Universal reference book for medicines

Active substance: carbamazepine

Type: Anticonvulsant drug

Manufacturer: UPDATE (Russia)
Composition, form of production and packaging
1 tab.

carbamazepine 200 mg

Excipients: silicon dioxide colloid (aerosil) 960 mcg, potato starch 96.64 mg, povidone K30 14.4 mg, polysorbate 80 1.6 mg, talc 3.2 mg, magnesium stearate 3.2 mg.

10 pieces.
- Cellular outline packaging.
10 pieces.
- packings cellular planimetric (5) - packs cardboard.
10 pieces.
- packings cellular planimetric (10) - packs cardboard.

Description of the drug approved by the manufacturer for the printed edition of 2011.


Antiepileptic agent (dibenzazepine derivative), which also has a normotimic, antimanic, antidiuretic (in patients with diabetes insipidus) and analgesic (in patients with neuralgia).

The mechanism of action is associated with blockade of the potential of dependent Na + channels, which leads to stabilization of the neuronal membrane, inhibition of the occurrence of serial discharges of neurons, and a decrease in the synaptic conduct of impulses.
Prevents the re-formation of Na + -dependent action potentials in depolarized neurons. Reduces the release of the excitatory neurotransmitter amino acid glutamate, increases the reduced convulsive threshold, and so on. reduces the risk of developing an epileptic attack. Increases the conductance for K +, modulates the potential-dependent Ca2 + channels, which can also cause the anticonvulsant effect of the drug. Corrects epileptic personality changes and, in the long run, improves the communicability of patients, contributes to their social rehabilitation. Can be prescribed as the main therapeutic drug and in combination with other anticonvulsant drugs. Effective in focal (partial) epileptic attacks (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, and also with a combination of these types (usually ineffective in small seizures - petit mal, absences and myoclonic seizures) .
Patients with epilepsy (especially in children and adolescents) have a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness.
The effect on cognitive function and psychomotor parameters depends on the dose and is highly variable.
The onset of an anticonvulsant effect varies from a few hours to several days (sometimes up to 1 month due to autoinduction of metabolism).
In the case of essential and secondary neuralgia of the trigeminal nerve, in most cases it prevents the occurrence of painful attacks. Effective for alleviating neurogenic pain in the dry spinal cord, post-traumatic paresthesia and postherpetic neuralgia. Relaxation of pain in trigeminal neuralgia is observed after 8-72 hours. With alcohol withdrawal syndrome, it increases the threshold of convulsive readiness (which is usually reduced in this condition) and reduces the severity of clinical manifestations of the syndrome (increased excitability, tremor, gait disturbance).
In patients with diabetes insipidus leads to rapid compensation of water balance, reduces diuresis and thirst.

Antipsychotic (antimanic) action develops after 7-10 days, may be due to oppression of the metabolism of dopamine and norepinephrine.


Absorption - slow, but quite complete (eating does not affect the speed and degree of absorption).
After a single dose, C max is reached after 12 hours. Equilibrium plasma concentrations of the drug are achieved after 1-2 weeks.
The concentrations of carbamazepine-10,11-epoxide (pharmacologically active metabolite) are about 30% of the concentration of carbamazepine.
The connection with plasma proteins in children is 55-59%, in adults 70-80%. In the cerebrospinal fluid (further CSF) and saliva, concentrations are created in proportion to the amount of the active substance unbound with proteins (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. A low-active 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. T 1/2 of a single admission of 25-65 hours (an average of about 36 hours), after repeated admission - 12-24 hours. In patients receiving additionally other anticonvulsants T 1/2 an average of 9-10 hours is in the form of inactive metabolites with urine (70%) and feces (30%).There is no evidence that the pharmacokinetics of carbamazepine change in elderly patients. Data on the pharmacokinetics of carbamazepine in patients with impaired renal or hepatic function are still insufficient.

Epilepsy (except absences, myoclonic or flaccid seizures) - partial seizures with complex and simple symptoms, primary and secondary generalized forms of attacks with tonic-clonic convulsions, mixed forms of seizures (monotherapy or in combination with other anticonvulsant drugs);
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, pain syndrome in diabetic polyneuropathy.
Prevention of phase-related affective disorders (manic-depressive psychosis, schizoaffective disorder, etc.).


Inside, regardless of food intake, along with a small amount of liquid.

Whenever possible, carbamazepine 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.
The addition of carbamazepine to already conducted antiepileptic therapy should be carried out gradually, at the same time the dosages of the medicines used are not changed or, if necessary, corrected.

For adults, the initial dose is 100-200 mg 1-2 times a day.
Then the dose is slowly increased to achieve the optimal therapeutic effect (usually 400 mg 2-3 times a day, maximum - 1.6-2 g / day).
Children from 3 years old - at an initial dose of 20-60 mg / day, gradually increasing by 20-60 mg every other day.

In children older than 3 years - in the initial dose of 100 mg / day, the dose is increased gradually, every week by 100 mg.
Supportive doses: 10-20 mg / kg per day.(in several receptions): for 4-5 years - 200-400 mg (in 1-2 doses), 6-10 years - 400-600 mg (in 2-3 doses), for 11-15 years - 600-1000 mg (in 2-3 administrations).
With neuralgia of the trigeminal nerve on the first day, 200-400 mg / day is prescribed, gradually increasing by no more than 200 mg / day.
up to the cessation of pain (an average of 400-800 mg / day), and then reduced to the minimum effective dose.
With a pain syndrome of neurogenic origin, the initial dose is 100 mg 2 times a day.
on the first day, then increase the dose by no more than 200 mg / day, if necessary, increasing it by 100 mg every 12 hours until pain is relieved. The maintenance dose is 200-1200 mg / day. in several receptions.
In the treatment of elderly patients and patients with hypersensitivity, the initial dose is 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 few days the dose can be increased 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 sedative-hypnotic drugs (clomethiazole, chlordiazepoxide).
Non-diabetes mellitus : the average dose for adults is 200 mg 2-3 times a day.
In children, the dose should be reduced in accordance with the age and body weight of the child.
Diabetic neuropathy, accompanied by pain : the average dose is 200 mg 2-4 times a day.
In the prevention of relapses affective and schizoaffective psychoses - 600 mg / day. in 3-4 reception.
In acute manic states and affective (bipolar) disorders, daily doses of 400-1600 mg.
The average daily dose is 400-600 mg (in 2-3 doses). In acute manic state, the dose is increased rapidly, with maintenance therapy of affective disorders - gradually (to improve tolerability).

From the side of the central nervous system: dizziness, ataxia, drowsiness, general weakness, headache, accommodation paralysis, tremor, tics, nystagmus, orofacial dyskinesia, oculomotor disorders, dysarthria, choreoathetoid disorders, peripheral neuritis, paresthesia, muscle weakness and paresis.

On the part of the psychic sphere: hallucinations, depression, loss of appetite, anxiety, aggressive behavior, agitation, disorientation, activation of psychosis.
Allergic reactions: urticaria, exfoliative dermatitis, erythroderma, lupus-like syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, multiform and erythema nodosum. Multiple reactions of delayed hypersensitivity with fever, skin rashes, vasculitis, lymphadenopathy, signs resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function are possible (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 from the lungs, characterized by fever, dyspnea, pneumonitis or pneumonia.
On the part of the hematopoiesis: leukopenia, thrombocytopenia, eosinophilia, leukocytosis, lymphadenopathy;
agranulocytosis, aplastic anemia, true erythrocytic aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia.
On the part of the digestive system (GIT): nausea, vomiting, dry mouth, diarrhea or constipation, abdominal pain, glossitis, stomatitis, pancreatitis.

On the part of the liver: increased activity of gamma-glutamyltransferase (usually has no clinical significance), increased activity of alkaline phosphatase and "hepatic" transaminases, hepatitis (granulomatous, cholestatic, parenchymal (hepatocellular) or mixed type);
liver failure.
From the side of the cardiovascular system (further SSS): violations of intracardiac conduction;
decrease or increase in blood pressure; bradycardia, arrhythmias, atrioventricular 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.
On the part of the endocrine system and metabolism: edema, weight gain, hyponatremia, increased prolactin levels (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), calcium-phosphorus metabolism in the bone tissue (decrease in Ca2 + and 25-OH-cholecalciferol concentration in blood plasma);osteomalacia; hypercholesterolemia and hypertriglyceridemia.
On the part of the genitourinary system: interstitial nephritis, renal failure, renal dysfunction (albuminuria, hematuria, oliguria, urea / azotemia increase), frequent urination, urinary retention, impaired sexual function / impotence.

From the musculoskeletal system: arthralgia, myalgia or convulsions.

From the sense organs: a violation of taste sensations, clouding of the lens, conjunctivitis;
hyper- or hypoacusia, changes in perception of pitch.
Other: disorders of skin pigmentation, purpura, acne, sweating, alopecia.


Hypersensitivity to carbamazepine and chemically similar drugs (tricyclic antidepressants) or to any other component of the drug, acute intermittent porphyria (including history), simultaneous administration of monoamine oxidase inhibitors (hereinafter MAO inhibitors) and for 2 weeks after their cancellation, violation of bone marrow hematopoiesis, atrioventricular blockade, pregnancy and lactation.

With caution .
Hyponatremia of breeding, elderly age, alcohol intake, oppression of bone marrow hematopoiesis against the background of medication (in history);hyperplasia of the prostate, increased intraocular pressure, severe heart failure, hepatic insufficiency, chronic renal failure.

When pregnancy occurs (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 of 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, can increase the risk of these disorders.
There are isolated reports of cases of congenital diseases and malformations, including non-vertebral arches (spina bifida), hypospadias. 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 continuing therapy. Mothers taking carbamazepine can breast-feed their children, provided that a child is observed to develop possible adverse reactions (eg, severe drowsiness, allergic skin reactions).

With caution : chronic renal failure.


With caution: liver failure.


The use is possible in children older than 3 years according to the dosing regimen.


With caution : the elderly.


Before starting treatment, it is necessary to perform a general blood test (including platelet count, reticulocyte count), a general urine test, determine the level of iron, the concentration of electrolytes and urea in the blood serum.
Subsequently, these indicators should be monitored during the first month of treatment on a weekly basis, and then on a monthly basis. When appointing patients with increased intraocular pressure, its periodic monitoring is necessary. 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.
Information about the possible effect of a drug for medical use on the ability to manage vehicles, mechanisms.
During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Symptoms: respiratory depression, hyperreflexia alternating with hyporeflexia, hypothermia, suppression of gastrointestinal motility, increased severity of side effects.

Treatment: there is no specific antidote.
Gastric lavage, the appointment of activated charcoal (late evacuation of gastric contents can lead to delayed absorption for 2-3 days and the re-emergence of symptoms of intoxication), symptomatic therapy. Intense diuresis, hemodialysis and peritoneal dialysis are ineffective (dialysis is indicated by a combination of severe poisoning and kidney failure). Children may have a need for exchange blood transfusion. It is recommended to carry out hemosorption on carbon sorbents.

Carbamazepine enhances the activity of microsomal liver enzymes and can reduce the effectiveness of drugs metabolized in the liver.
Simultaneous administration of carbamazepine with inhibitors of CYP3A4 may lead to an increase in its concentration in the blood plasma. Co-administration with CYP3A4 inducers can lead to an acceleration of the metabolism of carbamazepine and a decrease in its concentration in the blood plasma, on the contrary, their removal can reduce the biotransformation rate 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. Felbamate reduces the concentration of carbamazepine in the plasma and increases the concentration of carbamazepine-10,11-epoxide, the concentration of possible simultaneous reduction in serum felbamate. The concentration of carbamazepine reduce phenobarbital, phenytoin, primidone, metsuksimid, fensuksimid, theophylline, rifampicin, tsisplastin, doxirubicin possibly: clonazepam, valpromid, valproic acid, oxcarbazepine and vegetable preparations containing St. John's wort (Hypericum perforatum). There are reports on the possibility of displacing valproic acid, primidone carbamazepine and of its association with plasma proteins and increase in the concentration of the pharmacologically active metabolite (carbamazepine-10,11-epoxide). Isotretinoin modifies the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxide (requires monitoring carbamazepine plasma concentration).Carbamazepine can reduce the plasma concentration (decrease or even completely neutralize the effects) and require dose adjustments following drugs: klobazama, clonazepam, ethosuximide, primidone, valproic acid, alprazolam, steroids (prednisolone, dexamethasone), cyclosporine, doxycycline, haloperidol, methadone, oral preparations containing estrogens and / or progesterone (requires selection of alternative methods of contraception), theophylline, oral anticoagulants (warfarin, phenprocoumon, dicumarol) la otridzhina, topiramate, tricyclic antidepressants (imipramine, amitriptyline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors used in HIV therapy (indinavir, ritonavir, saquinovir), calcium channel blockers (digidropiridonov group,e.g., felodipine), itraconazole, levothyroxine, midazolam, olazapina, 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 or combined with paracetamol increases risk of toxic effects on the liver and reduces the therapeutic efficacy (acceleration paracetamol metabolism). The simultaneous appointment of carbamazepine with phenothiazines, pimozide, thioxane-tenami, molindone, haloperidol, maprotiline, clozapine and tricyclic antidepressants leads to increased inhibitory action on the central nervous system and weaken the anticonvulsant effect of carbamazepine. The simultaneous appointment with a diuretic (hydrochlorothiazide,furosemide) may lead to hyponatremia, accompanied by clinical manifestations. Reduces the effects of non-depolarizing muscle relaxants (pancuronium). Reduces the portability of ethanol. It accelerates metabolism of anticoagulants, hormonal contraceptive preparations, folic acid; praziquantel, may enhance the elimination of thyroid hormones. It accelerates metabolism of funds for general anesthesia (enflurane, halothane, halothane) with increased hepatotoxicity effects of the risk; enhances the formation of nephrotoxic metabolites methoxyflurane. It enhances the hepatotoxic effects of isoniazid.may intensify the elimination of thyroid hormones. It accelerates metabolism of funds for general anesthesia (enflurane, halothane, halothane) with increased hepatotoxicity effects of the risk; enhances the formation of nephrotoxic metabolites methoxyflurane. It enhances the hepatotoxic effects of isoniazid.may intensify the elimination of thyroid hormones. It accelerates metabolism of funds for general anesthesia (enflurane, halothane, halothane) with increased hepatotoxicity effects of the risk; enhances the formation of nephrotoxic metabolites methoxyflurane. It enhances the hepatotoxic effects of isoniazid.

The drug is released by prescription.


The drug is stored in a dry, dark place at a temperature not higher than 25 В° C.
Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiration date printed on the package.
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