Description
Release form
Long-acting tablets from white to white with a yellowish tint, roundish, flat, with beveled edges, with cross-shaped fault lines on both sides and 4 nicks on the side surface.
Packing
10 pcs. – blisters (5) – packs of cardboard.
Pharmacological action
Antiepileptic drug (dibenzazepine derivative). It 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 appearance of serial discharges of neurons and a decrease in synaptic conduction of impulses. Prevents the re-formation of Na + -dependent action potentials in depolarized neurons. Reduces the release of glutamate (amino acids with stimulating neurotransmitter properties), increases the reduced seizure threshold and, thus, reduces the risk of developing an epileptic seizure. It increases the transport of potassium ions, modulates voltage-dependent calcium channels, which can also contribute to the anticonvulsant effect of the drug. It is effective for focal (partial) seizures (simple and complex), accompanied or not accompanied by secondary generalization, for generalized tonic-clonic seizures, and also for a combination of these types of seizures (usually ineffective for small seizures – petit mal, absences and myoclonic seizures )
Patients with epilepsy (especially children and adolescents) have 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 performance is dose dependent.
The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to auto-induction of metabolism).
With essential and secondary trigeminal neuralgia in most cases it prevents the appearance of pain attacks. Relief of pain in trigeminal neuralgia is noted after 8-72 hours.
With alcohol withdrawal syndrome, it increases the seizure threshold (which is usually reduced in this condition) and reduces the severity of the clinical manifestations of the syndrome (increased irritability, tremor, gait disorders).
Antipsychotic (antimaniacal) action develops after 7-10 days, which may be due to inhibition of the metabolism of dopamine and norepinephrine.
A prolonged dosage form provides a more stable concentration of carbamazepine in the blood when taken 1-2 times / day.
Pharmacokinetics
Absorption
When taking the drug inside, carbamazepine is slowly but almost completely absorbed from the digestive tract (eating does not significantly affect the speed and extent of absorption).
After a single dose of the Cmax tablet 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.
Distribution of
Css in plasma is achieved after 1-2 weeks of continuous use (the rate of achievement depends on the individual characteristics of the metabolism: auto-induction of liver enzyme systems, hetero-induction by other drugs used simultaneously, as well as on the patient s condition, dose of the drug and duration of treatment). Significant interindividual differences in the Css value in the therapeutic range are observed: in most patients, these values range from 4 to 12 μg / ml (17-50 μmol / L). The concentration of carbamazepine-10,11-epoxide (pharmacologically active metabolite) is about 30% of the concentration of carbamazepine.
Binding to plasma proteins in children – 55-59%, in adults – 70-80%. The apparent Vd is 0.8-1.9 l / kg. Concentrations are created in the cerebrospinal fluid and saliva, proportional to the amount of active substance unbound with proteins (20-30%).
Crosses the placental barrier and is excreted in breast milk (concentration is 25-60% of that in blood plasma).
Metabolism
Metabolized in the liver, mainly along the epoxy pathway, with the formation of the main metabolites: active – carbamazepine-10,11-epoxide and inactive conjugate with glucuronic acid. The main isoenzyme that provides the biotransformation of carbamazepine to carbamazepine-10,11-epoxide is CYP3A4. As a result of these metabolic reactions, a metabolite of 9-hydroxymethyl-10-carbamoylacridane is also formed, which has weak pharmacological activity. Carbamazepine can induce its own metabolism.
The excretion of
T1 / 2 after oral administration of a single dose is 60-100 hours (an average of about 70 hours), with prolonged administration of T1 / 2 decreases due to auto-induction of the liver enzyme systems. After a single oral administration, 72% of the dose taken is excreted in the urine and 28% in the feces, with about 2% excreted in the urine as unchanged carbamazepine, and about 1% in the form of a 10.11-epoxy metabolite.
Pharmacokinetics in special clinical cases
There is no evidence to suggest that the pharmacokinetics of carbamazepine change in elderly patients.
Indications for
epilepsy: primary generalized seizures (with the exception of absences), partial forms of epilepsy (simple and complex seizures), secondary generalized seizures
trigeminal neuralgia
idiopathic neuralgia of glossopharyngeal hypertrophy syndrome , facial spasms with trigeminal neuralgia, tonic cramps, paroxysmal dysarthria and ataxia, paroxysmal paresthesias and bouts of pain
syndrome m alcohol withdrawal symptoms (anxiety, convulsions, hyperactivity, sleep disturbances)
psychotic disorders (affective and schizoaffective disorders, psychoses, dysfunction of limbic function
Contraindications
disorders of bone marrow hematopoiesis (anemia, leukopenia)
AV block
acute intermittent porphyria (including a history of)
simultaneous use with lithium drugs and antioxidants of the antioxidant drug mrd sensitivity .
With caution, the drug should be used in decompensated chronic heart failure, in case of impaired liver and / or kidney function,amazepine), with dilution hyponatremia (ADH hypersecretion syndrome, hypopituitarism, hypothyroidism, adrenal cortex insufficiency), with suppression of bone marrow hematopoiesis with the use of drugs (history), with prostate hyperplasia, increased intraocular pressure with simultaneous use of sedative and sedative drugs .
Use in case of impaired liver function
With caution, the drug should be used in case of impaired liver function.
Use in cases of impaired renal function
Caution is advised to use the drug in case of impaired renal function.
Use in children
The drug is prescribed for children over 6 years.
Use in elderly patients
For elderly patients, Finlepsin ® retard is prescribed in an initial dose of 200 mg 1 time / day, apply with caution.
Special instructions
The drug should be used only under the condition of regular medical supervision.
Monotherapy of epilepsy begins with the administration of the drug in low doses, gradually increasing them to achieve the desired therapeutic effect.
In some cases, treatment with antiepileptic drugs was accompanied by the occurrence of suicidal attempts / suicidal intentions. This was also confirmed by a meta-analysis of randomized clinical trials using antiepileptic drugs. Since the mechanism of the occurrence of suicidal attempts when using antiepileptic drugs is not known, their occurrence cannot be ruled out during treatment with Finlepsin ® retard. Patients and caregivers should be warned about the need to monitor the appearance of suicidal thoughts / suicidal behavior, and in case of symptoms, seek immediate medical attention.
It is advisable to determine the concentration of carbamazepine in plasma in order to select the optimal dose, especially with combination therapy. In some cases, the dose required for treatment can deviate significantly from the recommended initial and maintenance dose, for example, due to an 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 drugs. 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 canceled. Sudden discontinuation of carbamazepine can trigger epileptic seizures. If you need to abruptly interrupt treatment, the patient should be transferred to another antiepileptic drug under the cover of the preparation indicated in such cases (for example, diazepam iv or rectally, or phenytoin iv).
Several cases of vomiting, diarrhea and / or decreased nutrition, convulsions and / or respiratory depression in newborns whose mothers were taking carbamazepine at the same time as other anticonvulsants have been described (perhaps these reactions are manifestations of withdrawal syndrome in newborns).
It should be borne in mind that carbamazepine can adversely affect the reliability of oral contraceptives, therefore women of reproductive age should use alternative methods of pregnancy protection during treatment (intermenstrual bleeding in women is possible with the use of oral contraceptives).
Before prescribing carbamazepine and during treatment, monitoring of liver function indicators is necessary, especially in patients who have a history of liver disease, as well as elderly people. In the case of an increase in existing liver dysfunction or when an active liver disease occurs, the drug should be immediately discontinued. Before starting treatment, it is necessary to study the blood picture (including counting platelets, reticulocytes), the level of iron in the blood serum, a general urinalysis, the level of urea in the blood, the EEG, the determination of the concentration of electrolytes in the blood serum (and periodically during treatment, because possible development of hyponatremia). Subsequently, these indicators should be monitored during the first month of treatment weekly, and then monthly.
In most cases, a transient or persistent decrease in platelet and / or white blood cell counts is not a precursor to the onset of aplastic anemia or agranulocytosis. However, before starting treatment, as well as periodically during the treatment process, clinical blood tests should be performed, 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 withdrawal, but treatment should be discontinued if progressive leukopenia or leukopenia appears, accompanied by clinical symptoms of an infectious disease.
Carbamazepine should be discontinued immediately if hypersensitivity reactions or symptoms appear, suggesting the development of Stevens-Johnson syndrome or Lyell’s syndrome. Mild skin reactions (isolated macular or maculopapular rash) usually disappear within a few days or weeks even with continued treatment or after a dose reduction (the patient should be under medical supervision at this time).
When using the drug, the possibility of activating latently occurring psychoses should be taken into account, and in elderly patients, the possibility of developing disorientation or psychomotor agitation.
Possible impaired male fertility and / or impaired spermatogenesis (the relationship of these disorders with carbamazepine has not yet been established).
The patient should be informed of 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 undesirable reactions such as fever, sore throat, rash, ulceration of the oral mucosa, cause of hematomas, hemorrhage in the form of petechiae or purpura.
Before starting treatment, an ophthalmic examination is recommended, including fundus examination 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, the drug is prescribed in lower doses.
Although the relationship between the dose of carbamazepine is its concentration and clinical efficacy or tolerance 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 patient’s regular intake of the drug during pregnancy in treating children or adolescents with suspected malabsorption of the drug with suspected toxicity reactions in case the patient takes several drugs.
Against the background of the use of the drug, it is recommended to stop drinking alcohol.
Composition
1 tab.
carbamazepine 200 mg
Excipients: copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate (1: 2: 0.1) (Eudragit® RS30D) – 11 mg, triacetin – 2.2 mg, talc – 15.6 mg, methacrylic acid-Drag-30 and Ethacrylate-D 30 and Ethyl Acrylate 55-D 30 ) – 35 mg, microcrystalline cellulose – 21.8 mg, crospovidone – 12.4 mg, colloidal silicon dioxide – 1.33 mg, magnesium stearate – 0.67 mg.
Dosage and administration
The drug is taken orally during or after a meal with a sufficient amount of liquid.
For ease of use, the tablet (as well as its half or quarter) can be previously dissolved in water or in juice, because the property of prolonged release of the active substance after dissolving the tablet in a liquid is maintained. The range of doses used is 400-1200 mg / day. The daily dose is divided into 1-2 doses.
The maximum daily dose is 1600 mg.
Epilepsy
Whenever possible, Finlepsin ® Retard should be given as monotherapy. Treatment begins with the use of a small daily dose, which is subsequently slowly increased until the optimal effect is achieved.
The addition of Finlepsin ® retard to an ongoing antiepileptic therapy should be carried out gradually, while the doses of the drugs used are not changed or, if necessary, adjusted.
If you skip taking the next dose of the drug, you should take the missed dose as soon as you notice you can 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 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 divided doses), for children aged 11-15 years – 600-1000 mg / day (in 2 divided doses).
The recommended dosage schedule is presented in the table.
Age Initial dose Maintenance dose
Children 6 to 10 years of age 200 mg in the evening 200 mg in the morning and 200-400 mg in the evening
Children 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
Duration of use depends on the indication and individual patient response to the drug.
The decision to transfer the patient to the use of the drug Finlepsin ® retard, the duration of its use or the abolition of treatment is made individually by the doctor. The dose of the drug can be reduced or completely canceled no earlier than after a 2-3-year complete absence of seizures.
Treatment is discontinued, gradually reducing the dose over 1-2 years, under the supervision of an EEG. In this case, in children with a decrease in the daily dose, an increase in body weight with age should be taken into account.
Trigeminal neuralgia, idiopathic glossopharyngeal neuralgia
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 with a lower maintenance dose of 400 mg / day.
For elderly patients and patients with individual sensitivity to the action of carbamazepine, Finlepsin ® retard is prescribed in 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 in a dose of 600 mg 2 times / 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, Finlepsin ® retard can be combined with other drugs used to treat alcohol withdrawal, in addition to sedatives and sleeping pills.
During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma.
In connection with 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.
Side effects of
In assessing the frequency of occurrence of various adverse reactions, the following criteria were used: very often (? 10%), often (? 1%, but
From the side of the central nervous system and peripheral nervous system: often – dizziness, ataxia, drowsiness, general weakness , headache, accommodation paresis sometimes – abnormal involuntary movements (e.g. tremor, fluttering tremor, dystonia, tics), nystagmus rarely – hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, psychomotor fucking denie, disorientation, activation of psychosis, orofacial dyskinesia, oculomotor disturbances, speech disorders (e.g. dysarthria or slurred speech), choreoathetoid disorders, peripheral neuritis, paresthesias, muscle weakness and paresis. The role of carbamazepine in the development of central nervous system, especially in combination with antipsychotics, remains unclear.
The development of side effects from the central nervous system may be due to relative overdose of the drug or significant fluctuations in the concentration of carbamazepine in blood plasma.
Allergic reactions: often – urticaria, sometimes – erythroderma, multi-organ delayed-type hypersensitivity reactions with fever, skin rashes, vasculitis (including erythema nodosum, as a manifestation of cutaneous vasculitis), lymphadenopathy, signs resembling lymphoma, arthroenophileia, , hepatosplenomegaly and altered indicators of liver function (these manifestations are found in various combinations). Other organs (e.g. lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis or eosinophilic pneumonia may also be involved. If the above allergic reactions occur, the use of the drug should be discontinued. Rarely – lupus-like syndrome, skin itching, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), photosensitivity.
From the hemopoietic system: 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 does not have clinical significance, increased activity of alkaline phosphatase, sometimes diarrhea or constipation, abdominal pain, increased activity of the liver rarely transaminases – glossitis, gingivitis, stomatitis, pancreatitis, hepatitis (cholestatic, parenchymal), jaundice, granulomatous hepatitis, liver failure.
From the cardiovascular system: rarely – intracardiac conduction disturbances decrease or increase in blood pressure, bradycardia, arrhythmias, AV block with fainting, collapse, aggravation or development of chronic heart failure, exacerbation of coronary heart disease (including the appearance or frequency of angina attacks), thrombophlebitis, thromboembolic syndrome.
From the endocrine system and metabolism: often – edema, fluid retention, weight gain, hyponatremia (decreased 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 – an increase in prolactin concentration (may be accompanied by galactorrhea and gynecomastia) a decrease in the concentration of L-thyroxine and an increase in TSH concentration (usually not accompanied by clinical manifestations) disturbances in calcium-phosphorus metabolism in bone tissue (a decrease in the concentration of Ca2 + and 25-OH- colecalciferol in plasma): osteomalacia, hypercholesterolemia (including HDL cholesterol), hypertriglyceridemia and swollen lymph nodes, hirsutism.
From the genitourinary system: rarely – interstitial nephritis, renal failure, impaired renal function (e.g., albuminuria, hematuria, oliguria, increased concentration of urea / azotemia), increased urination, urinary retention, decreased potency.
From the musculoskeletal system: rarely – arthralgia, myalgia or cramps.
On the part of the sensory organs: rarely – disturbances in taste, increased intraocular pressure, clouding of the lens, conjunctivitis of hearing impairment, including tinnitus, hyperacusia, hypoacusia, changes in perception of pitch.
Dermatological reactions: disorders of skin pigmentation, purpura, acne, sweating, alopecia.
Drug interaction
With simultaneous use with inhibitors of the isoenzyme CYP3A4, an increase in the concentration of carbamazepine in blood plasma and the development of adverse reactions are possible.
Co-administration with CYP3A4 isoenzyme inducers 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 abolition can reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration.
When used together, the concentration of carbamazepine in the plasma is increased by verapamil, diltiazem, felodipine, dextropropoxyphene, viloxazine, fluoxetine, fluvoxamine, cimetidine, acetazolamide, danazole, desipramine, nicotinamide (in adults, only in high doses of jamezrominocinolides, macrolamine, macrolamine, ) azoles (itraconazole, ketoconazole, fluconazole), terfenadine, loratadine, isoniazid, propoxyphene, grapefruit juice, protease inhibitors used in the treatment of HIV infection (for example, ritonavir) (when using such combinations, correction of the dosage regimen or monitoring of the concentration of carbamazepine in the plasma is required).
Felbamate reduces the concentration of carbamazepine in the plasma and increases the concentration of carbamazepine-10,11-epoxide, while a simultaneous decrease in the concentration in serum of felbamate is possible.
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, valpromide, valproic acid, oxcarbazepine and herbal preparations containing St. John’s wort (Hypericum perforatum).
When used together, valproic acid and primidone can displace carbamazepine from binding to plasma proteins and increase the concentration of pharmacologically active metabolite (carbamazepine-10,11-epoxide). With the combined use of the drug Finlepsin ® retard with valproic acid, in exceptional cases, coma and confusion may occur.
When used together, isotretinoin alters the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxide (plasma concentration of carbamazepine must be monitored).
With the simultaneous use of carbamazepine can reduce the concentration in the plasma and, therefore, reduce or even completely level the effects and require dose adjustment of the following drugs: clobazam, clonazepam, digoxin, ethosuximide, primidone, valproic acid, alprazolam, GCS (prednisone, dexamethasone), cyclosporine, tetracyclines (doxycycline), haloperidol, methadone, oral preparations containing estrogen and / or progesterone (the selection of alternative methods of contraception is necessary), theophylline, oral anticoagulants (warfarin, fenprocumirum, laquam, dicame tricyclic antidepressants (imipramine, amitriptyline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors used in the treatment of HIV infection (indinavir, rito Avir, saquinavir), calcium channel blockers (dihydropyridine group, e.g., felodipine), itraconazole, levothyroxine, midazolam, olanzapine, praziquantel, risperidone, tramadol ziprasidone.
There is the possibility of increasing or decreasing phenytoin in blood plasma against the background of carbamazepine and increasing levels of mefenytoin (in rare cases).
With the simultaneous use of carbamazepine and lithium preparations, the neurotoxic effects of both active substances can be enhanced.
Tetracyclines may attenuate the therapeutic effect of carbamazepine.
Carbamazepine when combined with paracetamol increases the risk of toxic effects on the liver and reduces therapeutic efficacy (accelerating the metabolism of paracetamol).
The simultaneous administration of carbamazepine with phenothiazine, pimozide, thioxanthenes (chlorprothixene), molindone, haloperidol, maprotiline, clozapine and tricyclic antidepressants leads to an increase in the inhibitory 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, death (before the appointment of carbamazepine, MAO inhibitors should be canceled at least 2 weeks or, if the clinical situation allows, even for a longer period).
Concomitant administration with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia, accompanied by clinical manifestations.
Carbamazepine, when used together, attenuates the effects of non-depolarizing muscle relaxants (pancuronium). In the case of the use of such a combination, it may be necessary to increase the dose of muscle relaxants, while it is necessary to closely monitor patients, since a faster termination of their action is possible.
Reduces ethanol tolerance.
Myelotoxic drugs increase the manifestations of hematotoxicity of carbamazepine.
Accelerates the metabolism of indirect anticoagulants, hormonal contraceptives, folic acid praziquantel.
May enhance the elimination of thyroid hormones.
Accelerates the metabolism of anesthetics (enflurane, halotane, fluorotan) with an increased risk of hepatotoxic effects.
Enhances the formation of nephrotoxic metabolites of methoxyflurane.
Enhances the hepatotoxic effect of isoniazid.
Overdose
Symptoms and complaints that occur when an overdose usually reflects CNS, cardiovascular and respiratory disorders.
On the part of the CNS and the sense organs: suppression of the CNS function, disorientation, drowsiness, agitation, hallucinations, coma, blurred vision, indistinct speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia, turning into hyporeflexia, convulsions, psychomotor disorders, myoclonus, hypothermia, hypothermia.
From the cardiovascular system: tachycardia, decrease in blood pressure, sometimes increase in blood pressure, violations of intraventricular conduction with expansion of the QRS complex, fainting, cardiac arrest.
From the respiratory system: respiratory depression, pulmonary edema.
From the digestive system: nausea, vomiting, delayed evacuation of food from the stomach, decreased motility of the colon.
Urinary system: urinary retention, oliguria or anuria fluid retention.
From laboratory parameters: leukocytosis or leukopenia, hyponatremia, metabolic acidosis is possible, hyperglycemia and glucosuria are possible, increase in the muscle fraction of CPK.
Treatment: There is no specific antidote. Need symptomatic supportive treatment in OIT, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder function, correction of electrolyte disorders. It is necessary to determine the concentration of carbamazepine in plasma to confirm the poisoning by this agent and to assess the degree of overdose, gastric lavage, the appointment of activated carbon. Late evacuation of gastric contents may result in delayed suction for 2 and 3 days and re-emergence of intoxication symptoms during recovery). Forced diuresis, hemodialysis and peritoneal dialysis are ineffective, but dialysis is indicated by a combination of severe poisoning and renal failure. Children may need hemotransfusion.
Storage conditions
The product should be stored out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life
3 years.
Active ingredient
Carbamazepine
Terms and conditions
prescription
Dosage form
prolong tablets.
Possible product names
FINLEPSIN 0.2 N50 TABLE RETARD
Finlepsin 200 retard tablets retard 200 mg, 50 pcs.
Finlepsin Retard 0.2g No. 50
Finlepsin Retard 200mg Tab. prol. valid X50 (R)
Finlepsin retard 200mg No. 50
Teva Pharmaceutical Enterprises Co., Ltd., Israel
