Index of drugs

Epilepsy - the drug is indicated in the following types of seizures: partial complex seizures (psychomotor, temporal); generalized tonic-clonic seizures (grand mal); mixed attacks (including those mentioned above or other partial or generalized seizures). Trigeminal neuralgia - carbamazepine is indicated for the treatment of pain associated with typical trigeminal neuralgia. It is also effective in the neuralgia of the pharyngeal nerve. The drug should not be used to control other types of pain. Prevention of bipolar disorder in patients who do not respond to treatment with lithium preparations.

1 tabl contains 200 mg carbamazepine.

A preparation with anticonvulsant and analgesic effect in trigeminal neuralgia. It is currently believed that the mechanism of antiepileptic action of carbamazepine is based on inhibition of potential-dependent sodium channels. Carbamazepine binds to these channels and keeps them in an inactive state. Therefore, the excitability of cells is reduced and the frequency of serial discharges of the action potential decreases in response to repeated arousal. Carbamazepine does not affect the benzodiazepine receptor, adenosine, adrenergic receptors₂, GABA-ergic and receptors for stimulating amino acids. Carbamazepine also has weak cholinolytic activity. It is not a painkiller and does not relieve pain other than neuralgia (inhibits sensory guidance). It has a psychotropic effect (mainly antipsychotic, normothymic: anti-anginal and probably antidepressant). After oral administration, the drug is well absorbed from the gastrointestinal tract. The maximum concentration in the blood occurs within 12 h. 70-80% of the drug is bound to plasma proteins. The drug is metabolized in the liver, among others to active metabolites. It is excreted mainly in the urine (72%), the remainder in the faeces. T_0,5 after a single dose of carbamazepine is about 36 h. The drug penetrates the placental barrier, accumulating in the tissues of the fetus; it also passes into breast milk, reaching a concentration of 25% -60% in the blood in it.

Hypersensitivity to the active substance or to any of the excipients or to tricyclic antidepressants (e.g. Amitriptyline, desipramine, protryptipine and others). Treatment with MAO inhibitors (the use of carbamazepine is possible after a minimum of 14 days from the discontinuation of MAO inhibitors). History of bone marrow dysfunction. Atrioventricular block. Porphyrin synthesis disorders (acute porphyria).

Use cautiously in patients with mixed epileptic seizures, including atypical seizures. The benefits of treatment should be carefully weighed against the potential risk, particularly in patients who discontinued treatment with carbamazepine, and who have a history of cardiovascular, hepatic, renal and hematopoietic disorders, including adverse events with other medicinal products. Caution use in patients with elevated intraocular pressure.

Carbamazepine can be used in pregnant women or in women who plan to become pregnant only when the potential benefit outweighs the potential risk to the fetus. Following the use of carbamazepine, malformations and malformations (including spina bifida) and other congenital malformations, eg, craniofacial defects, cardiovascular malformations, hypospadias and multiple system disorders have been reported. The patient should be informed about the increased risk of malformation in the case of carbamazepine therapy and provide the possibility of performing pre-natal tests. Combined antiepileptic therapy is associated with a higher risk of congenital malformations of the fetus than monotherapy, therefore in women of childbearing age it is recommended to use carbamazepine, if possible, as monotherapy.If the anticonvulsant is used to prevent major seizures, do not stop the treatment suddenly because there is a risk of a convulsive state with hypoxia and a life-threatening condition. It can not be ruled out that seizures alone can cause fetal damage. Antiepileptic drugs may lead to folic acid deficiency - folate intake should be considered for women planning pregnancy and early pregnancy. In order to counteract haemorrhagic complications in a child, prophylactic administration of vitamin K to the mother is recommended in the last weeks of pregnancy and the newborn immediately after birth. Few cases of seizures and respiratory depression have been observed in newborns in connection with the mother taking carbamazepine in combination with another anticonvulsant. The newborn may also have symptoms of withdrawal syndrome (vomiting, diarrhea, eating disorders). Carbamazepine is excreted in human milk and may reach 60% of its concentration in the blood - because of the risk of side effects in the child, do not breast-feed while taking the medicine.

Very common: leukopenia, dizziness, ataxia, drowsiness, fatigue, nausea, vomiting, increased GGT activity due to the induction of hepatic enzymes (usually without clinical significance), skin hypersensitivity reactions, urticaria. Common: thrombocytopenia, eosinophilia, edema, fluid retention, weight gain, hyponatraemia, decreased plasma osmolality due to an effect resembling the action of an antidiuretic hormone (sometimes can lead to water intoxication with lethargy, vomiting, headache, confusion, neurological disorders), headache , double vision, accommodation disorder (eg blurred vision), dry mouth, increased ALP activity. Uncommon: unusual involuntary movements (eg tremor, dystonia, tics), nystagmus, diarrhea, constipation, elevation of aminotransferases, exfoliative dermatitis, erythroderma. Rare: leukocytosis, enlarged lymph nodes, folic acid deficiency, disorders due to delayed multiorgan hypersensitivity (fever, skin rash, vasculitis, lymphadenopathy, lymphoma-like disorders, arthralgia, leukopenia, eosinophilia, hepatomegaly with abnormal results of functional tests liver function disorders may also affect other organs, eg lungs, kidneys, pancreas, myocardium, colon), hallucinations (visual or auditory), depression, lack of appetite, anxiety, aggressive behavior, agitation, confusion, orofine-facial dyskinesia, oculomotor disorders, speech disorders (eg dysarthria or speech blurred), choreoathetical disorders, peripheral nerve inflammation, paresthesia, muscle weakness and symptoms of paresis, abnormal heart conduction, hypertension or hypotension, abdominal pain, cholestasis induced hepatitis, parenchyma or mixed type, jaundice, lupus-like syndrome, pruritus. Very rare: agranulocytosis, aplastic anemia, red blood cell aplasia, megaloblastic anemia, acute punctate porphyria, reticulocytosis, haemolytic anemia, aseptic meningitis with muscle clonic convulsions and peripheral eosinophilia, nano-mechanical reaction, angioneurotic edema, hyperprolactinemia (symptomatic or non-symptomatic) symptoms such as: galactorrhea, gynecomastia, abnormal results of thyroid functional tests), decrease in L-thyroxine (FT4, T4, T3), increase in TSH (usually without clinical symptoms), bone metabolism disorders (decrease in Calcium and 25-OH -cholecalciferol in the blood), leading to softening of the bones; increased cholesterol (including HDL) and triglycerides, psychosis, lens opacities, conjunctivitis, increased intraocular pressure, impaired hearing (eg tinnitus, increased hearing acuity, loss of hearing loss, change in tonal sensation), bradycardia, arrhythmia, AV blocking with syncope, congestive heart failure, exacerbation of coronary heart disease, circulatory collapse, thrombophlebitis, thromboembolism (eg pulmonary embolism), pulmonary hypersensitivity (characterized by e.g.fever, dyspnoea, pneumonia or atypical pneumonia), taste disorders, tongue inflammation, gingivitis, pancreatitis, granulomatous hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, erythema multiforme, erythema nodular, changes in skin pigmentation, purpura, acne, sweating, hair loss; hirsutism (causative relationship with carbamazepine has not been fully established), arthralgia, muscle pains or cramps, interstitial nephritis, renal failure, proteinuria, haematuria, oliguria, increased urea, azotemia, frequent urination, urinary retention, spermatogenesis abnormalities (reduction in the number and (or) sperm motility), sexual dysfunction, impotence. Not known: drug eruption with eosinophilia and systemic symptoms (DRESS), acute generalized pustular exanthema (AGEP). Neuroleptic malignant syndrome has been observed (causative relationship with carbamazepine use has not been fully established) and bone mineral density reduction, osteopenia, osteoporosis, fractures in patients using carbamazepine in long-term therapy. Patients with a HLA-A * 3101 allele of Japanese and European origin, as well as the HLA-B * 1502 allele in people of Chinese origin (Han ethnic group), Thai and other Asian countries have been reported to have severe skin reactions after carbamazepine treatment.

Orally. Treatment should be started with smaller doses of the drug and increased gradually if necessary. After the occurrence of the appropriate therapeutic effect, reduce the dose gradually to the minimum effective dose. In the case of epilepsy, carbamazepine should not be discontinued abruptly.Epilepsy. Carbamazepine can be used on its own or together with other anticonvulsants. During combined treatment, carbamazepine should be introduced gradually, keeping the same or lower dose of another anticonvulsant with the exception of phenytoin, the dose of which should be increased with carbamazepine.Adults and children> 12 years: initially 100-200 mg once or twice daily; increase the dose gradually at weekly intervals by 200 mg per day, in 3-4 divided doses, until the optimal response to treatment, most often up to a dose of 800-1200 mg per day. In children aged 12-15 years, the dose should not exceed 1000 mg daily, and in adolescents> 15 years not more than 1200 mg daily. Some adults require a dose of 1600 mg or even 2000 mg a day. Take the daily dose in 3-4 divided doses.Children 6-12 years old: initially 100 mg 2 times a day; increase the dose weekly by 100 mg a day, in 3-4 divided doses, until a satisfactory therapeutic effect is achieved. The dose should not exceed 1000 mg daily. The therapeutic effect usually occurs at a dose of 400-800 mg per day. Take the daily dose in 3-4 divided doses.Children <6 years: initially 10-20 mg / kg daily, in 2-3 divided doses. The dose should be increased weekly, in 3-4 divided doses, until a satisfactory therapeutic effect is achieved. The dose should not exceed 35 mg / kg. per day. Take the daily dose in 3- 4 divided doses.Trigeminal neuralgia. Adults: on the first day 100 mg twice daily; the dose can be increased daily by 200 mg a day, in 2 divided doses. Do not exceed the 1200 mg dose per day. In most patients, analgesia usually occurs at a dose of 400-800 mg per day. During treatment at least once every 3 months, try to reduce the dose to the lowest effective dose, or even discontinue the drug.Prevention of bipolar disorder in patients who do not respond to treatment with lithium products: the starting dose is 400 mg a day, in divided doses; the dose should be increased gradually until a satisfactory therapeutic effect is achieved or a daily dose of 1600 mg (taken in divided doses) is reached. Typically, a dose of 400-600 mg per day is used in divided doses.Special groups of patients. Whenever possible, patients of Chinese or Thai origin should be tested for the presence of the HLA-B * 1502 allele prior to the decision to initiate treatment, which strongly predicts the risk of developing a severe Stevens-Johnson syndrome.Way of giving. The drug should be taken with a small amount of water before, during or between meals.The tablets can be divided into halves.