Sedalit, 300 mg 50 pcs.

Sedalit is a normothetic drug (normalizes the mental state without causing general lethargy).

Sedalite also has antidepressant, sedative and antimanic effects. The effect is due to the lithium ions, which, being antagonists of sodium ions, displace them from the cells and thus reduce the bioelectrical activity of brain neurons.

Accelerates the breakdown of biogenic amines (decreases the concentration of norepinephrine and serotonin in brain tissue).

Sedalite increases the sensitivity of neurons of the hippocampus and other areas of the brain to the action of dopamine. It interacts with lipids formed during inositol metabolism.

Pharmacokinetics

When taken orally it is absorbed from the gastrointestinal tract. Cmax of the active substance in plasma is reached after approximately 9 hours.

It does not bind with plasma proteins.

It penetrates the placental barrier, is excreted with breast milk. It is not metabolized.

It is excreted by the kidneys – 95%, with the feces – less than 1%, with perspiration – 4-5%.

Indications

Active ingredient

Composition

1 film-coated tablet contains:

the active ingredient:

lithium carbonate 300 mg

How to take, the dosage

Ingestion (3 to 4 doses, the last before bedtime), after meals, the initial dose – 0.6 – 0.9 g/day with subsequent increase to 1.2 g/day, then the dose is increased daily by 0.3 until a daily dose of 1.5 – 2.1 mg; the maximum daily dose – 2.4 g. During therapy selection, plasma Li+ ion concentrations should not be less than 0.6 and not more than 1.2 -1.6 mmol/L. In doses exceeding 2 g/day the treatment duration is 1 – 2 weeks.
After manic symptoms have disappeared, daily dose is gradually reduced to a prophylactic dose (0.6 – 1.2 g). If after the dose reduction signs of mania reappear, the dose is increased.

In acute manic condition the therapeutic concentration of Li+ ions in blood should be 0.8 – 1.2 mmol/l, in maintenance treatment – 0.4 – 0.8 mmol/l; if Li+ ion concentration exceeds 1.2 mmol/l, the daily dose should be reduced.
Positive results of prophylactic monotherapy are observed when a stable blood concentration in adults is maintained within 0.4 – 0.8 mmol/l for at least 6 months, in children – at a dose that allows maintenance of therapeutic concentrations within 0.5 – 1 mmol/l.

Interaction

Co-administration with thiazide diuretics, indapamide may rapidly increase the concentration of lithium in the blood plasma and the development of toxic effects.

Concomitant use with ACE inhibitors may increase plasma lithium concentration and development of toxic effects; with NSAIDs – possible increase of lithium toxic effects; with iodine preparations – possible increase of risk of thyroid function disorders; with xanthine derivatives – possible increase of lithium excretion in urine, which may lead to decrease of its effectiveness.

Concomitant use with alprazolam may result in a clinically significant increase in plasma lithium concentration; with acyclovir – there has been a case of increased toxic effects of lithium; with baclofen – there have been described cases of increased hyperkinetic symptoms in patients with Huntington’s chorea.

In concomitant use of lithium carbonate with verapamil drug interaction has an unpredictable character. When concomitant use of lithium carbonate with diltiazem, a case of psychosis has been described.

Concomitant use with haloperidol may increase extrapyramidal symptoms; with carbamazepine, clonazepam – possible development of neurotoxicity.

Concomitant use with methyldopa may cause lithium toxicity; with metronidazole – possible increase in plasma lithium concentration.

In concomitant use with sodium chloride, sodium bicarbonate, high sodium intake increases the excretion of lithium, which may lead to a decrease in its effectiveness.

Concomitant use with norepinephrine may decrease the vasoconstrictive effect of norepinephrine; with phenytoin – there are described cases of development of symptoms of toxic effects of lithium; with fluoxetine – there may be increased concentration of lithium in blood plasma and development of toxic effects; with furosemide, bumetanide there are described cases of increased toxic effects of lithium.

In concomitant use with chlorpromazine and other phenothiazines decreases absorption of phenothiazines from gastrointestinal tract and decreases their concentration in plasma by 40%, increases intracellular concentration of lithium and urinary excretion rate, increases the risk of extrapyramidal reactions, delirium, cerebellar dysfunction (especially in elderly patients).

Special Instructions

With caution use in cardiovascular diseases (including AV-blockade, intraventricular blockade), CNS diseases (including epilepsy, parkinsonism, organic lesions, schizophrenia), severe dehydration, infectious diseases, urinary retention, renal failure, as well as diabetes, hyperparathyroidism, thyrotoxicosis, psoriasis, in weakened patients and in hyponatremia of any etiology.

The dosing regimen needs to be adjusted in elderly and debilitated patients.

Nausea and vomiting, as early signs of lithium toxicity, may be masked by the antiemetic effect of some phenothiazines.
During the first month of therapy, plasma lithium concentration should be monitored weekly. When stable concentrations are achieved, control is carried out monthly, then once every 2-3 months.

Do not drink alcohol during treatment.

Drug forms of prolonged action should not be used in children under 12 years of age, do not alternate with other dosage forms.

Impact on driving and operating machinery

Period of treatment, caution should be exercised when driving motor vehicles and engaging in other potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Contraindications

Hypersensitivity to lithium and other drug components; major surgical interventions; leukemia; pregnancy, breastfeeding; children under 12 years of age (effectiveness and safety of use not established); cardiovascular diseases associated with heart rhythm disturbances; Family history of Brugada syndrome; severe renal impairment; untreated or uncompensated hypothyroidism; low sodium levels, e.g., in patients with dehydration, patients on a salt-free diet, or patients with Addison’s disease.

With caution
Cardiovascular disease (including atrial-ventricular and intraventricular block), CNS disorders (epilepsy, parkinsonism), diabetes, thyrotoxicosis, hyperparathyroidism, infections, psoriasis, renal failure, urinary retention.

Side effects

CNS and peripheral nervous system disorders: muscle weakness, hand tremors, adynamia, somnolence, articulation disorders, hyperreflexia are possible with long-term use.

Cardiovascular system: disorders of cardiac rhythm.

Digestive system disorders: dyspepsia.

Endocrine system: rarely – thyroid disorders.

Others: increased thirst, disorders of hematopoiesis, leukocytosis, weight gain.