Active substanceCarbamazepineCarbamazepine
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: carbamazepine 0.2 g;

    Excipients: potato starch 80.5 mg, silicon dioxide colloid (aerosil) 16.4 mg, magnesium stearate 3.1 mg, talc 3.1 mg, povidone (polyvinylpyrrolidone) 14.4 mg, polysorbate (Tween 80) 2.5 mg.

    Description:

    Tablets are white or white with a yellowish tint of color, flat-cylindrical shape with a risk and chamfer.

    Pharmacotherapeutic group:antiepileptic agent
    ATX: & nbsp

    N.03.A.F.01   Carbamazepine

    Pharmacodynamics:

    Antiepileptic agent, a derivative of dibenzazepine, which also has a normotimic, antimanic and analgesic effect. Activates the central brake GABA-ergic system. It blocks the potential sodium channels of nerve cell membranes, which leads to functional stabilization of neurons, reduces the activity of excitatory neurotransmitter acids (glutamate, aspartate), interacts with central adenosine receptors (inhibition of adenylate cyclase activation). Increases the convulsive threshold, reduces the risk of developing an epileptic attack.It can be prescribed both as the main therapeutic agent, and in combination with other anticonvulsants. Corrects the epileptic personality changes, which leads to increased communication skills of patients and their social rehabilitation. In the case of essential neuralgia of the trigeminal nerve, in most cases it prevents the occurrence of paroxysmal pain. With an alcohol withdrawal syndrome increases the reduced convulsive threshold and, thus, reduces the risk of developing seizures, also reduces the severity of clinical manifestations of the syndrome (increased excitability, tremor, affective disorders). When diabetes insipidus reduces diuresis and thirst (due to antidiuretic effect).

    Pharmacokinetics:Absorption - slow, but fairly complete (eating does not affect the speed and degree of absorption). After a single intake, the maximum concentration (Cmah) is reached after 12 hours. Equilibrium concentrations of the drug in the plasma are achieved after 1-2 weeks (the rate of achievement depends on the individual features of the metabolism: autoinduction of the liver enzyme systems, heteroinduction by others,simultaneously applied, medicines), as well as on the patient's condition, dose of the drug and the duration of treatment. There are significant interindividual differences in the values ​​of equilibrium concentrations in the therapeutic range: in most patients the values ​​range from 4 to 12 μg / ml (17-50 μmol / l). The concentrations of carbamazepine-10,11-epoxide (pharmacologically active metabolite) are about 30% of the concentration carbamazepine. The connection with plasma proteins in children is 55-59%, in adults 70-80%. The apparent volume of distribution is 0.8-1.9 l / kg. In the cerebrospinal fluid (hereinafter referred to as CSF) and saliva, concentrations are created in proportion to the amount of protein unbound of the active substance (20-30%). Penetrates through the placental barrier. Concentration in breast milk is 25-60% of that in plasma.

    Metabolised in the liver, mainly along the epoxide route with the formation of the main metabolites: active - carbamazepine-10,11-epoxide and inactive conjugate with glucuronic acid. The main isoenzyme providing the biotransformation of carbamazepine in carbamazepine-10,11-epoxide is cytochrome P450 (CYP3A4). As a result of these metabolic reactions, a low-activity metabolite of 9-hydroxy-methyl-10 carbamoylacridan is also formed.Can induce own metabolism. The concentration of carbamazepine-10,11-epoxide is 30% of the concentration of carbamazepine.

    Half-life (T1 / 2) after taking a single oral dose of 25-65 hours (an average of about 36 hours), after repeated administration, depending on the duration of treatment 12-24 hours (due to autoinduction of the monooxygenase system of the liver). In patients receiving additionally other anticonvulsants (monooxygenase system inducers - phenytoin, phenobarbital) T1 / 2 - an average of 9-10 hours.

    It is excreted as inactive metabolites with urine (70%) and with feces (30%). Children, due to the faster elimination of carbamazepine, may require the use of higher doses of the drug per kg body weight, compared with adults. There is no evidence that the pharmacokinetics of carbamazepine change in elderly patients (compared with older adults). Data on the pharmacokinetics of carbamazepine in patients with impaired renal or hepatic function is not sufficient.

    Indications:

    Epilepsy (excluding absence, myoclonic or flaccid seizures) - partial seizures with complex and simple symptoms, primary and secondary generalized forms of seizures with tonic-clonic seizures,mixed forms of seizures (monotherapy or in combination with other anticonvulsants); idiopathic neuralgia of the trigeminal nerve, trigeminal neuralgia with multiple sclerosis, idiopathic glossopharyngeal neuralgia, alcohol withdrawal syndrome, treatment of affective disorders, polydipsia and polyuria in diabetes insipidus, diabetic polyneuropathy.

    Prevention of phase-related affective disorders (manic-depressive psychosis, schizoaffective disorder, etc.).

    Contraindications:

    Hypersensitivity to carbamazepine or chemically similar drugs (eg, tricyclic antidepressants) or to any other component of the drug, acute intermittent porphyria (including history), simultaneous administration of monoamine oxidase inhibitors (hereinafter MAO), disturbance of bone marrow hematopoiesis (anemia , leukopenia), atrio-ventricular blockade.

    Carefully:

    Hyponatremia of dilution (syndrome of hypersecretion of antidiuretic hormone (hereinafter ADH), hypopituitarism, hypothyroidism, adrenocortical insufficiency), elderly age, alcohol intake (CNS depression is increasing,increased metabolism of carbamazepine), oppression of bone marrow hematopoiesis against the background of taking medications (in the anamnesis); hyperplasia of the prostate, increased intraocular pressure, severe heart failure, liver failure, chronic renal failure.

    Pregnancy and lactation:In women of reproductive age Carbamazepine should, if possible, be used as monotherapy (using the lowest effective dose) - the incidence of congenital anomalies in newborns born to women who undergo combined antiepileptic treatment is higher than those who received each of these agents as monotherapy. At the onset of pregnancy (when deciding whether to prescribe carbamazepine during pregnancy), it is necessary to carefully compare the expected benefits of therapy and its possible complications, especially in the first 3 months. pregnancy. It is known that children born to mothers with epilepsy are predisposed to violations of intrauterine development, including malformations. Carbamazepine, like all other antiepileptic drugs, is capable of increasing the risk of these disorders. There are isolated reports of cases of congenital diseases and malformations, including non-vertebral arches (spina bifida). Patients should be provided with information on the possibility of increasing the risk of malformations and the ability to undergo antenatal diagnostics. Antiepileptic drugs increase the deficiency of folic acid, which is often observed during pregnancy, which can contribute to an increase in the frequency of birth defects in children (additional folic acid intake is recommended before and during pregnancy). In order to prevent increased bleeding in newborns, in the last weeks of pregnancy, as well as newborns, vitamin K1 is recommended. Carbamazepine penetrates into breast milk, it is necessary to compare the benefits and possible undesirable consequences of breastfeeding in conditions of ongoing therapy. Mothers accepting Carbamazepine, can breast-feed their children, provided that the child will be monitored for the development of possible adverse reactions (for example, pronounced drowsiness, allergic skin reactions).

    Dosing and Administration:

    Assign inside, regardless of the reception of food with a small amount of liquid.

    With epilepsy

    Wherever possible, carbamazepine should be administered as a monotherapy. Treatment begins with the application of a small daily dose, which is then slowly increased until an optimal effect is achieved.

    The addition of carbamazepine to already conducted antiepileptic therapy should be carried out gradually, while the doses of the drugs used do not change or, if necessary, be corrected.

    For adults the initial dose is 100-200 mg 1-2 times a day. Then the dose is slowly increased, until the optimal therapeutic effect is reached (usually 400 mg 2-3 times a day, maximum - 1600-2000 mg / day).

    For children from 4 months to 4 years, the average daily dose is 10-20 mg / kg of body weight: from 4 months to 1 year - 100-200 mg per day, from 1 to 5 years - 200-400 mg (in 1-2 doses ), from 6 to 10 years - 400-600 mg (2-3 times taken), for 11-15 years - 600-1000 mg (2-3 times taken).

    Supportive doses: 10-20 mg / kg per day (in several doses).

    With neuralgia of the trigeminal nerve and neurogenic pain syndrome

    Carbamazepine is prescribed starting from 100-200 mg 2 times a day, then the dose is gradually increased by no more than 200 mg per day until the pain ceases, on average, to 600-800 mg, then reduced to the minimum effective dose.The effect usually occurs 1-3 days after the start of treatment. Assign the drug for a long time; with the premature cancellation of the drug pain can resume. In the treatment of elderly patients, the initial dose should be 100 mg 2 times a day.

    Alcohol abstinence syndrome

    The average dose is 200 mg 3 times a day. In severe cases, during the first days the dose can be increased (for example, up to 400 mg 3 times a day). At the beginning of treatment for severe manifestations of abstinence it is recommended to appoint in combination with detoxification therapy and sedative-hypnotic drugs.

    Non-diabetes mellitus

    The average dose for adults is 200 mg 2-3 times a day. Diabetic neuropathy, accompanied by pain: the average dose is 200 mg 2-4 times a day

    For the prevention of affective disorders

    In the first week, the daily dose is 200-400 mg (2 tablets). Subsequently, the dose is increased by 200 mg per week, bringing it to 1 g. The daily dose is divided evenly into 3-4 doses. Just as with the use of other antiepileptic drugs, the transition to carbamazepine treatment should be gradual, with a decrease in the dose of the previous drug. Stop treatment with carbamazepine also need to gradually. The duration of treatment is set individually by the doctor.

    Side effects:Dose-dependent adverse reactions usually occur within a few days, both spontaneously and after a temporary dose reduction. The development of adverse reactions may be due to a relative overdose of the drug or significant fluctuations in the concentration of the active substance in the blood plasma. In such cases it is recommended to monitor the level of active substance in the blood plasma.

    From the central nervous system: very often - dizziness, ataxia, drowsiness, general weakness; often - headache, paresis of accommodation; sometimes - abnormal involuntary movements (eg, tremor, "fluttering" tremor - asterixis, dystonia, tics); nystagmus; rare - orofacial dyskinesia, oculomotor disturbances, speech disorders (eg dysarthria or slurred speech), horeoatetoidnye disorders, peripheral neuritis, paresthesia, muscle weakness, and paresis. The role of the carbamazepine as the drug causing or contributing to the development of neuroleptic malignant syndrome, especially when it is administered in conjunction with antipsychotics, remains unclear.

    From the psychic sphere: rarely - hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, agitation, disorientation; very rarely - activation of psychosis.

    Allergic reactions: often - hives; sometimes - exfoliative dermatitis, erythroderma; rarely - lupus-like syndrome, itching; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, multiform and erythema nodosum. Rarely, multiorgan hypersensitivity reactions with a fever, skin rashes, vasculitis, lymphadenopathy, signs resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function (these manifestations occur in various combinations). Other organs may also be involved (eg, lungs, kidneys, pancreas, myocardium, large intestine). Very rarely - aseptic meningitis with myoclonus, anaphylactic reaction, angioedema, hypersensitivity reactions on the part of the lungs characterized by fever, dyspnoea, pneumonitis or pneumonia.If the above hypersensitivity reactions occur, the drug should be discontinued.

    From the hematopoiesis: very often - leukopenia; often - thrombocytopenia, eosinophilia; rarely - leukocytosis, lymphadenopathy; very rarely - agranulocytosis, aplastic anemia, true erythrocyte aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia.

    From the side of the digestive system: very often - nausea, vomiting; often - dry mouth; sometimes - diarrhea or constipation, abdominal pain; very rarely - glossitis, stomatitis, pancreatitis. On the part of the liver: very often - increased activity of gamma-glutamyltransferase (due to the induction of this enzyme in the liver), which usually has no clinical significance; often - increased alkaline phosphatase activity; sometimes - increased activity of "liver" transaminases; rarely - hepatitis of cholestatic, parenchymal (hepatocellular) or mixed type, jaundice; very rarely - granulomatous hepatitis, hepatic insufficiency.

    From the cardiovascular system: rarely - violations of intracardiac conduction; declineor increased blood pressure; very rarely - bradycardia, arrhythmias, atrio-ventricular blockade with syncope, collapse, aggravation or development of congestive heart failure, exacerbation of coronary heart disease (including the appearance or increase in angina attacks), thrombophlebitis, thromboembolic syndrome.

    From the endocrine system and metabolism: often - swelling, fluid retention, weight gain, hyponatremia (decreased plasma osmolarity due to an effect similar to that of ADH, which in rare cases leads to hyponatremia of the dilution, accompanied by lethargy, vomiting, headache, disorientation and neurologic disorders); very rarely - an increase in the level of prolactin (may be accompanied by galactorrhea and gynecomastia); a decrease in the level of L-thyroxine (free T4, T3) and an increase in the thyroid-stimulating hormone (TSH) level (usually not accompanied by clinical manifestations); disorders of calcium-phosphorus metabolism in bone tissue (reduction of Ca2 + and 25-OH-cholecalciferol concentration in blood plasma); osteomalacia; hypercholesterolemia (including cholesterol and high-density lipoprotein (HDL) and hypertriglyceridemia.

    From the genitourinary system: very rarely - interstitial nephritis, kidney failure, renal dysfunction (eg, albuminuria, hematuria, oliguria, urea / azotemia increase), frequent urination, urinary retention, impaired sexual function / impotence.

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

    From the sense organs: very rarely - a violation of taste, clouding of the lens, conjunctivitis; Hearing impairment, incl. noise in the ears, hyperacusia, hypoacusia, changes in perception of the height of sound.

    Other: disorders of skin pigmentation, purpura, acne, sweating, alopecia. There have been reports of rare cases of hirsutism, but the causal relationship between this complication and carbamazepine is not clear.

    Overdose:

    Occurring in overdose symptoms and complaints usually reflect abnormalities from the CNS, SSS and respiratory system.

    central nervous system: oppression of the central nervous system, disorientation, drowsiness, agitation, hallucinations, coma; blurred vision, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (at the beginning), hyporeflexia (later); convulsions, psychomotor disorders, myoclonus, hypothermia, mydriasis;

    The cardiovascular system: tachycardia, lowering blood pressure, sometimes raising blood pressure, conduction disorders with expansion of the complex QRS; fainting, cardiac arrest; respiratory system: respiratory depression, pulmonary edema.

    Gastrointestinal tract: nausea and vomiting, delayed passage of food from the stomach, decreased motility of the colon.

    Urinary system: retention of urine, oliguria or anuria; fluid retention; hyponatremia of breeding.

    Laboratory and instrumental data: leukocytosis or leukopenia, hyponatremia, metabolic acidosis is possible, hyperglycemia and glucosuria are possible, muscle fraction of creatine phosphokinase is increased.

    Treatment: there is no specific antidote. Treatment is based on the clinical condition of the patient; (for confirmation of poisoning with this agent and evaluation of the degree of overdose), gastric lavage, the appointment of activated charcoal (late evacuation of gastric contents can lead to delayed absorption on days 2 and 3 and the re-emergence of symptoms of intoxication during the recovery period) .Intense diuresis, hemodialysis and peritoneal dialysis are ineffective (dialysis is indicated by a combination of severe poisoning and kidney failure). In young children, there may be a need for exchange blood transfusion. Symptomatic supportive treatment in the intensive care unit, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder function, correction of electrolyte disorders. With a decrease in blood pressure: the position with the raised leg of the bed, plasma substitutes, with inefficiency - in / in dopamine or dobutamine; with heart rhythm disturbances, treatment is selected individually; with convulsions - the introduction of benzodiazepines (for example, diazepam), with caution (because of the possible increase in respiratory depression), the introduction of other anticonvulsants (eg, phenobarbital). With the development of hyponatremia of dilution (water intoxication) - restriction of the introduction of fluids and slow intravenous infusion of 0.9% sodium chloride solution (may help prevent the development of cerebral edema). It is recommended to carry out hemosorption on carbon sorbents.

    Interaction:Carbamazepine enhances the activity of microsomal liver enzymes and can reduce the effect of certain drugs metabolized in the liver (oral anticoagulants, etc.). Cytochrome P450 (CYP3A4) is the main enzyme that provides the metabolism of carbamazepine. Simultaneous administration of carbamazepine with inhibitors CYP3A4 can lead to an increase in its concentration in the blood plasma and cause side reactions. Joint application of inducers CYP3A4 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.

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

    Felbamate reduces the concentration of carbamazepine in plasma and increases the concentration of carbamazepine-10,11-epoxide, while a simultaneous decrease in serum felbamate concentration is possible. The concentration of carbamazepine is reduced phenobarbital, phenytoin, primidon, metsuksimide, fensuksimid, theophylline, rifampicin, cisplatin, doxorubicin, perhaps: clonazepam, valpromid, valproic acid, oxcarbazepine and herbal preparations containing St. John's wort perfumed (Hypericum perforatum). There are reports of the possibility of displacing valproic acid and primidone carbamazepine from plasma protein binding and increasing the concentration of pharmacologically active metabolite (carbamazepine-10,11-epoxide). Isotretinoin changes the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxide (carbamazepine concentration in the plasma is monitored).

    Carbamazepine can reduce the concentration in the plasma (reduce or even completely neutralize the effects) and require correction of the doses of the following drugs: clobazam,clonazepam, ethosuximide, primidon, valproic acid, alprazolam, glucocorticosteroids (prednisolone, dexamethasone), cyclosporine, doxycycline, haloperidol, methadone, oral preparations containing estrogens and / or progesterone (the choice of alternative methods of contraception), theophylline, oral anticoagulants (warfarin, fenprocumone, dicumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriptyline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors HIV infection (indinavir, ritonavir, saquinovir), calcium channel blockers (a group of dihydropyridines, for example, felodipine), itraconazole, levothyroxine, midazolam, olanzapine, praziquantel, risperidone, tramadol, ziprasidone.

    It has been reported that in patients receiving carbamazepine phenytoin plasma levels may either rise or fall, and mephenytoin level - increase (in rare cases).

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

    The simultaneous appointment of carbamazepine with phenothiazines, pimozide, thioxanthenes, molindone, haloperidol, maprotiline, clozapine and tricyclic antidepressants leads to increased inhibitory action on the central nervous system and weaken the anticonvulsant effect of carbamazepine.

    MAO inhibitors increase the risk of developing hyperpyretic crises, hypertensive crises, seizures, fatal outcome (prior to prescribing carbamazepine, MAO inhibitors should be withdrawn at least 2 weeks or, if the clinical situation permits, even for a longer period).

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

    Weakens the effects of nondepolarizing muscle relaxants (pancuronium). If such a combination is used, it may be necessary to increase the dose of muscle relaxants, and careful monitoring of patients should be carried out, since a faster cessation of their effect is possible.

    Reduces the tolerance of ethanol.

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

    Accelerates the metabolism of agents for general anesthesia (enflurane, halothane, fluorotan) with increasing risk of hepatotoxic effects; enhances the formation of nephrotoxic metabolites of methoxyflurane. Enhances the hepatotoxic effect of isoniazid.

    Special instructions:

    Monotherapy epilepsy begins with the appointment of small doses, individually increasing them to achieve the desired therapeutic effect. It is advisable to determine the concentration in the plasma in order to select the optimal dose, especially with combination therapy. When transferring a patient to Carbamazepine should gradually reduce the dose of the previously prescribed antiepileptic agent until its complete cancellation. A sudden discontinuation of taking carbamazepine can provoke epileptic seizures. If it is necessary to abruptly terminate treatment, it is necessary to transfer the patient to another antiepileptic agent under the cover of the drug shown in such cases (for example, diazepam administered intravenously or rectally, or phenytoin administered intravenously). Several cases of vomiting, diarrhea and / or reduced nutrition, seizures and / or respiratory depression in newborns whose mothers have been taken Carbamazepine concomitantly with other anticonvulsants (perhaps these reactions are manifestations in newborn withdrawal syndrome). Before the appointment of carbamazepine and in the process of treatment, it is necessary to study the liver function, especially in patients whose history includes information on liver diseases, as well as in elderly patients. In case of strengthening of already existing violations of the liver function or when there is an active liver disease, the drug should be immediately canceled. Also, before the start of treatment, it is necessary to conduct blood sample studies (including platelet count, reticulocyte count), serum iron level, general urine analysis, blood urea level, electroencephalogram (EEG), determination of serum electrolyte concentration (and periodically during treatment, because it is possible to develop hyponatremia). Subsequently, these indicators should be monitored during the first month of treatment on a weekly basis, and then on a monthly basis. Carbamazepine should be immediately withdrawn when hypersensitivity reactions or symptoms, presumably indicative of the development of Stevens-Johnson syndrome or Lyell syndrome, appear.Slightly expressed skin reactions (isolated macular or maculopapular exanthema) usually pass for several days or weeks even after continuing treatment or after reducing the dose of the drug (the patient at this time should be under close medical supervision). Carbamazepine has a weak anticholinergic activity, when appointing patients with increased intraocular pressure, its constant monitoring is necessary. It should take into account the possibility of activation of latent psychoses, and in elderly patients - the possibility of developing disorientation or arousal. To date, individual reports of male fertility impairment and / or spermatogenesis disorders have been reported (the relationship of these disorders to carbamazepine has not yet been established). There are reports of women developing bleeding during menstruation in cases when oral contraceptives were used simultaneously. Carbamazepine can adversely affect the reliability of oral contraceptives, so women of reproductive age during treatment should use alternative methodsprotection from pregnancy. Carbamazepine should be used only under medical supervision. It is necessary to inform patients about the early signs of toxicity inherent in probable hematologic disorders, as well as symptoms from the skin and liver. The patient is informed of the need to consult a doctor immediately if there are undesirable reactions such as fever, sore throat, rash, ulceration of the oral mucosa, unjustified bruising, hemorrhages in the form of petechiae or purpura. In most cases, a transient or persistent decrease in the number of platelets and / or leukocytes is not a harbinger of the onset of aplastic anemia or agranulocytosis.

    Nevertheless, before the start of treatment, as well as periodically during the treatment should be carried out clinical blood tests, including counting the number of platelets and, possibly, reticulocytes, as well as determine the level of iron in the blood serum. Non-progressive asymptomatic leukopenia does not require withdrawal, however, treatment should be discontinued if progressive leukopenia or leukopenia occurs, accompanied by clinical symptoms of an infectious disease.Before the beginning of treatment it is recommended to conduct an ophthalmological examination, including examination of the fundus by a slit lamp and measurement of intraocular pressure, if necessary. In the case of prescribing patients with increasing intraocular pressure, a constant monitoring of this indicator is required.

    It is recommended to abandon the use of ethanol.

    Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very low, nevertheless, regular determination of the level of carbamazepine can be useful in the following situations: with a sharp increase in the frequency of seizures; to check whether the patient is taking the drug properly; during pregnancy; when treating children or adolescents; with suspected drug absorption abnormalities; if there is a suspicion of the development of toxic reactions in the event that the patient takes several medicines.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Tablets 200 mg.

    Packaging:

    10 tablets per contour cell pack.

    For 500, 600, 1000, 1200 tablets in a can of polymer (for hospitals).

    By 1,2,3,4 or 5 contour squares with instructions for use in a pack of cardboard.
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N003759 / 01
    Date of registration:13.11.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:ALSI Pharma, ZAO ALSI Pharma, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspALSI Pharma CJSC ALSI Pharma CJSC Russia
    Information update date: & nbsp18.07.2011
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