COMPOSITION

Each tablet contains carbamazepine 200 mg.

THERAPEUTIC INDICATIONS

- Epilepsy: partial attacks with a complex symptomatology (psychomotor attacks, partial attacks with an elementary symptomatology (focal epilepsy); major epilepsy, primarily of focal genesis (major epilepsy during sleep, diffuse major epilepsy); mixed forms of epilepsy;
- Prevention of the development of convulsive attacks in abstinence alcoholic syndrome (apply in a hospital);
- Trigeminal neuralgia, facial muscles spasms in trigeminal neuralgia;
- Glossopharyngeal neuralgia;
- Pain syndrome in diabetic neuropathy;
- Epileptiform convulsions in disseminated sclerosis, tonic convulsions, paroxysmal dysarthria and ataxia, paroxysmal paresthesia and attacks of pain;
- Psychosis (mainly in manic-depressive states, hypochondriac depression); secondary prophylaxis of affective and schizo-affective psychosis;
- Diabetes insipidus of central genesis, polyuria and polydipsia of neurohormonal nature.

CONTRAINDICATIONS

- Hypersensitization to carbamazepine or tricyclic antidepressants or other drug compounds;
- Disorder of bone marrow hematosis (anemia, leukopenia), acute intermittent porphyria (including in a past history);
- Atrioventricular heart block;
- Co-administration with monoamine oxidase inhibitor (MOI) (structural similarity with tricyclic antidepressants). Before Melepsin administration MOI should be withdrawn at the least prior 2 weeks or even more to their application;
- Co-administration with lithium preparations;
- Hyponatremia (hypersecretory syndrome of ADH, hypopituitarism, hypothyroidism, adrenocortical insufficiency);
Melepsin is also contraindicated for elderly patients with hepatic insufficiency, chronic renal impairment, prostatic hypertrophy, increased intraocular pressure and for patients with a n active form of alcoholism (inhibition of CNS and carbamazepine metabolism is increased).

ADVERSE EFFECTS

Very often – dizziness, ataxia, somnolence, asthenia; seldom – hallucinations (visual and auditory), depression, loss of appetite, anxiety, aggressive behavior, excitation, disorientation. Allergic reactions. Effects from hemopoietic organ: very often – leucopenia. Effects from GIT: very often – nausea, vomiting; often – dry mouth; sometimes diarrhea or constipation, abdominal pains. Other: abnormalities of skin pigmentation, purpura, acne, hyperhidrosis, alopecia.

DOSAGE AND ADMINISTRATION

Orally.
In epilepsy:
For adults and adolescents of 15 and older: orally 200-400 mg as the initial daily dose; then taking into consideration the clinical effect the dose is gradually increased not more than 200 mg/daily with one week interval up to the maintaining dose of 800-1200 mg/daily. The frequency of application is 1-4 times/daily.
For children at the age of 4 and younger the treatment is recommended to initiate from 20-60 mg/daily and increase the dose for 20-60 mg daily.
For children elder 4 the treatment is recommended to initiate from 100 mg/daily; the dose is increased gradually – every week for 100 mg.

The maintaining doses: 10-20 mg/kg daily (in several intakes):
- For 4-5 years – 200-400 mg (in 1-2 intakes),
- 6-10 years – 400-600 mg (in 2-3 intakes),
- For 11-15 years – 600-1000 mg (in 2-3 intakes).
The maximum doses: orally for adults and adolescents of 15 and older – 1200 mg/daily;
for children – 1000 mg/daily.
Prevention of the development of convulsive attacks in abstinence alcoholic syndrome (apply in a hospital):
The average daily dose is 200 mg in the morning and 400 mg in the evening. In severe cases the daily dose may be increased up to 1200 mg. The treatment is discontinued by the gradual dose reduction within 7-10 days. During treatment a regular control of carbamazepine plasma level is required.
Trigeminal neuralgia and glossopharyngeal neuralgia:
The initial dose is 200-400 mg/daily. This dose is increased right up to the complete disappearance of pains to 400-800 mg/daily, divided into 1-2 intakes. After this the treatment may be continued with the maintaining dose of 400 mg/daily divided into 2 intakes.
Pain syndrome in diabetic neuropathy:
The average daily dose is 200 mg in the morning and 400 mg in the evening. In rare cases it may be prescribed up to 1200 mg/daily.

PREGNANCY AND LACTATION

The application during pregnancy is possible under the strict indications and doctor's control.
Melepsin is eliminated in the human milk; therefore the discontinuation of the breath-feeding is recommended or the close medical monitoring for a new-born.

MANUFACTURED FORM

Tablets for oral use 200 mg. 10 tablets are in PVC and aluminum foil blisters. 5 or 10 blisters with a leaflet are in a carton box.