Finlepsin 200 retard, sustained release pills 200mg 50pcs

Composition

of 1 tab.

carbamazepine 200 mg.

Auxiliary substances:

ethylacrylate copolymer,

methyl methacrylate and trimethylammoniumchloride (1: 2: 0.1) (Eudragit® RS30D) – 11 mg,

triacetin – 2.2 mg,

talc – 15.6 mg,

copolymer of methacrylic acid and ethylacrylate (Eudragit®L30D-55) – 35 mg,

microcrystalline cellulose – 21.8 mg,

crospovidon – 12.4 mg,

silicon dioxide colloid – 1.33 mg,

magnesium stearate – 0.67 mg

Pharmacological action

An antiepileptic drug (a dibenzazepine derivative) that also has antidepressant, antipsychotic, and antidiuretic effects. Finlepsin has an analgesic effect in patients with neuralgia. The main mechanism of action of the drug is associated with the blockade of potential-dependent sodium channels, as a result of which the membranes of overexcited neurons are stabilized, the occurrence of serial discharges of neurons is inhibited, and synaptic conduction of impulses is reduced. The drug also prevents the re-formation of Na+ – dependent action potentials in depolarized neurons.

In addition, it significantly reduces the release of glutamate (an amino acid with excitatory neurotransmitter properties), increases the reduced threshold of convulsive readiness and, thus, reduces the risk of developing an epileptic seizure. Increases the transport of potassium ions, modulates potential-dependent calcium channels, which can also contribute to the anticonvulsant effect of the drug. The effect of the drug is also manifested in focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, in generalized tonic-clonic epileptic seizures, as well as in a combination of these types of seizures (usually ineffective in small seizures – petit mal, absences and myoclonic seizures).

Patients with epilepsy (especially children and adolescents) showed a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness. The effect on cognitive function and psychomotor parameters depends on the dose.

The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).

With essential and secondary trigeminal neuralgia, in most cases it prevents the appearance of pain attacks. Pain relief in trigeminal neuralgia is noted after 8-72 hours.

In alcohol withdrawal syndrome, it increases the threshold of convulsive readiness (which is usually reduced in this condition) and reduces the severity of clinical manifestations of the syndrome (increased excitability, tremor, gait disorders).

The antipsychotic (antimanic) effect develops after 7-10 days, which may be due to inhibition of dopamine and norepinephrine metabolism.

The prolonged dosage form provides maintenance of a more stable concentration of carbamazepine in the blood when taken 1-2 times / day.

Suction

When taken orally, carbamazepine is slowly but almost completely absorbed from the gastrointestinal tract (food intake does not significantly affect the rate and degree of absorption).

After a single dose of the tablet, the Cmax is reached in 32 hours. The average Cmax of the unchanged Active ingredient after a single dose of 400 mg of carbamazepine is about 2.5 mcg / ml.

The distribution

of Css in plasma is achieved after 1-2 weeks of continuous use (the rate of achievement depends on individual metabolic characteristics: autoinduction of liver enzyme systems, heteroinduction by other drugs used simultaneously, as well as on the patient’s condition, the dose of the drug and the duration of treatment). There are significant inter-individual differences in the value of Css in the therapeutic range: in most patients, these values range from 4 to 12 micrograms/ml (17-50 micromol/l). The concentration of carbamazepine-10,11-epoxide (a pharmacologically active metabolite) is about 30% of the concentration of carbamazepine.

Binding to plasma proteins in children – 55-59%, in adults-70-80%. Apparent Vd is 0.8-1.9 l / kg. In the cerebrospinal fluid and saliva, concentrations are created proportional to the amount of the Active ingredient not bound to proteins (20-30%).

Penetrates the placental barrier and is excreted in breast milk (the concentration is 25-60% of that in blood plasma).

Metabolism

It is metabolized in the liver, mainly by the epoxy pathway, with the formation of the main metabolites: active-carbamazepine-10,11-epoxide and inactive conjugate with glucuronic acid. The main isoenzyme responsible for biotransformation of carbamazepine to carbamazepine-10,11-epoxide is CYP3A4. These metabolic reactions also produce the metabolite 9-hydroxy-methyl-10-carbamoyl acridane, which has weak pharmacological activity. Carbamazepine can induce its own metabolism.

Elimination

of T 1/2 after oral use of a single dose is 60-100 hours (on average about 70 hours), with prolonged use, T 1/2 decreases due to autoinduction of liver enzyme systems. After a single oral dose,72% of the dose is excreted in the urine and 28% in the feces; about 2% is excreted in the urine as unchanged carbamazepine, and about 1% as the 10,11 — epoxy metabolite.

Pharmacokinetics in special clinical cases

There are no data indicating that the pharmacokinetics of carbamazepine change in elderly patients.

Indications

• epilepsy, primary generalized seizures (with the exception of absence seizures), and partial forms of epilepsy (simple and complex seizures), secondary generalized seizures;
• trigeminal neuralgia;
• idiopathic neuralgia of the glossopharyngeal nerve;
• pain in diabetic polyneuropathy;
• epileptiform seizures in multiple sclerosis, spasms of the facial muscles in neuralgia of the trigeminal nerve tonic seizures, paroxysmal dysarthria and ataxia, paroxysmal paresthesia and pain;
• alcohol withdrawal syndrome (anxiety, convulsions, hyperexcitability, sleep disturbances);
• psychotic disorders (affective and schizoaffective disorders psychosis, dysfunction of limbic

Use during pregnancy and lactation

The drug should be used only under the condition of regular medical supervision.

Monotherapy of epilepsy begins with the appointment of the drug in low doses, gradually increasing them until the desired therapeutic effect is achieved.

In some cases, treatment with antiepileptic drugs was accompanied by the occurrence of suicidal attempts/suicidal intentions. This was also confirmed in a meta-analysis of randomized clinical trials using antiepileptic drugs. Since the mechanism of occurrence of suicidal attempts when using antiepileptic drugs is not known, it is impossible to exclude their occurrence during treatment with Finlepsin ® retard. Patients and service personnel should be warned to monitor the occurrence of suicidal thoughts/suicidal behavior, and if symptoms occur, seek immediate medical attention.

It is advisable to determine the concentration of carbamazepine in plasma in order to select the optimal dose, especially in combination therapy. In some cases, the dose required for treatment may significantly deviate from the recommended initial and maintenance dose, for example, due to accelerated metabolism due to the induction of microsomal liver enzymes or as a result of drug interaction during combination therapy.

Finlepsin ® retard should not be combined with sedative-hypnotic agents. If necessary, it can be combined with other substances used to treat alcohol withdrawal.

When transferring a patient to carbamazepine, the dose of the previously prescribed antiepileptic drug should be gradually reduced until it is completely discontinued. Sudden discontinuation 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 IV or rectally, or phenytoin IV).

Several cases of vomiting, diarrhoea and/or malnutrition, convulsions and/or respiratory depression have been reported in newborns whose mothers have taken carbamazepine concomitantly with other anticonvulsants (these reactions may be manifestations of withdrawal syndrome in newborns).

It should be borne in mind that carbamazepine can negatively affect the reliability of oral contraceptives, so women of reproductive age should use alternative methods of pregnancy prevention during treatment (intermenstrual bleeding is likely in women with simultaneous use of oral contraceptives).

Before prescribing carbamazepine and during treatment, monitoring of liver function indicators is necessary, especially in patients with a history of liver diseases, as well as in the elderly. If pre-existing liver function disorders increase or if active liver disease occurs, the drug should be discontinued immediately.Before starting treatment, it is necessary to conduct a study of the blood picture (including platelet count, reticulocytes), serum iron level, general urinalysis, blood urea level, EEG, determination of serum electrolyte concentration; blood (and periodically during treatment, since 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 white blood cells is not a harbinger of the onset of aplastic anemia or agranulocytosis. However, clinical blood tests should be performed before starting treatment, as well as periodically during treatment, including counting the number of platelets and possibly reticulocytes, as well as determining the level of iron in the blood serum. Non-progressive asymptomatic leukopenia does not require discontinuation, but treatment should be discontinued if progressive leukopenia or leukopenia is accompanied by clinical symptoms of an infectious disease.

Carbamazepine should be discontinued immediately if hypersensitivity reactions or symptoms suspected to indicate the development of Stevens-Johnson syndrome or Lyell’s syndrome occur. Mild skin reactions (isolated macular or maculopapular rash) usually resolve within a few days or weeks, even with continued treatment or after reducing the dose of the drug (the patient should be under medical supervision at this time).

When using the drug, the possibility of activation of latent psychoses should be taken into account, and in elderly patients — the possibility of developing disorientation or psychomotor agitation.

Possible disorders of male fertility and / or disorders of spermatogenesis (the relationship of these disorders with the use of carbamazepine has not yet been established).

The patient should be informed about possible early signs of toxic reactions from the hematopoietic system, liver and dermatological reactions and the need to immediately consult a doctor in case of adverse reactions such as fever, sore throat, rash, ulceration of the oral mucosa, causeless occurrence of hematomas, hemorrhages in the form of petechiae or purpura.

Before starting treatment, it is recommended to conduct an ophthalmological examination, including examination of the fundus with a slit lamp and measurement of intraocular pressure, if necessary. When prescribing the drug to patients with increased intraocular pressure, its constant monitoring is necessary.

Patients with severe diseases of the cardiovascular system, liver and kidney damage, as well as the elderly are prescribed the drug in lower doses.

Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very small, however, regular determination of the concentration of carbamazepine in plasma is also useful for a sharp increase in the frequency of seizures; to check the regularity of taking the drug by the patient; during pregnancy; in the treatment of children or adolescents; in case of suspected malabsorption of the drug; in case of suspected development of toxic reactions

Against the background of the use of the drug, it is recommended to stop drinking alcohol.

Use in children

The drug is prescribed for children over 6 years of age

Contraindications

• disorders of bone marrow hematopoiesis (anemia, leukopenia);
• AV block;
• acute intermittent porphyria (including in the anamnesis);
• simultaneous use with lithium preparations and MAO inhibitors;
• hypersensitivity to the components of the drug;
• hypersensitivity to tricyclic antidepressants.

With caution, the drug should be used in decompensated chronic heart failure, with impaired liver and/or kidney function, in elderly patients, in patients with chronic alcoholism (CNS depression increases, carbamazepine metabolism increases), with dilution hyponatremia (ADH hypersecretion syndrome, hypopituitarism, hypothyroidism, adrenal cortical insufficiency), with inhibition of bone marrow hematopoiesis while taking drugs (in the anamnesis), with prostatic hyperplasia, increased intraocular pressure; when used simultaneously with sedatives and hypnotic medications.

Use in patients with liver function disorders

With caution, the drug should be used in case of impaired liver function.

Use in patients with impaired renal function

The drug should be used with caution in patients with impaired renal function.

Use in elderly patients

Elderly patients are prescribed Finlepsin® retard at an initial dose of 200 mg 1 time / day, use with caution.

Side effects

When assessing the frequency of occurrence of various adverse reactions, the following criteria were used: very often (≥10%), often (≥1%, but

From the central nervous system and peripheral nervous system: often – dizziness, ataxia, drowsiness, general weakness, headache, paresis of accommodation; sometimes – abnormal involuntary movements (for example, tremor, “fluttering” tremor, dystonia, tics), nystagmus; rarely – hallucinations (visual or auditory), depression, decreased appetite, anxiety, aggressive behavior, psychomotor agitation, disorientation, activation of psychosis, orofacial dyskinesia, oculomotor disorders, speech disorders (such as dysarthria or slurred speech), choreoathetoid disorders, peripheral neuritis, paresthesias, muscle weakness, and paresis. The role of carbamazepine in the development of NMS, especially in combination with neuroleptics, remains unclear.

The development of side effects from the central nervous system may be due to a relative overdose of the drug or significant fluctuations in the concentration of carbamazepine in blood plasma.

Allergic reactions: often – urticaria; sometimes-erythroderma, delayed multi-organ 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 indicators (these manifestations occur in various combinations). Other organs may also be involved (e. g., lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis, or eosinophilic pneumonia. If the above-mentioned allergic reactions occur, the drug should be discontinued. Rarely – lupus-like syndrome, pruritus of the skin, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), photosensitivity.

From the hematopoietic system: often-leukopenia, thrombocytopenia, eosinophilia; rarely-leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocytic 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-diarrhea or constipation, abdominal pain, increased activity of hepatic transaminases; rarely-glossitis, gingivitis, stomatitis, pancreatitis, hepatitis (cholestatic, parenchymal), jaundice, granulomatous hepatitis, liver failure.

From the cardiovascular system: rarely-disorders of intracardiac conduction; decrease or increase in blood pressure, bradycardia, arrhythmias, AV block with syncope, collapse, aggravation or development of chronic heart failure, exacerbation of coronary heart disease (including the appearance or increase in angina attacks), thrombophlebitis, thromboembolic syndrome.

Endocrine and metabolic disorders: often – edema, fluid retention, weight gain, hyponatremia (decrease in plasma osmolarity due to an effect similar to ADH, which in rare cases leads to dilution hyponatremia, accompanied by lethargy, vomiting, headache, disorientation and neurological disorders); rarely – increased prolactin concentration (may be accompanied by galactorrhea and gynecomastia); decrease in L-thyroxine concentration and increased TSH concentration (usually not accompanied by clinical manifestations); violations of the ability to control blood flow, calcium-phosphorus metabolism in bone tissue (decrease in Ca%^%2+ and 25-OH-colecalciferol concentrations in blood plasma): osteomalacia, hypercholesterolemia (including HDL cholesterol), hypertriglyceridemia and enlarged lymph nodes, hirsutism.

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

Musculoskeletal disorders: rarely-arthralgia, myalgia, or convulsions.

From the side of the senses: rarely-taste disorders, increased intraocular pressure, clouding of the lens, conjunctivitis; hearing disorders, including tinnitus, hyperacusis, hypoacusia, changes in pitch perception.

Dermatological reactions: skin pigmentation disorders, purpura, acne, sweating, alopecia.

Interaction

When used concomitantly with inhibitors of the CYP3A4 isoenzyme, an increase in the concentration of carbamazepine in blood plasma and the development of adverse reactions may occur.

Combined use with inducers of the CYP3A4 isoenzyme can lead to an acceleration of metabolism and a decrease in the concentration of carbamazepine in blood plasma and a decrease in the therapeutic effect. On the contrary, their withdrawal may reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration.

When used together, the concentration of carbamazepine in plasma is increased by verapamil, diltiazem, felodipine, dextropropoxifene, 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, propoxifene, grapefruit juice, protease inhibitors used in the treatment of HIV infection (for example, ritonavir) (when using such combinations, dosage adjustment or monitoring of the concentration of carbamazepine in plasma is required).

Felbamate reduces the plasma concentration of carbamazepine and increases the concentration of carbamazepine-10,11-epoxide, while simultaneously reducing the serum concentration of felbamate.

When used together, the concentration of carbamazepine is reduced by phenobarbital, phenytoin, primidone, metsuximide, fensuximide, theophylline, rifampicin, cisplatin, doxorubicin. A similar effect may be caused by clonazepam, valpromid, valproic acid, oxcarbazepine and herbal preparations containing St. John’s wort (Hypericum perforatum).

When used together, valproic acid and primidone can displace carbamazepine from plasma protein binding and increase the concentration of the pharmacologically active metabolite (carbamazepine-10,11-epoxide). When Finlepsin® retard is co-administered with valproic acid, coma and confusion may occur in exceptional cases.

When co-administered, isotretinoin changes the bioavailability and/or clearance of carbamazepine and carbamazepine-10,11-epoxide (monitoring of carbamazepine plasma concentrations is necessary).

When used concomitantly, carbamazepine may reduce plasma concentrations and, consequently, reduce or even completely neutralize the effects and require dose adjustment of the following drugs: clobazam, clonazepam, digoxin, ethosuximide, primidone, valproic acid, alprazolam, CORTICOSTEROIDS (prednisone, dexamethasone), cyclosporine, tetracyclines (doxycycline), haloperidol, methadone, oral drugs containing oestrogen and/or progesterone (alternative methods of contraception should be selected), theophylline, oral anticoagulants (warfarin, fenprocumone, dicumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriptyline, nortriptyline, clomipramine), clozapine, felbamate, thiagabine, oxcarbazepine, protease inhibitors used in the following cases: treatment of HIV infection (indinavir, ritonavir, saquinavir), calcium channel blockers (dihydropyridine group, for example, felodipine), itraconazole, levothyroxine, midazolam, olanzapine, praziquantel, risperidone, tramadol, ziprasidone.

There is a possibility of an increase or decrease in phenytoin in blood plasma against the background of carbamazepine and an increase in the level of mephenytoin (in rare cases).

Simultaneous use of carbamazepine and lithium preparations may increase the neurotoxic effects of both active substances.

Tetracyclines may weaken the therapeutic effect of carbamazepine.

Carbamazepine, when used together with paracetamol, increases the risk of its toxic effect on the liver and reduces the therapeutic effectiveness (acceleration of paracetamol metabolism).

Simultaneous use of carbamazepine with phenothiazine, pimozide, thioxanthenes (Chlorprothixen), molindone, haloperidol, maprotilin, clozapine and tricyclic antidepressants leads to an increase in the depressive effect on the central nervous system and a weakening of the anticonvulsant effect of carbamazepine.

MAO inhibitors increase the risk of developing hyperthermic crises, hypertensive crises, seizures, and death (before carbamazepine is prescribed, MAO inhibitors should be discontinued at least 2 weeks in advance or, if the clinical situation allows, even longer).

Concomitant use with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia, accompanied by clinical manifestations.

Carbamazepine, when used together, weakens the effects of non-depolarizing muscle relaxants (pancuronium). If such a combination is used, it may be necessary to increase the dose of muscle relaxants, while careful monitoring of patients is necessary, since their action may be discontinued more quickly.

Reduces the tolerance of ethanol.

Myelotoxic drugs increase the manifestations of carbamazepine hematotoxicity.

Accelerates the metabolism of indirect anticoagulants, hormonal contraceptives, folic acid; praziquantel.

May increase the elimination of thyroid hormones.

Accelerates the metabolism of anaesthetic agents (enflurane, halothane, fluorotane) with an increased risk of hepatotoxic effects.

Increases the formation of nephrotoxic metabolites of methoxyflurane.

Increases the hepatotoxic effect of isoniazid.

How to take, course of use and dosage

The drug is taken orally during or after a meal, washed down with a sufficient amount of liquid.

For ease of use, the tablet (as well as its half or quarter) can be pre-dissolved in water or juice, since the property of prolonged release of the Active ingredient after the tablet is dissolved in the liquid is preserved. The dose range is 400-1200 mg / day. The daily dose is divided into 1-2 doses.

The maximum daily dose is 1600 mg.

Epilepsy

Where possible, Finlepsin retard should be administered as monotherapy. Treatment begins with the use of a small daily dose, which is then 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 you miss the next dose of the drug, you should take the missed dose as soon as you notice it, and you should not take a double dose of the drug.

Adults

The initial dose is 200-400 mg / day, then the dose is slowly increased until the optimal therapeutic effect is achieved. The maintenance dose is 800-1200 mg / day in 1-2 divided doses.

Children

The initial dose for children aged 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 aged 6-10 years – 400-600 mg / day (in 2 doses), for children aged 11-15 years – 600-1000 mg/day (in 2 doses).

The recommended dosage regimen is shown in the table.

Age Initial dose Maintenance dose Children from 6 to 10 years old 200 mg in the evening 200 mg in the morning and 200-400 mg in the evening Children from 11 to 15 years old 200 mg in the evening 200-400 mg in the morning and 400-600 mg in the evening Adults 200-300 mg in the evening 200-600 mg in the morning and 400-600 mg in the evening

The duration of use depends on the indication and the individual reaction of the patient to the drug.

The decision to transfer the patient to the use of Finlepsin® retard, the duration of its use or discontinuation of treatment is made by the doctor individually. The dose of the drug can be reduced or completely canceled no earlier than after 2-3 years of complete absence of seizures.

Treatment is stopped, gradually reducing the dose over 1-2 years, under the control of EEG. At the same time, in children, when reducing the daily dose, the increase in body weight with age should be taken into account.

Trigeminal neuralgia, idiopathic neuralgia of the glossopharyngeal nerve

The initial dose is 200-400 mg / day in 2 divided doses. The initial dose is increased until the pain disappears completely, on average up to 400-800 mg / day. After that, in a certain part of patients, therapy can be continued at a lower maintenance dose of 400 mg / day.

Elderly patients and patients with individual sensitivity to the action of carbamazepine, Finlepsin ® retard is prescribed at an initial dose of 200 mg 1 time/day.

Pain in diabetic neuropathy

The drug is prescribed 200 mg in the morning and 400 mg in the evening. In exceptional cases, the drug 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 in 2 divided doses.

If necessary, the drug Finlepsin ® retard can be combined with other drugs used to treat alcohol withdrawal, except sedatives and sleeping pills.

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

Due to the development of adverse reactions from the central nervous system and the autonomic nervous system, patients are carefully monitored in a hospital setting.

Epileptiform seizures in multiple sclerosis

The average daily dose is 200-400 mg 2 times/day.

Treatment and prevention of psychosis

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

Overdose

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

From the central nervous system and sensory organs: central nervous system depression, disorientation, drowsiness, agitation, hallucinations, coma, blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia that turns into hyporeflexia, convulsions, psychomotor disorders, myoclonus, hypothermia, mydriasis.

From the cardiovascular system: tachycardia, decreased blood pressure, sometimes increased blood pressure, disorders of intraventricular conduction with expansion of the QRS complex, fainting, cardiac arrest.

Respiratory system disorders: respiratory depression, pulmonary edema.

From the digestive system: nausea, vomiting, delayed evacuation of food from the stomach, decreased colon motility.

From the urinary system: urinary retention, oliguria or anuria; fluid retention.

From the side of laboratory parameters: leukocytosis or leukopenia, hyponatremia, possible metabolic acidosis, possible hyperglycemia and glucosuria, increased muscle fraction of CPK.

Treatment: there is no specific antidote. Symptomatic maintenance treatment in the ICU, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder function, and correction of electrolyte disorders are required. It is necessary to determine the concentration of carbamazepine in plasma to confirm poisoning with this agent and assess the degree of overdose, gastric lavage, and the appointment of activated charcoal. Late evacuation of gastric contents may lead to delayed absorption on days 2 and 3 and the re-appearance of intoxication symptoms during recovery). Forced diuresis, hemodialysis, and peritoneal dialysis are ineffective; however, dialysis is indicated for a combination of severe poisoning and renal failure. Children may need blood transfusion.

Special instructions

The drug should be used only under the condition of regular medical supervision.

Monotherapy of epilepsy begins with the appointment of the drug in low doses, gradually increasing them until the desired therapeutic effect is achieved.

In some cases, treatment with antiepileptic drugs was accompanied by the occurrence of suicidal attempts/suicidal intentions. This was also confirmed in a meta-analysis of randomized clinical trials using antiepileptic drugs. Since the mechanism of occurrence of suicidal attempts when using antiepileptic drugs is not known, it is impossible to exclude their occurrence during treatment with Finlepsin ® retard. Patients and service personnel should be warned to monitor the occurrence of suicidal thoughts/suicidal behavior, and if symptoms occur, seek immediate medical attention.

It is advisable to determine the concentration of carbamazepine in plasma in order to select the optimal dose, especially in combination therapy. In some cases, the dose required for treatment may significantly deviate from the recommended initial and maintenance dose, for example, due to accelerated metabolism due to the induction of microsomal liver enzymes or as a result of drug interaction during combination therapy.

Finlepsin ® retard should not be combined with sedative-hypnotic agents. If necessary, it can be combined with other substances used to treat alcohol withdrawal.

When transferring a patient to carbamazepine, the dose of the previously prescribed antiepileptic drug should be gradually reduced until it is completely discontinued. Sudden discontinuation 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 IV or rectally, or phenytoin IV).

Several cases of vomiting, diarrhoea and/or malnutrition, convulsions and/or respiratory depression have been reported in newborns whose mothers have taken carbamazepine concomitantly with other anticonvulsants (these reactions may be manifestations of withdrawal syndrome in newborns).

It should be borne in mind that carbamazepine can negatively affect the reliability of oral contraceptives, so women of reproductive age should use alternative methods of pregnancy prevention during treatment (intermenstrual bleeding is likely in women with simultaneous use of oral contraceptives).

Before prescribing carbamazepine and during treatment, monitoring of liver function indicators is necessary, especially in patients with a history of liver diseases, as well as in the elderly. If pre-existing liver function disorders increase or if active liver disease occurs, the drug should be discontinued immediately. Before starting treatment, it is necessary to conduct a study of the blood picture (including platelet count, reticulocytes), serum iron level, general urinalysis, blood urea level, EEG, determination of serum electrolyte concentration; blood (and periodically during treatment, since 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 white blood cells is not a harbinger of the onset of aplastic anemia or agranulocytosis. However, clinical blood tests should be performed before starting treatment, as well as periodically during treatment, including counting the number of platelets and possibly reticulocytes, as well as determining the level of iron in the blood serum. Non-progressive asymptomatic leukopenia does not require discontinuation, but treatment should be discontinued if progressive leukopenia or leukopenia is accompanied by clinical symptoms of an infectious disease.

Carbamazepine should be discontinued immediately if hypersensitivity reactions or symptoms suspected to indicate the development of Stevens-Johnson syndrome or Lyell’s syndrome occur. Mild skin reactions (isolated macular or maculopapular rash) usually resolve within a few days or weeks, even with continued treatment or after reducing the dose of the drug (the patient should be under medical supervision at this time).

When using the drug, the possibility of activation of latent psychoses should be taken into account, and in elderly patients — the possibility of developing disorientation or psychomotor agitation.

Possible disorders of male fertility and / or disorders of spermatogenesis (the relationship of these disorders with the use of carbamazepine has not yet been established).

The patient should be informed about possible early signs of toxic reactions from the hematopoietic system, liver and dermatological reactions and the need to immediately consult a doctor in case of adverse reactions such as fever, sore throat, rash, ulceration of the oral mucosa, causeless occurrence of hematomas, hemorrhages in the form of petechiae or purpura.

Before starting treatment, it is recommended to conduct an ophthalmological examination, including examination of the fundus with a slit lamp and measurement of intraocular pressure, if necessary. When prescribing the drug to patients with increased intraocular pressure, its constant monitoring is necessary.

Patients with severe diseases of the cardiovascular system, liver and kidney damage, as well as the elderly are prescribed the drug in lower doses.

Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very small, however, regular determination of the concentration of carbamazepine in plasma is also useful for a sharp increase in the frequency of seizures; to check the regularity of taking the drug by the patient; during pregnancy; in the treatment of children or adolescents; in case of suspected malabsorption of the drug; in case of suspected development of toxic reactions

Against the background of the use of the drug, it is recommended to stop drinking alcohol.

Form of production

Long-acting Finlepsin retard tablets are white to white with a yellowish tinge of color, rounded, flat, with beveled edges, with cross-shaped fault lines on both sides and 4 notches on the side surface.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Shelf

life is 3 years.

Active ingredient

Carbamazepine

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets

Purpose

For adults by doctor’s prescription, Children by doctor’s prescription, Children over 6 years of age

Indications

Epilepsy, Alcoholism, Mental Disorders, Trigeminal Neuralgia