Tradename:

Tegretol SR

Tegretol SR

Composition:

Each tablet contains:

Carbamazepine 200 mg

Auxiliary components:

colloidal silicon dioxide (aerosil), potato starch, povidone K30, polysorbate 80, talc, magnesium stearate.

Properties:

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

The mechanism of action is associated with the blockade of potential-dependent Na+ –

channels, which leads to stabilization of the neuronal membrane, inhibition of the occurrence of serial neuronal discharges and a decrease in synaptic impulse conduction. Prevents the re-formation of Na + -dependent action potentials in depolarized neurons. Reduces the release of the excitatory neurotransmitter amino acid glutamate, increases a reduced seizure threshold, etc. reduces the risk of developing an epileptic seizure. Increases conductivity for K +, modulates voltage-gated Ca2 + -channels, which can also cause the anticonvulsant effect of the drug. Corrects epileptic personality changes and, ultimately, increases the communication skills of patients, contributes to their social rehabilitation. It can be prescribed as the main therapeutic drug and in combination with other anticonvulsant drugs. Effective for focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types (usually ineffective for small seizures – petit mal, absences and myoclonic seizures) .

Indications:

Epilepsy (excluding absences, myoclonic or

flaccid seizures) – partial seizures with complex and simple symptoms, primary and secondary generalized forms of seizures with tonic-clonic seizures, mixed forms of seizures (monotherapy or in combination with other anticonvulsants); idiopathic trigeminal neuralgia, trigeminal neuralgia in 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 affective disorders (manic-depressive psychosis, schizoaffective disorders, etc.).

Method of administration and dosage:

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

Epilepsy. Whenever possible, carbamazepine should be given as monotherapy. Treatment begins with a small daily dose, which is then slowly increased until the optimal effect is achieved.

The addition of carbamazepine to antiepile therapy already in progress should be carrie out gradually, while the doses of the drugs

used are not changed or, if necessary, adjusted.

For adults, the starting dose is 100-200 mg 12 times a day. Then the dose is slowly increased until the optimal therapeutic effect is achieved (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 over 3 years old – at an initial dose of 100 mg / day, the dose is increased gradually, every week by 100 mg. Maintenance doses: 10-20 mg / kg per day. (in several doses): for 4-5 years old – 200-400 mg (in 1-2 doses), 6-10 years old – 400-600 mg (in 2-3 doses), for 11-15 years old – 600-1000 mg (23 divided doses).

Contraindications:

Hypersensitivity to carbamazepine and chemically similar drugs (tricyclic antidepressants) or to any other componen the drug, acute intermittent porphyria (including a history), concomitant use of monoamine oxidase inhibitors (hereinafter MAO inhibitors) and within 2 weeks after them withdrawal, violation of bone marrow hematopoiesis, atrioventricular block, pregnancy and lactation.

Carefully. Hyponatremia of dilution, old age, alcohol intake, inhibition of bone marrow hematopoiesis while taking medications

(history); hyperplasia of the prostate, increased intraocular pressure, severe heart failure, liver failure, chronic renal failure.

Precautions:

Before starting treatment, it is necessary to conduct a general blood test (including counting platelets, reticulocytes), 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 weekly during the first month of treatment, and then monthly. When prescribed to patients with increased intraocular pressure, its periodic monitoring is necessary. Non-progressive asymptomatic leukopenia does not require withdrawal, however, treatment should be discontinued progressive leukopenia or leukopenia appears, accompanied by clinical symptoms of an infectious disease.

Side effects:

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

From the mental sphere: hallucinations, depression, loss of appetite, anxiety, aggressive behavior, agitation, disorientation, activation of psychosis. Allergic reactions: urticaria, exfoliative dermatitis, erythroderma.

From the side of hematopoiesis: leukopenia, thrombocytopenia, eosinophilia, leukocytosis, lymphadenopathy; agranulocytosis, aplastic anemia, true erythrocytic aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia.

From the digestive system (hereinafter refe to as the gastrointestinal tract): nausea, vomiting, dr mouth, diarrhea or constioation. abdominal pain, glossitis, stomatitis, pancreatitis.

From the liver: increased activity of gammaglutamyltransferase (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 musculoskeletal system: arthralgia, myalgia or convulsions.

From the senses: disturbances in taste, lens opacity, conjunctivitis; hyper- or hypoacusia, changes in pitch perception.

Others: skin pigmentation disorders, purpura, acne, sweating, alopecia.

Storage method:

At a temperature not higher than 30 degrees. In a dry place.

Packaging:

The cardboard box contains 2 blisters of 10 tablets, paper instructions.