Composition, form of production and packaging
Tablets of white color, round, flat, with a facet, on one side are marked "CG", on the other - "G / K" and risk.
1 tab.
carbamazepine 200 mg
[PRING] microcrystalline cellulose - 65 mg, carmellose sodium - 10 mg, magnesium stearate - 3 mg, silicon dioxide colloid - 2 mg.
10 pieces. - blisters (5) - packs of cardboard.
The tablets are white, rod-shaped, flat, with a bevel; on one side is marked "CG / CG", on the other - "LR / LR", with a risk on both sides.
1 tab.
carbamazepine 400 mg
[PRING] microcrystalline cellulose - 130 mg, carmellose sodium - 20 mg, magnesium stearate - 6 mg, silicon dioxide colloid - 4 mg.
10 pieces. - blisters (3) - packs of cardboard.
Syrup in the form of a viscous suspension of white color, with the smell of caramel.
5 ml
carbamazepine 100 mg
[PRING] polyethylene glycol 400 stearate (macrogol stearate) 0.1 g, sodium saccharinate 0.04 g, hydroxyethylcellulose 300 mPas (HEC 250) 500 mg, avicel RC581 (microcrystalline cellulose and carmellose sodium) 1 g, sorbitol liquid (70% non-crystallizing sorbitol) 25 g, propylene glycol 2.5 mg, methyl parahydroxybenzoate (methylparaben) 0.12 g, propyl parahydroxybenzoate (propylparaben) 0.03 g, sorbic acid 0.1 g, aroma caramel 52929 A 0.05 g, purified water.
100 ml - bottles of dark glass (1) complete with a dosage spoon - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
PHARMACHOLOGIC EFFECT
Antiepileptic drug. Tegretol is a dibenzodiazepine derivative. Along with antiepileptic, the drug also has a neurotropic and psychotropic effect.
As an antiepileptic agent, Tegretol is effective in focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, and also with a combination of these types of seizures.
In clinical studies with the use of Tegretol as a monotherapy in patients with epilepsy (especially in children and adolescents), the psychotropic effect of the drug was noted, which in particular manifested itself in a positive effect on the symptoms of anxiety and depression, as well as in reducing irritability and aggressiveness.According to a number of studies, the effect of Tegretol on cognitive function and psychomotor indices depended on the dose and was either questionable or negative.In other studies, the positive effect of the drug on the indicators characterizing attention, the ability to learn and remember.
As a neurotropic agent Tegretol is effective in a number of neurological diseases, for example it prevents pain attacks in idiopathic and secondary neuralgia of the trigeminal nerve. In addition, Tegretol is used to alleviate neurogenic pain in various conditions, incl. dry spinal cord, post-traumatic paresthesia and postherpetic neuralgia. With alcohol withdrawal syndrome Tegretol increases the threshold of convulsive readiness (which is reduced in this condition) and reduces the severity of clinical manifestations of the syndrome, such as excitability, tremor, gait disorders. In patients with diabetes insipidus of central genesis, Tegretol reduces diuresis and thirst.
As a psychotropic agent, Tegretol is effective in affective disorders, namely for the treatment of acute manic conditions, for the supportive treatment of bipolar affective (manic-depressive) disorders (both as monotherapy and in combination with antipsychotics, antidepressants or lithium preparations), with schizoaffective psychosis, manic psychosis, where it is used in combination with neuroleptics, as well as in acute polymorphous schizophrenia (rapid cycling episodes).
The mechanism of action is associated with the blockade of potential-dependent sodium channels, which leads to the stabilization of membranes of overexcited neurons, inhibition of the occurrence of serial discharges of neurons, and a decrease in synaptic impulses. Anticonvulsant effect is mainly due to the stabilization of neuronal membranes and a decrease in the release of glutamate, a decrease in the activity of the excitatory neurotransmitter amino acid glutamate. Glutamate is the main mediator, there is not a single publication about the role of aspartate. Increases the lowered convulsive threshold of the central nervous system and, thus, reduces the risk of developing an epileptic attack. Increased potassium conductivity and modulation of calcium channels activated by high membrane potential can also contribute to the anticonvulsant effect of the drug. Eliminates epileptic personality changes and ultimately enhances the communicability of patients and contributes to their social rehabilitation. Can be prescribed as the main therapeutic agent and in combination with other anticonvulsants.
PHARMACOKINETICS
Suction
After ingestion, carbamazepine is absorbed almost completely, albeit relatively slowly. After a single administration of a regular tablet, C max is achieved after 12 hours. There are no clinically significant differences in the degree of absorption of the active substance after the use of various dosage forms of the oral preparation.After a single oral tablet administration of the drug containing 400 mg of carbamazepine, the average C max of the unchanged active substance is about 4.5 Ојg / ml.
After ingestion (single or repeated) of tablets, retard C max is reached within 24 hours, its value is 25% less than in the case of taking a conventional tablet. When taking retard tablets daily fluctuations in carbamazepine concentration in plasma are less pronounced, while there is no significant decrease in the minimum value of C ss . When taking the drug in the form of retard tablets 2 times / day, fluctuations in the concentration of the active substance in the plasma are very small.Bioavailability of the active substance from retard tablets is approximately 15% lower than in other drug forms of the drug.
The intake of food does not significantly affect the rate and extent of absorption of carbamazepine, no matter what form of Tegretol dosage form is used.
C ss of carbamazepine in plasma are achieved within 1-2 weeks, which depends on the individual characteristics of the metabolism (autoinduction of enzymatic systems of the liver with carbamazepine, heteroinduction by other, simultaneously used drugs), as well as on the patient's condition, dose of the drug and duration of treatment. There are significant interindividual differences in C ss values ​​in the therapeutic range: in most patients these 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 of carbamazepine.
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 non-protein-bound active substance (20-30%). The concentration of carbamazepine in breast milk is 25-60% of its level in the blood plasma.
Carbamazepine penetrates the placental barrier. If the absorption of carbamazepine is considered complete, the apparent V d is 0.8-1.9 l / kg.
Metabolism
Carbamazepine is metabolized in the liver, mainly along the epoxide route, resulting in the formation of the main metabolites - the 10,11-translodiol derivative and its conjugate with glucuronic acid. The main isoenzyme providing the biotransformation of carbamazepine in carbamazepine-10,11-epoxide is CYP3A4. As a result of these metabolic reactions, a low-activity 9-hydroxy-methyl-10-carbamoylacridan metabolite is also formed.
Excretion
After a single dose of the drug inside T 1/2 unchanged carbamazepine averages about 36 hours, and after repeated administration of the drug - an average of 16-24 hours (due to autoinduction of the monooxygenase system of the liver), depending on the duration of treatment. In patients taking concurrently other drugs that induce the same enzyme system of the liver (eg, phenytoin, phenobarbital), T 1/2 carbamazepine averages 9-10 hours.
After a single oral intake of 400 mg of carbamazepine, 72% of the dose taken is excreted in the 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 pharmacologically active 10,11-epoxide metabolite and about 30% - in the form of final metabolites formed as a result of the epoxide pathway of metabolism.
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 (Tegretol can be used both as monotherapy and as part of a combination therapy; Tegretol is usually ineffective in small seizures (petit mal, absence) and myoclonic 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;
- Diabetic neuropathy with pain syndrome;
- diabetes insipidus of central genesis; polyuria and polydipsia of neurohormonal nature.
DOSING MODE
The drug can be taken during, after meals or in between meals with a small amount of liquid.
Retard tablets (whole pill or half if prescribed by a doctor) should be swallowed whole, without chewing, with a small amount of liquid. Because the active substance is released from the retard tablets slowly and gradually, they are prescribed 2 times / day.
Transfer of a patient from taking conventional tablets to taking retard tablets: Clinical experience shows that in some patients with the use of retard 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 should be given as 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.
In the event that Tegretol is added to the existing antiepileptic therapy, it should be done gradually, while the doses of the drugs used do not change or, if necessary, be corrected.
For adults, the initial dose of Tegretol is 100-200 mg 1 or 2 times / 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, given in 2-3 doses. Some patients may require a dose of Tegretol, 1.6 g / day or 2 g / day.
In children aged 4 years and under, it is recommended to start treatment with 20-60 mg / day and increase the dose by 20-60 mg every other 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.
Supportive doses for children are 10-20 mg / kg / day (in several steps):
Age of the child
up to 1 year 100-200 mg (in 1 administration)
1-5 years 200-400 mg (in 1-2 administration)
6-10 years 400-600 mg (in 2-3 administrations)
11-15 years 600-1000 mg (in 2-3 administrations)
With neuralgia of the trigeminal nerve, the initial dose of Tegretol 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 started with a combination of Tegretol with sedative-hypnotic drugs (eg, clomethiazole, chlordiazepoxide). After resolving the acute phase, treatment with Tegretol can be continued as a monotherapy.
In diabetes insipidus of central genesis, the average dose for adults is 200 mg 2-3 times / day. In children, the dose of the drug should be reduced in accordance with the age and body weight of the child.
With diabetic neuropathy with pain syndrome, the average dose of Tegretol 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). With an acute manic state, the dose of Tegretol should be increased fairly quickly. In the case of maintenance therapy of bipolar disorders, in order to ensure optimal tolerability, it is recommended that the dose be gradually increased by a small amount.
SIDE EFFECT
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 often, especially at the beginning of treatment with Tegretol, when used too large initial dose of the drug or in the treatment of elderly patients.
When assessing the frequency of occurrence of various adverse reactions, the following grades were 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%.
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 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 or slurred speech), 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.
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: 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).
Dermatological reactions: very rarely photosensitivity, multiform and nodosum erythema, skin pigmentation disorders, purpura, acne, sweating, hair loss. There have been reports of rare cases of hirsutism, but the causal relationship between this complication and the use of Tegretol remains unclear.
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.
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: rare - multiorgan delayed type hypersensitivity with fever, skin rashes, vasculitis, lymphadenopathy, symptoms resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function (indicated manifestations occur in different combinations). They may also be involved other organs (e.g., lung, kidney, pancreas, heart, colon); 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, fibrillation, AV-block with syncope, collapse, congestive heart failure, coronary artery disease exacerbation, 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; change indicators of thyroid function - reduction of L-thyroxine (FT4, 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 similarities with tricyclic antidepressants). Before the appointment of Tegretol MAOIs should be canceled at least 2 weeks, or if the clinical situation allows, even for a longer period;
- hypersensitivity to carbamazepine or chemically similar drugs (e.g., tricyclic antidepressants) or to other components of the formulation.
PREGNANCY AND LACTATION
Tegretol treatment of epilepsy during pregnancy should be undertaken with extreme caution.
In women of childbearing age Tegretol should, wherever 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. Recommended regular monitoring of carbamazepine plasma.
If pregnancy occurs in a woman receiving Tegretol, or if there is a question on the appointment of Tegretol 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 as monotherapy, to date not available. There are, however, isolated reports of congenital diseases and malformations, including spina bifida (spina bifida) and other congenital anomalies (including craniofacial and cardiovascular system) have been observed in patients treated with Tegretol.Patients should be given information about the possibility of an increased risk of malformations and opportunity to 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. Mother taking Tegretol 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).
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.
APPLICATION FOR CHILDREN
In children aged 4 years and younger are recommended to start treatment with the use of 20-60 mg / day and increase the dose by 20-60 mg every other day.
In children older than 4 years of treatment can be started with the use of the drug at a dose of 100 mg / day; the dose is increased gradually - each week on 100 mg.
Maintenance dose for children is 10-20 mg / kg / day (in divided doses):
Age child daily dose
up to 1 year of 100-200 mg (1 dose)
1-5 years 200-400 mg (1-2 doses)
6-10 years 400-600 mg (2-3 doses)
11-15 600-1000 mg (2-3 doses)
APPLICATION IN ELDERLY PATIENTS
The recommended starting dose for elderly patients is 100 mg of 2 times / day.
SPECIAL INSTRUCTIONS
During the reception, Tegretol may develop agranulocytosis, and aplastic anemia. However, due to the fact that these states are very rare, it is difficult to calculate the specific values ​​of their risk. It is known that the overall risk of agranulocytosis in the general population who are not receiving treatment, is 4.7 cases per 1 million population per year, and aplastic anemia -. 2.0 cases per 1 million population per year..
During application Tegretol 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.
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 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.
Tegretol should be used only on condition of medical supervision.
Caution must be exercised when applying Tegretol in patients with mixed seizures including absence seizures (typical and atypical). In all these cases, Tegretol may intensify attacks. If this happens, Tegretol should be discontinued.
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.
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.
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, 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.
Before treatment Tegretol 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 has weak anticholinergic activity. Therefore, in case of the drug in patients with elevated intraocular pressure requires continuous monitoring of this parameter.
It should take into account the possibility of activation of a latent psychosis occurring, and in elderly patients - the possibility of disorientation or agitation.
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 is not established yet.
Known reports of occurrence of bleeding in women in the period between periods when both used oral contraceptives. Tegretol can substantially reduce the therapeutic effect of oral contraceptive preparations due to the induction of microsomal enzymes, so that women of childbearing age Tegretol treatment period should apply alternative methods of protection against pregnancy.
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 may trigger epileptic seizures. If necessary to abruptly interrupt treatment Tegretol 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-reactions of hypersensitivity to carbamazepine and oxcarbazepine.
Cross-hypersensitivity reactions may also occur between carbamazepine and phenytoin.
Tegretol, like other psychoactive drugs, may reduce alcohol tolerance. In this regard, the patient is advised to give up alcohol.
Described several cases of seizures and / or respiratory depression in newborns whose mothers took Tegretol concomitantly with other anticonvulsants. In addition, in connection with taking Tegretol mothers also reported several cases of vomiting, diarrhea and / or malnutrition in infants. Perhaps these reactions are manifestations of neonatal withdrawal syndrome.
Impact on the ability to drive vehicles and manage mechanisms
The ability of the patient receiving Tegretol, to quick reaction, especially at the beginning of 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
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.
GIT: 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 clinical comprising
