Epilepsy: complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization; generalized tonic-clonic seizures; mixed forms of seizures.
active substance: carbamazepine;
1 tablet contains carbamazepine 200 mg;
Excipients: microcrystalline cellulose, hypromellose E5, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
It is an antiepileptic medication. It has an anti-manic, normotimic (normalizing mood) effect. The active substance activates the inhibitory GABAergic system in the brain. It also blocks the voltage-dependent Na-channels of the membranes of nerve cells, which leads to the stabilization of their function, reduces the activity of neurotransmitter acids (aspartate, glutamate), interacts with brain adenosine receptors. Increases the seizure threshold, corrects epileptic personality changes.
- with epilepsy;
- with complex and simple partial convulsive seizures (with / without loss of consciousness, with / without signs of secondary generalization);
- with mixed forms of convulsive seizures;
- with generalized tonic-clonic seizures;
- in acute manic conditions;
- with alcohol withdrawal syndrome;
- with bipolar affective disorders;
- with idiopathic trigeminal neuralgia, trigeminal neuralgia in multiple sclerosis;
- with idiopathic neuralgia of the glossopharyngeal nerve.
- with intolerance to the components;
- in case of allergic reactions to tricyclic antidepressants in the past;
- with AV block;
- with inhibition of bone marrow function;
- with hepatic porphyria (acute intermittent, mixed, late porphyria of the skin), incl. in past;
- when treated with MAO inhibitors.
Due to the faster elimination of carbamazepine, children may need to use higher doses of the drug (per kilogram of body weight) compared to adults. The tablets can be taken by children over 5 years of age.
Application during pregnancy and lactation
Mezacar is contraindicated during these periods.
Method of application and dosage
Mezacar should be administered orally; usually the daily dose of the drug should be divided into two or three doses. The drug can be taken during, after a meal or in between meals with a small amount of liquid, such as a glass of water.
Treatment should begin with a low daily dose with a gradual increase in the dose of the drug, which should be adjusted to the needs of each patient.
To select the optimal dose of the drug may be useful to determine the level of carbamazepine in blood plasma.
Especially in the case of combination therapy, therapeutic doses should be calculated based on the determination of plasma carbamazepine levels and efficacy.
Experience has shown that therapeutic levels of carbamazepine are in the range of 4-12 μg / ml.
- Adults: the recommended initial dose of the drug is 100-200 mg 1-2 times a day. Then slowly increase the dose to achieve the optimal effect; often the daily dose is 400 mg twice or thrice a day (corresponding to 800-1200 mg). Some patients may require a dose of Mezacar of up to 1,600 mg or even 2,000 mg per day, although these high doses should be avoided due to the higher frequency of adverse events.
- Elderly patients: the dose of Mezacar should be carefully considered in elderly patients due to possible drug interactions. The recommended starting dose is 100 mg twice a day.
- Children: treatment can be started with 100 mg / day; increase the dose gradually – every week by 100 mg.
The usual dose of the drug is 10-20 mg / kg body weight per day (taken in several doses).
Age of the child in relation to the daily dose:
- 5-10 years – 400-600 mg (for 2-3 receptions);
- 10-15 years – 600-1000 mg (for 2-5 receptions);
- for children over 15 years of age dosage as in adults.
The following maximum daily doses are recommended for different ages:
- up to 6 years: 35 mg / kg / day
- 6-15 years: 1000 mg / day
- > 15 years: 1200 mg / day.
Symptoms: disorientation, drowsiness, decreased level of consciousness, agitation, blurred vision, hallucinations, coma, slurred speech, ataxia, dysarthria, nystagmus, dyskinesia, hyper / hyporeflexia, psychomotor disorders, convulsions, myoclonus, mydriasis, hypothermia, pulmonary depression , tachycardia, arterial hyper / hypotension, fainting, cardiac conduction disturbances, cardiac arrest, retention of food in the stomach, metabolic acidosis, rhabdomyolysis, urinary retention, oliguria / anuria, hyperhydration, fluid retention, hyponatremia, hyperglycemia, increased muscle CPK fraction.
Treatment: hospitalization, gastric lavage, use of sorbents, determination of the concentration of carbamazepine in the blood, supportive treatment, monitoring of heart function, correction of electrolyte disorders.
- Blood test changes: reticulocytosis, thrombocytopenia, leukopenia, eosinophilia, leukocytosis, lymphadenopathy, agranulocytosis, folic acid deficiency, aplastic anemia, erythrocytic aplasia, pancytopenia, anemia, porphyria, megaloblastic anemia, hemolytic anemia.
- Immune disorders: delayed-type hypersensitivity, skin rash, vasculitis, lymphadenopathy, hepatosplenomegaly, bile duct disappearance syndrome, aseptic meningitis with myoclonus, peripheral eosinophilia; angioneurotic edema, anaphylactic shock, hypogammaglobulinemia.
- Endocrine disorders: edema, weight gain, decreased plasma osmolarity, hyponatremia, hyperhydration (lethargy, vomiting, headache, confusion), increased prolactin levels (galactorrhea, bone metabolism disorders, gynecomastia).
- Metabolic disorders: decreased appetite, folate deficiency.
- Mental disorders: hallucinations, depression, anxiety, agitation, aggressiveness, confusion, activation of psychosis.
- Neurological disorders: dizziness, cephalalgia, ataxia, drowsiness, diplopia, blurred vision, involuntary movements (tremor, dystonia, fluttering tremor, tic), orofacial dyskinesia, nystagmus, eye movement disorders, dysarthria, slurred speech, peripheral neuropathy, chorerestoesthesia, chorerestoesthesia paresis, muscle weakness, impaired taste, aseptic meningitis.
- Visual disorders: disturbance of accommodation, glaucoma, clouding of the lens, conjunctivitis.
- Hearing disorders: hearing impairment, ringing in the ears, increased / decreased hearing sensitivity.
- Cardiovascular disorders: intracardiac conduction disorders, arterial hypotension / hypertension, bradycardia, arrhythmia, syncope, congestive heart failure, circulatory collapse, exacerbation of coronary artery disease, thromboembolism, thrombophlebitis.
- Respiratory disorders: shortness of breath, pneumonitis, pneumonia.
- Digestive disorders: nausea, dry mouth, diarrhea / constipation, stomatitis, abdominal pain, glossitis, pancreatitis, increased levels of gamma glutamyltransferase, alkaline phosphatase, transaminases, hepatitis, biliary tract disappearance syndrome, granulomatous hepatitis, jaundice, liver failure.
- Skin changes: allergic dermatitis, erythroderma, urticaria, exfoliative dermatitis, systemic lupus erythematosus, Stevens-Johnson syndrome, epidermal necrolysis, pruritus, photosensitivity, erythema nodosum or multiforme, purpura, acne, skin pigmentation disorders, increased hair loss, increased sweating …
- Musculoskeletal disorders: muscle weakness, arthralgia, muscle spasms.
- Genitourinary disorders: tubulointerstitial nephritis, kidney failure, renal dysfunction (hematuria, albuminuria, oliguria, azotemia), urinary retention, frequent urination, impotence, spermatogenesis disorders, erectile dysfunction.
- General disorders: weakness.
Store at a temperature not exceeding 25 ° C.
Keep out of reach of children.