Finlepsin retard, 50 pcs., 200 mg, extended-release tablets

Nosological classification (ICD-10)

• F10.3 Withdrawal state
• F25 Schizoaffective disorders
• F28 Other non-organic psychotic disorders
• G35 Multiple sclerosis
• G40 Epilepsy
• G50.0 Trigeminal neuralgia
• G52.1 Lesions of the glossopharyngeal nerve
• G63.2 Diabetic polyneuropathy (E10-E14+ with common fourth character .4)
• R20.2 Paresthesia of the skin
• R25.2 Cramp and spasm
• R27.0 Ataxia, unspecified
• R47.1 Dysarthria and anarthria
• R52.9 Pain, unspecified

Compound

Finlepsin price, where to buy

The price of Finlepsin tablets in different regions of Russia differs slightly. At the same time, you can buy Finlepsin 200 mg, 50 pieces each, for 215-270 rubles. The price of Finlepsin retard (400 mg, etc.) varies between 260-330 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Finlepsin tablets 200 mg 50 pcs. Teva Operations Poland Sp.z.
  o.o. 157 rub. order

Pharmacy Dialogue

• Finlepsin tablets 200 mg No. 50Teva

  155 rub. order

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Pharmacy24

• Finlepsin retard 200 mg No. 50 tablets TOV Teva Operations Poland, Poland
  416 UAH. order
• Finlepsin 200 mg No. 50 tablets TOV Teva Operations Poland, Poland

  370 UAH. order

• Finlepsin 400 mg N50 tablets TOV Teva Operations Poland, Poland

  528 UAH order

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PaniPharmacy

• Finlepsin retard tablets Finlepsin retard tablets 200 mg No. 50 Poland, Pliva Krakow

  363 UAH. order

• Finlepsin tablets Finlepsin tablets 200 mg No. 50 Poland, Teva Operations Poland

  270 UAH. order

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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 Ca2+ channels, which may also 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 petit mal seizures, 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.

Reviews about Finlepsin

In most cases, users leave reviews about Finlepsin retard , which they or their loved ones have been taking for several years. Some patients suffering from epilepsy note that taking this drug has an undesirable effect on their intellectual activity, leading to the development of apathy and impaired social communication. However, despite these symptoms, patients confirm the high effectiveness of the medicine, allowing them to forget about the attacks.

There are reviews when Finlepsin was used in the treatment of panic attacks associated with the fear of open or, conversely, closed spaces. As a result of treatment, in most cases, panic goes away, but some continue to be bothered by unsteadiness in gait.

Thus, Finlepsin is one of the most common anticonvulsant and antiepileptic drugs, which is successfully used in clinical practice. According to experts, treatment with this particular remedy allows you to achieve incredible results. The main thing is to strictly follow all doctor’s prescriptions regarding dosing of the drug and lifestyle changes, to know exactly what Finlepsin tablets are for and take them only as indicated.

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 of 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, a metabolite, 9-hydroxymethyl-10-carbamoylacridan, is also formed, which has weak pharmacological activity. 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.

Pharmacological properties of the drug Finlepsin retard

Pharmacodynamics . Anticonvulsant, derivative of tricyclic iminostilbene. It has a moderate antidepressant and normothymic effect. The therapeutic effect is primarily due to the inhibition of synaptic transmission of excitation, and thereby reducing the spread of convulsive attacks. At higher concentrations, carbamazepine causes a decrease in post-tetanic potentiation. Reduces pain in trigeminal neuralgia. This effect is due to inhibition of synaptic transmission of stimulation in the spinal nucleus of the trigeminal nerve. Pharmacokinetics. After oral administration, carbamazepine is absorbed slowly and almost completely. The half-life is 8.5 hours and has a wide range (approximately 1.72–12 hours). After a single dose, the maximum concentration of carbamazepine in the blood plasma in adults is achieved after 4-16 hours (very rarely - after 35 hours), in children - after approximately 4-6 hours. The concentration of carbamazepine in the blood plasma is not linearly dependent on the dose and at When used in higher doses, the plasma concentration curve has the appearance of a plateau. When using extended-release tablets, a lower concentration of carbamazepine in the blood plasma is achieved than when using regular tablets. Equilibrium concentration is achieved after 2–8 days. There is no close correlation between the dose of carbamazepine and steady-state plasma concentrations. Regarding the therapeutic and toxic concentrations of carbamazepine in the blood plasma, it is indicated that attacks may disappear when its level in the blood plasma is 4–12 μg/ml. Concentrations of the drug in blood plasma exceeding 20 mcg/ml worsen the picture of the disease. The drug, with a concentration of the active substance in the blood plasma of 5–18 mcg/ml, eliminates pain in trigeminal neuralgia. 70–80% of carbamazepine is bound to plasma proteins. The portion of carbamazepine not bound to proteins remains constant at a concentration of 50 μg/ml. 48–53% of the pharmacologically active metabolite carbamazepine-10, 11-epoxide is bound to plasma proteins. The concentration of carbamazepine in the cerebrospinal fluid is 33% of the concentration in the blood plasma. Carbamazepine crosses the placental barrier and is excreted into breast milk. After taking a single dose, carbamazepine is eliminated from the blood plasma with a half-life of 36 hours. With prolonged treatment, the half-life is reduced by 50% due to the induction of microsomal liver enzymes. In healthy people, the total plasma clearance is approximately 19.8 ml/h/kg body weight, in patients with monotherapy - approximately 54.6 ml/h/kg, in patients with combination treatment - approximately 113.3 ml/h/kg . After a single oral dose of carbamazepine, 72% of the dose in the form of metabolites is excreted from the body by the kidneys. The remaining 28% is excreted along with feces, partially unchanged. Only 2–3% of the substance excreted in the urine is unchanged carbamazepine.

Indications for Finlepsin® retard

epilepsy: primary generalized seizures (with the exception of absence seizures), partial forms of epilepsy (simple and complex seizures), secondary generalized seizures;

trigeminal neuralgia;

idiopathic glossopharyngeal neuropathy;

pain due to damage to peripheral nerves in diabetes mellitus, pain due to diabetic neuropathy;

epileptiform convulsions in multiple sclerosis, spasms of the facial muscles in trigeminal neuralgia, tonic convulsions, paroxysmal speech and movement disorders (paroxysmal dysarthria and ataxia), paroxysmal paresthesia and attacks of pain;

alcohol withdrawal syndrome (anxiety, convulsions, hyperexcitability, sleep disturbances);

psychotic disorders (affective and schizoaffective disorders, psychoses, disorders of the limbic system).

Indications for use of Finlepsin

Main indications for use of Finlepsin:

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

Contraindications

hypersensitivity to carbamazepine and other components of the drug, as well as to tricyclic antidepressants;

disorders of bone marrow hematopoiesis (anemia, leukopenia);

acute intermittent porphyria (including history);

atrioventricular block;

simultaneous administration of lithium drugs and MAO inhibitors.

With caution: 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.

Contraindications to the use of the drug Finlepsin retard

• bone marrow damage, suppression of bone marrow function in the patient's medical history;
• AV block;
• known hypersensitivity to carbamazepine, tricyclic antidepressants or other components of the drug;
• acute intermittent porphyria;
• concomitant treatment with an MAO inhibitor;
• concomitant treatment with voriconazole, as it may cause treatment failure;
• children under 6 years of age.

In the following cases, Finlepsin retard should be prescribed only after a thorough study of the potential benefits of using the drug compared to the likely risks:

• any current or past diseases of the hematopoietic system, any reactions from the blood system to other medications in the patient’s history;
• disturbance of sodium metabolism;
• serious functional disorders of the heart, liver and kidneys;
• myotonic dystrophy, since with this disorder there is often a disturbance in cardiac conduction.

Use during pregnancy and breastfeeding

For women of reproductive age, Finlepsin® retard is, if possible, prescribed as monotherapy, in the minimum effective dose, because the incidence of congenital anomalies in newborns from mothers taking combined antiepileptic treatment is higher than with monotherapy.

When pregnancy occurs, it is necessary to compare the expected benefits of therapy and possible complications, especially in the first trimester of pregnancy. It is known that children of mothers with epilepsy are predisposed to disorders of intrauterine development, including malformations. Finlepsin® retard may increase the risk of these disorders. There are isolated reports of cases of congenital diseases and malformations, including spina bifida.

Antiepileptic drugs increase folic acid deficiency, which is often observed during pregnancy, which may increase the incidence of birth defects in children, so folic acid supplementation is recommended before and during pregnancy. In order to prevent hemorrhagic complications in newborns, it is recommended that women in the last weeks of pregnancy, as well as newborns, be prescribed vitamin K.

Carbamazepine passes into breast milk, so the benefits and possible undesirable effects of breastfeeding should be weighed against ongoing therapy. If breastfeeding continues while taking the drug, the child should be monitored due to the possibility of adverse reactions (for example, severe drowsiness, allergic skin reactions).

Side effects

When assessing the frequency of occurrence of various adverse reactions, the following gradations were used: very often (10% or more); often (1–10%); sometimes (0.1–1%); rarely (0.01–0.1%); very rare (less than 0.01%).

The development of adverse reactions from the central nervous system may be a consequence of a relative overdose of the drug or significant fluctuations in the concentration of carbamazepine in the blood plasma.

From the side of the central nervous system: often - dizziness, ataxia, drowsiness, general weakness, headache, accommodation paresis; sometimes - abnormal involuntary movements (for example, 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), choreoathetoid disorders, peripheral neuritis, paresthesia , muscle weakness and symptoms of paresis. The role of the drug in the development of neuroleptic malignant syndrome, especially in combination with antipsychotics, remains unclear.

Allergic reactions: often - urticaria; sometimes - erythroderma, multiorgan delayed-type hypersensitivity reactions with fever, skin rashes, vasculitis (including erythema nodosum as a manifestation of cutaneous vasculitis), lymphadenopathy, signs resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function tests (these manifestations occur in various combinations), other organs may also be involved (for example, lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis or eosinophilic pneumonia. If the above reactions occur, use of the drug should be discontinued; rarely - lupus-like syndrome, skin itching, 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 GGT activity (due to the induction of this enzyme in the liver), which usually has no clinical significance, increased alkaline phosphatase activity; sometimes - increased activity of liver transaminases, 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 disorders; decrease or increase in blood pressure, bradycardia, arrhythmias, AV block with fainting, collapse, worsening or development of chronic heart failure, exacerbation of coronary heart disease (including the appearance or increased frequency of angina attacks), thrombophlebitis, thromboembolic syndrome.

From the endocrine system and metabolism: often - edema, fluid retention, weight gain, hyponatremia (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), decreased concentration of L-thyroxine and increased concentration of thyroid-stimulating hormone (usually not accompanied by clinical manifestations), disturbances of calcium-phosphorus metabolism in bone tissue (decreased concentration of Ca2+ and 25-OH-cholecalciferol in blood plasma): osteomalacia, hypercholesterolemia (including HDL cholesterol), hypertriglyceridemia and enlarged lymph nodes, hirsutism.

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

From the musculoskeletal system: rarely - arthralgia, myalgia or convulsions.

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

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

Side effects of the drug Finlepsin retard

The side effects that were observed occurred more frequently with combination treatment than with monotherapy. Depending on the dose and mainly at the beginning of treatment, certain side effects may occur. In general, they disappear on their own after 8–14 days or after a temporary dose reduction. From the central nervous system and psyche Confusion, drowsiness, dizziness, fatigue, impaired coordination of movements (cerebellar ataxia) and headache may often occur. Elderly patients may experience confusion and restlessness. In isolated cases, depressive mood, aggressive behavior, slowness of thinking, decreased motivation, as well as perception disorders (hallucinations) and tinnitus are noted. When treated with Finlepsin retard, latent psychoses may become more active. Rarely, involuntary movements such as large-scale tremors, muscle contractions, or nystagmus occur. In addition, in elderly patients with brain damage, involuntary movements in the maxillofacial area may occur in the form of grimacing (maxillofacial dyskinesia), rotational movements (choreoathetosis), neuroleptic malignant syndrome, and polyneuropathy. Isolated cases of speech impairment, false sensations, muscle weakness, neuritis (peripheral neuritis), as well as paralysis of the lower limbs (paresis) and taste disturbances have been reported. On the part of the organ of vision In some cases, inflammation of the mucous membrane of the eye (conjunctivitis) occurs, sometimes developing into visual disturbances (impaired accommodation, double vision, blurred images), increased intraocular pressure. There have been reports of cases of lens opacity. Retinotoxicity was detected in 2 patients after prolonged therapy with carbamazepine. After stopping carbamazepine, the severity of these phenomena decreased significantly. From the organ of hearing: Decreased hearing, increased auditory perception, impaired perception of pitch. From the musculoskeletal system In isolated cases, arthralgia, myalgia, and muscle spasms were noted. These phenomena disappeared after stopping the drug. On the skin There have been reports of cases of allergic reactions from the skin with or without fever, for example, urticaria, pruritus, sometimes large lamellar or scaly inflammation of the skin (exfoliative dermatitis, erythroderma), Lyell's syndrome, photosensitivity, exudative erythema multiforme, erythema nodosum, Stevens syndrome - Johnson), petechial hemorrhages in the skin and disseminated lupus erythematosus). In isolated cases, hair loss (alopecia) and sweating (diaphoresis), changes in skin pigmentation, acne, hirsutism and vasculitis were noted. From the circulatory and lymphatic system When treated with Finlepsin retard, hemogram disorders may occur: leukocytosis, eosinophilia or leukopenia, thrombocytopenia. According to the literature, the most common form of leukopenia occurs benign (transient in approximately 10% of cases, and permanent in 2% of cases). There are isolated cases of blood diseases, sometimes life-threatening, such as agranulocytosis, aplastic anemia along with other forms of anemia (hemolytic, megaloblastic), reticulocytosis, pancytopenia, erythrocyte aplasia, as well as enlargement of the spleen and lymph nodes. As a rule, this occurs in the first 4 months of treatment. From the gastrointestinal tract Sometimes - loss of appetite, dry mouth, nausea and vomiting, rarely diarrhea or constipation. Isolated cases of abdominal pain and inflammation of the mucous membrane of the nasopharynx (stomatitis, gingivitis, glossitis) are known. There are indications in the literature that carbamazepine can sometimes cause pancreatitis. From the liver and gallbladder Sometimes changes in liver function test parameters are noted, in some cases jaundice occurs, in isolated cases - various forms of hepatitis (cholestatic, hepatocellular, granulomatous, mixed). In isolated cases, acute hepatitis with liver failure developed in the first few months against the background of allergic manifestations. Hormonal and water-salt metabolism Individual cases of enlarged mammary glands in men (gynecomastia) and spontaneous leakage of milk from the mammary glands in women (galactorrhea) have been reported. Finlepsin retard can affect indicators of thyroid function (triiodothyronine, thyroxine, thyroid-stimulating hormone and free thyroxine), especially when combined with other antiepileptic drugs. The most common side effect was hyponatremia, sometimes accompanied by fluid retention, weight gain, and decreased plasma osmotic concentration. In very rare cases, this has resulted in water intoxication with vomiting, headache, confusion, drowsiness and other neurological disorders. Individual cases of edema and weight gain have been observed. Finlepsin retard may reduce serum calcium levels. In isolated cases, this leads to softening of the bones (osteomalacia). In extremely rare cases, cholesterol levels may increase, including HDL cholesterol and TG, as well as free cortisol in the blood serum. Carbamazepine may reduce serum folate levels. A decrease in serum vitamin B12 levels and an increase in homocysteine ​​levels have also been reported under the influence of carbamazepine. In two cases, acute intermittent porphyria occurred. On the part of the respiratory system, isolated disorders have been described, which were accompanied by fever, shortness of breath (dyspnea), inflammation and the development of pulmonary fibrosis. From the genitourinary system Rarely, renal dysfunction occurs, which is manifested by proteinuria, hematuria, oliguria, interstitial nephritis, in isolated cases they develop into renal failure. Perhaps these disorders are due to the drug's own antidiuretic effect. Sometimes dysuria, polakiuria and urinary retention occur. In addition, there are known cases of sexual disorders, such as impotence, decreased libido, and impaired spermatogenesis. From the cardiovascular system Very rarely, mainly in elderly people or in patients with impaired heart function, bradycardia, cardiac arrhythmias, congestive heart failure, circulatory collapse, as well as worsening of coronary heart disease may occur. Disturbances in the conduction of excitation in the myocardium (AV blockade) are rarely observed, which is occasionally accompanied by fainting conditions. In addition, in some cases, significant fluctuations in blood pressure are detected. A drop in blood pressure mainly occurs when the drug is used in high doses. Vasculitis, thrombophlebitis and thromboembolism were also observed. Hypersensitivity reactions Rarely, delayed-type hypersensitivity reactions to the drug develop, accompanied by fever, skin rash, swollen lymph nodes, joint pain, leukocytosis, enlarged liver and spleen, changes in liver function tests, with involvement of other organs, such as the lungs, kidneys, pancreas and myocardium. In isolated cases, an acute generalized reaction and aseptic meningitis with manifestations of myoclonus, eosinophilia, anaphylactic reactions and angioedema were observed.

Interaction

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

The plasma concentration of carbamazepine is increased by 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.

Felbamate 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 require dose adjustment of the following drugs: clobazam, clonazepam, digoxin, ethosuximide, primidone, valproic acid, alprazolam, corticosteroids (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 , фелбамата, тиагабина, окскарбазепина, ингибиторов протеаз, применяемых при терапии ВИЧ-инфекции (индинавира, ритонавира, саквинавира), БКК (группа дигидропиридина, например фелодипин), итраконазола, левотироксина, мидазолама, оланзапина, празиквантела, рисперидона, трамадола, зипрасидона.

There is a possibility of an increase or decrease in phenytoin plasma levels in the presence of carbamazepine and an increase in mephenytoin levels. 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.

MAO inhibitors increase the risk of developing hyperpyretic crises, hypertensive crises, convulsions, and death (before prescribing carbamazepine, MAO 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, and 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.

Directions for use and doses

Orally, during or after meals, with a sufficient amount of liquid. For ease of use, the tablet (as well as half or a quarter of it) can be pre-dissolved in water or juice, because the property of prolonged release of the active substance after dissolving the tablet in the liquid is preserved. The range of doses used is 400–1200 mg/day, divided into 1–2 doses per day.

The maximum daily dose should not exceed 1600 mg.

Epilepsy

Where possible, Finlepsin® retard should be prescribed as monotherapy. Treatment begins with a small daily dose, which is subsequently slowly increased until the optimal effect is achieved. The addition of Finlepsin® retard to existing antiepileptic therapy should be carried out gradually, while the doses of the drugs used are not changed or, if necessary, adjusted. 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 initial dose is 200–400 mg/day, then the dose is gradually increased until the optimal effect is achieved. Maintenance dose: 800–1200 mg/day, divided into 1–2 doses per day.

Children. The initial dose for children from 6 to 15 years is 200 mg/day, then the dose is gradually increased by 100 mg/day until the optimal effect is achieved. Maintenance doses for children 6–10 years old: 400–600 mg/day (in 2 doses); for children 11–15 years old - 600–1000 mg/day (in 2 doses).

The following dosage regimen is recommended:

The duration of use depends on the indication and the patient's individual response to treatment. The decision to transfer the patient to Finlepsin® retard, the duration of its use and discontinuation of treatment is made by the doctor individually. The possibility of reducing the drug dose or stopping treatment is considered after a 2-3 year period of complete seizure freedom.

Treatment is stopped, gradually reducing the dose of the drug over 1–2 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.

Trigeminal neuralgia, idiopathic glossopharyngeal neuralgia

The initial dose is 200–400 mg/day, divided into 2 doses. The initial dose is increased until pain disappears completely, on average to 400–800 mg/day. After this, in a certain part of patients, treatment can be continued with a lower maintenance dose of 400 mg.

For elderly patients and patients sensitive to carbamazepine, Finlepsin® retard is prescribed at an initial dose of 200 mg 1 time per day.

Pain due to diabetic neuropathy

The average daily dose is 200 mg in the morning and 400 mg in the evening. In exceptional cases, Finlepsin® retard can be prescribed at a dose of 600 mg 2 times a day.

Treatment of alcohol withdrawal in a hospital setting

The average daily dose is 600 mg (200 mg in the morning and 400 mg in the evening). In severe cases, in the first days the dose can be increased to 1200 mg/day, divided into 2 doses.

If necessary, Finlepsin® retard can be combined with other substances used to treat alcohol withdrawal, except sedative-hypnotics.

During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma.

Due to the possible development of side effects from the central and autonomic nervous system, patients are closely monitored in a hospital setting.

Epileptiform seizures in multiple sclerosis

The average daily dose is 200–400 mg 2 times a day.

Treatment and prevention of psychosis

The initial and maintenance doses are usually the same - 200–400 mg/day. If necessary, the dose can be increased to 400 mg 2 times a day.

Special instructions for the use of the drug Finlepsin retard

Since Finlepsin retard can provoke new or intensify existing special forms of seizures (so-called absence seizures), it is not recommended for use in patients with such forms of seizures. Finlepsin retard should not be used simultaneously with MAO inhibitors. Therapy with MAO inhibitors is stopped no later than 14 days before starting treatment with Finlepsin retard. For elderly patients, Finlepsin retard is prescribed in lower doses. Due to the possible occurrence of side effects, as well as hypersensitivity reactions to the drug, it is recommended (especially with prolonged use) to periodically monitor the hemogram and check the function of the liver and kidneys. This is done before the start of treatment, then during the 1st month of treatment - once a week, and after that - once a month. After the first 6 months of therapy, this control is carried out 2–4 times a year. In the following cases, careful monitoring of the patient's condition is necessary: ​​fever, infections, skin rash, general weakness, sore throat, ulcers on the oral mucosa, easy appearance of hematomas, increased levels of liver transaminases, decreased leukocytes 3000/mm3 and granulocytes below 1500/mm3, decreased platelets below 125,000/mm3, an increase in the level of iron in the blood serum over 150 mcg%, a decrease in reticulocytes below 0.3% = 20,000/mm. Carbamazepine should be discontinued if the red blood cell count decreases below 4 million/mm3, with petechial or purpuric hemorrhages, hematocrit decreases below 32%, hemoglobin decreases below 11 g%, leukocytes decreases below 2000/mm3, granulocytes below 1000/mm3 and platelets below 80 000 mm3, for symptomatic hematopoietic disorders. You should also regularly monitor the concentration of the drug Finlepsin retard and other antiepileptic drugs in the blood plasma during combination therapy and, if necessary, reduce the daily dose. Termination of therapy with Finlepsin retard in patients with epilepsy and transferring them to other antiepileptic drugs is not carried out suddenly, but by gradually reducing its dose. In patients with glaucoma, intraocular pressure is regularly monitored. It is necessary to take into account that the side effects of the drug Finlepsin retard can be similar to withdrawal symptoms in alcoholism. If, in exceptional cases, for the prevention of manic-depressive phases when only lithium preparations are insufficiently effective, Finlepsin retard is prescribed in combination with them, in order to prevent unwanted interactions, it is necessary to ensure that a certain concentration of carbamazepine in the blood plasma (8 mcg/ml) is not exceeded, the lithium content is maintained in the low therapeutic range (0.3–0.8 mEq/L), treatment with antipsychotics was carried out more than 8 weeks ago, and do not allow it to be carried out simultaneously. If a patient develops symptoms such as fever, sore throat or allergic skin reactions in the form of a skin rash with swollen lymph nodes or flu-like symptoms during treatment with Finlepsin retard, a blood test is necessary. If serious allergic reactions are detected, the use of Finlepsin retard should be stopped immediately. Finlepsin retard should not be combined with sedative-hypnotics. However, according to clinical requirements, if necessary, Finlepsin retard can be combined with other substances used to treat alcohol withdrawal. During therapy, it is necessary to regularly monitor the content of the drug Finlepsin retard in the blood plasma. Due to the development of side effects from the central nervous system and the autonomic nervous system, patients are carefully monitored. During treatment with carbamazepine, patients should avoid exposure to the sun to prevent the risk of photosensitivity. When switching from the immediate release dosage form to Finlepsin retard extended release tablets, ensure that an equivalent serum level of carbamazepine is achieved. Simultaneous administration of carbamazepine with grapefruit juice leads to an increase in the level of carbamazepine in the blood plasma, therefore Finlepsin retard should not be taken with grapefruit juice. Use during pregnancy and lactation The use of the drug during pregnancy in patients with epilepsy requires special attention. If a woman receiving Finlepsin retard has established or is planning a pregnancy, or during pregnancy there is a need to use the drug, the potential benefits of using the drug should be carefully weighed against the potential risk (especially in the first trimester of pregnancy). If possible, Finlepsin retard should be prescribed to women of reproductive age as monotherapy, since the incidence of congenital malformations in children whose mothers received combination therapy with antiepileptic drugs is higher than in children whose mothers received monotherapy. It is recommended to prescribe the drug in the minimum effective doses and monitor the level of carbamazepine in the blood plasma. Patients should be informed of the possible increased risk of developing birth defects and should be given the opportunity for antenatal screening. It is known that folic acid deficiency may develop during pregnancy. Antiepileptic drugs may increase folic acid deficiency. This may lead to an increased incidence of birth defects in children whose mothers receive antiepileptic therapy. Therefore, supplemental use of folic acid before and during pregnancy is recommended. Carbamazepine passes into breast milk. The benefits of breastfeeding against the potential for long-term side effects in infants must be carefully weighed. Women receiving Finlepsin retard can breastfeed, provided that the baby is monitored for the development of possible adverse reactions (for example, excessive drowsiness, allergic skin reactions). Children. Due to the high content of active substance and insufficient experience with the use of extended-release tablets, Finlepsin retard should not be prescribed to children under 6 years of age. The ability to influence the reaction rate when driving vehicles or working with other mechanisms Due to side effects on the central nervous system, in particular dizziness, drowsiness and fatigue that occur at the beginning of treatment, after increasing the dose or when using a combination with other drugs acting on the central nervous system, Finlepsin retard, even when used correctly, can affect the response of patients (regardless of the effect on the underlying disease), significantly impairing the ability to drive vehicles and operate complex machinery. This effect is enhanced when combined with alcohol. While using the drug, you should not drive vehicles or operate other machinery.

Overdose

Symptoms: symptoms that occur during overdose usually reflect disorders of the central nervous system, cardiovascular and respiratory systems.

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

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 and vomiting, delayed evacuation of food from the stomach, decreased colon motility.

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

Laboratory indicators: leukocytosis or leukopenia, hyponatremia, possible metabolic acidosis, hyperglycemia and glycosuria, increased muscle fraction of creatine phosphokinase.

Treatment: there is no specific antidote. Symptomatic supportive treatment in the intensive care unit, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder 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 a combination of severe poisoning and renal failure. Children may require blood transfusions.

Overdose of the drug Finlepsin retard, symptoms and treatment

An overdose of the drug requires urgent medical intervention. The picture of an overdose of the drug Finlepsin retard is characterized by an increase in side effects such as trembling (tremor), convulsive seizures that occur when the brain is excited (tonic-clonic seizures), agitation, as well as impaired breathing and function of the cardiovascular system with often reduced (sometimes also elevated) blood pressure, tachycardia and conduction dysfunction (AV block, ECG changes), cardiac arrest, accompanied by loss of consciousness and respiratory depression. The following may occur: dizziness, ataxia, drowsiness, stupor, nausea, vomiting, agitation, confusion, involuntary movements, dilated pupils, nystagmus, flushing, urinary retention, cyanosis, opisthotonus, abnormal reflexes (weakening or strengthening of reflexes). In isolated cases, leukocytosis, leukopenia, neutropenia, glucosuria or acetonuria were observed. When assessing intoxication, it is necessary to take into account the possibility of multiple intoxication with other pharmacological drugs that could be used for suicidal purposes. Intoxication with carbamazepine occurs mainly when taken in very high doses from 4 to 10 g. The level of the drug in the blood plasma is more than 20 mcg/ml. People have survived after intentionally or accidentally taking high doses of carbamazepine that produced plasma concentrations of 38 mcg/mL. There is no specific antidote for the treatment of acute poisoning with Finlepsin retard. Treatment for overdose with Finlepsin retard is usually carried out depending on the severity of poisoning in a hospital setting. In case of overdose, treatment is symptomatic: if possible, quickly remove the toxic substance from the stomach by inducing vomiting and/or gastric lavage, as well as using activated charcoal and laxatives. For convulsive attacks, anticonvulsants may be used. It is not recommended to prescribe barbiturates due to respiratory depression, especially in children. Due to the high binding of carbamazepine to blood proteins, forced diuresis, as well as hemodialysis or peritoneal dialysis are ineffective