undesirable effects develop, breastfeeding should be discontinued.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

When treated with Finlepsin retard, you should refrain from driving a car and engaging in potentially hazardous activities.

Overdose

Symptoms usually reflect disorders of the central nervous system, cardiovascular and respiratory systems.

Central nervous system and sensory organs - depression of the functions of the central nervous system, disorientation, drowsiness, agitation, hallucinations, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (initially), hyporeflexia (later), convulsions, psychomotor disorders, myoclonus, hypothermia, mydriasis);

The cardiovascular system: tachycardia, decreased blood pressure, sometimes increased blood pressure, intraventricular conduction disturbances with widening of the QRS complex; fainting, cardiac arrest;

Respiratory system: respiratory depression, pulmonary edema;

Digestive system: nausea, vomiting, delayed evacuation of food from the stomach, decreased colon motility;

Urinary system: urinary retention, oliguria or anuria; fluid retention; hyponatremia.

Treatment:

There is no specific antidote. Symptomatic supportive treatment in the intensive care unit, monitoring of heart function, body temperature, corneal reflexes, bladder renal function, and correction of electrolyte disorders are necessary. It is necessary to determine the concentration of carbamazepine in plasma to confirm poisoning with this drug and assess the degree of overdose, gastric lavage, and the administration of activated charcoal. Late evacuation of gastric contents can lead to delayed absorption on days 2 and 3 and the reappearance of symptoms of intoxication during the recovery period.

Forced diuresis, hemodialysis and peritoneal dialysis are ineffective; however, dialysis is indicated for the combination of severe poisoning and renal failure. Children may require blood transfusion.

Release forms and packaging

The drug Finlepsin Retard helps normalize the condition of epileptic seizures, eliminates pain and negative symptoms in disorders of the nervous system. It affects a number of biochemical processes in the body, so this medicine should be used under the supervision of a specialist. The advantages include low price.

Carbamazepine. The name in Latin is Carbamazepine.

ATX

N03AF01 Carbamazepine

Release forms and composition

The drug can only be purchased in tablet form. The difference between Finlepsin Retard is the presence of a shell characterized by special properties. It provides a prolonged effect of the drug. This means that the active substance is released slowly. The drug is one-component. The main substance is carbamazepine. Its quantity in 1 tablet: 200 and 400 mg. Other components:

  • copolymer of ethyl acrylate, trimethylammonioethyl methacrylate, methyl methacrylate;
  • triacetin;
  • copolymer of methacrylic acid and ethyl acrylate;
  • talc;
  • crospovidone;
  • microcrystalline cellulose;
  • magnesium stearate;
  • colloidal silicon dioxide.

You can purchase the medicine in packages containing 3, 4 or 5 blisters (each containing 10 tablets).

How it works

Main properties:

  • antiepileptic;
  • pain reliever;
  • antidiuretic;
  • antipsychotic.

The pharmacological action of this drug is based on blocking sodium channels. The desired effect can be obtained only if they are voltage-dependent. As a result, there is an elimination of increased excitability of neurons, which is due to the stabilization of their membranes. Also, under the influence of the drug, the intensity of the process of synaptic conduction of impulses decreases.

Antiepileptic therapy is based on increasing the lower limit of seizure readiness.

There is a decrease in the intensity of production of glutamate, an amino acid that increases the excitation of neurotransmitters. Thanks to these properties, the likelihood of developing an epileptic attack is reduced. The main component is involved in the transport of potassium and calcium ions.

The drug is active and reduces the intensity of negative symptoms when attacks of various types occur. During the treatment of patients with diagnosed epilepsy, there is an improvement in such pathological conditions as anxiety, depression, aggressiveness, irritability.

The antipsychotic effect is due to inhibition of the metabolic processes of norepinephrine and dopamine. With alcohol poisoning, the intensity of the development of seizures decreases. This is due to an increase in the lower limit of convulsive readiness. If trigeminal neuralgia develops, Finlepsin Retard reduces the severity of pain attacks. In addition, timely treatment with this drug helps prevent the occurrence of pain with such a diagnosis.

Pharmacokinetics

The duration of release of the active substance is 12 hours. At the end of this period, there is an increase in the level of efficiency to the maximum. The drug is completely absorbed by the walls of the gastrointestinal tract.

The active substance binds to plasma proteins with varying intensity: up to 60% in children, 70-80% in adult patients.

The metabolism of carbamazepine occurs in the liver, resulting in the release of 1 active and 1 inactive component. This process is realized with the participation of the CYP3A4 isoenzyme.

Most of the carbamazepine in a transformed form is excreted during urination, a small proportion is excreted in feces during defecation. Of this amount, only 2% of the active substance is removed unchanged. In children, carbamazepine is metabolized faster. For this reason, it is used in higher dosages.

What is it prescribed for?

The main area of ​​application is epilepsy. In addition, the drug is effective in the following pathological conditions and symptoms:

  • seizures of various types: partial, convulsive;
  • mixed forms of epilepsy;
  • neuralgia of various types: trigeminal nerve, idiopathic glossopharyngeal neuralgia;
  • pain caused by peripheral neuritis, which may be a consequence of diabetes mellitus;
  • convulsive conditions that occur with spasms of smooth muscles, multiple sclerosis;
  • speech impairment, limited movements (pathologies of a neurological nature);
  • attacks of pain due to dysfunction of the autonomic nervous system;
  • alcohol poisoning;
  • psychotic disorders.

Contraindications

The drug does not have many restrictions on its use, including:

  • disruption of the hematopoietic system, which is accompanied by pathological conditions such as leukopenia, anemia;
  • AV block;
  • genetic disease porphyria, accompanied by a disorder of pigment metabolism;
  • individual negative reaction or hypersensitivity.

There are a number of pathological conditions in which monitoring of carbamazepine in plasma is mandatory:

  • violation of bone marrow hematopoiesis;
  • neoplasms in the prostate;
  • increased intraocular pressure;
  • failure of cardiac function;
  • hyponatremia;
  • alcoholism.

How to take Finlepsin Retard

The drug is equally effective when taken before and after meals. The tablet cannot be chewed, but can be dissolved in any liquid. The scheme differs depending on the type of pathological condition. Often no more than 1200 mg of the substance is prescribed per day. The dose is divided into 2 doses, but the drug can be taken once. The maximum permissible daily amount is 1600 mg. Instructions for use for various pathologies:

  • epilepsy: the initial amount of medication varies between 0.2-0.4 g per day, then it is increased to 0.8-1.2 g;
  • trigeminal neuralgia: begin the course of therapy with 0.2-0.4 g per day, gradually the dose increases to 0.4-0.8 g;
  • alcohol poisoning: 0.2 g in the morning, 0.4 g in the evening, in extreme cases the dose is increased to 1.2 g per day and divided into 2 doses;
  • therapy of psychotic disorders, convulsive conditions in multiple sclerosis: 0.2-0.4 g 2 times a day.

Pain due to diabetic neuropathy

Standard regimen: 0.2 g of the substance in the morning and double the dose (0.4 g) in the evening. In exceptional cases, 0.6 g is prescribed 2 times a day.

How long does it take to work?

Peak effectiveness is observed 4-12 hours after the start of treatment.

Cancel

It is forbidden to abruptly stop the course of therapy, as this may provoke the development of an attack. It is recommended to reduce the dose gradually over 6 months. If there is an urgent need to discontinue Finlepsin Retard, therapy with appropriate drugs is carried out. This reduces the likelihood of negative effects occurring.

Side effects of Finlepsin Retard

The disadvantage of the drug is the high risk of developing individual reactions of a different nature in response to therapy. This is due to the fact that the active substance in its composition is involved in the biochemical processes of the body. The risk of dizziness, drowsiness, sudden weakening of muscles, and headaches is noted. Involuntary movements, nystagmus, hallucinations, depression and other mental disorders rarely occur.

Gastrointestinal tract

There is dryness in the mouth and loss of appetite. Nausea occurs, followed by vomiting, changes in stool, and pain in the abdominal area. The following pathological conditions develop: stomatitis, colitis, gingivitis, pancreatitis, etc.

Blood-forming organs

Anemia, leukopenia, thrombocytopenia, agranulocytosis, porphyria of various types.

From the urinary system

Failure of kidney function, nephritis, various pathological conditions provoked by impaired urinary flow (fluid retention, incontinence).

From the cardiovascular system

Changes in intracardiac conduction, hypotension, pathological conditions caused by an increase in blood viscosity and an increase in the intensity of platelet aggregation, complications of coronary disease, heart rhythm disturbances.

From the endocrine system and metabolism

Obesity, swelling, which is associated with fluid retention in tissues, influence on the results of blood tests, changes in bone metabolism, which leads to diseases of the musculoskeletal system.

Allergies

Hives. Erythroderma may develop.

Impact on the ability to operate machinery

The drug has a negative effect on the functioning of many organs and systems, provokes dangerous symptoms: impaired consciousness, hallucinations, dizziness, etc. For this reason, caution should be exercised when driving vehicles. It's better to stop driving for a while.

special instructions

Begin the course of therapy with small doses. Gradually, the daily amount of the main component increases. It is important to monitor the level of carbamazepine in the blood.

It should be borne in mind that therapy with antiepileptic drugs provokes the emergence of suicidal intentions, so the patient should be monitored until the course of treatment is completed.

Before starting therapy, the condition of the liver and kidneys is assessed. You need to take a blood test, urine test, and conduct an electroencephalogram.

Use in old age

Patients over 65 years of age are allowed to use the medicine. However, the recommended dose is 0.2 g per day once.

Use during pregnancy and lactation

The drug can penetrate the placenta into breast milk, and the concentration of carbamazepine is 40-60% of the total amount contained in the blood. During pregnancy, there is a risk of developing pathologies in the fetus while taking the drug in question. However, it is still allowed to use the drug, but this should be done only according to strict indications, if the positive effects of treatment outweigh the possible harm.

Prescription of Finlepsin Retard for children

Use for renal impairment

The drug is approved for use in pathologies of this organ, but the patient’s condition must be monitored.

Use for liver dysfunction

It is allowed to prescribe the remedy in this case. If liver dysfunction worsens, you need to interrupt the course.

What to do in case of an overdose of Finlepsin Retard

There are a number of negative manifestations that occur with a regular and significant increase in the permissible amount of carbamazepine:

  • coma;
  • disruption of the nervous system: overexcitation, drowsiness, involuntary movements, blurred vision;
  • hypotension;
  • violation of the heart rhythm;
  • depression of the respiratory system;
  • vomiting and nausea;
  • changes in laboratory results.

Treatment is carried out aimed at eliminating the consequences. At the same time, the work of the heart is monitored and body temperature is monitored. Correction of water-electrolyte imbalance is carried out. The level of active substance in the blood is determined. Gastric lavage is performed. Take absorbent. Instead of activated carbon, any drug of this group can be prescribed: Smecta, Enterosgel, etc.

Interaction with other drugs

Before starting treatment, take into account the risk of complications, which may be caused by the use of other medications.

Carefully

An increase in the level of the main component in the blood plasma is provoked by the following drugs: Verapamil, Felodipine, Nicotinamide, Viloxazine, Diltiazem, Fluvoxamine, Cimetidine, Danazol, Acetazolamide, Desipramine, as well as a number of drugs from the group of macrolides and azoles. For this reason, dosage adjustments are made to normalize carbamazepine concentrations.

There is an increase in the effectiveness of folic acid and Praziquantel. In addition, the elimination of thyroid hormones is enhanced.

There is an increase in the effectiveness of Finlepsin Retard when used together with Depakine.

Prescribing Finlepsin Retard together with other drugs that inhibit CYP3A4 provokes the development of negative consequences. Conversely, CYP3A4 inducers help accelerate metabolic processes and eliminate the active substance, which leads to a decrease in the effectiveness of the drug.

Alcohol compatibility

It is prohibited to drink alcohol-containing drinks during Finlepsin therapy. The substances act on the basis of opposite principles, and there is a decrease in the effectiveness of the drug. In addition, alcohol increases the load on the liver.

Finlepsin retard 400 is an excellent anticonvulsant medicine with complex pharmacological effects. Prescribed for both children and adults.

Finlepsin retard 400 is an excellent anticonvulsant medicine with complex pharmacological effects.

International nonproprietary name

Carbamazepine.

ATX and registration number

The product code is N03AF01.

Number – P N015417/01.

Pharmacotherapeutic group

Antiepileptic drug.

Mechanism of action

The medicine belongs to the antiepileptic group. It also has pronounced antipsychotic, antidepressant, analgesic and antidiuretic properties.

The pharmacological effect of the drug is characterized by blocking sodium channels and restoration of neuronal membranes, which leads to a decrease in nerve impulses.

The drug reduces the release of glutamate and suppresses the development of convulsive syndrome in epilepsy. Increases the conductivity of potassium cations and modulates calcium channels.

The drug is particularly effective in neurological and mental pathologies, and in the treatment of various forms of epileptic seizures.

The drug helps eliminate symptoms of anxiety and depression, relieves feelings of aggression, nervousness and irritability. The effect on psychomotor function depends on the therapeutic dose.

The anticonvulsant properties of the drug begin to appear quickly, lasting from 2 hours to several days. In rare cases, the therapeutic effect lasts a month, it depends on the metabolism of the medicinal components.

The product is widely used to relieve pain in neuralgia, myalgia, and arthralgia. The analgesic effect lasts up to several hours and begins 8-72 hours after administration.

The drug helps eliminate signs of intoxication and relieves seizures during alcohol withdrawal.

The development of the antipsychotic effect occurs a week after the start of the course. This property is associated with a decrease in the adsorption of norepinephrine and dopamine in the body.

When administered parenterally, the components of the drug are slowly but completely absorbed from the digestive tract.

After a single use, the highest concentration of the main substance is achieved after 32 hours.

The half-life lasts 60-100 hours and depends on the functioning of the excretory system. Metabolism of the drug takes place in the liver, the drug is excreted by the kidneys in the urine and some in the feces.

Composition and release form

The medicine is sold only in tablet form. Externally they are white or other light shades (yellow) are present.

The main component is carbamazepine 400 mg. Additional substances are talc, magnesium stearate, cellulose and other chemical compounds.

Package

Indications for use

According to the instructions for use, the main indications for prescribing the drug are:

  • Various forms of epilepsy in adult and childhood patients.
  • Neuralgia.
  • Pain due to diabetes mellitus, diabetic neuropathy, and damage to nerve endings.
  • Paresis, convulsive states, ataxia.
  • Treatment of alcohol withdrawal to prevent severe symptoms and the development of muscle cramps.
  • Mental disorders (depression, severe stress, psychosis, hallucinations, schizophrenic conditions).

The drug is used to reduce irritability, increased restlessness, anxiety and excitement.

Contraindications

You should not take the medicine for the following conditions:

  • hypersensitivity to medicinal components;
  • disorders of hematopoietic function (decreased platelet count, anemia, leukopenia);
  • history of porphyria;
  • atrioventicular block.

Care must be taken in prescribing the drug to patients with pathologies of the heart, kidneys and liver. Also for elderly people, with alcohol dependence, prostate diseases, and with simultaneous use of the drug with sedatives and hypnotics.

Method of application and dosage of Finlepsin retard 400

The drug is intended for parenteral administration, regardless of food. The tablet should be taken with water or allowed to be dissolved in liquid.

The drug is often prescribed at a dose of 400-1200 mg per day, depending on the type of pathology, age and individual characteristics. The largest amount of the drug per day should not exceed 1600 mg.

For the treatment of epilepsy, the drug is prescribed as monotherapy. The course begins with a minimum dose, gradually increasing it to the optimal value.

If you miss the next dose, you should drink it immediately. However, you should not take a double dose.

For adults with epileptic seizures, 200-400 mg is prescribed. Afterwards, maintenance treatment is prescribed at 800-1200 mg twice a day.

In childhood, it is recommended to take 200 mg tablets starting from 6 years of age. Then the dosage is gradually increased according to clinical indications. Maintenance therapy for children depends on age.

The therapeutic dose and course duration are calculated by a medical specialist. It determines when to stop or prescribe the drug, reduce or increase the dosage.

Reducing the dose of the drug followed by discontinuation is carried out gradually over a long period of time.

When treating pain due to neuralgia, tablets of 200-400 mg are prescribed 2 times a day. Initially, the patient is given the maximum dose, followed by maintenance therapy in the amount of 400 mg per day.

To relieve pain in diabetic neuropathy, the drug is prescribed to be taken twice a day in an amount of 600 mg. In rare cases, the patient may be prescribed 600 mg twice a day in one go.

In case of alcohol withdrawal, patients are advised to consume 600-1200 mg 2 times a day, depending on the severity of symptoms, to prevent signs of intoxication. In case of urgent need, the drug is combined with other drugs.

During the course of treatment, it is imperative to monitor the level of the active substance in the blood plasma.

As a result of the high risk of side effects from the nervous system, the patient should be monitored regularly.

For the treatment of psychosis, 200-400 mg per day is prescribed. In severe condition, 400 mg is prescribed twice a day.

Special instructions when using Finlepsin retard 400

As a result of the possible occurrence of side effects, laboratory tests should be systematically performed to monitor therapy and monitor liver and kidney function.

To reduce the risk of developing an epileptic attack, it is recommended to gradually increase the dose of the drug and subsequently discontinue it when treating the disease.

It is necessary to control intraocular pressure, especially in persons with ophthalmic diseases.

The medicine reduces the therapeutic properties of oral contraceptives.

Women taking the drug and breastfeeding may experience diarrhea, vomiting, poor nutrition, convulsions, and respiratory depression in the child. For this reason, it is advisable to stop breastfeeding during the treatment period.

It is advisable not to combine the drug with drugs from the group of sedatives and sleeping pills.

It should be remembered that in elderly people, when taking the drug, disorientation in space and high excitability of the nervous system are possible.

During the course of therapy, it is necessary to avoid drinking alcohol.

Patients with pathologies of the cardiovascular system, pancreas, kidneys and liver need to take a minimum dose.

During pregnancy and lactation

The drug may be used as prescribed by a doctor if the risks to the mother exceed the negative effect of the drug on the fetus.

In childhood

For children, the medicine is prescribed in an individual dose, according to age and type of pathology.

In old age

For liver dysfunction

It is necessary to change the dose of the drug. In case of acute deficiency, use is contraindicated.

For impaired renal function

It is allowed to use the product with a reduced therapeutic dosage.

Side effects

  • headaches, dizziness, hallucinations of various etiologies, paresis, nystagmus, tremor, depression, anxiety, anxiety, ataxia, sleep problems, weakness, malaise, high excitability, gait disturbance, aggression;
  • allergic reactions often develop, they are accompanied by itching, rash, fever, nasal congestion, leukopenia, decreased levels of lymphocytes, eosinophils in the blood, anaphylactic shock and edema in severe cases;
  • there are disturbances in the hematopoietic system;
  • from the digestive system, stool disorders, vomiting, nausea are observed, stomatitis, hepatitis, inflammation of the tongue, jaundice, epigastric pain may occur;
  • possible changes in blood pressure, heart rhythm disturbances, thrombophlebitis, fainting;
  • there may be weight gain, increased prolactin levels, hyponatremia, swelling, increased cholesterol, metabolic disorders;
  • rarely develop problems with urination, disorders of the excretory system, inflammation of the kidneys, insufficiency of their functions;
  • possible change in taste, tinnitus, flashing dots before the eyes, changes in hearing and vision acuity, blurred vision;
  • the skin becomes sweaty, acne and pigmentation appear.

Effect on driving

While using the drug, you should not drive a car yourself, since the medicine has a strong effect on the central nervous system.

Overdose of Finlepsin retard 400

Overdose symptoms are associated with taking high doses of the drug and are characterized by increased side effects. Often manifested by disturbances in the functioning of the heart, lungs and central nervous system.

The main signs of overdose are convulsions, coma, hallucinations, fainting, drowsiness, ataxia, hearing and vision impairment, mental disorders, decreased body temperature, decreased breathing, problems with urination, and colon function. Muscle weakness, decreased blood pressure, swelling, and cardiac arrest are noted.

Treatment of overdose is symptomatic, maintenance therapy is carried out and the functioning of important organs and systems is monitored.

Drug interactions

Combining the drug with the CYP3A4 isoenzyme leads to an increase in the main component and the development of side effects.

Fluoxetine, Diltiazem, Danazol, Verapamil, Fluvoxamine, Nicotinamide, drugs from the macrolide group, azoles (Ketoconazole, Voriconazole), and protease inhibitors also increase the concentration of the substance.

On the contrary, the level of carbamazepine in the blood is reduced by Primidon, Phenabarbitl, Felbamate, Theophylline, herbal remedies, Clonazepam.

It is necessary to change the therapeutic dose of Cyclosporine, Clobazam, Digoxin, estrogen and progesterone drugs, anticoagulants, calcium channel blockers, drugs used to treat HIV infections, since the drug reduces their pharmacological effectiveness.

You cannot use the drug in parallel with lithium, this increases the toxic effect on the body.

Tetracyclines reduce the therapeutic properties of the drug.

When combining the drug with antidepressants, phenothiazine, clozapine, pimozide, the anticonvulsant effect is reduced and the function of the central nervous system is inhibited.

Do not use the drug together with MAO inhibitors or diuretics.

When combined with muscle relaxants, the therapeutic dose of the latter should be increased.

The drug helps suppress the negative effects of ethanol on the body, but they cannot be used in parallel.

The drug increases the metabolism of folic acid, anesthesia drugs, indirect anticoagulants and contraceptives.

Alcohol compatibility

You should not combine medicine with alcoholic drinks to avoid side effects and other unpredictable phenomena (convulsions, withdrawal symptoms).

Conditions for dispensing from pharmacies

The medicine can be purchased with a doctor's prescription.

Price

The average cost of a medicine is 160 rubles.

Storage conditions

The drug should be stored in its original packaging, in a dry and dark place out of reach of children. Optimum temperature up to +25 C°.

Best before date

Manufacturer

Teva Operations Poland (Poland).

Menarini-Von Heyden GmbH (Germany).

Analogs

You can replace the medicine with analogues such as: Storilat, Carbamazepine, Stazepin, Tegretol.

Finlepsin is an anticonvulsant medication that relieves pain, helps with epilepsy and additionally has an antipsychotic effect. One of the varieties of this drug is Finlepsin retart.

Both forms of the medication have several differences, although many people believe that the drugs are the same thing. Only a doctor can determine which is better - Finlepsin or Finlepsin retard. The products cannot be purchased without a prescription.

Finlepsin is an anticonvulsant. Acts on skeletal muscles. It is used to relieve seizures and reduce the likelihood of their occurrence. In addition, the remedy is used for mental disorders if anxiety occurs.

Release form: tablets. They are round, convex on both sides. They have a whitish tint. The main active ingredient is carbamazepine. One tablet contains 200 mg of this compound. In addition, the composition also includes auxiliary compounds. Tablets are sold in blisters of 10 pcs. There are up to 5 such plates in a pack.

Carbamazepine is a derivative of dibenzazepine. The substance blocks the effect on sodium channels of the cellular structures of the nervous system, including the brain. Their increased activity is eliminated, impulses are suppressed.

The drug has a therapeutic effect:

  1. Anticonvulsant. Acts on motor neurons of the human brain. Thanks to this, the medicine helps with seizures due to epilepsy.
  2. Antipsychotic. Anxiety and nervousness decrease, the depressive mood will not be as pronounced, and aggressiveness of various etiologies disappears. The latter even applies to alcohol addiction and alcohol withdrawal.
  3. Painkiller. Helps with neuritis, when neurocytes become inflamed. The etiology can be any.

After taking the tablets orally, the active compound gradually and completely enters the general bloodstream. It is evenly distributed throughout the tissues and penetrates into the central parts of the nervous system. The drug breaks down in the liver, forming active and inactive compounds that are excreted from the body in urine and feces. The half-life is up to 1.5 days.

Finlepsin tablets should be taken during or after eating. They cannot be chewed or crushed into powder. It is recommended to drink plenty of water.

The treatment regimen and dosage depend on the disease:

  1. Epilepsy. In this case, the medication is suitable for monotherapy. At the beginning of treatment, dosages are minimal. For adult patients - 1-2 tablets, i.e. 200-400 mg. As a maintenance amount, the drug is taken from 800 to 1200 mg per day. This daily dose is divided into 2-3 doses. The maximum amount should not be more than 2 g. For children under 5 years of age, the dosage is 100-200 mg, but it can be increased to 400 mg. For a child under 12 years of age - from 200 to 600 mg.
  2. Neuralgia of the glossopharyngeal nerve. You should start with 200-400 mg and increase to 800 mg.
  3. Alcohol withdrawal. Treatment is carried out in a hospital setting. The initial dose is 600 mg per day. This amount should be divided into 3 servings, but then the daily dose should be increased to 1200 mg. The use of the drug should be stopped gradually.
  4. Pain due to neuropathy caused by diabetes. 600 mg per day is allowed. In the most severe cases - up to 1200 mg.
  5. Epileptic type seizures associated with multiple sclerosis. It is recommended to take 400-800 mg once a day.
  6. Psychoses. To treat and prevent them, you first need to take 200 mg per day, and then increase the volume to 800 mg.

Characteristics of Finlepsin retard

The drug is an anticonvulsant. It can be purchased in tablet form for oral use. They are whitish, round, sold in blisters of 10 pieces. Each contains 200 and 400 mg of carbamazepine, the main active ingredient. In addition, there are also auxiliary connections.

The dosage and duration of therapy is determined by the doctor individually for each patient, depending on the characteristics of his body and the severity of the disease. Initially, the dosage ranges from 100 to 400 mg per day. If necessary (there is no therapeutic effect), you can increase the dosage every week by 200 mg. The entire amount is supposed to be divided into 4 doses, although you can take it at a time. The tablet should be swallowed whole and washed down with plenty of water.

For children under 6 years of age, the dosage is calculated depending on weight - 10 mg for every 1 kg of body weight. The resulting amount should be divided into 3 doses. Children from 6 to 14 years old are prescribed 200 mg per day, but this portion must be taken 2 times. If the effect is insufficient, then it is allowed to increase by 100 mg. The maximum amount per day for children is 1000 mg, for adults - 1200 mg.

Comparison of Finlepsin and Finlepsin retard

To determine which drug is better, it is necessary to study them, highlight their similarities and distinctive features.

Similarities

Indications for the use of Finlepsin and Finlepsin retard are various problems in the functioning of the central nervous system, which lead to movement disorders, mental disorders, and pain. Both drugs are prescribed in the following cases:

  • epilepsy and increased frequency of seizures;
  • seizures of the epileptic type, caused by muscle spasms, multiple sclerosis, and also leading to disturbances in the sensitivity of the skin, problems with gait and speech;
  • pain due to neuritis and neuralgia of the facial nerves;
  • pain associated with disorders of carbohydrate metabolic processes in diabetes mellitus;
  • psychotic disorders.

Both drugs are also used as adjuncts in the treatment of chronic forms of alcoholism and alcohol withdrawal syndrome.

Contraindications to the use of Finlepsin and Finlepsin retard are as follows:

  • disorders of hematopoietic functions;
  • atrioventricular block;
  • porphyria in acute form;
  • individual poor tolerability of the drug or its components, as well as medications from the group of tricyclic antidepressants.

You cannot take lithium preparations and Finlepsin or Finlepsin retard at the same time. The same applies to the use of monoamine oxidase enzyme inhibitors with them. The drug is prescribed with caution during pregnancy and lactation, dysfunction of the heart, liver, kidneys, and prostate.

The side effects of both drugs are the same. These include:

  • nausea, vomiting, feeling of dry mouth, increased activity of liver enzymes, abdominal pain, alternating diarrhea and constipation, stomatitis, hepatitis, pancreatitis;
  • increased body temperature;
  • interstitial nephritis and various problems with the genitourinary system;
  • hearing impairment;
  • dizziness, muscle weakness, drowsiness, loss of appetite.

In all these cases, it is necessary to stop using the drugs.

What is the difference

Finlepsin retard differs slightly from the original drug. It has a prolonged effect due to other proportions of the main component in the tablets. When the medicine enters the stomach, it is released gradually. Thanks to this, the concentration of the substance in the blood is maintained at a sufficient level for a long time, reducing the risk of adverse reactions.

The simultaneous use of both drugs is not allowed. In addition, it must be taken into account that an increase or decrease in phenytoin in the blood plasma is possible when taking carbamazepine.

Which is cheaper?

Finlepsin can be purchased in Russia for 225-245 rubles. The price for Finlepsin retard is about 220 rubles.

Which is better - Finlepsin or Finlepsin retard

The drugs are interchangeable medications, that is, they are considered analogues. The drugs have the same indications, contraindications, side effects and therapeutic effects.

The only difference is the higher concentration of the active compound in Finlepsin retard, due to which the therapeutic effect will last longer. As for the cost, the difference is insignificant.

But any drug is prescribed only by a doctor. They can be purchased at a pharmacy only with a prescription.

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