Composition, form of production and packaging
Tablets of prolonged action, covered with a brick-orange shell , oval, slightly biconcave, with a risk on each side; with the label "HC" on one side, "CG" on the other.
1 tab.
carbamazepine 200 mg
[PRING] cellulose microcrystalline, carmellose sodium, polyacrylate dispersion 30% (Eudragit E 30 D), ethyl cellulose aqueous dispersion, talc, silicon dioxide colloidal anhydrous, magnesium stearate.
Sheath composition: hypromellose, talc, titanium dioxide, castor oil (macrogol glycerolinzinoleate), iron oxide red, iron oxide yellow.
10 pieces. - blisters (5) - packs of cardboard.
Tablets of prolonged action, covered with a coat of brown-orange color, oval, slightly biconcave, with a risk on each side; with the label "ENE / ENE" on one side, "CG / CG" on the other.
1 tab.
carbamazepine 400 mg
[PRING] microcrystalline cellulose, carmellose sodium, polyacrylate dispersion 30% (Eudragit E 30 D), ethyl cellulose aqueous dispersion, talc, silicon dioxide colloidal anhydrous, magnesium stearate.
Sheath composition: hypromellose, talc, titanium dioxide, castor oil (macrogol glycerolinzinoleate), iron oxide red, iron oxide yellow.
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Antiepileptic drug.
Carbamazepine, the active substance of the preparation Tegretol CR, is a derivative of dibenzoazepine. Along with antiepileptic, the drug also has a neurotropic and psychotropic effect.
The mechanism of action of carbamazepine is currently only partially explained. Carbamazepine stabilizes membranes of overexcited neurons, suppresses serial discharges of neurons and reduces the synaptic transmission of exciting impulses. Probably the main mechanism of action of carbamazepine is the prevention of repeated occurrence in the depolarized neurons of sodium-dependent action potentials due to the blockade of "action" -dependent and potential-dependent sodium channels.
When used as a monotherapy in patients with epilepsy (especially in children and adolescents), a psychotropic effect of the drug was noted that included a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness. There is no unambiguous data on the effect of the drug on cognitive and psychomotor functions: in some studies, a double or negative effect was shown that depended on the dose of the drug, in other studies, the positive effect of the drug on attention and memory was revealed.
As a neurotropic drug, the drug is effective in a number of neurological diseases. So, for example, with idiopathic and secondary neuralgia of the trigeminal nerve, he prevents the occurrence of paroxysmal pain attacks.
With the alcohol withdrawal syndrome, the drug raises the threshold of convulsive readiness, which in this condition is usually reduced, and reduces the severity of clinical manifestations of the syndrome, such as increased excitability, tremor, gait disturbance.
In patients with diabetes insipidus, the drug reduces diuresis and thirst.
As a psychotropic drug, the drug is effective in affective disorders, namely, in the treatment of acute manic conditions, with the supportive treatment of bipolar affective (manic-depressive) disorders (either as monotherapy or in combination with antipsychotics, antidepressants or lithium preparations), with attacks of schizoaffective psychosis, with manic attacks, where it is used in combination with neuroleptics, as well as with manic-depressive psychosis with fast cycles. The ability of the drug to suppress manic manifestations may be due to the inhibition of the exchange of dopamine and noradsnaline.
PHARMACOKINETICS
Suction
After ingestion, carbamazepine is absorbed almost completely, albeit relatively slowly.
After ingestion (single or repeated) of prolonged action tablets, C max is reached within 24 hours, its value is approximately 25% less than in the case of a conventional tablet. When taking prolonged-action tablets, the carbamazepine concentration in plasma is significantly less, and there is no significant decrease in the minimum value of equilibrium concentration. When taking the drug in the form of long-acting tablets 2 times / day, the fluctuations in the concentration of the active substance in the plasma are very slight. Bioavailability of the active ingredient from long-acting tablets is approximately 15% lower than that of other oral dosage forms.
The intake of food does not significantly affect the speed and degree of absorption of carbamazepine.
C ss carbamazepine in plasma is achieved within 1-2 weeks. The time of its achievement is individual and depends on the degree of autoinduction of enzymatic systems of the liver with carbamazepine, the heteroinduction of other, simultaneously used drugs, as well as on the condition of the patient before the appointment of therapy, the 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 these values ​​range from 4 to 12 μg / ml (17-50 μmol / l).
Distribution
The binding of carbamazepine to plasma proteins is 70-80%. The concentration of unchanged carbamazepine in the cerebrospinal fluid and saliva is proportional to the proportion of the active substance not associated with plasma proteins (20-30%). The concentration of carbamazepine in breast milk is 25-60% of its level in the blood plasma.
Carbamazepine penetrates the placental barrier. Given the complete absorption of carbamazepine, the apparent V d is 0.8-1.9 l / kg.
Metabolism
Carbamazepine is metabolized in the liver. The main pathway of biotransformation is epoxidation, as a result of which the main metabolites are formed: 10,11-translodiol derivative and its conjugate with glucuronic acid. The main isoenzyme providing the biotransformation of carbamazepine in carbamazepine is 10,11-epoxide, is cytochrome P 450 3A4. As a result of these metabolic reactions, a small amount of another metabolite, 9-hydroxy-methyl-10-carbamoylacridan, is also formed.
Another important pathway for the metabolism of carbamazepine is the formation of various monohydroxylated derivatives, as well as N-glucuronides.
Excretion
T 1/2 of unchanged carbamazepine after a single oral intake is about 36 hours on average, and after repeated administration of the drug - an average of 16-24 hours, depending on the duration of treatment (due to autoinduction of the monooxygenase system of the liver). It was shown that in patients taking simultaneously other drugs inducing liver enzymes (eg, phenytoin, phenobarbital), T 1/2 carbamazepine averages 9-10 hours.
When ingested, T 1/2 carbamazepine-10,11-epoxide is approximately 6 hours.
After a single oral intake of carbamazepine at a dose of 400 mg, 72% of the dose is taken with urine and 28% with feces. About 2% of the dose is taken with urine in the form of unchanged carbamazepine, about 1% - in the form of a pharmacologically active 10,11-epoxide metabolite. After a single oral intake, 30% of carbamazepine is excreted in the urine as final products of epoxidation.
Pharmacokinetics in special clinical cases
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 to suggest that the pharmacokinetics of carbamazepine change in elderly patients (compared to older adults).
Data on the pharmacokinetics of carbamazepine in patients with impaired renal or hepatic function have not been reported to date.
INDICATIONS
- Epilepsy: complex or simple partial epileptic seizures (with or without loss of consciousness) with secondary generalization or without it; generalized tonic-clonic epileptic seizures; mixed forms of epileptic seizures;
- acute manic conditions and maintenance therapy of bipolar affective disorders with the purpose of preventing exacerbations or alleviating clinical manifestations of exacerbation;
- alcohol withdrawal syndrome;
- idiopathic neuralgia of the trigeminal nerve and trigeminal neuralgia in multiple sclerosis (typical and atypical); idiopathic neuralgia of the glossopharyngeal nerve;
- pain syndrome with diabetic neuropathy;
- Polyuria and polydipsia of neurohormonal nature in diabetes insipidus of central genesis.
DOSING MODE
The drug can be taken during, after meals or in between meals with a small amount of liquid.
The drug can be used as a monotherapy or as part of a combination therapy.
Tablets of prolonged action (whole tablet or half if prescribed by a doctor) should be swallowed whole, without chewing, squeezed with a small amount of liquid.Because the active substance is released from the tablets of prolonged action slowly and gradually, they are prescribed 2 times / day.
Considering that Tegretol CR is prescribed 2 times / day, the optimal scheme of therapy is determined by the doctor on the basis of the recommendations given.
When transferring a patient from taking conventional tablets to taking prolonged-action tablets, clinical experience shows that in some patients with the use of long-acting tablets, it may be necessary to increase the dose of the drug.
Given the drug interaction and the different pharmacokinetics of antiepileptic drugs, elderly patients of Tegretol dose should be selected with caution.
In epilepsy , whenever possible, Tegretol CR should be given as a monotherapy.
Treatment begins with the application of a small daily dose, which is then slowly increased until an optimal effect is achieved.
To select the optimal dose of the drug, it is recommended to determine the level of the active substance in the blood plasma.
When Tegretol CR is added to other antiepileptic drugs, the dose of Tegretolum is increased gradually. If necessary, appropriate correction of the doses taken.
For adults, the initial dose of Tegretol CR is 100-200 mg once or twice a day. Then the dose is slowly increased until the optimal therapeutic effect is achieved; it is usually achieved at a dose of 400 mg / day 2-3 times / day. Some patients may need a dose of Tegretol CR, which is 1.6 g / day or 2 g / day.
In children over the age of 4, treatment can be initiated with the use of the drug at a dose of 100 mg / day; The dose is increased gradually - every week by 100 mg. In children under 3 years of age, carbamazepine is preferably administered in the form of a syrup due to the difficulty of using solid dosage forms in this age group.
Supportive doses for children are 10-20 mg / kg / day (in several steps):
Age of the child
4-5 years 200-400 mg
6-10 years 400-600 mg
11-15 years 600-1000 mg
With neuralgia of the trigeminal nerve, the initial dose of Tegretol CR is 200-400 mg / day. It is slowly increased until the pain disappears (usually to a dose of 200 mg 3-4 times / day), and then gradually reduced to a minimal maintenance level. The recommended initial dose for elderly patients is 100 mg 2 times / day.
In alcohol withdrawal syndrome, the average dose is 200 mg 3 times / day. In severe cases, during the first few days the dose may be increased (for example, to a dose of 400 mg 3 times / day). In severe manifestations of alcohol abstinence, treatment is initiated with a combination of Tegretol CR with sedative-hypnotic drugs (eg, clomethiazole, chlordiazepoxide). After resolving the acute phase, treatment with Tegretol CR can be continued as a monotherapy.
In polyuria and polydipsia of neurohormonal nature in diabetes insipidus of central genesis, the average dose for adults is 200 mg 2-3 times / day. In children, thedose of the drug should be reduced in accordance with the age and body weight of the child.
With pain syndrome with diabetic neuropathy, the average dose of Tegretol CR is 200 mg 2-4 times / day.
In acute manic conditions and maintenance treatment of affective (bipolar) disorders, daily doses are 400-1600 mg. The average daily dose is 400-600 mg (in 2-3 doses). In acute mania, the dose of Tegretol CR should be increased rather quickly. With maintenance therapy for bipolar disorders, in order to ensure optimal tolerability, each next dose increase should be small, the daily dose increases gradually.
SIDE EFFECT
When assessing the frequency of occurrence of various adverse reactions, the following grades are used: "very often" -? 10%; "often" - from? 1% to <10%;"sometimes" - from? 0.1% to <1%; "rarely" - from? 0.01% to <0.1%; "very rarely" - <0.01%.
Certain types of side effects, for example, from the side of the central nervous system (dizziness, headache, ataxia, drowsiness, general weakness, diplopia), gastrointestinal tract (nausea, vomiting) or allergic skin reactions, occur more or less frequently, especially at the beginning of treatment with Tegretol CR use of a too large initial dose of the drug or in the treatment of elderly patients.
Dose-dependent side effects usually occur within a few days, both spontaneously and after a temporary dose reduction. The development of side effects from the CNS may be a consequence of a relative overdose of the drug or significant fluctuations in the concentrations 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 psychic sphere: rarely - hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, agitation, disorientation; very rarely - activation of psychosis.
From the side of the central nervous system and peripheral nervous system: very often - dizziness, ataxia, drowsiness, general weakness; often - headache, diplopia, impaired vision accommodation (eg, blurred vision); sometimes - abnormal involuntary movements (eg, tremor, "fluttering" tremor / asterixis /, dystonia, tics), nystagmus; rarely - orofacial dyskinesia, oculomotor disorders, speech disorders (eg, dysarthria), choreoathetoid disorders, peripheral neuritis, paresthesia, muscle weakness and paresis symptoms.
The role of carbamazepine as a drug that causes or contributes to the development of a malignant neuroleptic syndrome, especially when carbamazepine is prescribed together with neuroleptics, remains unclear.
Dermatological reactions: very rarely photosensitivity, erythema multiforme and nodosum, skin pigmentation disorders, purpura, acne, increased sweating, hair loss.There have been reports of rare cases of hirsutism, but the causal relationship between this complication and the use of Tegretol CR remains unclear.
Allergic reactions: very often allergic skin reactions, urticaria, which can be very pronounced; sometimes - exfoliative dermatitis, erythroderma; rarely - lupus-like syndrome, itching; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
On the part of the hematopoiesis system: very often - leukopenia; often - thrombocytopenia, eosinophilia; rarely - leukocytosis, lymphadenopathy, deficiency of folic acid; very rarely - agranulocytosis, aplastic anemia, true erythrocyte aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia.
During the administration of the drug, agranulocytosis and aplastic anemia can develop. However, due to the fact that these conditions occur very rarely, it is difficult to quantify the risk of their occurrence. It is known that the total risk of developing agranulocytosis in the general population not receiving treatment is 4.7 cases per million population per year, and aplastic anemia 2.0 cases per million population per year.
On the part of the liver: very often - an increase in the level of gamma-glutamyltransferase (due to the induction of this enzyme in the liver), which usually has no clinical significance; often - increasing the level of alkaline phosphatase; sometimes - increased levels of transaminases; rarely - hepatitis of cholestatic, parenchymal (hepatocellular) or mixed type, jaundice; very rarely - granulomatous hepatitis, hepatic insufficiency.
From the digestive tract: very often - nausea, vomiting; often - dry mouth; sometimes - diarrhea or constipation, abdominal pain; very rarely - glossitis, stomatitis, pancreatitis.
Hypersensitivity reactions: rarely - multi-organ hypersensitivity of delayed type with 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, heart, large intestine); very rarely - aseptic meningitis with myoclonus and peripheral eosinophilia; anaphylactic reaction, angioedema.
In the event of the aforementioned hypersensitivity reactions using the product should be discontinued.
Cardio-vascular system: rarely - a violation of intracardiac conduction, hypertension or hypotension; very rarely - bradycardia, arrhythmias, AV-block with syncope, collapse, congestive heart failure, aggravation of coronary artery disease, thrombophlebitis, thromboembolism.
On the part of the endocrine system and metabolism:often - edema, fluid retention, weight gain, hyponatremia and reduced plasma osmolarity due to an effect similar to the action of antidiuretic hormone, which rarely leads to dilution hyponatremia, accompanied by lethargy, vomiting, headache, disorientation and neurological disorders; very rarely - increased prolactin levels, accompanied or not by such manifestations as galactorrhoea, gynecomastia; changes in thyroid function parameters - decrease of L-thyroxine (FT 4 , T 4 , T 3) And increase the level of thyroid stimulating hormone, which usually is not accompanied by clinical symptoms; disorders of bone metabolism (decrease in calcium levels and 25-OH-kolekaltsiferola plasma), which leads to osteomalacia; in some cases - increasing cholesterol concentration (Xc), Xc including HDL, and triglycerides.
From the urogenital system: very rarely - interstitial nephritis, renal insufficiency, renal failure (e.g., albuminuria, hematuria, oliguria, increase urea / azotemia), frequent urination, urinary retention, sexual function disorders / impotence.
From the senses:very rarely - a violation of taste sensations, cataract, conjunctivitis; hearing disorders, including tinnitus, hyperacusis, Gipoakuzija, changes in the perception of pitch.
On the part of the musculoskeletal system: very rarely - arthralgia, muscle pain or cramps.
The respiratory system: very rarely - hypersensitivity reactions on the part of the lungs characterized by fever, dyspnoea, pneumonitis or pneumonia.
CONTRAINDICATIONS
- AV-block;
- presence in the history of episodes of suppression of bone marrow hematopoiesis, or information on acute intermittent porphyria;
- combination with MAO inhibitors (structural similarity with tricyclic antidepressants);
- hypersensitivity to carbamazepine or chemically similar drugs (e.g., tricyclic antidepressants) or to other components of the formulation.
PREGNANCY AND LACTATION
Tegretol CR treatment of epilepsy during pregnancy should be undertaken with extreme caution.
In women of childbearing age Tegretol CR should, whenever possible, be used as a monotherapy, as the incidence of congenital anomalies in fetuses born to women who were treated with a combination of antiepileptic drugs is greater than in those who received each of these agents as monotherapy.
Should be given the minimum effective dose of Tegretol CR. Recommended regular monitoring of carbamazepine plasma.
If pregnancy occurs in a woman receiving Tegretol CR, or if there is a question on the appointment of Tegretol CR during pregnancy, you need to carefully compare the expected benefits of therapy and its possible complications, especially in the I trimester of pregnancy.
We know that children born to mothers with epilepsy are more likely prone to violations of fetal development, including malformations. It has been reported that carbamazepine, like all major antiepileptic drugs, can increase the risk of these disorders, although the final confirmation of this, that would be obtained as a result of controlled studies with the use of Tegretol CR as monotherapy, to date not available. There have been reports of cases of congenital diseases and malformations, including spina bifida (spina bifida) and other congenital anomalies (including craniofacial and cardiovascular system) have been observed in patients taking Tegretol CR.Patients should be given information about the possibility of an increased risk of malformations and the possibility to pass antenatal diagnosis.
It is known that during pregnancy folic acid deficiency develops. It has been reported that antiepileptic drugs increase the deficit. This may contribute to increased incidence of birth defects in children born to women taking antiepileptic drugs. Therefore, prior to and during pregnancy recommended supplementation of folic acid.
In order to prevent excessive bleeding in newborns of women in the last weeks of pregnancy and the newborn is recommended to prescribe vitamin K 1 .
Carbamazepine is excreted in breast milk, concentration therein constitute 25-60% of the level in the blood plasma. Therefore, you should weigh the benefits and possible adverse effects of breastfeeding in the face of continued therapy Tegretol CR. Mother taking Tegretol CR may continue breast feeding, but with the proviso that the child will be placed under surveillance in respect of possible side effects (e.g., drowsiness expressed, allergic skin reactions).
Described several cases of seizures and / or respiratory depression in newborns whose mothers took the drug along with other anticonvulsants. In addition, also reported several cases of vomiting, diarrhea and / or malnutrition in infants whose mothers received Tegretol CR. Perhaps these reactions are manifestations of neonatal withdrawal syndrome.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients who have a history of information on kidney diseases, the drug should be given only after a thorough analysis of the relation of the expected effect of the treatment and possible therapy and risk while ensuring careful and regular monitoring.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Before the appointment of Tegretol and during treatment is necessary to study liver function, especially in patients with a history of which there is evidence of liver disease and in elderly patients. In the case of amplification of already existing liver dysfunction or when the active liver disease Tegretol should be discontinued immediately.
SPECIAL INSTRUCTIONS
The drug is usually not effective for small seizures (petit mal, absence) and myoclonic seizures.
During application Tegretol CR marked with different frequency transient or sustained reduction in the number of platelets or leukocytes. However, in most cases, these side effects are usually transient and not precursors of start aplastic anemia or agranulocytosis. However before treatment and periodically during the treatment process should be carried out clinical blood tests, including counting the number of platelets and possibly reticulocytes and also determine the level of iron in the serum.
The drug should be used only on condition that the regular medical supervision.
In cases where during treatment were low levels of leukocyte or platelet (or their tendency to reduction) should carefully watch the condition of the patient and expanded clinical blood indices analysis. If revealed signs of significant bone marrow suppression, Tegretol CR should be discontinued.
Tegretol should be lifted immediately in the event that there are signs and symptoms, presumably indicating the development of severe dermatological reactions, such as Stevens-Johnson syndrome or Lyell's syndrome.
Caution must be exercised when applying Tegretol CR in patients with mixed seizures including absence seizures (typical and atypical). In all these cases, Tegretol CR may intensify attacks. If this happens, Tegretol CR should be discontinued.
Before the appointment of Tegretol CR and in the course of treatment is necessary to study liver function, especially in patients with a history of which there is evidence of liver disease and in elderly patients. In the case of amplification of already existing liver dysfunction or when the active liver disease Tegretol CR should be revoked immediately.
Patients who have a history of information about heart disease, liver and renal adverse hematological reactions to other drugs or abolishing the previously performed treatments Tegretol CR, the drug should be given only after a thorough analysis of the relation of the expected effect of the treatment and possible therapy risk and ensuring careful and regular monitoring.
Should be brought to the attention of patients about the early signs of toxicity inherent probable hematological disorders, as well as the symptoms of the skin and liver. The patient is informed of the need to consult a doctor immediately in case of occurrence of adverse reactions such as fever, sore throat, rash, oral ulcers, wanton occurrence hematomas, hemorrhages in the form of petechiae or purpura.
Before treatment Tegretol CR and periodically during therapy to study of urinalysis and urea level in blood.
Mild skin reactions, e.g., isolated or macular makulo-papular rash, in most cases are not severe transient and usually disappear within a few days or weeks, even with continued treatment or after reduction of the dose. Nevertheless, the patient at this time should be under close medical supervision.
Tegretol CR has weak anticholinergic activity. Therefore, in case of the drug in patients with elevated intraocular pressure requires continuous monitoring of this parameter.
There are currently registered anecdotal reports of male fertility disorders and / or disorders of spermatogenesis. However, the causal relationship of these disorders with taking Tegretol CR has not yet been established.
The drug may reduce the effectiveness of drugs containing estrogen and / or progesterone, so that women of childbearing age during drug treatment should apply alternative methods of contraception.
Although the relationship between the magnitude of the dose and carbamazepine plasma level, and between carbamazepine plasma level and clinical efficacy or tolerability is very small, nevertheless regular determination of carbamazepine levels may be useful in the following situations: when a sharp increase in seizure frequency; in order to check whether the patient is taking medication properly; during pregnancy; when treating children or adolescents; in cases of suspected violation of absorption of the drug; in cases of suspected development of toxic reactions if the patient is taking several medications.
Sudden discontinuation of Tegretol CR may trigger epileptic seizures. If necessary to abruptly interrupt treatment Tegretol CR epileptic, in this case it is necessary to make the transition to another antiepileptic agent undercover shown in such cases the drug (e.g., diazepam, administered in / or rectally, or phenytoin administered in / in).
Perhaps the development of cross-hypersensitivity reactions to carbamazepine and oxcarbazepine in approximately 25-30% of patients.
Cross-hypersensitivity reactions may also occur between carbamazepine and phenytoin.
Before the appointment of the drug MAO inhibitors should be discontinued at least 2 weeks, or if the clinical situation allows, even for a longer period.
Impact on the ability to drive vehicles and manage mechanisms
The ability of the patient receiving Tegretol CR, to quick reaction, especially early in therapy or during the selection of the dose may be impaired due to the occurrence of drowsiness and dizziness. Therefore, when driving or operating machinery, patients should exercise caution.
OVERDOSE
Overdose is usually manifested symptoms of the CNS, cardiovascular and respiratory systems.
Symptoms
Central nervous system: depression of the central nervous system; disorientation, drowsiness, agitation, hallucinations, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (first), hyporeflexia (later); convulsions, psychomotor disturbances, myoclonus, hypothermia, mydriasis.
Respiratory system: respiratory depression, pulmonary edema.
Cardiovascular system: tachycardia, hypotension; sometimes - hypertension, conduction disturbances with the extension of the QRS complex; heart failure, syncope caused by heart failure.
GI:vomiting, delayed passage of food from the stomach, decreased motility of the colon.
Urinary system: urinary retention, oliguria or anuria; fluid retention; hyponatremia dilution effect caused carbamazepine, similar to the action of antidiuretic hormone.
Changes in the laboratory parameters: hyponatremia, metabolic acidosis is possible, it is possible hyperglycaemia, increased muscle creatinine phosphokinase fraction.
Treatment
Initially, the treatment should be based on the clinical condition of the patient; hospitalization. It is identified carbamazepine plasma concentrations for confirmation of poisoning with this agent and assess the degree of overdose.
Implemented by evacuation of stomach contents, gastric lavage, administration of activated charcoal. Late evacuation of gastric contents may result in delayed absorption and re-emergence of symptoms of intoxication in the recovery period. Apply symptomatic supportive therapy in the intensive care unit, monitoring of heart function, careful correction of electrolyte disorders.
specific recommendations
With the development of hypotension shown in / or administration of dopamine dobutamine; in the development of cardiac arrhythmias treatment picked individually; in the development of seizures - administering benzodiazepines such as diazepam or other anticonvulsants, such as phenobarbital (with caution due to increased respiratory depression) or paraldehyde; when developing hyponatremia (water intoxication) - restricted fluid administration and careful in / in a 0.9% sodium chloride solution, which may help prevent the development of brain lesions. It recommended holding hemosorption on coal sorbents. It reported on the ineffectiveness of forced diuresis, hemodialysis and peritoneal dialysis. May re-gain overdose symptoms on the 2nd and 3rd day after the start, due to the depot carbamazepine.
DRUG INTERACTION
Isoenzyme CYP3A4 is the major enzyme ensuring the formation of carbamazepine-10,11-epoxide. The simultaneous use of Tegretol CR CYP3A4 inhibitors can lead to increased plasma concentrations of carbamazepine, which in turn may cause side effects. The combined use of CYP3A4 inducers may accelerate metabolism Tegretol CR and thus a possible reduction in the plasma concentration of carbamazepine, and hence to the possibility
