Index of drugs

Epilepsy: partial or complex partial seizures and generalized tonic-clonic seizures; mixed forms of seizures. Manic syndromes and prevention of manic-depressive disorders (bipolar). Alcoholic abstinence syndrome. Idiopathic neuralgia of the trigeminal nerve and trigeminal neuralgia in the course of multiple sclerosis. Carbamazepine is usually ineffective in seizures with loss of consciousness (petit mal) and in myoclonic seizures.

1 tabl about release contains 300 mg or 600 mg carbamazepine.

A medicine with anticonvulsant effect. In addition, it has anticholinergic, sedative and antidepressant properties, as well as antidiuretic properties due to its action on o.u.n. The drug in addition to the antiepileptic effect also has a positive effect on the accompanying psychological changes (raising mood). The preparation is the first-line drug in trigeminal neuralgia. Relieves the symptoms of abstinence associated with alcohol withdrawal in alcoholics. After one dose of T_0,5 is 25-65 h; however, excretion is significantly faster (12-17 h) after repeated administration as a result of the metabolism selfinduction. Consumption of food does not affect the effect of sustained release. The drug is metabolized in the liver, excreted through the kidneys.

Hypersensitivity to carbamazepine or drugs with a similar chemical structure (ie tricyclic antidepressants) or to any of the excipients. Atrioventricular block. History of bone marrow dysfunction. Hepatic porphyria (eg acute intermittent porphyria, mixed porphyria, late porphyria). Concomitant use of MAO inhibitors (they should be discontinued at least 2 weeks before treatment with carbamazepine).

Pre-treatment (before treatment) and periodic (during treatment) of urine tests and determination of blood urea nitrogen are recommended. Before starting treatment, a blood test should be performed, including the number of platelets and reticulocytes and serum iron levels to determine the initial value. Then, you should periodically perform the above tests. Patients should be advised to report symptoms such as fever, sore throat, rash, mouth ulcers, easy bruising, ecchymosis or purpura to the doctor. If during treatment the number of white blood cells or the number of platelets decreases, the patient should be closely monitored and morphologic parameters monitored. Treatment should be discontinued if the patient develops leukopenia with clinical signs such as fever or sore throat. Treatment should also be discontinued in case of any symptoms of bone marrow suppression. Hepatic tests should be performed before and during treatment, especially in patients with a history of liver disease and in the elderly. A slight increase in GGT or alkaline phosphatase activity may be associated with induction of the liver enzyme; such strengthening of the metabolic rate is not an indication for discontinuation of carbamazepine. The evolving signs and symptoms of liver dysfunction or active liver disease should be immediately evaluated and carbamazepine discontinued until the results are obtained. If mild skin reactions occur during treatment, patients should be under strict medical supervision and if symptoms worsen, discontinue carbamazepine. If symptoms suggest severe skin reactions should be immediately discontinued carbamazepine. Exercise caution in patients of the Chinese, Thai and other Asian populations (Malaysia, Philippines) due to the risk of severe skin reactions. Studies have shown a correlation between skin reactions and the presence of the HLA-B * 1502 allele in these patients. Before beginning treatment with carbamazepine in patients of the aforementioned origin in genetic risk populations, testing for the HLA-B * 1502 allele is recommended; in patients with a positive test, carbamazepine can only be used when there are no other options for therapy. The incidence of the HLA-B * 1502 allele is negligible in people of European, African, Spanish, Japanese and Korean origin (<1%). Also, the presence of the HLA-A * 3101 allele may increase the risk of skin reactions. The incidence of the HLA-A * 3101 allele varies considerably between different ethnic groups. In the population of Europeans it ranges from 2 to 5%, and in Japanese people about 10%.There is insufficient data to recommend screening for the HLA-A * 3101 allele prior to initiating carbamazepine treatment. For patients of European or Japanese origin who have been diagnosed with the HLA-A * 3101 allele, the use of carbamazepine may be considered when the benefits of treatment outweigh the risks. If signs of a hypersensitivity reaction develop during treatment (including multi-organ hypersensitivity, which may affect the skin, hematopoietic and lymphatic systems or other organs), carbamazepine should be discontinued immediately. Cross-hypersensitivity may occur between carbamazepine and oxcarbamazepine or phenytoin. Caution should be exercised in patients with mixed epileptic seizures, which include typical or unusual attacks of loss of consciousness - in these cases carbamazepine may aggravate seizures; in the event of worsening of seizures, carbamazepine should be discontinued. Particularly with caution (after considering the benefit / risk ratio) and only under strict medical supervision, use in patients with cardiovascular disease, liver or kidney disorders, adverse hematological reactions to other medicines in the past, as well as in those who have previously been discontinued use of the preparation. Caution should be exercised in patients with increased intraocular pressure (carbamazepine has weak anticholinergic activity) in the elderly (risk of confusion and arousal). For patients using oral contraceptives, the risk of contraception should be weighed down. Consider monitoring blood levels in the following situations: significant increase in seizure frequency, pregnancy, treatment of children and adolescents, suspected malabsorption of the drug, suspected toxic effect of combination therapy, the need to check that the patient follows the recommendations and regularly takes the drug. During the change from using the oral form to suppositories, an increase in the incidence of seizures may occur. Sudden discontinuation of carbamazepine may result in an increase in the number of seizures; if you suddenly discontinue carbamazepine treatment, another appropriate anti-epileptic medicine should be given (such as diazepam, rectal, phenytoin). Due to the possibility of suicidal thoughts and behaviors, all patients taking the preparation should be under constant medical supervision.

If anticonvulsant therapy is necessary, it should not be interrupted during pregnancy, as it may pose a risk to the mother and the fetus. Carbamazepine showed low teratogenic effects in animal studies. In pregnancy, it is recommended to monitor the concentration of carbamazepine in the blood (therapeutic range 3-12 mg / l = 13-50 μmol / l). Carbamazepine is excreted in breast milk. In order to slow the withdrawal of the drug from the body of the newborn, breast-feeding should be gradually reduced. Carbamazepine penetrating into breast milk may cause the baby to have difficulty sucking.

Very common: leukopenia, dizziness, ataxia, drowsiness, fatigue, nausea, vomiting, increased GGT activity (due to induction of hepatic enzymes, usually without clinical significance), allergic dermatitis, urticaria (can be significantly increased). Common: thrombocytopenia, eosinophilia, edema, fluid retention, weight gain, hyponatremia and decreased plasma osmolarity due to antidiuretic hormone-like effects (in rare cases leading to water intoxication with coma: coma, vomiting, headache, confusion and neurological disorders) ), headache, diplopia, accommodation disorders (eg blurred vision), dry mouth, increased ALP activity. Uncommon: abnormal movements (eg tremor, tremor, dystonia, tics), nystagmus, diarrhea, constipation, increased transaminase, exfoliative dermatitis and erythroderma. Rare: leukocytosis, generalized lymphadenopathy, folic acid deficiency, delayed multi-organ hypersensitivity reaction (including: fever, rash, vasculitis, generalized enlargement of lymph nodes, lymphoma, joint pain, leukopenia, eosinophilia, hepatomegaly and impaired test results) liver function, side effects may also affect other organs, e.g.liver, lungs, kidneys, pancreas, myocardium, colon), hallucinations (visual and auditory), depression, anorexia, anxiety, aggressive behavior, agitation, confusion, facial muscle dyskinesia, oculomotor disorders, speech disorders (eg dysarthria, blurred talking), choreoathetosis, peripheral neuritis, paresthesia, muscle weakness, paresis, myocardial disturbances, hypotension or hypertension, abdominal pain, cholestatic, parenchymatous (hepatocellular) hepatitis or mixed forms of hepatitis, jaundice, systemic lupus erythematosus, pruritus . Very rare: agranulocytosis, plastic anemia, pancytopenia, pure red cell aplasia, acute porphyria, mixed porphyria, late porphyria, reticulocytosis, haemolytic anemia, aseptic meningitis with clonic seizures, peripheral eosinophilia, anaphylactic reactions, angioneurotic edema, elevation prolactin with or without gynecomastia, or abnormal thyroid function tests (reduction of L-thyroxine - FT4, T4, T3 and increase in TSH, usually without clinical symptoms), disturbances of bone metabolism (decrease cholecaliphene in the blood, may lead to osteomalacia), increase in cholesterol (including HDL cholesterol and triglycerides), psychosis activation, taste disorders, neuroleptic malignant syndrome, lens opacities, conjunctivitis, increased blood pressure and intraocular, hearing disorders, e.g. tinnitus, hyperaesthesia, hearing loss, change in tonal sensation, bradycardia, arrhythmias, atrio-ventricular block with fainting, circulatory collapse, congestive heart failure, exacerbation of coronary heart disease, thrombophlebitis, disease thromboembolic (e.g. lung), pulmonary hypersensitivity (characterized by fever, dyspnea, infiltration or pneumonia), inflammation of the tongue, stomatitis, pancreatitis, granulomatous hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, erythema nodosum and multiforme, changes in skin pigmentation, purpura, acne, excessive sweating, hair loss (hirsutism is also observed, but the causal relationship is unclear), joint pain, muscle pain, muscle spasms, interstitial nephritis, renal failure, kidney dysfunction kidney (eg proteinuria, hematuria, oliguria, increased urea nitrogen, azotemia), frequent urination, urinary retention, sexual dysfunction, impotence, and spermatogenesis disorders (reduced sperm count and motility). There have been reports of cases of suicidal ideation and behavior during anti-epileptic therapy or shortly after discontinuation of treatment. There have been reports of a reduction in bone mineral density, osteopenia, osteoporosis and fractures in patients using carbamazepine in long-term therapy (the mechanism of action of carbamazepine affecting bone metabolism has not been established). 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.Anticonvulsant therapy. When introducing carbamazepine, it is advisable to gradually reduce the doses of previously administered anticonvulsants.Adults and children> 10 yo: initially 150 mg twice daily, then the dose is slowly increased until the optimal dose is reached; it is recommended to increase the evening dose. The maintenance dose is 600 mg per day. If the medicine is taken once a day, take it in the evening.Children 6-10 yrs.: 15-20 mg / kg per day; 150 or 300 mg 2 times a day (in the morning and in the evening).Manic syndrome and prevention of manic depressive disorders (bipolar disorder): usually 300-1500 mg per day; most often 600 mg daily in 2 divided doses. In the treatment of acute mania, the dose should be increased at a rapid rate, while in the prophylaxis of bipolar disorder, the dose should be increased gradually.Trigeminal neuralgia: initially 300 mg once a day, then slowly increasing the dose until the pain subsides.Later, the minimum effective dose should be set, gradually reducing the therapeutic dose. The usual daily dose is 600 mg.Alcoholic abstinence syndrome: usually 600 mg per day; in severe cases, 1200 mg can be given per day for the first few days of treatment.Special groups of patients. In patients with renal insufficiency (GRF <10 ml / min) and in dialysis patients, 75% of the usual dose should be administered. 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.Method of administration. The tablets should be swallowed with liquid, during or after a meal. Tablets may be divided without loss of sustained release properties. They can also be dissolved in various liquids (1 cup of water, tea, milk or fruit juice in addition to grapefruit juice); drink the solution immediately after preparation.