Indications for use
- epilepsy: complex or simple partial epileptic seizures (with or without loss of consciousness) with or without secondary generalization; generalized tonic-clonic epileptic seizures; mixed forms of epileptic seizures (carbamazepine can be used both as monotherapy and as part of combination therapy; carbamazepine is usually ineffective in small seizures /petit mal, absans/ and myoclonic seizures;- acute manic states and maintenance therapy of bipolar affective disorder to prevent exacerbations or reduce clinical manifestations of exacerbation;
- alcohol withdrawal syndrome;
- idiopathic trigeminal neuralgia and trigeminal neuralgia in multiple sclerosis (typical and atypical); idiopathic lingual neuralgia;
- diabetic neuropathy with pain syndrome;
- non-sugar diabetes of central genesis; polyuria and polydipsia of neurohormonal nature.
Information on proper use
How to use and dosage
Oral tablets.
Carbamazepine-NIKA can be used both as monotherapy and as part of combination therapy.
The drug can be taken during, after meals or between meals together with a small amount of liquid.
Adults.
Epilepsy
The dose is selected individually. The plasma concentration of carbamazepine can be monitored to determine the optimal dose.
The therapeutic plasma concentration of carbamazepine is 4-12 µg/mL (17-50 µmol/g).
When adding carbamazepine to other antiepileptic drugs taken, the dose of carbamazepine is increased gradually. If necessary, appropriate correction of doses of the drugs taken is carried out. For adults, the initial dose is 100-200 mg 1-2 times a day. Then the dose is slowly increased until the optimal therapeutic effect is achieved; it is usually achieved at a dose of 400 mg 2-3 times a day. The maximum daily dose is 1600-2000 mg.
In elderly patients it is recommended to start treatment with a low dose, although there is no reason to believe that doses for this category of patients may differ from the above.
In trigeminal neuralgia, the recommended initial dose is 200-400 mg per day. The dose can be gradually increased until a satisfactory clinical effect is obtained, in some cases it can be 1600 mg per day. After the pain syndrome enters the remission stage, the dose can be gradually reduced.
Alcohol withdrawal syndrome
The average dose is 200 mg 3 times a day. In severe cases during the first few days, the dose can be increased (e.g., a dose of 400 mg 3 times a day).
In severe manifestations of alcohol withdrawal, treatment is started with carbamazepine in combination with sedative and sedative drugs (e.g., clomethiazole, chlordiazepoxide). After resolution of the acute phase, treatment with carbamazepine may be continued as monotherapy.
Non-diabetes of central genesis
The average dose for adults is 200 mg 2-3 times a day. In children, the dose of the drug should be reduced according to the age and body weight of the child.
Diabetic neuropathy with pain syndrome
The average dose of carbamazepine is 200 mg 2-4 times a day.
Acute manic states 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). In acute manic state, the dose of carbamazepine should be increased rather quickly. In case of maintenance therapy of bipolar disorders, in order to ensure optimal tolerability, it is recommended to gradually increase the dose by a small amount.
Use in children
The main indication for the use of carbamazepine in children is epilepsy. This dosage form of the drug should be used for the treatment of the same forms of epilepsy in children over 3 years of age as in adults.
Treatment can be started with a dose of 100 mg per day; the dose is increased gradually, not more than 100 mg per week. Maintenance doses for children are set at the rate of 10-20 mg/kg body weight per day (in several receptions):
-from 3 to 5 years - 200-400 mg (in 1-2 receptions),
-from 6 to 10 years - 400-600 mg (in 2-3 receptions),
- from 11 to 15 years - 600-1000 mg (in 2-3 doses),
-in adolescents over 15 years of age, adult doses are used.
Maximum daily dose for children:
-under 6 years - 35 mg/kg,
- from 6 to 15 years - 1000 mg,
- in adolescents over 15 years of age - 1200 mg.
Since the recommended initial dose for children aged 3 years and younger is 20-60 mg per day with a gradual increase by 20-60 mg/day every other day, it is advisable to take carbamazepine in the form of other dosage forms (suspension).
Discontinuation of the drug
Sudden discontinuation of the drug may provoke epileptic seizures. If it is necessary to discontinue the drug in an epileptic patient, switching to another antiepileptic drug should be done under the cover of a drug indicated in such cases (e.g. diazepam given intravenously or rectally, or phenytoin given intravenously).
Changes have been made to the instructions for use. The updated instructions are available above in PDF format.
