Sedalite tablets p / o 300mg, No. 50

Manic and hypomanic states of various origins, affective psychoses (manic-depressive, schizoaffective), alcoholism (affective disorders); migraine, Meniere's syndrome, sexual disorders, drug dependence (some forms).

Inside (for 3-4 doses, the last time - before bedtime), after meals, the initial dose is 0.6-0.9 g / day, followed by an increase to 1.2 g / day, then the dose is increased daily by 0.3 g until a daily dose of 1.5-2.1 g is reached; the maximum daily dose is 2.4 g. During the selection of therapy, the concentration of Li + ions in the plasma should be at least 0.6 and not higher than 1.2-1.6 mmol / l. In doses exceeding 2 g / day, the duration of treatment is 1-2 weeks.
After the disappearance of manic symptoms, the daily dose is gradually reduced to a prophylactic dose (0.6-1.2 g). If, after reducing the dose, signs of mania reappear, the dose is increased.
In an acute manic state, the therapeutic concentration of Li + ions in the blood should be 0.8-1.2 mmol / l, with maintenance treatment - 0.4-0.8 mmol / l; if the concentration of Li + ions exceeds 1.2 mmol / l, the daily dose should be reduced.
A positive result of prophylactic monotherapy is manifested when maintaining a stable blood concentration in adults in the range of 0.4-0.8 mmol / l for at least 6 months, for children - at a dose that allows maintaining therapeutic concentrations in the range of 0.5-1 mmol / l.

Active substance :
lithium carbonate 300 mg.
Excipients :
Core : potato starch, talc, calcium stearate
Sheath : hypromellose (hydroxypropyl methylcellulose), medium molecular weight povidone (medium molecular weight polyvinylpyrrolidone), polysorbate (tween-80), titanium dioxide, talc, tropeolin

Hypersensitivity, severe surgery, leukemia, pregnancy, lactation.

With care
Diseases of the cardiovascular system (including atrioventricular and intraventricular blockade), diseases of the central nervous system (epilepsy, parkinsonism), diabetes mellitus, thyrotoxicosis, hyperparathyroidism, infections, psoriasis, renal failure, urinary retention, impaired water and electrolyte exchange (dehydration - simultaneous treatment with diuretics, salt-free diet, retention of Na + ions, vomiting, diarrhea).

Trade name of the drug:

SedaliteЃ

International non-proprietary name:

Lithium carbonate

Dosage form:

film-coated tablets

Composition

Active substance :
lithium carbonate 300 mg.
Excipients :
Core : potato starch, talc, calcium stearate
Sheath : hypromellose (hydroxypropyl methylcellulose), medium molecular weight povidone (medium molecular weight polyvinylpyrrolidone), polysorbate (tween-80), titanium dioxide, talc, tropeolin

Description Round, biconvex, yellow film-coated tablets.

Pharmacotherapeutic group

Normotimic agent.

ATX code: N05AN01

Pharmacological properties

Pharmacodynamics
Normotimic agent (normalizes mental state without causing general inhibition), also has antidepressant, sedative and antimanic effects. The effect is due to lithium ions (Li +), which, being antagonists of sodium ions (Na +), displace them from cells and, thereby, reduce the bioelectric activity of brain neurons. Accelerates the breakdown of biogenic amines (the content of norepinephrine and serotonin in the brain tissues decreases). Increases the sensitivity of neurons in the hippocampus and other areas of the brain to the action of dopamine. Interacts with lipids formed during the metabolism of inositol.
In therapeutic concentrations, it blocks the activity of inosyl-1-phosphatase and reduces the concentration of neuronal inositol, which plays a role in the regulation of neuronal sensitivity.
The beneficial effect of lithium preparations for migraine headaches may be associated with changes in serotonin concentrations; in depression - with an increase in serotonergic activity and a decrease in the regulation of the function of beta-adrenergic receptors.

Pharmacokinetics
Absorption is fast and complete within 6-8 hours. It does not bind to blood proteins. The therapeutic range of blood concentrations is from 0.6 to 1.2 mmol / L. The time to reach the maximum concentration in the blood (Cmax) is 1-3 hours. Stable serum concentration is achieved after 4 days. The drug crosses the blood-brain barrier (BBB) ??(concentrations in the cerebrospinal fluid are half the level in plasma), the placental barrier, and penetrates into breast milk. Biotransformation is not exposed. The half-life (T?) In adults - 24 hours, in adolescents - 18 hours, in the elderly - up to 36 hours. The values ??of T? depend on the amount of Na + ions in plasma. It is excreted by the kidneys - 95%, with feces - less than 1%, with sweat - 4-5%. Excretion by the kidneys depends on the ratios of the concentrations of Li +, Na + and K + ions in the blood.

Indications for use

Manic and hypomanic states of various origins, affective psychoses (manic-depressive, schizoaffective), alcoholism (affective disorders); migraine, Meniere's syndrome, sexual disorders, drug dependence (some forms).

Contraindications

Hypersensitivity, severe surgery, leukemia, pregnancy, lactation.

With care
Diseases of the cardiovascular system (including atrioventricular and intraventricular blockade), diseases of the central nervous system (epilepsy, parkinsonism), diabetes mellitus, thyrotoxicosis, hyperparathyroidism, infections, psoriasis, renal failure, urinary retention, impaired water and electrolyte exchange (dehydration - simultaneous treatment with diuretics, salt-free diet, retention of Na + ions, vomiting, diarrhea).

Method of administration and dosage

Inside (for 3-4 doses, the last time - before bedtime), after meals, the initial dose is 0.6-0.9 g / day, followed by an increase to 1.2 g / day, then the dose is increased daily by 0.3 g until a daily dose of 1.5-2.1 g is reached; the maximum daily dose is 2.4 g. During the selection of therapy, the concentration of Li + ions in the plasma should be at least 0.6 and not higher than 1.2-1.6 mmol / l. In doses exceeding 2 g / day, the duration of treatment is 1-2 weeks.
After the disappearance of manic symptoms, the daily dose is gradually reduced to a prophylactic dose (0.6-1.2 g). If, after reducing the dose, signs of mania reappear, the dose is increased.
In an acute manic state, the therapeutic concentration of Li + ions in the blood should be 0.8-1.2 mmol / l, with maintenance treatment - 0.4-0.8 mmol / l; if the concentration of Li + ions exceeds 1.2 mmol / l, the daily dose should be reduced.
A positive result of prophylactic monotherapy is manifested when maintaining a stable blood concentration in adults in the range of 0.4-0.8 mmol / l for at least 6 months, for children - at a dose that allows maintaining therapeutic concentrations in the range of 0.5-1 mmol / l.

Side effect
Dyspepsia, discomfort, myasthenia gravis, hand tremor, weakness, drowsiness, increased thirst, arrhythmias, inhibition of hematopoiesis, hypothyroidism, leukocytosis, increased body weight.
With prolonged use - impaired concentration of the kidneys, dysarthria, hyperreflexia, decreased urine output, collapse, coma.

Overdose

Symptoms: early - diarrhea, drowsiness, loss of appetite, muscle weakness, nausea, vomiting, dysarthria, tremor; later - dizziness, blurred vision, impaired coordination of movement, polyuria, confusion, severe convulsions. Treatment: as a first aid, it is advisable to introduce a large amount of liquid and sodium chloride (sodium ions Na +) inside; in severe cases, inpatient treatment is required.

Interaction with other medicinal products
Lithium preparations reduce the pressor effect of norepinephrine, as well as the mineral-corticosteroid effect of fludrocortisone, enhance the neurotoxic effects of haloperidol; reduce the absorption of phenothiazines in the gastrointestinal tract, which leads to a decrease in their concentration in the blood by 40%; reduce the antidiuretic effect of carbamazepine, desmopressin, lipressin, hormones of the posterior lobe of the pituitary gland (antidiuretic hormone); increase the risk of hypothyroidism when combined with calcium iodide, iodinated glycerin, potassium iodide; enhance the muscle relaxant effect of atracurium, pancuronium, ditilin; reduce the central stimulating effect of amphetamines.
Preparations containing sodium ions Na + or food products reduce the effectiveness of Li + preparations.
Urea, aminophylline, caffeine, difyllin, choline theophyllinate, theophylline increase the excretion of Li + ions by the kidneys and reduce its pharmacological effect.
Metronidazole, fluoxetine, diuretics, non-narcotic anti-inflammatory drugs (NSAIDs), angiotensin-converting enzyme inhibitors - slow down the excretion of Li + ions by the kidneys and increase its toxic effects.
Molindone stimulates the development of neurotoxicity (confusion, delirium, epileptic seizures, somnambulism or pathological changes in the electroencephalogram); methyldopa increases the risk of developing toxicity of Li + preparations even at normal plasma concentrations; blockers of 'slow' calcium channels (BMCC) increase the incidence of neurotoxic complications (ataxia, tremor, nausea, vomiting, diarrhea, tinnitus).
When combined with antipsychotics, thymoleptics, neuroleptics, an increase in body weight is possible. Incompatible with ethanol containing beverages.

special instructions

During the first month of therapy, the concentration of Li + ions in the plasma is determined weekly, then, upon reaching a stable concentration, the control is carried out monthly, then at 2-3 months. Blood samples are always taken in the morning, i.e. 12 hours after taking the last dose at night or 24 hours after taking a single dose in the morning.
At the beginning of treatment, it can provoke depression or mania.

Influence on the ability to drive vehicles and mechanisms
During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

On 10 tablets in a blister strip packaging from PVC film and printed aluminum foil varnished.
5 blister packs, together with the instructions, are placed in a carton box.

Shelf life

3 years.
Do not use the drug after the expiration date.

Storage conditions

Store at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Vacation conditions

Prescribed by a doctor.